Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Litigation

Taxing Patents – Axing Innovation

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Posted in USPTO

On November 7, 2025

In July 2025, The Wall Street Journal reported that it had received information indicating that the Department of Commerce was considering taxing U.S. patents. This is an unexpected and novel idea that has never been undertaken in the United States. Since then, commentators have expressed their opinion that this proposal would be detrimental to the innovation seen in the U.S.  The present article summarizes those opinions. As some background to this proposal, U.S. patent owners currently are obligated to pay maintenance fees on their patents in order to keep those patents active. On an annual basis, the United States Patent and Trademark Office (USPTO) collects about $4.5 billion in these maintenance fees, as well as other fees collected by the USPTO for filing a patent application, prosecuting that patent application, and issuing a patent. Additional USPTO fees associated with patent office procedures include Post-Grant Reviews (PGR) and Inter Parties Review (IPR) related fees. Thus, the USPTO does accumulate many dollars for the use of its role in furthering innovation through the U.S. patent system. This revenue is responsible for the USPTO being one of the government’s self-funded agencies. In fact, one of the arguments being levied against this proposed new tax is that the USPTO would then be funded well above what is needed for the USPTO to be self-funded. Commerce...

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...

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...

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