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Patent Litigation

A&O Shearman

Patents and politics part 2: Director Squires administers an “America First IP agenda”

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In the first installment of patents and politics, we reported that the United States was potentially entering into an era of IP policy driven by President Trump’s America First rhetoric. In March, Mr. John Squires,...more

Knobbe Martens

Reap What You Sow: Industry-Specific Applications of Data Processing Do Not Survive § 101

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AGI SURETRACK LLC v. FARMERS EDGE INC. - Before Moore, Mayer, and Lourie. Appeal from the District of Nebraska. Patents claiming data collection, processing, and transmission using generic computer components are...more

Fish & Richardson

ITC Q1 2026 Round-Up: Domestic Industry, Redesigns, and Infringement Analysis

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The first quarter of 2026 saw several meaningful Section 337 decisions from the U.S. International Trade Commission (“Commission”). These decisions addressed the domestic industry requirement, the impact of redesigned...more

BakerHostetler

Unanimous Court Resets Inducement Landscape, Tightens Pleading Standard

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The Supreme Court just handed generic manufacturers – and really, all patent defendants – a major win in Hikma v. Amarin, unanimously reversing the Federal Circuit and tightening the standard for induced infringement under §...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Supreme Court’s Unanimous Ruling in Hikma v. Amarin: A Game-Changer for Skinny Label Strategies

The pharmaceutical industry has been watching Hikma Pharmaceutical USA Inc. v. Amarin Pharma, Inc. (No. 24-889) closely for its potentially sweeping implications for generic drug competition, as discussed in our prior posts –...more

McDermott Will & Schulte

E-I-E-I-No patents for data harvesting

Addressing patent eligibility and attorneys’ fees, the US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that five farming data patents were directed to patent-ineligible subject matter, but...more

McDonnell Boehnen Hulbert & Berghoff LLP

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (2026)

In a decision that, in retrospect, is not surprising (in view of the haste with which the Court took up the case after granting certiorari; see “Solicitor General Proves Persuasive; Supreme Court Grants Hikma’s...more

Venable LLP

Supreme Court Clarifies Standard for Pleading Inducement of Patent Infringement in Hikma v. Amarin

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On June 4, 2026, a unanimous Supreme Court in Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, clarified the standard for pleading induced patent infringement under 35 U.S.C. § 271(b). ...more

Venable LLP

aBLA Resubmissions: Xbrane’s Xlucane (ranibizumab) and Alvotech’s AVT05 (golimumab) and AVT06 (aflibercept)

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On June 3, 2026, Xbrane announced the resubmission of its aBLA for Xlucane (ranibizumab), a proposed biosimilar of Genentech’s Lucentis® (ranibizumab) after receiving a second Complete Response Letter (CRL) from the FDA in...more

Womble Bond Dickinson

What the Supreme Court’s Latest Decision on Skinny Labeling Means for Branded Drug Manufacturers

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On June 4, 2026 in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the U.S. Supreme Court issued a unanimous decision that materially recalibrates inducement analysis in the context of Section viii carve-outs....more

Stradling Yocca Carlson & Rauth

You Had Your Chance: Director Squires Slams the Door on Second-Bite IPR Petitions

Background - In a precedential Director discretionary denial issued May 14, 2026, USPTO Director John A. Squires denied institution of inter partes review in Magnolia Medical Technologies, Inc. v. Kurin, Inc., holding that...more

McDonnell Boehnen Hulbert & Berghoff LLP

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2026)

The measurement of the hydrogen ion concentration in an aqueous solution is represented (on a logarithmic scale) as the pH, wherein water under ambient conditions (a temperature of 25°C) has a neutral pH of 7 and the solution...more

Fitch, Even, Tabin & Flannery LLP

Beyond Skinny Labels: Supreme Court Clarifies Limits of Induced Infringement Claims

On June 4, in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the Supreme Court unanimously reversed the Federal Circuit, holding that a complaint for induced infringement must “plausibly allege” that the generic drug...more

Bradley Arant Boult Cummings LLP

One Question Too Few: A Win on Eligibility Undone by the Verdict Form

In Ollnova Technologies Ltd. v. ecobee Technologies ULC, the Federal Circuit handed Ollnova a string of doctrinal wins — three of its four patents cleared the patent eligibility hurdle under 35 U.S.C. § 101 — only to throw...more

WilmerHale

Supreme Court Clarifies Pleading Standard for Induced Infringement in Hikma v. Amarin

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On June 4, the Supreme Court unanimously decided Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. This case concerns the requirements for induced infringement, specifically in the context of “skinny labels” for generic...more

Hogan Lovells

Supreme Court clarifies limits of induced infringement liability for skinny labels

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The U.S. Supreme Court has now issued its decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., unanimously reversing the Federal Circuit and narrowing the circumstances in which generic drug manufacturers may...more

A&O Shearman

First Jury Verdict For Private Plaintiffs In Pay-For-Delay Litigation Results In $885 Million Award

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On May 18, 2026, a jury in the U.S. District Court for the District of Massachusetts, in a case before Judge Myong J. Joun, returned a verdict finding a global pharmaceutical company liable for approximately $885 million in...more

Whiteford

Patent Fee-Shifting after mCom, Realtime and Dragon - What Changed in the Enforcement Calculus

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Patent enforcement has always required two decisions, not one. The first is the obvious question: can the patent owner prove infringement and survive the expected validity challenges? The second is the question that...more

Bradley Arant Boult Cummings LLP

6 Questions to Ask Before Filing an IPR Petition

On October 17, 2025, USPTO Director John Squires issued a memorandum announcing that he would be sole decision-maker for institution of inter partes review (IPR) and post-grant review (PGR) proceedings....more

Bradley Arant Boult Cummings LLP

Hikma v. Amarin and a Clarified Standard for Induced Patent Infringement Under 35 U.S.C. § 271(b)

In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (June 4, 2026), a unanimous Supreme Court has further clarified what it takes to plead — and ultimately prove — that a defendant induced another party to infringe a...more

Fenwick & West LLP

Supreme Court Clarifies ‘Skinny Label’ Induced Infringement Standard, Backing Generic Drugmakers

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The Supreme Court unanimously ruled in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc., No. 24-889, that a branded pharmaceutical company alleging induced patent infringement against a generic manufacturer must plausibly...more

Dinsmore & Shohl LLP

Supreme Court Clarifies Requirements for “Active Steps” in Induced Patent Infringement Claims

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Key Takeaways: Induced infringement requires clear affirmative conduct. Actions required by law, standard industry practices and omissions do not count as “active steps.”...more

Dinsmore & Shohl LLP

Interpreting pH in Pharmaceutical Patent Claims: Lessons from Actelion v. Mylan

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Key Takeaways - Leaving pH measurement conditions undefined let the court apply a default standard temperature, which defeated literal infringement...more

Fenwick & West LLP

Federal Circuit Vacates Smart Thermostat Verdict, Clarifies Jury Instruction and Verdict Form Requirements

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The Federal Circuit’s new precedential decision in Ollnova Technologies Ltd. v. ecobee Technologies ULC may have significant implications for how patent cases are tried, particularly in multi-patent disputes involving...more

A&O Shearman

Federal Circuit Affirms Indefiniteness Of "About" In Patent Claiming pH Range For Poultry Processing Method

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On May 4, 2026, the United States Court of Appeals for the Federal Circuit (Judges Lourie, Prost, and District Judge Burroughs) affirmed a decision of the United States District Court for the Eastern District of Arkansas...more

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