Tagged: Biotech / Biotechnology
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...
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...
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...
