In The News

• September 12, 2012
  'Cases Defining Patent Safe Harbors Could Influence Biosimilar Development'
  Inside Health Reform
  D. Christopher Ohly
  In this article from Inside Health Reform, Schiff Hardin partner Chris Ohly comments on how recent cases regarding Hatch-Waxman patent infringement could affect the growing biosimilar industry. The U.S. Court of Appeals for the Federal Circuit recently held that Amphastar Pharmaceuticals did not infringe patents alleged to cover test methods used during manufacturing of Amphastar's FDA-approved generic product, based upon the court's application of a 'research exemption' in the U.S. patent statute. The decision appears to diverge from an earlier case in which the Federal Circuit ruled that this statutory 'safe harbor' only applies to uses of patented technologies prior to FDA approval, and then only in connection with activities intended for use in submissions to the FDA. Mr. Ohly notes that the decision could affect how brand companies manage product life cycles and that the two cases could eventually reach Supreme Court review.
• February 1, 2012
  'Fresh from the biotech pipeline — 2011'
  Nature Biotechnology
  D. Christopher Ohly
  This article about the U.S. FDA approval process for biosimilar drugs quotes Schiff Hardin partner Chris Ohly. Mr. Ohly, who focuses on pharmaceuticals in the firm's Intellectual Property Group, comments that companies moving through the biosimilar and interchangeable drug approval process may end up innovating their products as a result.
• April 25, 2011
  'Patents on the line'
  BioCentury
  D. Christopher Ohly
  In this article about challenges in the Supreme Court to patent protections, Schiff Hardin partner Chris Ohly is quoted regarding the standards used to invalidate a patent.
• February 11, 2011
  'Patent reform looks likely to pass this year'
  BioPharm Insight
  D. Christopher Ohly
  Schiff Hardin's Christopher Ohly, a partner in the firm's Intellectual Property group, is quoted in this pharmaceutical news service story on patent reform legislation. Mr. Ohly points out likely consequences of the legislation, including the significant change to first-to-file priority in patent applications.