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Patent Infringement Pharmaceutical Industry Supreme Court of the United States

Jones Day

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

Jones Day on

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

White & Case LLP

A Decade of FTC v. Actavis: The Reverse Payment Framework is Older, but Are Courts Wiser in Applying It

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In 2013, the United States Supreme Court significantly changed the landscape of patent settlements in the pharmaceutical industry with its FTC v. Actavis, Inc. decision. In Actavis, the Court held that certain types of...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

Axinn, Veltrop & Harkrider LLP

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

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

Axinn, Veltrop & Harkrider LLP

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

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

Axinn, Veltrop & Harkrider LLP

GSK v. Teva's Continued Ripple Effects

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

Wilson Sonsini Goodrich & Rosati

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

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

Axinn, Veltrop & Harkrider LLP

Axinn IP Update: Supreme Court Denies Cert. in Skinny Label Case, but the Impacts from GSK v. Teva Continue

Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more

Foley Hoag LLP

The Fate of the Skinny Label: Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC

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On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

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

Amgen Inc. v. Sanofi Live Coverage

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

Saul Ewing LLP

Supreme Court Grants Cert in Amgen v. Sanofi on Question of Enablement

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​On November 4, 2022, the Supreme Court granted certiorari in Amgen v. Sanofi, No. 21-757, agreeing to review, “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Grants Certiorari in Amgen v. Sanofi

High Court Will Tackle Proper Enablement Standard - Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...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

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

Troutman Pepper Locke

Supreme Court Denies Review In Three Section 101 Cases

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On January 13, 2020, the U.S. Supreme Court denied certiorari in the following cases...more

Sunstein LLP

March 2019 IP Update - Secret Sales Trigger the On-Sale Bar under the Patent Statute, Says the Supreme Court

Sunstein LLP on

Before enactment of the America Invents Act (AIA) in 2011, it was understood that an inventor’s secret commercialization of an invention through sale or use can operate like prior art against that inventor’s subsequent patent...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

Latham & Watkins LLP

Supreme Court Says a Secret Sale Qualifies as Prior Art Under AIA

Latham & Watkins LLP on

Helsinn confirmed that the AIA did not alter the meaning of the “on-sale” bar. In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc, the Supreme Court addressed whether a confidential sale of an invention to a...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

Fish & Richardson on

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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