The “Apple v. Samsung” Global Patent Battles Continue

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 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). [1]

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.

On December 2, 2011, the district court denied Apple’s motion for preliminary injunction for the following devices:

(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).

(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).

(3) Samsung 4G LTE smartphone for allegedly infringing on U.S. Patent No. 7,469,381 (the ‘381 patent”)[2]

The federal circuit affirmed the court’s order in part, but remanded for further proceeding with respect to the D’889 Patent. [3]  On June 26, 2012, the district court found the balance of hardship for the D’889 patent to tip in Apple’s favor.[4] 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.”[5]  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.”[6] 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.[7]

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.

Germany: 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.

Australia: 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.

Other Countries: 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.

 

Aftermath

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.


[2] Apple, Inc. v. Samsung Electronics Co., Ltd., 11-CV-01846-LHK, 2011 WL 7036077 (N.D. Cal. Dec. 2, 2011) aff’d in part, vacated in part, remanded, 678 F.3d 1314 (Fed. Cir. 2012)

[3]Apple, Inc. v. Samsung Electronics Co., Ltd., 678 F.3d 1314 (Fed. Cir. 2012)

[4] Apple, Inc. v. Samsung Electronics Co., Ltd., 11-CV-01846-LHK, 2012 WL 2401680 (N.D. Cal. June 26, 2012)

[5] Id.

[6] Id.

[7] Id.

Bear Declines Invitation to Oust MDL from Patent Infringement Realm

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 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.

In May, the JPML granted a motion by Bear Creek Technologies to centralize fourteen separate actions to one district. In re Bear Creek Technologies, Inc., 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.

The legal issue was whether §299 modifies §1407. §1407 in the pertinent part states:

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.

28 U.S.C.S. §1407 (2012).

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.

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.

One month later, the JPML reaffirmed its Bear Creek holding in Maxim. In re Maxim Integrated Products, Inc., 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.

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.

Supreme Court Unanimously Rules for Generic Manufacturers in Improper Patent Listing Case

By Charles Pierce

In Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. ___ (2012), the Supreme Court unanimously clarified the prerequisites of 21 U.S.C. §355(j)(5)(C)(ii)(I) counterclaims seeking to correct or delete patent information that a name-brand pharmaceuticals manufacturer submits to the FDA.

Repaglinide is a drug that has been approved by the FDA for the treatment of diabetes.  The FDA approved three methods: repaglinide alone, repaglinide in combination with metformin, and repaglinide in combination with thiazolidinediones.  The compound was covered by the ‘035 patent that Novo had owned, but the patent had expired in 2009.  Novo currently owns the ‘358 patent, a method-of-use patent which claims “a method for treating [diabetes by] administering . . . repaglinide in combination with metformin.”

Generic drug makers, rather than submit a new drug application (NDA), may submit an abbreviated new drug application (ANDA) that piggy back on the brand’s NDA.  Following the expiration of the ‘035 patent, Caraco filed such an ANDA seeking permission to market a generic version of repaglinide alone and repaglinide in combination with thiazolidinediones for the treatment of diabetes.  Before the FDA granted approval, Novo changed its use code for the ‘358 patent to cover all methods of using repaglinidine.  Caraco then filed a certification stating that the ‘358 patent would not be infringed, and Novo treated this as an act of infringement and sued.  Caraco filed a counterclaim under § 355.

21 U.S.C. §355(j)(5)(C)(ii)(I) states that when sued for infringement, an ANDA applicant may:

“Assert a counterclaim seeking an order requiring the [brand] to correct or delete the patent information submitted by the [brand] under subsection (b) or (c) [of §355] on the ground that the patent does not claim either –

(aa) the drug for which the [brand’s NDA] was approved; or

(bb) an approved method of using the drug.”

The parties disagreed on the meaning of the phrase “on the ground that the patent does not claim . . .  an approved method of using the drug.”  Novo argued that this should mean that the only time a counterclaim is allowed is when the patent does not claim any approved method of using the drug.  Caraco argued that instead, a counterclaim was allowed when the ANDA applicant applies for a method of using the drug not covered by the patent.  The Supreme Court agreed with Caraco.

