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		<title>Patent and Trademark Office Publishes Final Rules for Derivation Proceedings</title>
		<link>http://smiplaw.wordpress.com/2012/10/03/patent-and-trademark-office-publishes-final-rules-for-derivation-proceedings/</link>
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		<pubDate>Wed, 03 Oct 2012 13:31:53 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Stein McEwen News]]></category>

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		<description><![CDATA[By Charles Pierce On September 10, The Patent and Trademark Office published finals rules designed to ensure that a person applying for a patent is the true inventor through a new trial proceeding, the derivation proceeding.  An applicant who is &#8230; <a href="http://smiplaw.wordpress.com/2012/10/03/patent-and-trademark-office-publishes-final-rules-for-derivation-proceedings/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1545&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p style="text-align:left;" align="center"><strong>By Charles Pierce</strong></p>
<p>On September 10, The Patent and Trademark Office published finals rules designed to ensure that a person applying for a patent is the true inventor through a new trial proceeding, the derivation proceeding.  An applicant who is not first to file (the petitioner) will be able to petition for a derivation proceeding and attempt to show that  another applicant’s (the respondent) claimed invention was derived from the petitioner’s invention.  Derivation proceedings will take place before the Patent Trial and Appeal Board.</p>
<p>The petition must show by substantial evidence that the petitioner’s application has at least one claim which is the same or substantially similar to the respondent’s claimed invention and demonstrate that the respondent’s claimed invention was derived from the petitioner’s invention.  The petitioner must also show, for each of his claims, why the respondent’s claimed invention is substantially similar, and identify how the claim should be construed.<sup>[1]  </sup>Such a petition must be filed within one year of the publication of the petitioner’s relevant claims.<sup>[2]</sup></p>
<p>These new rules will be codified in 37 C.F.R. Part 42, Subpart E, and will take effect on March 16, 2013.  The full text of the rules along with the PTO’s responses to comments may be found at <a href="http://www.uspto.gov/aia_implementation/Derivation_Proceedings.pdf">http://www.uspto.gov/aia_implementation/Derivation_Proceedings.pdf</a> or <a href="https://www.federalregister.gov/articles/2012/09/11/2012-22204/changes-to-implement-derivation-proceedings">77 Fed. Reg. 56067 (Sept. 11, 2012)</a>.</p>
<p>[1] Changes to Implement Derivation Proceedings, 77 Fed. Reg. 56067, 56091 (Sept. 11, 2012) (to be codified at 47 C.F.R. Part 42).<br />
[2] <em>Id</em>.</p>
<br />Filed under: <a href='http://smiplaw.wordpress.com/category/stein-mcewen-news/'>Stein McEwen News</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1545/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1545/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1545&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Update on Implementation of American Invents Act Effective As of September 16, 2012</title>
		<link>http://smiplaw.wordpress.com/2012/09/13/update-on-implimentation-of-american-invents-act-effective-as-of-september-16-2012/</link>
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		<pubDate>Thu, 13 Sep 2012 12:33:16 +0000</pubDate>
		<dc:creator>SteinMcewen, LLP</dc:creator>
				<category><![CDATA[Feature Comments]]></category>
		<category><![CDATA[Patent Reform]]></category>
		<category><![CDATA[USPTO Practice]]></category>

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		<description><![CDATA[By Dennis Clarke and James McEwen On September 16, 2011, the “Leahy-Smith America Invents Act” (AIA) was signed into law. The AIA makes the most substantial changes in U.S. patent law in decades and sets various dates on which these &#8230; <a href="http://smiplaw.wordpress.com/2012/09/13/update-on-implimentation-of-american-invents-act-effective-as-of-september-16-2012/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1548&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p>By <a href="http://www.smiplaw.com/pro_clarke.cfm" target="_blank">Dennis Clarke </a>and <a href="http://www.smiplaw.com/pro_mcewen.cfm" target="_blank">James McEwen</a></p>
<p>On September 16, 2011, the “Leahy-Smith America Invents Act” (AIA) was signed into law. The AIA makes the most substantial changes in U.S. patent law in decades and sets various dates on which these changes are to take effect.</p>
<p>The most profound of those changes is the switch to a first-inventor-to-file system, in place of the current first-to-invent practice in the U.S. This change takes effect only for applications originally filed on or after March 16, 2013. However, on <strong>September 16. 2012</strong>, other major changes will take effect, including the possibility of requesting <em>inter partes</em> review and other post-grant trial procedures before the newly renamed “Patent Trial and Appeal BoarcL” This paper will predominantly relate to the new requirements relating to declarations and assignments and other miscellaneous provisions that have an effective date of September 16, 2012. The new trial proceedings are discussed briefly hereinbelow.</p>
<p><strong><span id="more-1548"></span>Applicability Date for Rules Relating to New Declarations</strong></p>
<p>The new rules concerning</p>
<p>(1) the inventor’s oath or declaration, and</p>
<p>(2) the ability of an assignee to file an application as applicant</p>
<p>apply only to patent applications filed under 35 USC § 111 or 363 on or after September 16, 2012.</p>
<p><strong>The new declaration rules do not apply to applications entering the U.S. national stage based on international applications filed before September 16, 2012. </strong>With regard to international applications, the new rules apply only to those international applications filed (i e., having an international filing date) on or after September 16, 2012.</p>
<p>In contrast, the rules <strong>do apply to any new continuations or divisional applications filed on or after September 16, 2012</strong>.  Any new continuation or divisional application filed on or after September 16, 2012, (including by-pass continuations of PCT applications filed in lieu of a national stage application) will require the new forms. For such continuations or divisionals, a copy of the old form may not be filed in the parent. If an application was filed before September 16, 2012, without a declaration and the requirement for filing the declaration comes due after September 16, 2012, the old declaration must be used, as the new requirements apply only if the application itself is filed on or after September 16, 2012.</p>
<p><strong>Note particularly that the wording of the old forms does not include some of the wording required for the new forms, so the use of an old declaration form in an application filed on or after September 16, 2012, will not be accepted by the USPTO</strong>. As some applications will continue to be governed by the old rules, it is important to maintain a supply of the old forms for use in those cases.</p>
<p><strong>Emphasis on Use of Applicant Data Sheets</strong></p>
<p>Previously, applicants could use Applicant Data Sheets (ADS) optionally and their benefit was relatively minimal.  However, for applications on or after September 16, 2012, an ADS is <strong>required</strong> when claiming any form of priority, including both claims to prior US applications and to prior foreign applications.  Therefore, except where the application is first filed in the United States, applicants must ensure that an ADS is used.</p>
<p>The USPTO has also provided an additional incentive to use the ADS: where an ADS is used, the oath or declaration can be submitted at any time prior to the Notice of Allowance, at which time it will be required to be submitted along with the surcharge normally assessed in a Notice of Missing Parts.  This is contrast with existing practice where examination cannot start until the oath or declaration is submitted. Therefore, the use of an ADS will provide an additional advantage and allow for applicants to file applications more rapidly.</p>
<p><strong>New Distinction Between “Applicant” and “Inventor”</strong></p>
<p>One important change in the law and regulations that goes into effect for applications filed on or after September 16, 2012, is the following: <strong>there is now a distinction between the “applicant” and the “inventor.”</strong> Whereas previously only the inventor could be the applicant in the U.S., now it is permissible for any of the following to file and prosecute the application: (1) the assignee, (2) one to whom the inventor is obligated to assign the invention, or (3) a party who has a “sufficient proprietary interest” in the invention. Nevertheless, regardless of who is designated the “applicant,” each of the inventors must still execute an oath or declaration.</p>
<p><strong>Use of a “Substitute Statement”</strong></p>
