OnPoint Analytics specializes in pharmaceutical litigation of all types including patent validity (secondary considerations), patent damages (lost profits and reasonable royalties), antitrust claims, unfair competition, fraud on the market, and injunctive relief. OnPoint tracks major developments in pharmaceutical approval, sales and marketing and has developed a comprehensive database addressing emerging biologic and biosimilar therapies. In its Pharma Corner, OnPoint provides commentary on major issues and events for the Pharma sector.
Patent Proliferation: A 30-year increase in the number of patents per drug
September 12, 2016 – Over the past 30 years, there has been a marked increase in the average number of patents covering a single drug. Will it change the way pharmaceutical patents are litigated?
Biologics Exclusivity and the TPP: An International Balancing Act
October 6, 2015 – With sufficient participation, trade pacts have the potential to set international standards that eventually become global norms. This is exactly what opponents on both sides of the Trans-Pacific Partnership (TPP) agreement fear will happen when it comes to biosimilar drug development. The deal, announced October 5, 2015, would apparently commit the 12 participant nations to guarantee at least 5 years of data exclusivity for biologic drugs, thereby assuring them immunity from biosimilar competition for at least that period, regardless of the existence of any patent protection.
Biosimilar Conversion: How Slippery is the Slope?
August 21, 2015 – There is no doubt that massive capital has lined up behind biosimilar drug development. But there is less certainty about the extent to which biosimilars will capture the biologics market. Many commentators have predicted that biosimilars’ encroachment on branded biologics will be modest. Recent signs suggest that, once biosimilars enter the global market, they may quickly capture a significant share—the slope may be more slippery than expected.
Amgen v. Sandoz – Let’s Just Agree to Disagree
July 22, 2015 – Yesterday ended the long wait for the first appellate court interpretation of the 2010 Biologics Price Competition & Innovation Act. A 3-judge panel of the Federal Circuit (Lourie, Newman & Chen) struggled with arguably inconsistent language in the Act, which Judge Lourie described as “a riddle wrapped in an enigma.” OnPoint, specializing in pharmaceutical analytics and litigation, analyzes the economic ramifications of the decision for biosimilar drug development.