The Supreme Court first examined the statutory context and noted that the statute contemplates that a single patented use should not prevent an ANDA from being approved.  By Novo’s reading, a patent claiming a single method of use would be sufficient to deny both FDA approval and a cause of action to ANDA applicants seeking to market the drug for unrelated uses.  Finding this result to be contrary to the statutory intention, the Court ruled for Caraco’s interpretation.

Novo also argued that Caraco’s counterclaim should fail because use codes are not patent information submitted under subsections (b) or (c) for the purposes of the statute.  The Supreme Court again disagreed with Novo.  First, the Court ruled that a use code does qualify as patent information because it describes the method of use claimed in a patent.  Use codes are required under 21 CFR §314.53 and when issuing §314.53, the FDA noted that its authority stemmed from 21 U.S.C. §355.  Because of this, the Court then decided that subsections (b) or (c), which require an NDA applicant to submit the patent number and expiration date of any patent claiming the drug or its method of use, cover use codes.  The Supreme Court also noted that if a counterclaim in such a case was not allowed, than the term “correct” in “assert a counterclaim seeking an order requiring the [brand] to correct or delete the patent information” would be read out of §355(j)(5)(C)(ii)(I).  Thus, the Court ruled that use codes are patent information submitted under subsections (b) or (c).

Finally, the Court rejected Novo’s legislative history arguments.  Novo first argued that Caraco’s interpretation of §355 would resurrect a scheme rejected by Congress.  A 2002 bill had sought to require brands to file patent information, and allow generic companies to bring actions to correct such information.  The bill failed, but the Supreme Court here declined to view the failure as a Congressional rejection of the requirement, noting that bills may be proposed and rejected for any number of reasons.

The Supreme Court then rejected Novo’s final argument – that the counterclaim was established only in response to the Federal Circuit’s decision in Mylan Pharmaceuticals, Inc. v. Thompson, 267 F. 3d 1323 (Fed. Cir. 2001).  In Mylan, the Federal Circuit had decided that no action to delist an improperly listed patent from the Orange Book was available.  The Court noted that even assuming that Congress was responding to Mylan, the situation presented in this case was similar to that in Mylan: an unrelated drug patent blocked FDA approval for a generic manufacturer.  The Supreme Court unanimously ruled for Caraco, deciding that a cause of action exists for generic manufacturers when the brand lists a method-of-use patent that does not cover a method of use for which the generic manufacturer seeks FDA approval.

Supreme Court Holds that New Evidence May Be Presented in § 145 Actions, Must Be Reviewed De Novo

By Charles Pierce

In Kappos v. Hyatt, 566 U.S. ___ (2012), the Supreme Court unanimously ruled that in a 35 U.S.C. § 145 action, there are no evidentiary restrictions beyond those imposed by the Federal Rules of Evidence, and the Federal Rules of Civil Procedure.  The Supreme court also held that when new evidence is presented, the district court must make a de novo finding on a disputed question of fact.

In 1995, Gilbert Hyatt filed U.S. Patent Application No. 08/471,701 (the ‘702 application), “Improved Memory Architecture Having a Multiple Buffer Output Arrangement.”  After amendments, the ‘702 application had a total of 117 claims, which were all rejected by the examiner.  Hyatt appealed to the Board of Patent Appeals and Interferences,  and the Board approved 38 claims, but upheld the examiner’s rejection for lack of adequate written description for the rest.  Hyatt then filed an action under 35 U.S.C. § 145 in District Court.

35 U.S.C. § 145 states,

An applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia if commenced within such time after such decision, not less than sixty days, as the Director appoints. The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims involved in the decision of the Board of Patent Appeals and Interferences, as the facts in the case may appear, and such adjudication shall authorize the Director to issue such patent on compliance with the requirements of law. All the expenses of the proceedings shall be paid by the applicant.

In his § 145 action, Hyatt submitted to the District Court a written declaration identifying portions of the patent specification that he viewed as supporting his claims.  The District Court declined to consider Hyatt’s declaration, on the ground that applicants may not present new issues unless there was some reason presented for failure to present the issue to the Patent Office.  The District Court then granted summary judgment to the Director of the Patent Office, after reviewing the remaining evidence under the substantial evidence standard.

