Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Litigation

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.: Should “Intent” Be Reconsidered in 271(e)(1)?

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Posted in Customs / ITC / Patent / Pharmaceuticals

On April 9, 2024

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Appeal No. 22-1877 (Fed. Cir. March 25, 2024) Considerations of 271(e)(1), a 2-1 decision on appeal from a grant of summary judgement of non-infringement, addressed the question of whether 35 U.S.C. § 271(e)(1)’s safe harbor applies to the importation of two medical devices (transcatheter heart valve systems) into the U.S. for purposes of exhibiting the devices at a prominent medical conference that reported on the latest developments in cardiovascular medicine.

Baxalta Inc. v. Genentech, Inc.: The Federal Circuit Addresses Enablement After Amgen v. Sanofi

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Posted in Biotech / Patent / Pharmaceuticals

On September 28, 2023

Baxalta Inc., v. Genentech, Inc., Appeal No. 2022-1461 (Fed. Cir. Sept. 20, 2023) is another in the line of cases where claims to biological compounds are drafted functionally and raise §112 issues. This decision was an appeal from a grant of summary judgment that held certain claims of Baxalta’s ‘590 patent invalid for lack of enablement. The technology involved antibodies for enhancing the mechanism for blood clotting to treat patients with hemophilia type A. Claim 1 of the patent recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.” (Emphasis added). The claim is drafted functionally; it describes what the antibody does, rather than what the antibody actually is, and it encompasses any antibody capable of achieving that function. The specification of the ‘590 patent disclosed only 11 actual antibodies that fell within the claim’s scope, and referred to generally known methods for producing and screening antibodies. Relying on the analysis provided by the Supreme Court’s recent decision, Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the court found that the ‘590 patent’s specification simply provided a roadmap for one to engage in the same iterative, trial-and-error process that the inventors used to find their 11 antibodies. It did not identify any common...

PTAB Finds Service of Complaint for Infringement Without Exhibits Does Not Trigger 35 U.S.C. § 315(b) Time Bar

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Posted in USPTO

On September 25, 2023

In Lightricks Ltd. v. Plotagraph, Inc., the Patent Trial and Appeal Board (PTAB or “Board”) recently clarified the standard for what triggers the 35 U.S.C. § 315(b) time bar for filing a petition for inter partes review. Section 315(b) requires that petitions for inter partes review be filed with the Board within “[one] year after the date on which the petitioner … is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b). In Lightricks v. Plotagraph, the Patent Owner (“PO”) argued that the petition at issue was filed outside of the one-year anniversary of the service of its complaint for infringement in the related federal district court action and was therefore time barred. The PO had attempted to serve its complaint at two of the petitioner’s office locations more than one year before the petition was filed. However, the exhibits to the complaint were not included in either of those two service attempts. The petitioner argued that the date of service for purposes of § 315(b) was the date that it filed a waiver of service with the district court, and that because the waiver of service was filed less than one year before the petition was filed, the petition was not time barred under § 315(b). The Board agreed with...

The District of Delaware Adopts the Federal Circuit’s Factors in Rejecting Regulatory Bar in a Protective Order

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Posted in Pharmaceuticals

On August 30, 2023

In Amicus Therapeutics US, LLC v. Teva Pharmaceuticals USA, Inc., United States Magistrate Judge Christopher J. Burke rejected the defendants-generic drug manufacturers’ demand that a so-called regulatory bar be included in the parties’ proposed protective order. In denying the request, Judge Burke adopted the Federal Circuit’s approach as set forth in cases like In re Deutsche Bank Trust Co. Ams., 605 F.3d 1373 (Fed. Cir. 2010). Despite denying the defendants’ request, and while noting the rarity of courts ordering the inclusion of similar provisions in protective orders, Judge Burke explicitly left the door open to the possibility, emphasizing the highly fact-sensitive nature of these disputes. The defendants sought the inclusion of a regulatory bar that would preclude anyone who was granted access to information marked “Confidential” or “Highly Confidential” under the proposed protective order from participating in any FDA proceedings concerning migalastat (the drug at issue in the case), including by filing a citizen petition. In deciding under what factors to analyze this discovery dispute, Judge Burke identified two possibilities: (a) the Third Circuit’s Pansy factors, or (b) the Federal Circuit’s Deutsche Bank factors. The court and the parties agreed the latter should be applied because the Third Circuit’s Pansy factors generally concern whether information should be protected from intentional disclosure from the public, whereas...