<p>While the inventors must sign a new oath or declaration form, the new rules provide that if an inventor is dead or legally incapacitated, cannot be found after diligent search, or refuses to sign, then a “Substitute Statement” can be signed by (1) the assignee or (2) one to whom the inventor is obligated to assign the invention or (3) another party who can prove that it has sufficient proprietary interest in the invention. It is no longer necessary to have heirs or executors sign in the case of a deceased inventor or to submit a detailed proof of facts (as previously required) in the case of an inventor who cannot be found after diligent effort or who refuses to sign. However, in the event that a Substitute Statement is filed, the facts and circumstances supporting the signor’s right to sign the statement should be collected and stored, in the event that the issue arises in an enforcement or validity lawsuit at a later date.</p>
<p><strong>Oath or Declaration of the Inventor</strong></p>
<p>The requirement to have an oath or declaration filed by each inventor can be satisfied by filing:</p>
<p>(1)    an oath or declaration by each inventor,</p>
<p>(2)    a Substitute Statement with respect to an inventor that is dead, legally incapacitated, cannot be found or refuses to sign, or</p>
<p>(3)    an assignment that contains the statements required for an oath or declaration by the inventor.</p>
<p>If the oath or declaration, Substitute Statement, or combined declaration/assignment is filed with an Application Data Sheet (ADS), it is not necessary for the above documents to identify all of the inventors, the post office address, residence and citizenship of the inventors, priority information, etc.  in the oath itself.</p>
<p>While it is no longer required that the declaration state that the person making the declaration acknowledges the duty of disclosure and has reviewed and understands the contents of the application, the regulations <em>still require</em> that the inventor be aware of the duty of disclosure and have reviewed and understood the contents of the application. <em><br />
</em></p>
<p><strong>Due Date for Filing Declarations</strong></p>
<p>The filing of the declaration may be postponed until the application is otherwise in condition for allowance, provided that a signed ADS has ben submitted. Thus, if the filing fee is paid at the time of filing, a Notice of Missing Parts will no longer be issued requiring the ffiing of a declaration, at least until such time that a Notice of Allowance is issued. Nevertheless, it is our recommendation that the declaration or other appropriate paper be <strong>filed as soon as possible</strong> after filing the application to avoid possible patent term adjustment and other ramifications.</p>
<p><strong>Requirements for Assignees and for Those with Appropriate Proprietary Interest in the Invention</strong></p>
<p>If the applicant is the assignee, it will be necessary to record the assignment from the inventors to that assignee in the Assignment Branch. If the applicant is “one to which the inventor is obligated to assign the invention,” <em>e.g</em>., as a result of an employment agreement, but no assignment has been obtained, it will be necessary to record in the Assignment Branch a copy of the employment agreement or other contract that obligates the inventor to assign the invention. If the applicant is one who has “a sufficient proprietary interest” in the invention, then it is necessary to file a petition and proof of pertinent facts supporting such “interest.” That petition will have to be granted before that applicant can control prosecution. Should such a situation arise, please advise and we will provide you with the details of what is required in order to prove such pertinent facts.</p>
<p><strong>PCT International Applications</strong></p>
<p>With respect to international applications, it is indicated above that the new rules will apply only to international applications filed internationally on or after September 16, 2012. The date the application enters the U.S. national stage is not relevant to whether the old or new law applies. When filing a new international application on or after September 16, 2012, <strong>you should bear in mind</strong> that it is no longer necessary to designate the inventors as “applicants for the U.S. only.” Because the new law and rules permit (1) the assignee or (2) another person to whom the inventor is under an obligation to assign the invention or (3) who otherwise shows sufficient proprietary interest in the matter to be named as the applicant, such a person can be the applicant for the purpose of the U.S. designation in the international application. This will alleviate many of the difficulties currently encountered as a result of this requirement, for example, of obtaining the signatures of all of the applicants/inventors in the case of withdrawals. Now, only the “applicant’s” signature will be required.</p>
<p>A declaration of inventorship may currently be submitted as part of the PCT application, as provided for in PCT Rule 4.1 7(iv), for example. However, until the PCT regulations are changed, it will not be possible to use this PCT declaration in any international application filed on. or after September 16, 2012. It is our understanding that WIPO is in the process of amending the rules to take into account the changes in the statute and regulations in the United States, but these will likely not go into effect until January 1, 2013.</p>
<p><strong>Post-Grant Trial Procedures</strong></p>
<p><strong>It is important to note that September 15, 2012, is the last date on which an applicant can ifie for inter partes reexamination under the old rules</strong>. The procedures for <em>inter partes</em> review, which will replace <em>inter partes</em> reexaminations as of September 16, 2012, will be quite different, as the review will be more like a trial that is heard by a tribunal of administrative patent judges rather than being considered by an examiner, Furthermore, it is expected that the attorney time and, therefore, the costs, will increase significantly for <em>inter partes</em> review under the new law, with the fee for filing an <em>inter partes</em> review petition being $27,200.00 (plus $600.00 for each claim over 20) while the current <em>inter partes</em> reexamination fee is $8,800.00.</p>
<p>Please also note that <em>inter partes</em> review will only be available for patents that have issued more than nine months prior to the date of filing of the request for <em>inter partes</em> review. It is otherwise applicable to all patents regardless of their issue date. Prior to September 16, 2012, <em>inter partes</em> reexamination had been available even for recently issued patents, but was not available for patents that issued prior to the effective date of the <em>inter partes</em> reexamination regulations.</p>
<p>The AIA barely changes the <em>ex parte</em> reexamination process. The major change is the significant jump in the fee for <em>ex parte</em> reexamination beginning on September 16, 2012: <strong>from $2,520.00 to $17,750.00.</strong></p>
<p>Except for “covered business methods,” the post grant review system (with its broad base of potential challenges) will only be available to challenge granted patents that are filed as applications after the March 16, 2013, date of changeover to the “first-inventor-to-file” system. Therefore, except for “covered business methods,” post grant review challenge will not be in effect for quite some time.</p>
<p>If you have any question about post-grant review, please let us know and we will provide more detailed explanations. Please understand that we have had very substantial experience in interference practice under the old Board practice and the new post-grant administrative trials will use very similar procedures as had been used in such interferences. Thus, we feel that we will be able to “hit the ground running” when these new procedures go into effect, and we look forward to serving your needs in such post-grant “trials.”</p>
<p><strong>Conclusion</strong></p>
<p>We stand ready to answer all of your questions and to provide all of the assistance needed to navigate the U.S. Patent practice under the AIA and implementing regulations.</p>
<br />Filed under: <a href='http://smiplaw.wordpress.com/category/feature-comments/'>Feature Comments</a>, <a href='http://smiplaw.wordpress.com/category/feature-comments/patent-reform/'>Patent Reform</a>, <a href='http://smiplaw.wordpress.com/category/feature-comments/uspto-practice/'>USPTO Practice</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1548/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1548/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1548&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness</title>
		<link>http://smiplaw.wordpress.com/2012/09/07/in-re-hyon-substantial-evidence-standard-helps-preserve-finding-of-obviousness/</link>
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		<pubDate>Fri, 07 Sep 2012 12:21:38 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Invalidity]]></category>
		<category><![CDATA[Obviousness]]></category>
		<category><![CDATA[Patents]]></category>

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		<description><![CDATA[By Chris Reaves A recent appeal of a lengthy prosecution ended last week, when the Federal Circuit in In re Hyon, 102 USPQ2d 1889 (Fed. Cir. 2012) upheld the Board of Patent Appeals and Interferences (BPAI) findings that a person &#8230; <a href="http://smiplaw.wordpress.com/2012/09/07/in-re-hyon-substantial-evidence-standard-helps-preserve-finding-of-obviousness/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1525&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p><strong>By Chris Reaves</strong></p>
<div>
