News & Analysis as of

Pharmaceutical Patents Supreme Court of the United States Appeals

DLA Piper

Purdue Appeals Federal Circuit Obviousness Decision to the Supreme Court

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Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

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On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2024 #3

Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more

McDermott Will & Schulte

Pay for Delay Is Sometimes Okay

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

McDermott Will & Schulte

PTO Continues to Wave Wands in Assessing Enablement

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

McDonnell Boehnen Hulbert & Berghoff LLP

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more

Haug Partners LLP

Baxalta’s Antibody Patent Held Invalid under Amgen’s Enablement Standard by the Federal Circuit

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In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more

McDermott Will & Schulte

Beware Enablement of Genus Antibody Claims

The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v....more

Haug Partners LLP

D.C. Circuit Dismisses FTC Antitrust Suit: Exclusive Pharma Patent Licenses Remain Permissible Under The Patent Act

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On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

A&O Shearman on

On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

McDermott Will & Schulte

New Technology Does Not Alter Enablement Rules

Exploring the applicability of its enablement law to life sciences, the Supreme Court of the United States issued a unanimous opinion, concluding that patent claims covering a genus of antibodies defined in part by functional...more

Bradley Arant Boult Cummings LLP

Is SCOTUS Looking to Change the Enablement Requirement for Patents?

The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more

McDermott Will & Schulte

Supreme Court to Consider Enablement Requirement

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The Supreme Court of the United States agreed to consider how much a patent must disclose in order to meet the enablement requirement under 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (Supr. Ct....more

White & Case LLP

Biogen rehearing denied: Is SCOTUS the next step?

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On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. ("Petition Denial"), in which a Federal Circuit...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

Harris Beach Murtha PLLC

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Shook, Hardy & Bacon L.L.P.

"Secret Sale" of Drug Counts as Prior Art in Patent Battle

On January 22, 2019, the U.S. Supreme Court affirmed the U.S. Court of Appeals for the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229 (Jan. 22, 2019)....more

McDermott Will & Schulte

Secret Sales Still Qualify as Prior Art Under AIA

Addressing whether the on-sale bar of America Invents Act (AIA) 35 USC § 102(a)(1) applies to confidential sales where specific details are not made public, the Supreme Court of the United States found that the post-AIA...more

Ward and Smith, P.A.

On-Sale Bar: Less clever way of saying, Happy Hour? Maybe. Important for Patent Protection? Yes.

Ward and Smith, P.A. on

If the term "happy hour" in this article's title caught your attention, you may be disappointed by what comes next. This article is actually about limitations on patent protection, which I would argue is just as...more

White & Case LLP

Supreme Court Says America Invents Act Did Not Alter On-Sale Bar

White & Case LLP on

Squib of Holding and Key Implication: The United States Supreme Court, in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., held on January 22, 2019 that "a commercial sale to a third party who is required to keep...more

McAfee & Taft

Gavel to Gavel: Supreme Court provides clarity

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Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more

Polsinelli

Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the...

Polsinelli on

The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act...more

Weintraub Tobin

Can Secret Sales Prohibit Patenting Your Invention?

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Prior to the Leahy-Smith America Invents Act (“AIA”), the patent statute (35 U.S.C. § 102(b)) prohibited patenting an invention that was “on sale in this country, more than one year prior to the date of the application for...more

Fish & Richardson

The “On Sale Bar” Remains a Trap for the Unwary

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Inventors should not delay the filing of their patent applications, and preferably should file within one year of any commercialization of the invention, as confirmed by the Supreme Court on January 22, 2019....more

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