On appeal, the Federal Circuit first affirmed the district court’s decision, then granted rehearing en banc and held that new evidence in §145 proceedings is subject only to the Federal Rules of Evidence and the Federal Rules of Civil Procedure, and that when new evidence is introduced, the district court must make a de novo finding.  The Director then appealed, and the Supreme Court affirmed the en banc decision.

The Supreme Court reasoned that “§ 145 neither imposes evidentiary limits nor establishes a heightened standard of review.”  566 U.S. ___, ___ slip op. at 6.  Rejecting the Director’s argument that administrative law principles should apply to § 145, the Supreme Court noted that unlike the APA, 35 U.S.C. § 145 does not limit judicial review to the administrative record.  The Supreme Court also cited the lack of limits in the text of the statute, the competence of a district court to receive new evidence and act as fact finder, and that § 145 does not provide for remand to the PTO.

The Supreme Court also based its reasoning on Butterworth v. United States ex rel. Hoe, 112 U.S. 50 (1884), a case filed under R. S. 4915, the direct predecessor to § 145.  In Butterworth, the court had described R. S. 4915 proceedings as independent from Patent Office hearings, and ruled that parties may introduce additional evidence.  The Supreme Court also distinguished Morgan v. Daniels, 153 U.S. 120 (1894) (which applied a deferential standard to an R. S. 4915 review), as Morgan involved an interference proceeding and such proceedings are no longer addressed in the same section of the Patent Act as district court challenges.  Finally, in Morgan, no new evidence was presented.  Butterworth being closer than Morgan to the facts of this case, the Supreme Court held that new evidence may be presented with no restriction save for the Federal Rules of Evidence and the Federal Rules of Civil Procedure, and that where new evidence is presented, the district court must review it de novo.

Eastern District of Texas Presents Their Take on the Model Discovery Order

By Kevin M. Repper

The use of e-discovery requests present a broad spectrum of challenges including preservation of attorney client privileges and work product, production format and the disproportionate costs included in massive searches and data collection. Particularly, patent cases have been a victim of noticeably higher expenses when dealing with e-discovery.

Patent cases generally require discovery of the accused products work, what the prior art discloses, and the proper calculation of damages. These topics tend to cause disproportionate, overbroad email production requests, having overwhelming time and production costs. Generally, such expansive production costs outweigh the substantive benefits of the requests.

Thus, the Model Order Limiting E-Discovery in Patent Cases was created.  The order was intended to be a helpful starting point for district courts to use in requiring the responsible, targeted use of e-discovery in patent cases.  The goal of the Model Order is to allow a more efficient discovery process, especially with the discovery of mass e-mails. Further, the Model Order promotes the gathering of material information as apposed to permitting an unlimited fishing expedition.

As mentioned above, one of the intended purposes of the Model Order was to give district courts a basic outline, in which the court could further add too as they saw fit.  On March 2, 2012, the Eastern District of Texas unveiled its own model discovery order as an appendix to local rule amendments.  The model discovery order is the work product of a group of the Eastern District’s Local Rules Advisory Committee after reviewing the Federal Circuit Model Order.

Some examples of the changes between the Eastern District of Texas’s model order and the Federal Circuits Model Order are summarized below:

  • The Eastern District of Texas Model Order allows the modification of the Order in the Court’s discretion or by agreement of the parties instead of a showing of good cause as outlined in the Federal Circuits Model Order.
  • The Eastern District of Texas Model Order strikes the provision in the Federal Circuit Model Order which states that the costs will be shifted for disproportionate  Electronically Stored Information (ESI) production requests and a party’s  nonresponsive or dilatory discovery tactics will be cost-shifting      considerations.
  • The Eastern District of Texas Model Order discloses that absent a showing of good cause, general ESI production requests under Federal Rules of Civil Procedure 34 and 45, or compliance with a mandatory disclosure requirement of this Court, shall not include metadata.
  • The Eastern District of Texas added parameters to apply to the ESI production including the format of the documents and other basic requirements and omissions.
  • The Eastern District of Texas outlined the method of requesting email production and changed the limit on custodians and search terms.