<p>A recent appeal of a lengthy prosecution ended last week, when the Federal Circuit in <em>In re Hyon</em>, 102 USPQ2d 1889 (Fed. Cir. 2012) upheld the Board of Patent Appeals and Interferences (BPAI) findings that a person of ordinary skill would have reason to combine two references to create the invention at issue.  The Board’s decision, though possibly “flawed,” could not be found unreasonable under the applicable standard of review, emphasizing the challenge that patent prosecutors face in overcoming a factual finding.</p>
<p><strong>Background</strong></p>
<p>The applicants, Suong-Hyu Hyon and Masanori Oka, were granted U.S. Patent No. 6,168,626 on a specific type of “Ultra High Molecular Weight Polyethylene” (abbreviated throughout the patent and the opinion as “UHMWPE”), and on the method for creating these material.  The inventors intended the material to be used for artificial joints although the claims were not limited to this embodiment.  The patent had only eleven claims, with limitations such as thickness of the UHMWPE and orientation of the crystal planes within.</p>
<p>Deciding these limitations were unnecessary, the applicants filed a reissue application (No. 10/643,674) within the two-year window, cancelling the original claims and adding several dozen new claims.  These new claims generally consisted of a method of four steps:</p>
<p style="padding-left:30px;">(a) crosslinking an ultra high molecular weight polyethylene block having a molecular weight not less than 5 million by irradiating the block with a high energy radiation at a level of at least 1 MR;</p>
<p style="padding-left:30px;">(b) heating said crosslinked block up to a compression deformable temperature below the melting point of the UHMWPE;</p>
<p style="padding-left:30px;">(c) subjecting said heated block to pressure; and then</p>
<p style="padding-left:30px;">(d) cooling said block.</p>
<p>(All claims to the UHMWPE material itself were eventually cancelled voluntarily.)</p>
<p>The examiner rejected all the reissue claims as obvious over two prior art patents, “Zachariades” and “Kitamaru” (Patent Nos. 5,030,402 and 3,886,056, respectively).  As the applicants acknowledged, Zachariades contained all the steps of the applicants’ claims, but in a different order – irradiation occurred after cooling.  (The exact radiation levels and molecular weights also varied, but not to a degree that the examiner thought relevant, and the applicants did not address this difference before either the Board or the Federal Circuit.)  Kitamaru, meanwhile, used a somewhat different method to prepare UHMWPE for use in films and sheets, but it began the process with an irradiation step.  The examiner found that it would be obvious to take the teaching of Kitamaru, to begin with the irradiation crosslinking, and apply it to Zachariades.</p>
<p>The applicants appealed to the Board of Patent Appeals and Interferences, arguing that there was no motivation to combine the references.  The Board, however, affirmed the rejection, and the applicants appealed again to the Federal Circuit.</p>
<h2>Ruling: Board Had Substantial Evidence to Support Finding</h2>
<p>The majority opinion, written by Judge Bryson and joined by District Judge Jeremy Fogel (N.D. Cal., sitting by designation), opened by recalling that “existence of a reason for a person of ordinary skill to combine references” is a factual finding, reviewed under the “substantial evidence” standard.</p>
<p>Examining the applicants’ arguments, the majority first rejected the suggestion that the prior art came from “fundamentally different material technologies.”  Both patents spoke to the preparation of UHMWPE products, and although each focused on different embodiments, “[n]either reference limits the structure of the UHMWPE product that can be made”.</p>
<p>The majority also found arguments that Zachariades taught against irradiating before molding, or that the examiner and Board had cherry-picked one aspect of Kitamaru to combine with Zachariades, unconvincing.  Although its claims were limited to irradiating after molding, nowhere had Zachariades stated that the opposite was unfeasible or inadvisable.  More importantly, Kitamaru had emphasized that irradiation before molding was the key to creating desired improvements in UHMWPE, namely “a higher melting or softening point, improved transparency, and excellent dimensional stability.”  Therefore, the suggestion to select that element from the reference was in the reference itself.</p>
<p>Judge Newman, in dissent, found it telling that Kitamaru predated Zachariades (indeed, the former issued over a decade before the latter was filed).  It was therefore “noteworthy that Zachariades, seeking mechanical strength and dimensional stability, did not follow the known Kitamaru processing sequence, but instead crosslinked the polyethylene after deformation”.  Newman found this sufficient to show that a person of ordinary skill would not find the results of the combination predictable; had it been obvious to combine, Zachariades would have already done it in his own patent.  The Board, she concluded, had engaged in impermissible hindsight analysis, “reasoning backward from” the patent at issue to see what Zachariades himself had not.</p>
<h2>Analysis: Don’t Directly Challenge a “Reason to Combine” Finding</h2>
<p>The majority emphasizes the standard of review in its decision.  “Substantial evidence,” a standard used in review of factual findings by both juries and quasi-judicial agency decisions, requires deference to the Board’s decision unless it was without “such relevant evidence as a reasonable mind might accept as adequate to support [the] conclusion” (Universal Camera Corp. v. NLRB, 340 U.S. 474).  In other words, unless no reasonable fact-finder could come to the same conclusion given the same evidence, the appellate court will affirm.</p>
<p>Given this emphasis, the standard was likely what tipped the court.  The applicants may have presented a sufficiently convincing case under a preponderance standard, but could not show that the Board’s decision was “unreasonable.”  (Notably, the dissent did not mention the standard of review once, merely calling the Board’s reasoning “flawed”.)</p>
<p>The substantial evidence standard reminds prosecutors that the Board hearing is the stage to win questions of obviousness.  A Circuit panel with a clear focus on this standard is highly unlikely to overturn such a finding, so prosecutors should treat the Board as their only chance.  Should that fail, however, a prosecutor can also focus more energy on the meaning of claims, both prior art and present, which are reviewed de novo.  Finally, although expensive, a § 145 civil action can reset the entire record and remove all deference (see the recent <em>Kappos v. Hyatt</em>, 132 S.Ct. 1690), should the applicant be in true need of a do-over.</p>
<p>The opinion is available at: <a href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1239.pdf">http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1239.pdf</a></p>
<p align="left">Oral arguments may be heard at: <a href="http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2011-1239.mp3">http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2011-1239.mp3</a> (NOTE: the Federal Circuit’s oral argument database has been inconsistently accessible as of this article’s posting)</p>
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<br />Filed under: <a href='http://smiplaw.wordpress.com/category/patents/invalidity/'>Invalidity</a>, <a href='http://smiplaw.wordpress.com/category/patents/invalidity/obviousness/'>Obviousness</a>, <a href='http://smiplaw.wordpress.com/category/patents/'>Patents</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1525/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1525/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1525&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Federal Circuit Reaffirmed Lead Compound Analysis for Evaluating Obviousness of a New Chemical Compound</title>
		<link>http://smiplaw.wordpress.com/2012/09/04/federal-circuit-reaffirmed-lead-compound-analysis-for-evaluating-obviousness-of-a-new-chemical-compound/</link>
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		<pubDate>Tue, 04 Sep 2012 14:38:53 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Obviousness]]></category>
		<category><![CDATA[Patents]]></category>

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		<description><![CDATA[James Jang In Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012), the Federal Circuit affirmed the decision of the district court that the patent was not obvious based on prior art evidence, nor the asserted claims &#8230; <a href="http://smiplaw.wordpress.com/2012/09/04/federal-circuit-reaffirmed-lead-compound-analysis-for-evaluating-obviousness-of-a-new-chemical-compound/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1506&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p align="left"><strong>James Jang</strong></p>
<p align="left">In <em>Otsuka Pharmaceutical Co. v. Sandoz, Inc.</em>, 678 F.3d 1280 (Fed. Cir. 2012), the Federal Circuit affirmed the decision of the district court that the patent was not obvious based on prior art evidence, nor the asserted claims were invalid for nonstatutory double patenting.</p>
