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More Lessons from Mumbai – Reflections on a Hatch-Waxman and PIV Litigation Panel Discussion

Reflecting back on our time at the 13th Annual Pharma IPR Conference in Mumbai, there was a lively discussion during the panel that I moderated on Industry Insights on Hatch-Waxman and Paragraph IV Litigation. The legal issues facing generic pharmaceutical companies are constantly in flux, and it was interesting to receive insights from the panelists – Gautam Bakshi, Head & Patent Counsel – Intellectual Property Management at Unichem Laboratories, Kaushal Joshi, Sr. Director IP & Legal at Kashiv BioSciences, and Madhav Trivedi, Associate Director IPR at Arcolab Private Ltd (a Strides group company).

Induced infringement issues and labeling carveouts following GSK v. Teva are always hot topics at pharmaceutical patent conferences. The panelists explained that, when facing method-of-use patents, their internal teams always start by evaluating whether it is possible to avoid such patents by carving out indications or language from their proposed product labels. However, such evaluations are multi-faceted and require not only an evaluation of the patent infringement issues by IP counsel but coordination with regulatory personnel to ensure that any proposed labeling carveouts will actually receive approval by FDA. Of course, coordinating such an evaluation with U.S. legal counsel experienced with both patent issues and the FDA regulatory regime is of paramount importance.

Another hot topic involved the value of Section 112 defenses of enablement and written description following last year’s Supreme Court decision in Amgen v. Sanofi. Although that case involved a patent directed to antibodies, its impact can be felt in cases involving both small molecules and biologics. Section 112 defenses are showing up more prominently in pharmaceutical cases, and the interplay between obviousness and Section 112 defenses need to be carefully choreographed in cases, especially for the experts who will be addressing such issues in their reports and at trial.

The panel also discussed the importance of the 180-day generic marketing exclusivity period. 180-day exclusivity has been credited with encouraging prompt challenges to brand company patents and speeding the entry of generic competition. That being said, the panel also highlighted the role that settlements entered by first applicants can have in discouraging later applicants from advancing their patent challenges, especially when most settlement agreements include “most favored nations” clauses and entry date acceleration clauses. The panel again stressed the importance of having counsel experienced in both patent and FDA issues in order to deal with the 180-day exclusivity period and settlement issues, enabling companies to bring their products to market in the most efficient and profitable manner.

It is always interesting to obtain industry perspectives on the important issues that we work on every day, and I am appreciative of the panelists for their work in preparing for the conference and for their thoughtful comments. These perspectives will enable us to more effectively assist clients in navigating the complex patent and FDA issues faced by generic and biosimilar companies. 


intellectual property, fda, generics, patents, pharma, regulatory