On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from Syndax…
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/ Administrative Law, Health
Getinge, a Swedish public limited company, announced on September 11, 2024 that it completed acquisition of Paragonix Technologies, Inc., a U.S. company specializing in organ transport products and services. According to…
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/ Health, Mergers & Acquisitions, Science, Computers, & Technology
Before Reyna, Prost, and Schall. Appeal from the United States District Court for the Northern District of California. Summary: Claims are patent-eligible under 35 U.S.C. § 101 where the written description discloses improving…
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/ Intellectual Property, Science, Computers, & Technology
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing warnings…
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/ Administrative Law, Consumer Protection, Health
Congratulations on successfully trademarking your product or brand! Now it’s crucial to protect that investment through diligent trademark oversight and enforcement. This involves actively monitoring for, and taking appropriate…
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/ Business Organizations, Consumer Protection, Intellectual Property
Before Dyk, Reyna, and Stark. Appeal from the United States District Court for the Western District of Texas. Summary: When assessing patent eligibility under 35 U.S.C. § 101, combining two abstract ideas does not make either…
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/ Civil Procedure, Communications & Media Law, Intellectual Property, Science, Computers, & Technology
Before Dyk, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: An expert witness can testify from the perspective of a POSITA at the time of the invention even if they did…
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/ Civil Procedure, Intellectual Property, Science, Computers, & Technology
Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional language…
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/ Civil Procedure, Intellectual Property, Science, Computers, & Technology
Today Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) introduced the Patent Eligibility Restoration Act (PERA), bipartisan legislation mirroring a proposed law introduced last year by Senators Thom Tillis (R-NC) and…
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/ Constitutional Law, Intellectual Property, Science, Computers, & Technology
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,…
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/ Administrative Law, Health, Science, Computers, & Technology
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456 (D…
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/ Civil Procedure, Health, Intellectual Property
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability…
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/ Administrative Law, Health, Science, Computers, & Technology
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological…
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/ Administrative Law, Health, Intellectual Property
Medical device companies are often well versed in prosecuting multiple patents within a single “family.” Indeed, such families are often of significant value to early stage (and later stage) medical device companies. But a…
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/ Business Organizations, Civil Procedure, Intellectual Property, Science, Computers, & Technology
Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Colorado. Summary: Awarding attorneys’ fees may be an abuse of discretion if the court relies on factors that should be given…
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/ Business Torts, Civil Procedure, Intellectual Property