<p align="left">The Defendants are drug manufacturers who submitted ADNA filings to the Food and Drug Administration (FDA) for an approval to manufacture, use, or sale of generic aripiprazole products. Otsuka Pharmaceutical Corporation brought action against the drug manufacturers for infringement of patent on the compound claimed in Patent No. 5,006,528, aripiprazole, an atypical antipsychotic compound approved by the FDA for the treatment of schizophrenia. The Defendants counterclaimed that the patent was invalid for obviousness and nonstatutory double patenting. The Federal Circuit analyzed three ‘lead compounds’ asserted by the Defendants, unsubstituted butoxy compound, 2,3-dichloro propoxy compound, and OPC-4392 compound. A ‘lead compound’ means “a compound in the prior art that would be most promising to modify in order to improve upon its &#8230; activity and obtain a compound with better activity.” <em>Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.</em>, 492 F.d 1350, 1357 (Fed. Cir. 2007). The patents which disclosed the lead compounds, unsubstituted butoxy and 2,3-dichloro propoxy, also disclosed numerous examples of agents useful for the central nervous system, including an antischizophrenia agent.</p>
<p align="left">In its ruling, the Federal Circuit reaffirmed the lead compound analysis, employed in <em>Takeda Chemical Industries</em> and <em>Eisai Co. v. Dr. Reddy’s Labs,</em> 533 F.3d 1354 (Fed. Cir. 2008) for evaluating obviousness of a new chemical compound, which were the first two lead compound cases decided post-<em>KSR</em>. The Federal Circuit explained that the lead compound analysis consists of a two-part inquiry:</p>
<blockquote>
<p align="left"><em>First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts . . . . The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.</em></p>
</blockquote>
<p align="left">The Federal Circuit also noted that for the lead compound selection, mere structural similarity between a prior art compound and the claimed compound is not enough, but it should be guided by the compound’s “pertinent properties.”</p>
<p align="left">Applying this approach, the Federal Circuit rejected the Defendant’s argument that the lead compound analysis applied by the district court was a “rigid” obviousness analysis precluded by <em>KSR</em> because the court assumed that only the most obvious choice could serve as a lead. The Federal Circuit found that after evaluating all of the potential choices available to one of ordinary skill the district court correctly determined that the compounds asserted by the Defendants, unsubstituted butoxy, 2,3-dichloro propoxy, and OPC-4392, would not have been selected as lead compounds. Furthermore, focusing on the pertinent property of the new compound, rather than the structural similarity, Federal Circuit found that two other compounds — clozapine and risperidone — were viable lead compounds because these were the only capable antipsychotic compounds at the time of the invention. The Federal Circuit concluded that the Defendants failed to prove that the patent would have been obvious under 35 U.S.C. § 103.</p>
<p align="left">The ruling in <em>Otsuka Pharmaceutical Co.</em> might be seen as the Federal Circuit’s return to the “rigid” motivation rules precluded by <em>KSR.</em><sup>1</sup> However, It appears that the Federal Circuit attempted to avoid this concern by addressing that to keep with the “flexible” nature of the obviousness inquiry, “the reason or motivation for modifying a lead compound may come from any number of sources and need not necessarily be explicit in the prior art.” This is consistent with the rulings in the previous chemical compound cases after <em>KSR</em>, such as <em>Eisai Co. v. Dr. Reddy’s Labs</em>, where Judge Rader found that the decision in <em>KSR</em> for flexibility would not preclude the Federal Circuit from assessing motivation in the case. Thus, the post-<em>KSR</em> chemical compound cases may imply that the flexible motivation test is still viable.<sup>2</sup></p>
<p align="left"><strong>“Laundry List” of potential effects is not sufficient to prove the obviousness </strong></p>
<p align="left">The Federal Circuit also rejected the Defendants’ argument that the three lead compounds asserted by the Defendants were known to have antipsychotic activity so that the claimed compound, aripiprazole, would have been obvious to one of ordinary skill. The Federal Circuit found that the patents’ “laundry list” of the potential central nervous system controlling effects, would not have informed one of ordinary skill in the art that the three compounds would have antipsychotic activity.</p>
<p align="left"><strong>Nonstatutory Double Patenting</strong></p>
<p align="left">The double patenting doctrine is a judicially created doctrine “precluding one person from obtaining more than one valid patent for either (a) the ‘same invention,’ or (b) an ‘obvious’ modification of the same invention.” In re Longi, 759 F.2d 887, 892. The latter is referred to as the obviousness-type double patenting. The Federal Circuit differentiated obviousness-type double patenting from obviousness under § 103 by addressing that when examining the obviousness-type double patenting in chemical compound cases, the earlier-filed application need not qualify as prior art and “the issue is not whether a skilled artisan would have selected the earlier compound as a lead compound.” However, the Federal circuit rejected the Defendants’ argument that the double patenting never requires identifying the motivation to modify the earlier claimed compound. The Federal Circuit noted that the identification of the reason for modification is an essential part of the question whether the two claimed compounds are “patentably distinct” in the obviousness-type double patenting analysis.</p>
<p align="left">In concluding that the asserted claims were not invalid for obviousness-type double patenting, the Federal Circuit also noted that predictability is an important element to consider in the obviousness analysis. The Federal Circuit held that given the high degree of unpredictability in antipsychotic drug discovery at the time of the invention, “the prior art would not have provided a skilled artisan with a reason to make the necessary structural changes.”</p>
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<p align="left">1.<a title="" href="/Users/cpierce/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/6KXU48J2/Case%20summary_Otsuka%20Pharmaceutical%20Co%20v%20%20Sandoz%20Inc_1st%20draft.docx#_ednref1"> </a>Mark D. Janisal, <em>Tuning the Obviousness Inquiry After KSR</em>, 7 Wash. J. L. Tech. &amp; Arts 335 at 344-45 (2012), <em>available at</em> <a href="http://digital.law.washington.edu/dspace-law/bitstream/handle/1773.1/1125/7WJLTA335.pdf?sequence=4">http://digital.law.washington.edu/dspace-law/bitstream/handle/1773.1/1125/7WJLTA335.pdf?sequence=4</a>.</p>
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<p>2. <em>Id.</em> at 342-44.</p>
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<br />Filed under: <a href='http://smiplaw.wordpress.com/category/patents/invalidity/obviousness/'>Obviousness</a>, <a href='http://smiplaw.wordpress.com/category/patents/'>Patents</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1506/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1506/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1506&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>The “Apple v. Samsung” Global Patent Battles Continue</title>
		<link>http://smiplaw.wordpress.com/2012/08/09/the-apple-v-samsung-global-patent-battles-continue/</link>
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		<pubDate>Thu, 09 Aug 2012 20:32:08 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Injunctions]]></category>
		<category><![CDATA[Irreperable Harm]]></category>
		<category><![CDATA[Litigation]]></category>
		<category><![CDATA[Patents]]></category>
		<category><![CDATA[Uncategorized]]></category>

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		<description><![CDATA[Meera El-Farhan   What started a year ago, with Apple filing suit in the U.S. District Court for the Northern District of California against Samsung Electronics Co., has now expanded to more than 50 patent war lawsuits across four continents &#8230; <a href="http://smiplaw.wordpress.com/2012/08/09/the-apple-v-samsung-global-patent-battles-continue/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1500&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p><strong>Meera El-Farhan</strong></p>
<p><strong> </strong></p>
<p>What started a year ago, with Apple filing suit in the U.S. District Court for the Northern District of California against Samsung Electronics Co., has now expanded to more than 50 patent war lawsuits across four continents and at least eight countries. Throughout this escalating legal global battle, with billions of dollars at stake, the smartphone and tablet powerhouses continue, however, to be dependent business partners, and Samsung remains Apple’s largest semiconductor component supplier for iOS devices (a deal worth $8 billion). <a title="" href="#_ftn1">[1]</a></p>
<p>In its initial 38-page complaint, Apple claimed unfair competition, trademark infringements, and patent infringements; whereby, Apple alleged Samsung’s smartphones and Galaxy Tab 10.1 “slavishly” copied the iPhone and iPad designs. Samsung responded to Apple’s design patent and trade dress infringement claims by filing cross-claims. Samsung sought revocation of the patent claims and further alleged that the iPhone and iPad infringed on Samsung’s technology patents (including wireless data communication technology). Additionally, Samsung filed suit in South Korean, Japanese, and German courts.</p>
<p>On December 2, 2011, the district court denied Apple’s motion for preliminary injunction for the following devices:</p>
<p>(1) Samsung Galaxy S 4G and Infuse 4G smartphones for allegedly infringing on U.S. Des. Patent No. 618, 677 (“the D’677 patent”), U.S. Des. Patent No. 593,087 (the D’087 patent”), and (3) U.S. Patent No. 7, 469,381 (the ‘381 patent).</p>
