Gibbons Law Alert

Gibbons Law Alert

Category: Pharmaceuticals

Pending Patent Legislation: What to Expect if It Passes

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Posted in Pharmaceuticals

On October 9, 2025

In 2025, Congress is occupied with serious legislative issues, among which are some pending patent issues. Time will tell if these pending pieces of patent legislation, some of which have been pending for a year or more, will see the light of day in the current Congressional Session. However, it is worth at least taking a look at these proposed pieces of legislation to determine and understand how the patent laws may be affected by their potential passage. There are at least four pieces of proposed patent legislation that are pending: The ETHICS Act (Eliminating Thickets to Increase Competition Act)[1] This legislation was introduced with bipartisan support from Senators Peter Welch (D-VT), Josh Hawley (R-MO), and Amy Klobuchar (D-MN) and basically limits the number of drug patents that can be asserted by the patent holder of the drug patents. This Act would apply to Abbreviated New Drug Application (ANDA) or 505(b)(2) or biosimilar drug applications (BLA) litigation. The Act states that a person who brings a patent infringement action under 35 U.S.C. section 271 (e), described in subparagraph (B) (generic or biosimilar), can only assert one patent per PATENT GROUP.  A PATENT GROUP is defined as meaning two or more commonly owned patents or patent applications subject to a terminal disclaimer. If passed, this Act...

DNJ Court Denies Motion to Amend Invalidity and Non-Infringement Contentions Citing Lack of Diligence

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Posted in Pharmaceuticals

On June 13, 2025

In IBSA Institut Biochimique SA v. Accord Healthcare, Inc., the United States District Court for the District of New Jersey recently denied Accord Healthcare, Inc.’s (“Accord”) motion seeking leave to amend its Invalidity and Non-Infringement Contentions, finding that Accord did not establish the diligence required to support its motion. The case is a Hatch-Waxman litigation involving several patents covering IBSA’s Tirosint® product, which is used for the treatment of hypothyroidism. Motions to amend contentions require a showing of good cause under Local Patent Rule 3.7. In considering Accord’s motion, the court noted that diligence is the “key factor” that it considers when deciding a motion to amend contentions. And, courts must consider both whether the party seeking to amend was diligent in moving to amend upon discovery of new prior art and whether the party was diligent in discovering the basis for the proposed amendment. With respect to Accord’s motion to amend its invalidity contentions, the court did not dispute that Accord was diligent in moving to amend upon the discovery of new prior art. But, the court did find that Accord was not diligent in discovering the bases for its proposed amendments, which were based on references that were publicly available and readily accessible to Accord for a significant amount of time before Accord...

District of Delaware Court Dismisses, with Prejudice, Claims Withdrawn Pursuant to Case Narrowing Order

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Posted in Pharmaceuticals

On November 18, 2024

In Exeltis USA Inc. v. Lupin Ltd., the United States District Court for the District of Delaware recently ruled, over the plaintiffs’ objection, that claims dismissed by the plaintiffs in response to the District Court’s case narrowing order were dismissed with prejudice. Exeltis is a Hatch-Waxman litigation involving patents covering Exeltis’s SLYND® product. During the case, the court entered a case narrowing order that required the plaintiffs to reduce the number of asserted claims and the defendants to reduce the number of invalidity defenses. The parties complied with the order, and the plaintiffs then won at trial. Following trial, the plaintiffs argued that the claims dismissed pursuant to the court’s case narrowing order should be without prejudice based on “fundamental fairness.” The court disagreed, finding that fundamental fairness was best supported by the certainty that came with a dismissal with prejudice. This ruling appears to have created a split within the District of Delaware. In Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, 645 F. Supp. 3d 335 (D. Del. 2022), another Delaware Court held that claims withdrawn pursuant to the court’s case narrowing order were dismissed without prejudice. In light of the court’s ruling in Exeltis, plaintiffs in Hatch-Waxman cases in the District of Delaware should be aware of the risk that the court...

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...

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...

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...

Citing Need for Claim Construction, DNJ Court Denies Defendant’s Motion for Judgment on Pleadings

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Posted in Patent / Pharmaceuticals

On October 31, 2022

In Tolmar Therapeutics, Inc. v. Foresee Pharmaceuticals Co., Ltd., the United States District Court for the District of New Jersey recently denied the defendant’s motion for judgment on the pleadings, reasoning that the motion could not be decided without claim construction. The plaintiff alleges that the defendant’s product CAMCEVI® infringes the plaintiff’s patent, which also covers the plaintiff’s Eligard® product. Both products are approved prostate cancer medications. Claim 1 of the patent-in-suit is directed to a controlled release composition that includes a polymer with an alkane diradical that comprises “about 4 to about 8 carbons.” The defendant moved for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c) arguing (1) that the term “about 4 to about 8 carbons” in the patent-in-suit meant that the defendant’s use of 12 carbons (see, e.g., ECF No. 39 at 1) in its product could not literally infringe; and (2) that the plaintiff could not rely on the doctrine of equivalents, because the use of the term “about” in the claims limited the applicability of the doctrine of equivalents and because of the disclosure-dedication rule. In denying the defendant’s motion, United States District Judge Evelyn Padin reasoned that both the plaintiff’s literal infringement and doctrine of equivalents theories required the court to construe the term “about 4...

DNJ Court Denies Request for Early Summary Judgment Finding Motion Made Mid-Fact Discovery Premature

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Posted in Patent / Pharmaceuticals

On September 29, 2022

In Metacel Pharmaceuticals LLC v. Rubicon Research Private Limited, the United States District Court for the District of New Jersey recently denied the defendant’s request for leave to file a motion for summary judgment with respect to patent infringement. The plaintiff opposed the motion arguing that discovery was ongoing, and, in particular, the defendant had not yet produced certain samples necessary for the plaintiff to evaluate infringement. The plaintiff also argued there were also claim construction issues in the case that had not been resolved. The defendant’s motion was filed approximately two months before the parties’ opening claim construction briefs were due and, per the case’s scheduling order (ECF No. 25), fact discovery was to conclude 30 days after the court’s claim construction opinion. Agreeing with the plaintiff’s position, United States Magistrate Judge José R. Almonte found the defendant’s motion was “premature” and concluded that motions for summary judgment should be filed after claim construction. Gibbons will continue to monitor and report developments in Hatch-Waxman litigation in the District of New Jersey.

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