The district’s proposal includes a redline/strikeout comparison to the Federal Circuit model order and detailed commentary explaining the rationale for the deviations from the Federal Circuit model. The district’s proposed order makes some useful modifications to the Federal Circuit’s model e-discovery order, and it would not be surprising if there were further modifications in the future to tailor to other district’s needs.

Federal Circuit Overturns District Court’s Claim Construction in Markem-Imaje Corp. v. Zipher Ltd.

.By Zi Wang

In Markem-Imaje Corp. v. Zipher Ltd., 657 F.3d 1293 (Fed. Cir. 2011), the Federal Circuit per curiam majority overturned the district court’s claim construction and summary judgment of noninfringement.

Markem-Imaje Corp. sued Zipher Ltd. and Videojet Technologies, Inc. (together “Zipher”), requesting a declaratory judgment that Zipher’s ‘572 patent is not infringed by Markem.  The ‘572 patent is directed to a heat transfer printing apparatus that provides increased control over the acceleration, deceleration, speed, and positional accuracy of the printing operation.  In transfer printers in general, the ink ribbon is wound on two spools, one spool for supplying the ribbon for positioning on the substrate, and the other spool for taking up the ribbon after use.  Maintaining correct ribbon tension is essential for proper functioning of the printer.  The patent specification explains the problems with the mechanism that has been used to provide ribbon tension in prior art printers.  It then distinguishes the prior apparatus from what the ‘572 patent calls the “push-pull” mechanism of the ‘572 apparatus, and claims that this new mechanism solves various problems encountered with prior devices.  The “push-pull” mechanism is implemented using microcontroller-controlled stepper motors.

Claim 1, the broadest claim of the ‘572 patent, is directed to a tape drive that corrects tension divergences from the predetermined limit in this manner:

A tape drive comprising:

two motors, at least one of which is a stepper motor;

two tape spool supports on which spools of tape are mounted, each spool being driveable by a respective one of said motors;

a controller adapted to control energization of said two motors such that tape is transported in at least one direction between spools of tape mounted on the spool supports;

wherein the controller energizes both said motors to drive the spools in a tape transport direction, and

said controller calculates a length of tape to be added to or subtracted from tape extending between said spools in order to maintain tension in said tape between predetermined limit values and controls said motors to drive the spools to add or subtract the calculated length of tape to or from the tape extending between said spools.

The district court construed “driveable” and “drive” to mean “rotateable” and “rotate”, rejecting Zipher’s broader construction.  The district court reasoned that although the ordinary meaning of “drive” can be broad enough to encompass not only the rotation of the spools but also application of a holding torque that prevents the spool from rotating and that references to driving the spools in the specification could accommodate either construction, giving “drive” a meaning broader than “rotation” would be contradictory to the meaning of “drive” in the tape transport clause, which states that “the controller energizes both said motors to drive the spools in a tape transport direction.”  Moreover, according to the district court, because the claim clause “controls said motors to drive the spools” already used the word “control,” the patentee could not have intended “control” and “drive” to mean the same thing.  The district court also pointed to a few places in the specification that use the word “drive” narrowly.  The district court further construed the use of the plural word “spools” in the claim clause “to drive the spools to add or subtract the calculated length of tape” to mean that both spools must rotate to add or subtract a single calculated length of tape.

Because only a single spool is rotated to achieve each tension adjustment in Markem’s accused devices, the district court readily found noninfringement.  Zipher then appealed the district court’s claim construction and summary judgment to the Federal Circuit.

On appeal, Zipher argued that “drive”, similar to “control”, has the inclusive meaning of not only rotate but also “hold steady in a commanded position.”  Markem, on the other hand, relied on Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) for its position.  Phillips court stated that “claim terms are normally used consistently throughout the patent,” and that “a claim term should be construed consistently with its appearance in other places in the same claim or in other claims of the same patent.”  The Federal Circuit majority sided with Zipher, holding that “drive” need not be narrowly construed merely because a broader construction would make it similar to the word “control” that is also used in the claim.  The majority also stated that nothing in the specification or the overall invention as presented in the claim and as argued to the patent examiner requires the narrow construction.