District of New Jersey Grants Motion to Dismiss Inequitable Conduct Counterclaim and Strike Affirmative Defenses

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Posted in Patent

On May 19, 2023

In 2109971 Ontario Inc. d/b/a Xcella Furniture v. Best Deals Discount Furniture LLC, the United States District Court for the District of New Jersey recently granted plaintiff 2109971 Ontario Inc.’s (“Xcella Furniture”) motion to dismiss defendant Best Deals Discount Furniture’s (“Best Deals”) counterclaim for inequitable conduct as well as strike 29 of Best Deals’s affirmative defenses. The underlying case relates to Best Deals’s alleged infringement of a design patent related to articles of furniture. With respect to the inequitable conduct counterclaim, the district court found that Best Deals had failed to apply the correct legal standard for evaluating such a claim, which is that set forth in the Federal Circuit’s decision in Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326 (Fed. Cir. 2009). The district court noted that under Exergen, inequitable conduct “‘must be pled with particularity under Rule 9(b),’” which requires that the pleading “‘identify the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO.’” Id. at *5 (quoting Exergen, 575 F.3d at 1326-28). Best Deals, relying on cases from the District of Delaware that pre-dated Exergen, had argued that it needed only to “‘allege that there has been relevant prior art and acts sufficient to allege fraud.’” Id. at *4. The district court...

District of New Jersey Citing Litigation Tactics Orders Related Hatch-Waxman Cases to Be Tried Together

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Posted in Patent

On May 17, 2023

In Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., the United States District Court for the District of New Jersey recently ordered that two separate, but related, Hatch-Waxman cases must be tried together. The cases involve patents covering plaintiff Corcept Therapeutics, Inc.’s (“Corcept”) KORLYM® product for the treatment of Cushing’s syndrome. Each case involves two patents, all of which involve methods of treatment involving mifepristone. Defendant Teva Pharmaceuticals USA, Inc. (“Teva”), citing the similarities between the patents and issues in the two matters, submitted to the district court a proposed stipulation of judgment whereby the parties agreed that the outcome in the first case would govern the outcome in the second case. Corcept would not sign the stipulation. While it agreed that the validity issues between the two matters were identical, it disagreed that the infringement issues were the same and argued that the second matter would require additional discovery. The district court agreed with Teva, stating “Corcept’s decision to belatedly file [the second action] was of its own making and at its own peril.” (ECF No. 239 at 1.) And, the district court rejected Corcept’s argument that the case could have been resolved faster had Teva filed a declaratory judgment action when the patents in the second matter issued (the second set of patents...

Southern District of California Strikes Defendant’s Invalidity Theories and References for Failing to Comply With District’s Patent Local Rules

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Posted in Patent

On May 16, 2023

In Taction Technology, Inc. v. Apple Inc., the United States District Court for the Southern District of California recently granted plaintiff Taction Technology, Inc.’s (“Taction”) motion to strike portions of defendant Apple Inc.’s (“Apple”) amended invalidity contentions. The case is a patent infringement action that addresses the distinctions between discovery under the Federal Rules of Civil Procedure and contention disclosure requirements under a district’s local patent rules. In Taction, following the district court’s claim construction order, Apple served “Post Claim Construction Amended Invalidity Contentions” in which it alleged for the first time that two prior art references anticipate the asserted claims of two of the patents-in-suit and that the same prior art references satisfy a claim limitation at issue. Taction filed a motion to strike the two new prior art references. Apple raised multiple issues in opposition. First, Apple argued that the motion was not timely because it was not brought within the period to raise discovery disputes in the court’s case management order. The court rejected that argument because, in the Southern District of California, a challenge to a party’s infringement or invalidity contentions is not a “discovery dispute.” Second, Apple argued that the motion should be denied because it merely “supplemented” its invalidity contentions, as is allowed by Patent Local Rule 3.6. The...

