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Supreme Court of the United States › Patents › Pharmaceutical Industry

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

Proskauer - Minding Your Business on

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

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

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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

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

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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

Manatt, Phelps & Phillips, LLP

Supreme Court Holds Invalid Cholesterol Drug Patent That Covered Millions of Undisclosed Antibodies

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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

Axinn, Veltrop & Harkrider LLP

Large and Unjustified: Second Circuit Clarifies Pleading Requirements in Reverse Payments Cases

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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

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

BakerHostetler on

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Foley & Lardner LLP

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

Foley & Lardner LLP on

Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

Axinn, Veltrop & Harkrider LLP

Vanda Strikes Out at the Supreme Court

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Two weeks ago we discussed Vanda Pharmaceuticals’ ambitious cert petition asking the Supreme Court to discontinue the “reasonable expectation of success” standard for patent obviousness that for decades has been a mainstay of...more

Kramer Levin Naftalis & Frankel LLP

Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

Kramer Levin Naftalis & Frankel LLP on

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

Axinn, Veltrop & Harkrider LLP

Clarity May Be Around the Corner for Antitrust Scrutiny of Reverse Payment Settlements

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In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more

McDonnell Boehnen Hulbert & Berghoff LLP

In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

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Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more

Mintz - Intellectual Property Viewpoints

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Mintz - Intellectual Property Viewpoints on

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Smith Anderson

Stroke of Genus: Amgen Inc. v. Sanofi

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Buckingham, Doolittle & Burroughs, LLC

Amgen Ratifies CAFC’s Requirement to Enable a Claim’s Full Scope

Buckingham, Doolittle & Burroughs, LLC on

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

Axinn, Veltrop & Harkrider LLP

Supreme Court confirms full scope enablement standard in Amgen v. Sanofi

Axinn, Veltrop & Harkrider LLP on

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

Dinsmore & Shohl LLP

The More You Claim, The More You Must Enable: SCOTUS Delivers Amgen v. Sanofi Opinion

Dinsmore & Shohl LLP on

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

BakerHostetler

Now What? The Supreme Court Addresses Enablement

BakerHostetler on

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

Burns & Levinson LLP

Amgen v. Sanofi and Points Beyond

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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

Carlton Fields

U.S. Supreme Court Unanimously Upholds the Federal Circuit’s Enablement Inquiry for Patent Claims

Carlton Fields on

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

Mintz - Intellectual Property Viewpoints

Supreme Court Unanimously Affirms Amgen Repatha® Antibody Patents Invalid for Lack of Enablement

Mintz - Intellectual Property Viewpoints on

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

Wilson Sonsini Goodrich & Rosati

Broad Genus Patents Must Be Enabled over the Full Scope of the Claims

Wilson Sonsini Goodrich & Rosati on

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

Dorsey & Whitney LLP

Supreme Court Upholds Patent Law Precedent

Dorsey & Whitney LLP on

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

Goodwin

Supreme Court Affirms Amgen Patents’ Invalidity in Closely Watched Enablement Case

Goodwin on

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

Cooley LLP

Supreme Court Affirmance in Amgen v. Sanofi Leaves Legal Standard for Patent Enablement Undisturbed

Cooley LLP on

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

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