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Supreme Court of the United States › Today's Popular Updates › Pharmaceutical Patents

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 -
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

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

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The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

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In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

Mintz - Intellectual Property Viewpoints

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

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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

Saul Ewing LLP

Amgen v. Sanofi Ruling: Supreme Court Upholds Existing Legal Framework for Patent Enablement

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​On May 18, 2023, the Supreme Court unanimously affirmed the Federal Circuit's decision, Amgen Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021), that the claims of two of Amgen's patents were invalid for lack enablement. The...more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

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In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...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

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Renders Decision in Amgen v. Sanofi: Three Takeaways

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The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Decides Amgen v. Sanofi; Status Quo Extended

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The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

Harris Beach PLLC

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

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In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

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A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

McCarter & English, LLP

License To Sell Kills Patent: Supreme Court Holds Confidential Sales May Invalidate Patents In Helsinn Healthcare S.A. V. Teva...

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Can a confidential agreement between a pharmaceutical company and a distributor constitute a patent-invalidating offer for sale of a pharmaceutical product, even if information about the product is never revealed to the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Amgen v. Sanofi

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The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a)....more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

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On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Locke Lord LLP

Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars

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In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Sandoz, Inc. v. Amgen, Inc.

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On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc., Nos. 15-1039, 15-1195, in which it held that (a) a manufacturer of a licensed biological product cannot obtain federal injunctive relief to enforce 42...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

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The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

Fenwick & West Life Sciences Group

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

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On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

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Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

K&L Gates LLP

Teva and Its Potential Impact on Patent Litigation

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The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not...more

Robinson & Cole LLP

Supreme Court Starts 2015 Off with Focus on Facts Shaping Intellectual Property Disputes

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The U.S. Supreme Court kicked 2015 off with an intellectual property bang, issuing two important rulings earlier this week. Both decisions focus on the facts underpinning intellectual property disputes—who decides them and...more

Foley & Lardner LLP

U.S. Supreme Court Modifies Federal Circuit's Standard of Review for Claim Construction in Teva v. Sandoz

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On January 20, 2015, resolving a long debated issue, the U.S. Supreme Court set aside the Federal Circuit’s de novo review of every aspect of a lower court’s claim construction decision, rejecting that form of review where...more

McCarter & English, LLP

Supreme Court Refines the Federal Circuit’s Standard of Review for Claim Construction

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The Federal Circuit’s high rate of reversal of district court claim constructions is well documented. The de novo standard of review applied by the Federal Circuit to all aspects of claim construction has played a large part...more

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