Southern District of Florida Dismisses Patent Infringement Claims for Generalized Allegations and Declaratory Judgment Claims for Lack of Sufficient Immediacy

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Posted in Patent

On January 17, 2023

In Scilex Pharmaceuticals Inc. v. Aveva Drug Delivery Systems, Inc., Apotex Corp., and Apotex Inc., the United States District Court for the Southern District of Florida recently granted defendant Apotex, Inc.’s (“Apotex”) motion to dismiss various counts of the complaint. The case is a Hatch-Waxman litigation involving patents covering plaintiff Scilex Pharmaceuticals Inc.’s (“Scilex”) topical lidocaine patch ZTlido® and an ANDA that was filed by defendant Aveva Drug Delivery Inc. (“Aveva”). Apotex’s motion was based on three different grounds: (1) Rule 12(b)(2) for lack of personal jurisdiction; (2) Rule 12(b)(6) for the patent infringement counts of the complaint because Apotex was not the party that submitted the ANDA; and (3) Rules 12(b)(6) and 12(b)(1) of the declaratory judgment claims because Apotex did not submit the ANDA and/or because there was no immediacy to the controversy on claims for future infringement. See Reckitt Benkiser Inc. v. Watson Labs., Inc.-Fla., No. 09-60609, 2009 WL 10667836, at *2 (S.D. Fla. Oct. 13, 2009) (“The mere filing of a Paragraph IV certification constitutes an act of patent infringement . . .”). With respect to the first two grounds, the district court granted Apotex’s motion, but granted Scilex leave to amend the complaint with respect to the patent infringement claims. Apotex argued that the claims in the case were based...

Central District of California Court Grants Motions to Strike Previously Undisclosed Infringement and Invalidity Opinions and Exclude a Belated Rebuttal Expert Report

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Posted in Patent

On December 20, 2022

In Guangzhou Yucheng Trading Co., Ltd. v. Dbest Products, Inc., a patent infringement action in which the plaintiff, Guangzhou Yucheng Trading Co., Ltd.’s (“GYT”), sought a declaratory judgment that its “stair climber” portable shopping cart product does not infringe U.S. Patent No. 9,233,700 (“the ’700 Patent”), the court recently ruled on three motions relating to GYT’s expert witness, David G. Smith (“Smith”). In two of the motions, the defendant, Dbest Products, Inc. (“Dbest”), moved to exclude certain infringement and invalidity opinions offered by Smith, and in the third motion Dbest moved to exclude Smith’s rebuttal expert report. The court granted all three motions. With respect to infringement, Dbest argued that some of Smith’s opinions should be excluded because the opinions were based on claim construction arguments that were inconsistent with the court’s Claim Construction Order. The court agreed with Dbest and excluded Mr. Smith’s opinions as to four claim terms, because his opinions provided “narrowing constructions” that were inconsistent with the court’s construction of those terms. Id. at *10 (“An expert opinion that is contrary to or ignores a court’s claim construction is irrelevant and unhelpful to the trier of fact, and as such, is inadmissible and must be excluded.” (citations omitted)). The court did note that “experts ‘may introduce evidence as to the plain...

DNJ Court Grants Motion to Dismiss Based on Covenant Not to Sue

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Posted in Patent / Pharmaceuticals

On December 5, 2022

In Teva Branded Pharmaceutical Products R&D, Inc. v. Cipla Ltd., the United States District Court for the District of New Jersey recently granted the plaintiff, Teva Branded Pharmaceutical Products R&D, Inc.’s (“Teva”), motion to dismiss certain claims and counterclaims for lack of subject matter jurisdiction based on a covenant not to sue between Teva and defendant Cipla Ltd. (“Cipla”). The consolidated case is a Hatch-Waxman litigation involving several patents covering Teva’s Qvar® inhaler product. Originally, there were seven patents in dispute between the parties, but after Teva granted covenants not to sue for three of the patents to defendants Cipla and Aurobindo, the court entered stipulations and orders dismissing the parties’ claims and defenses as to those three patents. Thereafter, Teva provided defendants Cipla and Aurobindo each a covenant not to sue as to United States Patent No. 10,086,156 (“the ’156 patent”), another one of the original seven patents in dispute. Following the covenants not to sue, Teva and Aurobindo stipulated to the dismissal of the claims and counterclaims regarding the ’156 patent, but Teva and Cipla could not come to an agreement regarding the language for an order dismissing their respective claims and counterclaims. Consequently, Teva filed a motion to dismiss the claims and counterclaims relating to the ’156 patent. The court granted Teva’s...

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