In this Bloomberg Law article, “Generic, Biosimilar Maker’s Dual Patent Contests Still Safe,” David A. Manspeizer, partner in the New York office with more than 25 years of experience representing industry-leading, global pharmaceutical and biotechnology companies in complex patent litigation, was quoted.
But generic drugmakers’ ability to challenge brandname patents on dual tracks upsets laws designed to get lower-cost drugs on the market, Morrison & Foerster LLP partner and pharmaceutical and biotech patent litigator David A. Manspeizer told Bloomberg Law in an email.
‘‘I don’t think the issue is disruption of procedures, as much as it is balance,’’ said Manspeizer, who’s based in New York City. ‘‘Hatch-Waxman was a carefully crafted balance between the interests and needs of the branded and generic industries, and the public. That balance has shifted over the years since Hatch-Waxman was enacted, as the overall weakening of patent protections in the US has undermined that balance. The availability of IPR and PGR, with their lower burden of proof and different claim construction standard, have further shifted that balance.’’
The shift affects how much money gets spent on research and development of new drugs and the drug industry as a whole, Manspeizer said.
‘‘Because pharmaceutical R&D is so incredibly risky, undermining that carefully crafted balance, has, I believe, also resulted in accelerated industry consolidation,’’ he said.