In addition to the district court’s construction of “drive the spools”, Zipher also appealed its construction that the claims require “some method of deriving a tension measurement.”  The district court opined that “without having a reasonable estimate of the current tape tension, it is not possible to identify whether the tension is approaching or exceeding the limit values.”  Zipher argued that since the claim does not recite measuring tension, the district court’s construction would import a limitation into the claims from the specification and violate the mandate of Rambus Inc. v. Infineon Tech. AG, 318 F.3d 1081 (Fed. Cir. 2003) that “the claims need not recite every component necessary to enable operation of a working device.”  The majority again agreed with Zipher and drew an analogy with a car engine: “a claim to an engine providing motive power to a car should not be construed to incorporate a limitation for an exhaust pipe, though an engine may not function without one.”

Judge Newman dissented in part. She disagreed with the majority’s reliance on the “mandate” of Rambus.  According to Newman, the panel majority ignored “the paramount importance of the specification in claim construction.”  Citing a series of cases to support her position, Newman stated that she would hold that “while the invention is flexible as to how tension is measured, and permits measurement through indirect methods, some method of measurement is contemplated and required.”

This is the third time in 2011 that the Federal Circuit has been divided and reached contradictory decisions on the issue as to how to reconcile claim language with the description in the specification.  The other two cases are Arlington Industries Inc. v. Bridgeport Fittings Inc.,632 F.3d 1246 (Fed. Cir. 2011), and Retractable Technologies Inc. v. Becton, Dickinson & Co., 653 F.3d 1296 (Fed. Cir. 2011).  J. Lourie and CJ. Rader were on opposite sides of the issue in these two cases, each in turn penning the majority opinion in one and the dissenting opinion in the other.  The Federal Circuit rejected the opportunity to rehear Retractable en banc in Retractable Technologies Inc. v. Becton Dickinson & Co., 659 F.3d 1369 (Fed. Cir. 2011), before it was presented with the same problem in the present case.

Take-away points:  Patent prosecutors should use the same word in a consistent manner throughout the whole application to avoid ambiguity.  What’s more, contrary to good general practice in writing, it is probably preferable to stick with the same word when expressing the same idea in patent applications.

Federal Circuit Defines Language of 35 U.S.C. § 271(e)(2) in a Hatch-Waxman Controversy

By Kevin M. Repper

In the case of AstraZeneca Pharmaceuticals LP v. Apotex Corp., No. 2011-1182 (Fed. Cir. 2012), Astrazeneca holds the rights to three patents related to the drug rosuvastatin calcium. Two of the three patents involve methods of using rosuvastatin compounds. One of which is a method of treating heterozygous damilial hypercholesterolemia (HeFH) and the other is a method of lowering cardiovascular disease risk for individuals who have normal cholesterol levels but demonstrate elevated circulating C-reactive protein (CRP). The method of use patents expire in 2021 and 2018, respectively.

Apotex, a generic pharmaceutical manufacturer, filed an Abbreviated New Drug Applications (ANDA) with the FDA seeking to market generic rosuvastatin for treating hypercholesterolemia (HoFH) and hypertriglycerdemia while omitting or “carving out” patented indications directed towards the treatment of HeFH and elevated CRP. Under the Hatch-Waxman Act, the filed ANDA must provide a list of all the related patents and if the method of use patents do not claim a use for which the applicant is seeking approval, an applicant may instead submit a statement under 21 U.S.C. § 355(j)(2)(A)(viii) averring that the ANDA excludes all uses claimed in the patent (Section viii). Apotex properly submitted the Section viii statements regarding Astrazeneca’s method patents.

Astrazeneca brought an action against Apotex alleging that Apotex’s ANDAs, as filed, violated § 271(e)(2) because the use of the drug is claimed in AstraZeneca’s method patents. According to § 271(e)(2),  “it shall be an act of infringement to submit an application…for a drug claimed in a patent or the use of which is claimed in a patent…if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug…claimed in a patent of the use of which is claimed in a patent before the expiration of such patent.” Astrazeneca argued that because their method patents claim any use of the drug, Apotex’s filed ANDA falls within the meaning of § 271(e)(2) and has infringed on their patents.

