Certification Pledging Not to Infringe Insufficient to Avoid Infringement in Hatch-Waxman Litigation: Federal Circuit | Practical Law

Certification Pledging Not to Infringe Insufficient to Avoid Infringement in Hatch-Waxman Litigation: Federal Circuit | Practical Law

On September 26, 2013, the US Court of Appeals for the Federal Circuit reversed the US District Court for the District of New Jersey's grant of summary judgment of noninfringement after a manufacturer seeking to market a generic drug filed an ANDA application within the scope of the related patent, but certified to the district court that its eventual commercial product, as manufactured, would not infringe the patent.

Certification Pledging Not to Infringe Insufficient to Avoid Infringement in Hatch-Waxman Litigation: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 30 Sep 2013 • USA (National/Federal)
On September 26, 2013, the US Court of Appeals for the Federal Circuit reversed the US District Court for the District of New Jersey's grant of summary judgment of noninfringement after a manufacturer seeking to market a generic drug filed an ANDA application within the scope of the related patent, but certified to the district court that its eventual commercial product, as manufactured, would not infringe the patent.
In a September 26, 2013 opinion in Sunovion Pharm. v. Teva Pharm. USA, the US Court of Appeals for the Federal Circuit reversed the US District Court for the District of New Jersey's grant of summary judgment of noninfringement to the defendants, Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (Reddy), in a patent infringement suit brought by Sunovion. Reddy submitted a FDA Abbreviated New Drug Application (ANDA) to manufacture generic versions of Sunovion's sleep medication drug, Lunesta. The district court granted Reddy's motion because it was filed with a certification that Reddy's generic version of a Lunesta would not infringe Sunovion's patent. However, the Federal Circuit concluded an ANDA filing with the FDA within the scope of a valid patent claim is an infringement is a matter of law, even where it is accompanied by such a certification filing.
Sunovion owns US Patent No. 6,444,673 ('673 patent) for the pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in Lunesta. Reddy submitted an ANDA under the Hatch-Waxman Act seeking approval to manufacture, use and sell 1mg, 2mg and 3mg eszopiclone tablets as generic versions of Lunesta before the '673 patent expired. Sunovion then initiated this suit, claiming that Reddy's ANDA submission infringed claims 1, 2 and 8 of the '673 patent.
Reddy's original December 15, 2008 ANDA specification requested regulatory approval for generic eszopiclone products with "[n]ot less than 0.3% and [n]ot more than 1.0% levorotatory isomer." Reddy submitted an amendment to the FDA on April 26, 2012, revising its ANDA specification to request approval for products restricted to "NMT 0.6" of the levoratotry isomer, that is, between 0.0% and 0.6% of the isomer. Reddy later certified to the district court it would not market a product containing less than 0.3% of the levorotatory isomer.
The claims at issue are directed to pharmaceutical compositions that are "essentially free" of the levorotatory isomer. The district court construed the claim limitation "essentially free" to mean "less than 0.25% of the levorotatory isomer" and the Federal Circuit upheld this claim construction. This meant that Reddy's ANDA specification was covered by the claim.
On appeal, Sunovion argued that Reddy's amended ANDA specification, not the certification to the district court, should control the issue of infringement because it expressly defines Reddy's product in a way that directly addresses the infringement question, and includes the less than 0.25% purity range that would infringe the patent. Reddy argued that it does not infringe because:
  • Its internal manufacturing guidelines require generic eszopiclone products to contain at least 0.3% levorotatory isomer.
  • The certification assured the district court that the tablets would only market tablets containing 0.3-0.6% levorotatory isomer and 0.3 is more than 0.25.
  • After it sells the generic eszopiclone commercially, Sunovion can test to see if it infringes and then sue Reddy.
The Federal Circuit agreed with Sunovion and rejected Reddy's arguments. It noted that while traditional patent infringement occurs when a patented product is made, used or sold, under the Hatch-Waxman Act, filing an ANDA itself constitutes a technical infringement for jurisdictional purposes. Further, under Abbot Labs. v. TorPharm, Inc., the Federal Circuit has held that when an ANDA applicant asks the FDA to approve a product for sale that falls within the scope of an issued patent, a judgment of infringement must follow. The Federal Circuit concluded that:
  • Reddy's ANDA specification of levorotatory amounts from 0.0-0.6% is within the scope of the "less than 0.25%" limitation of the '673 patent claims and is therefore an infringement.
  • When Reddy's ANDA specification literally infringes as a matter of law, Reddy's "unforeseeable and unconventional" certification pledging not to infringe does not override the rule from Abbott Labs. In particular, the court noted that the Hatch-Waxman framework was set up for the FDA to approve a generic drug manufacturer's efforts to copy an approved product. The manufacturer cannot then rely on this form of supplementary evidence to avoid an infringement finding for a drug outside the scope of the patent that the FDA has indicated it may not approve.
Court documents: