Generic firms are increasingly attacking innovators' drug patents before they expire--even, in some cases, the previously invulnerable active ingredient patents--and courts are supporting some of their tactics. The primary means used by generic firms for mounting this offensive campaign: Paragraph IV filings, which claim that the innovator's patent is invalid or won't be infringed. It's a tactic that generic firms are relying on more heavily. While the details of each patent dispute differ widely, one thing is clear: generic firms are finding successful ways to maneuver around existing innovator patents. They are winning in court almost 75% of the time after litigating Paragraph IV challenges. In particular, the Pfizer/Reddy case exposes how generic firms can and will poke holes in an innovator's intellectual property. Notwithstanding that Pfizer had explored and patented the derivative salts of Norvasc, this case highlights how the timing of certain types of patents may be crucial. In addition, it may motivate pharmaceuticals to more comprehensively explore alternative forms and formulations of their compounds. Besides building a portfolio of strong patents, fully exploring the form and formulation space could result in a secondary benefit: discovering a superior product.
By Heather Slowik
Generic firms are increasingly attacking innovators' drug patents before they expire—even, in some cases, the previously invulnerable active ingredient patents—and...
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.
Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.
While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.
