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The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more
The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more
On May 13—and more than ten years after Federal Trade Commission v. Actavis, the leading U.S. Supreme Court case on reverse payment settlements—the Second Circuit for the first time weighed in on whether (and how) antitrust...more
Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more
As we continue to assess the ripple effects from the Supreme Court's denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of...more
The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...more
It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement...more
The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more
This month, the Supreme Court issued its opinion in Amgen Inc. v. Sanofi, the closely watched case involving the enablement standard for patent claims, particularly as applied to functionally defined genus claims. Genus...more
In May, the Supreme Court of the United States handed down its decision in Amgen Inc. v. Sanofi, which addressed the statutory enablement requirement for patents. The decision is consistent with ongoing efforts to strike a...more
What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more
A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more
On May 18, 2023, the U.S. Supreme Court handed down a unanimous decision in the much-anticipated Amgen Inc. v. Sanofi case. See 598 U.S. ___, No. 21-757, 2023 WL 3511533 (May 18, 2023). In so doing, the Court maintained the...more
On May 19, 2023, the Supreme Court in Amgen v. Sanofi, No. 21-757, unanimously held that the claims of two Amgen patents, both directed to a genus of potentially millions of antibodies, are invalid because the patents failed...more
Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) - The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more
The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more
The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...more
The legal standard for enablement – the statutory requirement under 35 USC § 112 that a patent must enable those skilled in the art to “make and use” the claimed invention – remains unchanged after the US Supreme Court...more
Summary - In Amgen v. Sanofi, the Supreme Court unanimously affirmed the District of Delaware and Federal Circuit findings that Amgen’s functionally defined patent claims to a class of therapeutic antibodies are invalid as...more
Executive Summary - In Amgen Inc. v. Sanofi, the United States Supreme Court affirmed the lower courts’ judgment that the asserted claims of U.S. Patent No. 8,829,165 (“the ’165 Patent”) and U.S. Patent No. 8,859,741 (“the...more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
On May 18, the Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The ruling affirmed the Federal Circuit’s reading of the Patent Act’s...more
A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more