<p>(2) Samsung Galaxy Tab 10.1 tablet computer for allegedly infringing on U.S. Des. Patent No. 504,889 (the D’889 patent”), and U.S. Patent No. 7469,381 (the ‘381 patent).</p>
<p>(3) Samsung 4G LTE smartphone for allegedly infringing on U.S. Patent No. 7,469,381 (the ‘381 patent”)<a title="" href="#_ftn2">[2]</a></p>
<p>The federal circuit affirmed the court’s order in part, but remanded for further proceeding with respect to the D’889 Patent. <a title="" href="#_ftn3">[3]</a>  On June 26, 2012, the district court found the balance of hardship for the D’889 patent to tip in Apple’s favor.<a title="" href="#_ftn4">[4]</a> The court acknowledged that “although Samsung will necessarily be harmed by being forced to withdraw its product from the market before the merits can be determined after full trial, the harm faced by Apple absent an injunction on the Galaxy Tab 10.1 is greater.”<a title="" href="#_ftn5">[5]</a>  The court further found the design to be an important driver for sales; thus the injunction was not based on “one aspect of the overall product.”<a title="" href="#_ftn6">[6]</a> However, as a condition of the injunction, the court ordered Apple to secure a $2.6 billion bond to repay Samsung for any damages in the event the injunction is found to have been issued wrongfully.<a title="" href="#_ftn7">[7]</a></p>
<p>With the trial starting on July 30, 2012, Apple demanding $2.5 billion in damages in addition to an injunction barring the sale of any infringing Samsung devices, in addition to the U.S. large electronic consumer market, the two electronic giants face high stakes in the trial’s outcome.</p>
<p><strong>Germany: </strong>a preliminary injunction in August of 2011 was ordered by a German court to ban the sales of Galaxy 10.1 Tab in all the European Union except for the Netherlands. A week later, the ban was scaled back to Germany, and the 10.1 tab was returned to the EU shelves. Samsung sidestepped the injunction by introducing a Galaxy Tab 10.1N model for Germany. Apple contested the new design immediately. Although Apple lost twice on appeal for banning the sale of the 10.1 Tab, the German court in July, 2012 ruled in favor of Apple by banning the sale of Galaxy Tab 7.7 in Europe.</p>
<p><strong>Australia: </strong>the battle extended to an Australian Federal Court in October, 2011. Apple sought, and was granted, an interlocutory injunction restraining Samsung from releasing the 10.1 Tab. Although the Australian Court granted Apple an interlocutory injunction, Samsung won on appeal. Apple continued to file for an appeal to the High Court.  The High Court, in refusing a special leave, allowed Samsung to sell the 10.1 just in time for  Christmas season. Samsung counter-sued Apple in April, 2012. The federal court began its hearing in late July, 2012.</p>
<p><strong>Other Countries: </strong>The UK court ruled in favor of Samsung by finding Tablets 10.1, 8.9, and 7.7 did not infringe upon the alleged Apple patent.  Samsung and Apple continue to battle in patent-related lawsuits in Japanese, Korean, and European courts.</p>
<p><strong> </strong></p>
<p><strong>Aftermath </strong></p>
<p>The multi-billion dollar patent warfare is likely to reshape legal and production strategies for both parties. Unfortunately, in the expanding smartphone market, price effects on consumer electronics are too uncertain to predict for now; however, the outcome of lawsuit battle will draw the line between competition and protection of intellectual property in the smartphone industry.</p>
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<p><a title="" href="#_ftnref1">[1]</a> <a href="http://www.iphone-my.com/news/samsung-apple-parts-2012-20132014/" rel="nofollow">http://www.iphone-my.com/news/samsung-apple-parts-2012-20132014/</a></p>
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<p><a title="" href="#_ftnref2">[2]</a> <em>Apple, Inc. v. Samsung Electronics Co., Ltd.,</em> 11-CV-01846-LHK, 2011 WL 7036077 (N.D. Cal. Dec. 2, 2011) <em>aff&#8217;d in part, vacated in part, remanded,</em> 678 F.3d 1314 (Fed. Cir. 2012)</p>
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<p><a title="" href="#_ftnref3">[3]</a><em>Apple, Inc. v. Samsung Electronics Co., Ltd.,</em> 678 F.3d 1314 (Fed. Cir. 2012)</p>
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<p><a title="" href="#_ftnref4">[4]</a> <em>Apple, Inc. v. Samsung Electronics Co., Ltd., </em>11-CV-01846-LHK, 2012 WL 2401680 (N.D. Cal. June 26, 2012)</p>
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<p><a title="" href="#_ftnref5">[5]</a> <em>Id. </em></p>
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<p><a title="" href="#_ftnref6">[6]</a> <em>Id. </em></p>
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<p><a title="" href="#_ftnref6">[7]</a> <em>Id. </em></p>
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<br />Filed under: <a href='http://smiplaw.wordpress.com/category/injunctions/'>Injunctions</a>, <a href='http://smiplaw.wordpress.com/category/injunctions/irreperable-harm/'>Irreperable Harm</a>, <a href='http://smiplaw.wordpress.com/category/litigation/'>Litigation</a>, <a href='http://smiplaw.wordpress.com/category/patents/'>Patents</a>, <a href='http://smiplaw.wordpress.com/category/uncategorized/'>Uncategorized</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1500/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1500/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1500&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>USPTO Issues Proposed Rules for Implementing the America Invents Act</title>
		<link>http://smiplaw.wordpress.com/2012/08/08/uspto-issues-proposed-rules-for-implementing-the-america-invents-act/</link>
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		<pubDate>Wed, 08 Aug 2012 11:56:06 +0000</pubDate>
		<dc:creator>SteinMcewen, LLP</dc:creator>
				<category><![CDATA[Feature Comments]]></category>
		<category><![CDATA[Patent Reform]]></category>
		<category><![CDATA[USPTO Practice]]></category>

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		<description><![CDATA[Charles Pierce and James G. McEwen On July 25, 2012, the United States Patent and Trademark Office (USPTO) announced proposed rules as a result of changes in the America Invents Act (AIA) converting the U.S. patent system from a first &#8230; <a href="http://smiplaw.wordpress.com/2012/08/08/uspto-issues-proposed-rules-for-implementing-the-america-invents-act/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1497&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<h2><a href="http://www.smiplaw.com/pro_pierce.cfm" target="_blank">Charles Pierce</a> and <a href="http://www.smiplaw.com/pro_mcewen.cfm" target="_blank">James G. McEwen</a></h2>
<p>On July 25, 2012, the United States Patent and Trademark Office (USPTO) announced proposed rules as a result of changes in the America Invents Act (AIA) converting the U.S. patent system from a first to invent to a first to file system.  These changes will take place on March 16, 2013.</p>
<p>The proposed rules are intended to promote consistency caused by the changes in the AIA for pending applications, and to implement the AIA for future applications.  Comments on the proposed rules are open until October 5, 2012.  Below is a summary of significant elements of the proposed rules.</p>
<p>The proposed rules will treat commonly owned or joint research agreement patents and patent application publications as having the same inventive entity for the purposes of 35 U.S.C. §§ 102 and 103 as required under 35 U.S.C. § 102(c) of the AIA.  35 U.S.C. §102(c) of the AIA essentially broadens the current 35 U.S.C. §§ 103(c) by making these provisions usable for novelty.  The broadened use of this exclusion should be beneficial to holders of large families of patents.</p>
<p>Since new 35 U.S.C. §102(b) provides exceptions to 35 U.S.C. §102(a) based upon prior disclosure by the inventor, the rule changes also allow the submission of affidavits or declarations to show that a disclosure upon which a claim rejection is based was made by an inventor, joint inventor, or someone who obtained the disclosed subject matter from the inventor or a joint inventor.  These provisions will also allow the submission of affidavits to show that there was a prior public disclosure by an inventor, joint inventor, or someone who obtained the disclosed subject matter from the inventor or a joint inventor.  This will be codified in 37 CFR §§ 1.104, 1.130, and 1.131.</p>
<p>Another change being implemented relates to using the effective dates of foreign priority applications against third party patents.  In order to ensure that the foreign priority documents are received in time for publication and use, the USPTO is now requiring that the certified copy be received within the deadline now only required for submitting the priority claim: the later of four months from the filing date or sixteen months from the foreign priority date.  The claim must also be included in an Application Data Sheet.  While these changes are likely not an issue where the applicant is able to retrieve priority documents using the priority document exchange (PDX) system, this timing will be an issue for all other applications.  Therefore, applicants need to ensure that the certified copies are provided as soon as possible in the prosecution process or be required to file a Petition for late acceptance.</p>
