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

·    News

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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.”

NEWS

• Center for Legal Policy Report Challenges FDA Regulation of Autologous Stem Cell Procedures:  In July 2012 the District Court for the District of Columbia held that stem cells used by Regenerative Sciences, LLC, are a drug under the FDCA and that the FDA has jurisdiction to regulate the procedure.  The case is on appeal.  The Manhattan Institute’s Center for Legal Policy argues that stem cells are not drugs, but part of the practice of medicine. 

• Cardiovascular MDx Firm DardioDX Files with SEC to Go Public:  CardioDx, of Palo Alto, CA filed with the SEC to go public with an intended offering of up to $86.3 million of common stock.  It has not yet priced its offering or stated the number of shares it plans to offer.  CardioDx plans on using ticker symbol “CDX.”

• CA Governor, Jerry Brown, Vetoes Bill to Hinder Use of Generic Drugs:  Governor Brown vetoed that bill that critics said would have made it harder for pharmacists to substitute cheaper, biosimilar, drugs for brand-name versions of biologics.  The bill would have allowed pharmacists to substitute biosimilars that had been deemed “interchangeable” by the FDA, but would require the pharmacists to tell the patient’s doctor whether a substitution was made.  The notification requirement is disputed by drug companies, patient groups, and healthcare providers.  The governor stated that the bill was premature because the Federal government has not yet determined standards for the biosimilar versions.