The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical marketing. Central to this legal dispute are U.S. Patents 9,700,537 and 10,568,861, owned by Amarin, which describe methods of reducing cardiovascular risk by administering icosapent ethyl, a compound found in the drug Vascepa®. Vascepa® had initially received FDA approval for treating severe hypertriglyceridemia, a condition marked by high levels of triglycerides in the blood. However, Amarin’s continued research into the drug’s benefits led to an expanded FDA approval in 2019, allowing Vascepa® to be marketed for reducing cardiovascular risk in certain patient populations.Continue Reading Federal Circuit Provides Insight on Induced Infringement Claims in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.

The USPTO has published updated patent eligibility guidance (effective July 17, 2024) for AI-related inventions to help determine subject matter eligibility under 35 § U.S.C. 101. This guidance is timely as roughly 20% of all recent patent filings are AI related. It is important to note that based on prior guidance from February 2024, if an AI tool itself invents something, that is not patentable. Only inventions with significant human contribution are patentable. Thus, this does not preclude AI-assisted inventions. This February guidance was supplemented in April 2024 with AI guidance for practitioners and a request for comments on the impact of AI on certain patentability considerations, including what qualifies as prior art and the assessment of the level of ordinary skills in the art. The period for comments remains open until July 29, 2024.Continue Reading USPTO Issues AI Subject Matter Eligibility Guidance

In Dragon Intellectual Property LLC v. Dish Network L.L.C. No. 22-1621 (Fed. Cir. May 20, 2024), the Federal Circuit clarifies the standard for “exceptional” cases under 35 U.S.C. § 285. The case concerns attorneys’ fees and the application of § 285 attorneys’ fees to inter partes review (“IPR”) proceedings, and addresses attorney liability for § 285 fee awards.Continue Reading The Federal Circuit Interprets the Application of 35 USC § 285 and Attorney’s Fees

In Intellectual Tech v. Zebra Technologies 2022-2207 (Fed. Cir. May 1, 2024), the Federal Circuit addressed a district court’s determination that the patent owner plaintiff lacked constitutional standing because it was divested of all exclusionary rights over the patent at issue upon default.Continue Reading Understanding Constitutional Standing: A Review of a Recent Federal Circuit Decision

In Virtek Visions international ULC v. Assembly Guidance Systems, Inc., DBA Aligned Vision Nos. 2022-1998, 2022-2022 (Fed Cir. Mar. 27, 2024), the Federal Circuit reviewed the Patent Trial and Appeal Board’s findings regarding patent obviousness for U.S. Patent No. 10,052,734. Specifically, appellate review of the Board’s findings related to the motivation to combine analysis.Continue Reading Conclusory Assertions Won’t Cut It: Federal Circuit Provides Further Insight into the Motivation to Combine Analysis

In SnapRays, d/b/a SnapPower v. Lighting Defense Group, the Federal Circuit found that a district court could exercise personal jurisdiction over a declaratory judgment defendant based on the defendant’s sending an Amazon Patent Evaluation Express (APEX) agreement to the declaratory judgment plaintiff alleging that the plaintiff infringed the defendant’s patents by selling products through Amazon into the state.Continue Reading Federal Circuit Finds Personal Jurisdiction in an Amazon Product Dispute

Dearest Gentle Reader, it seems that the scandalous allure of counterfeit goods has infiltrated our esteemed society with alarming frequency. Behind the shimmering facade of the finest of marketplaces, whispers abound of false jewels, imitation gowns, and even counterfeit carriages parading as the genuine article. One cannot help but ponder the lengths some would go to deceive, tarnishing the honor of reputable brands and defrauding unsuspecting patrons who seek nothing more than authenticity in their purchases.Continue Reading What Lady Whistledown Can Teach Us About Anti-Counterfeiting

Allegations in a complaint may be insufficient to raise a factual dispute under Step 2 of Alice when a patent’s specification contradicts those allegations by using the claimed technology in a way that demonstrates a person of ordinary skill in the art would have viewed the technology as routine, conventional, or well-known.Continue Reading Alice Step 2 May be Satisfied by a Patent’s Description and use of Claimed Technology

Quantum computing, a field that harnesses quantum physical phenomena such as superposition and entanglement to perform complex computational tasks, is an emerging technology area. The uncertainties regarding the feasibility of technical features and the knowledge possessed by those of ordinary skill in the art in this area give rise to interesting enablement questions.Continue Reading PTAB Rulings Shed Light On Quantum Computing Patents

In Maxell, Ltd. v. Amperex Technology Limited, 2023-1194 (Fed. Cir. Mar. 6, 2024), the Federal Circuit reaffirms that a patent claim that includes narrowing limitations requiring only some elements of a Markush group recited in the same claim are not indefinite under Section 112 so long as the claim, when read as a whole, is internally consistent and supported by the specification.Continue Reading Federal Circuit Finds that a Narrowing Claim Limitation that Expressly Requires Optional Elements of a Markush Group from the Same Claim is Neither Contradictory Nor Indefinite

In Ioengine, LLC v. Ingenico Inc. No. 2021-1227, 2021-1331, 2021-1332 (Fed. Cir. May 03, 2024), the case addresses the patentability/validity of three patents. In particular, this case discusses the application of the printed matter doctrine during inter partes review, the treatment of newly introduced claim constructions on appeal, and the PTAB’s anticipation and obviousness determinations.Continue Reading Interpreting the Printed Matter Doctrine in Inter Partes Review