<p>The last major change in this round of AIA rulemaking is relate to the transitional period between first to invent and first to file, and probably will have the greatest short term impact on patent practitioners.  In order to ensure that the USPTO can properly evaluate which set of rules to apply when faced with priority claims for applications filed prior to March 16, 2013, the USPTO is requiring the applicants identify which rules will apply.</p>
<p>Specifically, where the application is filed after March 16, 2013, but claims the benefit of a foreign, provisional, or nonprovisional application having an effective filing date prior to March 16, 2013, the applicant will need to provide a statement whether the claims in the application are entitled to the earlier effective filing date.  Also, if the nonprovisional application that claims such benefit does not contain a claim to a claimed invention that has an effective filing date on or after March 16, 2013, but discloses subject matter not also disclosed in the prior application, the applicant must provide a statement to that effect.  For example, under proposed 37 C.F.R. 1.55, where the application claims priority to a foreign application filed prior to March 16, 2013, the applicant will need to specify if there is new matter in the application, and whether the claims are supported by the foreign priority date.  Examples of such statements include “upon reasonable belief, this application contains subject matter not disclosed in the foreign application” or “upon reasonable belief, this application contains at least one claim that has an effective filing date subject matter on or after March 16, 2013”.</p>
<p>These statements will have to be filed within the later of four months from the actual filing date of the later application, four months from the date of entry into the national stage in an international application, or sixteen months from the filing date of the prior filed application, or the date that a first claim to a claimed invention that has an effective filing date on or after March 16, 2013 is presented in the application.  Failure to make such a statement after these deadlines will require a Petition, and any changes will result in the Examiner issuing a Request for Information under 37 CFR 1.105 to require the applicant to prove by line and element number where support is found.  For continuations, divisionals, and continuation in part applications, this requirement will be codified in 37 CFR § 1.78.</p>
<p>As these rules are still only being proposed, applicants and the legal community are reviewing the proposed changes and preparing comments.  While many of the changes seem consistent with the requirements of the AIA, the transitional requirement for identifying whether disclosures and claims can have an effective filing date in a prior application are likely the most controversial and the most likely to cause significant problems for applicants having families of patents.  Therefore, as a short term solution, in order to avoid these potential issues should the USPTO not retract this provision, applicants should ensure that they file applications prior to March 16, 2013 if any priority claim is going to be made to an application filed prior to March 16, 2013.</p>
<br />Filed under: <a href='http://smiplaw.wordpress.com/category/feature-comments/'>Feature Comments</a>, <a href='http://smiplaw.wordpress.com/category/feature-comments/patent-reform/'>Patent Reform</a>, <a href='http://smiplaw.wordpress.com/category/feature-comments/uspto-practice/'>USPTO Practice</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1497/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1497/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1497&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Stein McEwen issues Vol. 8, Issue 2 of the SteinMcEwen Newsletter (July 2012)</title>
		<link>http://smiplaw.wordpress.com/2012/08/04/stein-mcewen-issues-vol-8-issue-2-of-the-steinmcewen-newsletter-july-2012/</link>
		<comments>http://smiplaw.wordpress.com/2012/08/04/stein-mcewen-issues-vol-8-issue-2-of-the-steinmcewen-newsletter-july-2012/#comments</comments>
		<pubDate>Sat, 04 Aug 2012 12:36:37 +0000</pubDate>
		<dc:creator>SteinMcewen, LLP</dc:creator>
				<category><![CDATA[Stein McEwen News]]></category>

		<guid isPermaLink="false">http://smiplaw.wordpress.com/?p=1493</guid>
		<description><![CDATA[We are pleased to present the latest edition of the Stein McEwen, LP Newsletter, Vol. 8, Issue 3 (July 2012). The newsletter includes information on the following: USPTO Issues Proposed Rules for Implementing the America Invents Act In re Hyon: &#8230; <a href="http://smiplaw.wordpress.com/2012/08/04/stein-mcewen-issues-vol-8-issue-2-of-the-steinmcewen-newsletter-july-2012/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1493&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<table width="100%" border="0" cellspacing="0" cellpadding="0">
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<td valign="top">We are pleased to present the latest edition of the <a href="http://gallery.mailchimp.com/0beed760942ef137f59d061aa/files/newsletter_vol_8_iss_3_2012.pdf">Stein McEwen, LP Newsletter, Vol. 8, Issue 3 (July 2012)</a>.<br />
The newsletter includes information on the following:</p>
<ul>
<li>USPTO Issues Proposed Rules for Implementing the America Invents Act</li>
<li>In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness</li>
<li>Viacom v. YouTube: Open Questions of “Substantial Influence” Weaken a Safe Harbor</li>
<li>McDonnell Boehnen Hulbert &amp; Berghoff LLP Respond to John Wiley &amp; Sons Ltd.’s Copyright Infringement Complaint</li>
<li>Federal Circuit Finds Prior Use By Another Invalidates Patent</li>
<li>Per se legal? The Eleventh Circuit Rejects FTC’s “Unlikely to Prevail” Antitrust Challenge to “Reverse Payment” Patent Settlements</li>
<li>Bear Declines Invitation to Oust MDL from Patent Infringement Realm</li>
</ul>
<p>For more information on Stein McEwen, LLP, please visit <a href="http://www.smiplaw.com/">www.smiplaw.co</a></td>
</tr>
</tbody>
</table>
<br />Filed under: <a href='http://smiplaw.wordpress.com/category/stein-mcewen-news/'>Stein McEwen News</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1493/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1493/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1493&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Bear Declines Invitation to Oust MDL from Patent Infringement Realm</title>
		<link>http://smiplaw.wordpress.com/2012/07/30/bear-declines-invitation-to-oust-mdl-from-patent-infringement-realm/</link>
		<comments>http://smiplaw.wordpress.com/2012/07/30/bear-declines-invitation-to-oust-mdl-from-patent-infringement-realm/#comments</comments>
		<pubDate>Mon, 30 Jul 2012 21:12:23 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Litigation]]></category>
		<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://smiplaw.wordpress.com/?p=1490</guid>
		<description><![CDATA[By Kyle Meziere Recently, the Judicial Panel on Multidistrict Litigation (JPML) addressed the contention that the America Invents Act precludes multidistrict litigation (MDL) centralization for patent infringement proceedings. The current legality of MDL centralization was questioned due to an arguable &#8230; <a href="http://smiplaw.wordpress.com/2012/07/30/bear-declines-invitation-to-oust-mdl-from-patent-infringement-realm/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1490&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p>By Kyle Meziere</p>
<p>Recently, the Judicial Panel on Multidistrict Litigation (JPML) addressed the contention that the America Invents Act precludes multidistrict litigation (MDL) centralization for patent infringement proceedings. The current legality of MDL centralization was questioned due to an arguable conflict with 35 U.S.C. §299, which was enacted by the America Invents Act. The statute prohibits the alleged infringers, in most patent infringement cases, from being joined in one action. 35 U.S.C.S. §299 (§299). Since the 1960’s, pretrial proceedings for cases involving infringement of the same patent have commonly been centralized into one district under the authority of 28 U.S.C. §1407 (§1407). This has been a way for parties to conserve their resources. It also results in more consistency within a set of closely related cases. In the wake of §299’s implementation, the question of how §299 affects the availability of MDL centralization in patent infringement cases was raised.</p>
<p>In May, the JPML granted a motion by Bear Creek Technologies to centralize fourteen separate actions to one district. <em>In re Bear Creek Technologies, Inc.</em>, MDL 2344, 2012 U.S. Dist. LEXIS 60884 (J.P.M.L. May 2, 2012). In the process, the panel addressed the issue of whether §299 modified §1407. The motion stemmed from a group of cases involving alleged infringements upon Bear Creek’s patent for a “[s]ystem for interconnecting standard telephony communications equipment to internet protocol networks.” At the time of the motion, there were fourteen allegedly infringing entities, including Vonage Holdings Corporation.</p>
<p>The legal issue was whether §299 modifies §1407. §1407 in the pertinent part states:</p>
<p>When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings. Such transfers shall be made by the judicial panel . . . upon its determination that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.</p>
<p>28 U.S.C.S. §1407 (2012).</p>
<p>The statute requires the cases to be remanded back to their respective districts no later than the conclusion of the pre-trial proceedings. Section 1407 was enacted in 1968 and has been applied to several dozen patent infringement cases since.</p>
