Greenblum & Bernstein, P.L.C.
BIOTECHNOLOGY And BIOSIMILARS
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
September – October 2013
In This Issue
· ANDA Infringes Despite Promise Not To Infringe
Jill M. Browning
ANDA Infringes Despite Promise Not To Infringe
The Court of Appeals for the Federal Circuit held on September 26, 2013, in Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., that “if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue.”
Sunovion’s Lunesta patent claims a dextrorotatory isomer of zopiclone essentially free of levorotatory isomer. Defendant Reddy submitted an ANDA which included application for approval to manufacture, use, and sell generic versions of Lunesta prior to the expiration of the patent. Sunovion initiated suit based on Reddy’s ANDA submission. The district court construed “essentially free” to mean “less than 0.25% of Levorotatory isomer” and the Federal Circuit affirmed that construction based on the prosecution history of the patent. Reddy’s amended ANDA submission includes dextrorotatory isomer of zopiclone with 0.0-0.6% levororatory isomer.
Reddy submitted a declaration from an employee vowing that Reddy would only market generic eszopiclone tablets containing 0.3–0.6% levorotatory isomer in support of its motion for summary judgment of non-infringement. The district court found that the product would likely be outside the range of less than 0.25% levorotatory isomer and would therefore not infringe because of Reddy’s internal manufacturing guidelines and the certification to “constrain the amount of levorotatory isomer to not less than 0.3%, despite the contrary representation made to the FDA in Reddy’s amended ANDA specification.” The Federal Circuit, however, reversed noting that “Reddy’s ANDA specification clearly describes a product that meets the limitations of the asserted claims” and a “certification pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law. Simply saying ‘But I won’t do it’ is not enough to avoid infringement.”
The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC. For more information, contact Jill M. Browning at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191. Copyright 2013 GREENBLUM & BERNSTEIN, P.L.C.