However, the court took a different stance. The court understood the term “use” from § 271(e)(2) to mean “the use listed in the ANDA.” Accordingly, the court held that it is not necessarily an act of infringement under § 271(e)(2) to submit an ANDA for a drug if just any use of that drug is claimed in a patent; rather, infringement of method claims under § 271(e)(2) requires filing an ANDA wherein at least one “use” listed in the ANDA is claimed in a patent. The court concluded that there can be no cause of action for infringement of a method of use unless the accused ANDA actually seeks approval for a patented indication.

An obvious solution for patent holders is to patent the drug itself. Astra has a patent that claims rosuvastatin compounds and pharmaceutical compositions containing such compounds, however the patent was due to expire years prior to the expiration of the method patents. Also, Apotex is challenging the validity of the composition patent in another co-pending litigation. Other solutions may include determining as many methods of treatment for as many diseases as you can and patenting those methods. This however takes a lot of time and a lot of resources.

Another possible option would be to patent the method of what the drug actually does in the body in addition to the disease that the drug treats. For example, rosuvastatin calcium serves to reduce circulating cholesterol by competitively inhibiting 3-hydroxy-3-methylglutaryl-CoA reductase. A patentable method claim of rosuvastatin calcium could have been a method of inhibiting 3-hydroxy-3-methylglutaryl-CoA reductase.  This method claim would likely be broad enough to cover most methods of treatment of any particular disease, especially if the diseases were listed the specification. Therefore, the court may have ruled that the use was in fact covered by the claims.

Vexatious Plaintiff Is Slapped With $4.5M In Fees

By Zi Wang

In MarcTec LLC v. Johnson & Johnson, 664 F.3d 907 (Fed. Cir. 2012), the Federal Circuit affirmed the district court’s holding that the case is exceptional and awarded a total amount of more than $4.5 million in attorney and expert fees to the defendant.

Plaintiff MarcTec filed suit against Cordis, a subsidiary of Johnson & Johnson, alleging the latter of infringing the ‘753 and ‘290 patents. The two patents-in-suit are directed at surgical devices and implants with a therapeutic-agent-containing coating bonded by heat.  According to the prosecution history, in order to overcome the PTO’s rejection over the ‘417 patent, the patentee highlighted the fact that the coating is to be bonded by heat.  The patentee also tried to distinguish his invention from stents during prosecution for similar reasons.  The allegedly infringing product in question is the Cypher stent manufactured by Cordis.  The product utilizes the technology disclosed by the ‘417 patent, the same patent plaintiff distinguished and disclaimed to obtain allowance for his own patents. The Cypher’s coating is sprayed onto the stent at room temperature and bonds to it at room temperature. Continue reading

Federal Circuit Limits Domestic Industry Requirement For Licensors

In Mezzalingua Assocs., Inc. v. Int’l Trade Comm’n, 100 U.S.P.Q.2d 1462 (Fed. Cir. 2011), Mezzalingua d/b/a PPC manufactures cable connectors that are used to connect coaxial cables to electronic devices, such as cable television receivers.  PPC owns design patent, U.S. Patent No. D440,539 (“the ‘539 design patent”), which is for a design of one such connector.  PPC has granted only one license for the ‘539 design patent, which was executed in early 2004 between PPC and Arris International, Inc. at the conclusion of years of litigation.  Other than this license and its enforcement litigation, PPC does not use the ‘539 design patent. Continue reading

Federal Circuit considers boundaries of spoilation

In Hynix Semiconductor Inc. v. Rambus Inc., Nos. 2009-1299, 1347 (Fed. Cir. May 13, 2011), Hynix Semiconductor Inc. (“Hynix”) appealed the District Court of Northern California’s denial of Hynix’s motion to dismiss arising from Rambus Inc.’s (“Rambus) alleged spoliation of documents.

Hynix Semiconductor is a companion case to Micron Technology, Inc. v. Rambus Inc., No. 2009-1263, slip.op. (Fed. Circ. May 13, 2011) (“Micron II”). In Micron II the District Court of Delaware held that Rambus spoilated documents in dereliction of a duty to preserve and held Rambus’ patents unenforceable as a sanction. Both cases were decided contemporaneously by the Federal Circuit. Continue reading