<p>Vonage opposed centralization of the cases. It argued §299 prohibits centralization of cases which are related merely by the parties’ alleged infringement upon the same patent. Vonage cited specifically to the portion of §299 that reads: “accused infringers may not be joined in one action as defendants or counterclaim defendants, or have their actions consolidated for trial, based solely on allegations that they each have infringed the [same] patent . . . .” 35 U.S.C.S. §299 (2012). The JPML rejected this argument. The panel found the following arguments more persuasive. First, §299 does not manifest an intent to modify §1407, which had commonly been applied to patent infringement cases for 40 years at the time congress enacted §299. Secondly, §299 addresses only trial phase proceedings expressly.  Section 1407 applies to pretrial proceedings and requires cases to be remanded back to their respective districts before the trial phase begins. Thirdly, the JPML emphasized that their role is limited to centralizing the cases to one district; the district judge determines if the pretrial proceedings are to be consolidated. Accordingly, the panel found there was no conflict between the two statutes.</p>
<p>One month later, the JPML reaffirmed its <em>Bear Creek </em>holding in <em>Maxim. In re Maxim Integrated Products, Inc.</em>, MDL No. 2354, 2012 U.S. Dist. LEXIS 79496 (J.P.M.L. June 8, 2012). All of the suits Maxim sought to centralize involved infringement on various patents related to the secure transfer of data. The court reiterated that §1407 still allowed centralization of pre-trial proceedings for patent infringement cases. However, the parties opposed to centralization further argued that §299’s practical guarantee of separate trial proceedings should factor into the JPML’s judgment of whether centralization would further the goals of efficiency and justice. The panel found this argument to be sound, but not determinative.  The panel found that the cases’ similarities and the prospective efficiency of centralization overcame any inefficiency that resulted from the cases having to be remanded to their respective districts for trial. The court also noted that §299 may affect how the transferee judge deals with the cases. In particular, §299 may cause the transferee judge to remand the cases to their respective jurisdictions earlier than he may have before §299 was passed.</p>
<p>The effects of §299 on how the JPML gauges the appropriateness of MDL centralization for a particular set of cases and the statute’s effects on the decisions of the transferee judges remains to be seen. More importantly, however, MDL centralization remains available for dealing with patent infringement cases.</p>
<br />Filed under: <a href='http://smiplaw.wordpress.com/category/litigation/'>Litigation</a>, <a href='http://smiplaw.wordpress.com/category/uncategorized/'>Uncategorized</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1490/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1490/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1490&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Fourth Circuit Remands Rosetta Stone Ltd. v. Google Inc. 2010 Ruling</title>
		<link>http://smiplaw.wordpress.com/2012/07/20/fourth-circuit-remands-rosetta-stone-ltd-v-google-inc-2010-ruling/</link>
		<comments>http://smiplaw.wordpress.com/2012/07/20/fourth-circuit-remands-rosetta-stone-ltd-v-google-inc-2010-ruling/#comments</comments>
		<pubDate>Fri, 20 Jul 2012 14:36:39 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Keyword]]></category>
		<category><![CDATA[Trademarks]]></category>

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		<description><![CDATA[By Virginia Dudley On April 9, 2012, the U.S. Court of Appeals for the Fourth Circuit revived the trademark infringement case Rosetta Stone Ltd. v. Google Inc., 730 F. Supp. 2d 531 (E.D. Va. 2010). The Fourth Circuit overturned the &#8230; <a href="http://smiplaw.wordpress.com/2012/07/20/fourth-circuit-remands-rosetta-stone-ltd-v-google-inc-2010-ruling/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1487&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p>By Virginia Dudley</p>
<p>On April 9, 2012, the U.S. Court of Appeals for the Fourth Circuit revived the trademark infringement case <em>Rosetta Stone</em> <a href="http://scholar.google.com/scholar_case?case=17990940966060376496&amp;q=rosetta+stone+v.+google&amp;hl=en&amp;as_sdt=2,9&amp;as_vis=1"><em>Ltd. v. Google Inc.,</em> 730 F. Supp. 2d 531 (E.D. Va. 2010)</a>. The Fourth Circuit overturned the summary judgment granted in favor of Google by the U.S. District Court for the Eastern District of Virginia.</p>
<p>The <em>Rosetta Stone </em>case stemmed from Google’s sale of marks as AdWords. Adwords are Google’s online advertizing tool that allows a sponsor to “purchase” keywords that prompt the appearance of the sponsor’s advertisement when the keyword is entered as a search item. Rosetta Stone, a language-learning software company, was established in 1992 and began advertizing in connection with Google’s website in 2002.</p>
<p>Rosetta Stone initially accused Google of trademark infringement as a result of the website’s use of their mark in AdWords. In terms of this appeal, the Fourth Circuit re-addressed the possible elements of confusion, application of the functionality doctrine, dilution claims, and Google’s knowledge of infringement formerly discussed in favor of Google by the district court.</p>
<p>In August 2010, the district court rejected Rosetta Stone’s claim of an element of confusion caused by Google’s use of their mark by considering 3 out of 9 “likelihood-of-confusion” factors: (1) Google’s intent, (2) actual confusion, and (3) sophistication of the consuming public. The district court dismissed confusion claims against Google by ruling that Google did not intend to create confusion and that high consumer sophistication could be determined based on the nature and price of the product alone.</p>
<p>Conversely, the Fourth Circuit called for greater proper analysis of possible evidence of confusion and found a genuine issue of fact in terms of the previously discussed three factors of confusion. In particular, the Fourth Circuit reasoned that Google’s shifting trademark policies from the year 2004 on, as well as Rosetta Stone’s evidence of 123 complaints from those who had purchased knockoff software believing it to be legitimate, could reveal that Google had an intent to confuse. Also, the presence of confusion was further suggested by the difficulty Google’s own witnesses experienced in distinguishing between authentic and counterfeited Rosetta Stone advertisements on the search engine’s site.</p>
<p>Secondly, the district court held that the use of Rosetta Stone marks as keywords was protected by the functionality doctrine. The court found that Google’s use of Rosetta Stone’s trademarks as keywords was functional in that the keywords have “an essential indexing function because they enable Google to readily identify in its databases relevant information in response to a web user’s query.”<a title="" href="#_ftn1">[1]</a> Trademark law’s functionality doctrine states, “a product feature is functional if it is essential to the use or purpose of the article or if it affects the cost or quality of the article.” The district court claimed that Google’s AdWords were also protected under the Lanham Act, which states that a party cannot receive exclusive rights over solely functional features. 15 U.S.C. § 1114(a).</p>
<p>This past April, the Fourth Circuit stated that the district court did not consider whether the mark was functional in the way Rosetta Stone used the mark. Instead, the appellate court affirmed that the District Court focused solely on how Rosetta Stone’s mark made Google’s product more useful. The Fourth Circuit asserted that the functionality doctrine had been incorrectly applied to the case. In general, the Fourth Circuit emphasized that the words “Rosetta Stone” are not necessary to the function of the language-learning software, thus establishing the mark’s non-functional nature.</p>
<p>As for dilution claims against Google, the district court denied the presence of dilution in Google’s use of the mark. The district court also applied the fair use argument, which is present in the federal statute dealing with dilution 15 U.S.C. §1125 (c) (3) (a). The district court confirmed that Google did not use Rosetta Stone’s mark to identify its services. Moreover, the possibility of dilution of the mark was also disregarded by the district court as a result of the increase in public awareness of Rosetta Stone’s mark following its appearance in Google’s AdWords.</p>
<p>The Fourth Circuit, on the other hand, found evidence of dilution and stated that the notion of good faith arises in regards to the fair use inquiry mentioned by the district court.</p>
<p>Lastly, the Fourth Circuit addressed the extent of Google’s knowledge of infringement. In 2010, the district court referenced the Second Circuit ruling in <em>Tiffany v. eBay </em>600 F.3d 93 (2d Cir. 2010)to claim that generalized knowledge of infringement makes Google less liable. The district court also ruled that Google would not be liable unless Rosetta Stone could provide concrete evidence that the search engine was aware that an act of infringement was occurring.</p>
<p>However, the Fourth Circuit held that the district court’s decision was gathered in an inappropriate and untimely manner. As with many of the other aspects addressed in this case, the appellate court supported Rosetta Stone and called for further analysis on Google’s knowledge of infringement in its use of the words “Rosetta Stone.”</p>
