Recent Cases and Trends in U.S. Patent Litigation

At this webinar program, hosted by IP Essentia, Dr. Roshan Shrestha and Stephen Auten will discuss the most influential pharmaceutical patent rulings from 2025. These cases are shaping the future of patent litigation and prosecution strategy in the Hatch-Waxman and biologics landscapes. The discussion will cover how courts have addressed obviousness, enablement, claim construction, inducement, and post-expiration enforcement, as well as emerging policy trends influencing the industry.

Participants will gain practical insights into how these 2025 rulings redefine patent scope, litigation risk, and regulatory timing, and how practitioners can adapt prosecution and litigation strategies in light of emerging trends across small molecules and biologics.

The program will be held at 9:30 a.m. IST on November 3, 2025.

Cases to be discussed during this program are: 

• Purdue v. Accord – OxyContin® (oxycodone)
  Issue: The Supreme Court’s denial of certiorari leaves standing the Federal Circuit’s obviousness ruling and its nexus framework for secondary considerations.
• Bayer Pharma v. Mylan et al. – Xarelto® (rivaroxaban)
  Issue: The Federal Circuit found “clinically proven effective” to be a non-limiting phrase.  This may limit of the use of data from post hoc clinical success to support patentability.
• Novartis v. Torrent – Entresto® (sacubitril/valsartan)
  Issue: A precedential opinion holding that after-arising technologies need not be described or enabled to fall within valid claim scope.
• Biogen v. Genentech – Tysabri® (natalizumab)
  Issue: The district court ruled Biogen owes over $88 million in royalties for post-expiration sales of batches manufactured during patent life, spotlighting royalty obligations after patent expiry.
• Vifor v. Apotex – Injectafer® (ferric carboxymaltose injection)
  Issue: A twist on motion to transfer. Delaware court denied Apotex’s motion to transfer venue to New Jersey.
• Merck v. Aurobindo – Bridion® (sugammadex)
  Issue: The Federal Circuit resolved ambiguity in the patent term extension statute, holding that “the patent” refers to the original patent, not reissue, thus preserving Merck’s full PTE.
• HQ Specialty v. Amneal – Calcium Gluconate
  Issue: case involved correcting inventorship under §256, post trial motion practice and a Rule 59(e) motion to amend judgment.
• Novo Nordisk v. Mylan – Wegovy® (semaglutide)
  Issue:  Amendments made during prosecution can trigger prosecution history estoppel, leading the court to narrowly construe the claims ultimately paving the way for Mylan’s non-infringement ruling.