<p>Such recall of a former trademark infringement case also occurred on April 5, 2012 when the U.S. Court of Appeals for the Second Circuit heard <em>Viacom International Inc. v. YouTube Inc., </em>No. 10-3270 (2d Cir. April 5, 2012). Similar to <em>Rosetta Stone Ltd. v. Google Inc., </em>the Appellate Court pushed for greater analysis of trademark infringement claims against Google because they found the trial court to have been too swift in their decision making.</p>
<p>In sum, in focusing on the factors of confusion, mark functionality, dilution, and Google’s knowledge, the Fourth Circuit remanded the summary judgment granted by the U.S. District Court for the Eastern District of Virginia in favor of Google. [1]</p>
<p>[1] Rosetta Stone Ltd. v. Google Inc. Court of Appeals, Fourth Circuit 2012. <em>available at </em><a href="http://scholar.google.com/scholar_case?case=11203645518793090722&amp;q=rosetta+stone+v.+google&amp;hl=en&amp;as_sdt=2,9&amp;as_vis=1">http://scholar.google.com/scholar_case?case=11203645518793090722&amp;q=rosetta+stone+v.+google&amp;hl=en&amp;as_sdt=2,9&amp;as_vis=1</a></p>
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<p><a title="" href="#_ftnref1">[1]</a> <a href="http://pub.bna.com/ptcj/RosettaApr9.pdf">http://pub.bna.com/ptcj/RosettaApr9.pdf</a></p>
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<br />Filed under: <a href='http://smiplaw.wordpress.com/category/trademarks/keyword/'>Keyword</a>, <a href='http://smiplaw.wordpress.com/category/trademarks/'>Trademarks</a>  <a rel="nofollow" href="http://feeds.wordpress.com/1.0/gocomments/smiplaw.wordpress.com/1487/"><img alt="" border="0" src="http://feeds.wordpress.com/1.0/comments/smiplaw.wordpress.com/1487/" /></a> <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1487&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></content:encoded>
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		<title>Per se legal? The Eleventh Circuit Rejects FTC’s “Unlikely to Prevail” Antitrust Challenge to “Reverse Payment” Patent Settlements</title>
		<link>http://smiplaw.wordpress.com/2012/07/12/per-se-legal-the-eleventh-circuit-rejects-ftcs-unlikely-to-prevail-antitrust-challenge-to-reverse-payment-patent-settlements/</link>
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		<pubDate>Thu, 12 Jul 2012 14:57:01 +0000</pubDate>
		<dc:creator>mstein03</dc:creator>
				<category><![CDATA[Antitrust]]></category>
		<category><![CDATA[Patent Misuse]]></category>
		<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://smiplaw.wordpress.com/?p=1483</guid>
		<description><![CDATA[By Meera El-Farhan In F.T.C. v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (11th Cir. 2012) the U.S. Court of Appeals for the Eleventh Circuit rejected the Federal Trade Commission’s (“FTC”) antitrust challenge to “reverse payment” patent settlements. Under the terms &#8230; <a href="http://smiplaw.wordpress.com/2012/07/12/per-se-legal-the-eleventh-circuit-rejects-ftcs-unlikely-to-prevail-antitrust-challenge-to-reverse-payment-patent-settlements/">Continue reading <span class="meta-nav">&#8594;</span></a><img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=smiplaw.wordpress.com&#038;blog=24689237&#038;post=1483&#038;subd=smiplaw&#038;ref=&#038;feed=1" width="1" height="1" />]]></description>
				<content:encoded><![CDATA[<p>By Meera El-Farhan</p>
<p>In <em>F.T.C. v. Watson Pharmaceuticals, Inc.,</em> 677 F.3d 1298 (11th Cir. 2012) the U.S. Court of Appeals for the Eleventh Circuit rejected the Federal Trade Commission’s (“FTC”) antitrust challenge to “reverse payment” patent settlements. Under the terms of the “reverse payment” (or “pay-for-delay”) agreement, the patent owner of AndroGel, Solvay Pharmaceuticals, Inc. (“Solvay”), agreed to make over $20 million annual payments to the generic challengers Watson Pharmaceuticals, Inc., Par Pharmaceuticals, Inc., and Paddock Laboratories, Inc. In return, the generic challengers agreed to stay out of the market until 2015, unless another generic version was to enter the market before then.</p>
<p><strong> </strong></p>
<p>The FTC brought suit against all parties to the agreement. The FTC challenged the “pay-for-delay” settlement on the basis of unfair restraint of trade (the settlement allegedly being an “unlawful agreement not to compete,” in violation of section 5(a) of the Federal Trade Commission Act<a title="" href="#_ftn1">[1]</a> (“FTCA”)). The FTC argued that such monopolies allow both generic and patent holding pharmaceuticals to make more profits at the expense of consumer welfare (increasing drug costs by an estimated amount of $3.5 billion per year). On appeal, the FTC argued, among other things, that Solvay’s ‘894 patent <a title="" href="#_ftn2">[2]</a> was “unlikely to prevail.” According to the FTC, because the patent was unlikely to bar Watson and Par, and Paddock’s generic drug from entering the market the settlement was an unlawful restraint on competition.</p>
<p>The Eleventh Circuit rejected the “more likely than not” standard contended for by FTC. The court held the “unlikely to prevail” standard to be insufficient to state a claim; thus, a patent did not thereby exceed its “exclusionary potential.” The court adhered to the test set-forth by its precedent: “absent sham litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent.”<a title="" href="#_ftn3">[3]</a></p>
<p>Although critics of the court’s decision argue such a test makes reverse payments “per se lawful” due to resulting difficulty in challenging reverse payment agreements, the Eleventh Circuit proffered convincing arguments for rejecting the FTC’s challenge. Among other things, the court argued FTC’s “predict-the-likely-outcome-that-never-came” approach would not only impose a retrospective burden on parties and courts (even if the burden of proof fell on the plaintiff), but also, such a test would not align with the strong public policy favoring settlements.</p>
<p>The court noted that parties settle patent litigations to “cap the cost” of litigation and avoid the “all or nothing” outcomes from courts. Settlements are one option for parties who “might not want to play the odds for the same reason that one likely to survive a game of Russian roulette might not want to take a turn.” The Eleventh Circuit further explained that the costly and tedious process of developing new drugs should also be supported by strong public policy favoring settlements over costly litigation. The court, with reference to the maxim “More Money, More Problems,” sided with pharmaceutical companies’ incentive to recoup costs of research and development. The court proffered additional reasons such as the exclusive appellate jurisdiction of the U.S. Court of Appeals for the Federal Circuit over patent cases and the court’s lack of expertise to rule on the patent.</p>
<p>The heart of resolving such cases, as noted by the Eleventh Court, is in striking the balance between antitrust law interests (promoting competition) and intellectual property law interests (allowing temporary monopolies to provide innovators with incentives to create). Antitrust laws aim to protect consumers from artificially high prices, maximize efficiency of the market, and also promote improvement of products through competition. On the other hand, granting patents ensures parties have the incentive to innovate in the first place. Although one can easily recognize the tensions between antitrust law and intellectual property law, one must also recognize the common goal: promoting innovation for a better future.</p>
<p>However, there is no consensus over resolving this tension yet. In the Sixth Circuit and the District of Columbia Circuit, reverse payment agreements are <em>per se </em>unlawful under the Sherman Act.<a title="" href="#_ftn4">[4]</a> However, the Second Circuit, like the Eleventh Circuit, refused to assess the ex post validity of the patent at trial, but instead the court held that the question is whether &#8220;the exclusionary effects of the agreement exceed the scope of the patent&#8217;s protection.&#8221;<a title="" href="#_ftn5">[5]</a> In devising a test that can better serve both interests, <em>per se </em>rules are unlikely to accommodate such a goal. However, with a growing circuit split among federal courts, in addition to a silent United States Supreme Court (as it passed the opportunity to articulate a unifying a standard at this point in time), the FTC will have many more opportunities to argue for, perhaps better, multi-factored tests.</p>
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<p><a title="" href="#_ftnref1">[1]</a> 15 U.S.C. §45(a)(1) (2006).</p>
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<p><a title="" href="#_ftnref2">[2]</a> U.S. Patent No. 6,503,894 (filed Aug. 30, 2000) (issued Jan. 7, 2003).</p>
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<p><a title="" href="#_ftnref3">[3]</a> <em>F.T.C. v. Watson Pharmaceuticals, Inc.,</em> 677 F.3d 1298, 1312 (11th Cir. 2012)</p>
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<p><a title="" href="#_ftnref4">[4]</a> <em>See </em><em>In re Cardizem CD Antitrust Litig.,</em> 332 F.3d 896 (6th Cir. 2003); <em>see also</em> <em>Andrx Pharmaceuticals, Inc. v. Biovail Corp. Int&#8217;l, </em>256 F.3d 799 (D.C. Cir. 2001)<em></em></p>
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<p><a title="" href="#_ftnref5">[5]</a> <em>In re Tamoxifen Citrate Antitrust Litig.,</em> 466 F.3d 187, 213 (2d Cir. 2006)</p>
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