As US District Court dismisses patent use code counterclaim, all eyes move to the Supreme Court Prandin case, says law firm

Less than a month before the US Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories versus Novo Nordisk, concerning whether the patent delisting counterclaim provisions at FDC Act Sec 505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act, may be used to correct or delete an Orange Book-listed Patent Use Code (PUC), the US District Court for the District of New Jersey granted a Motion to Dismiss a similar counterclaim in Hoffmann-La Roche vs Orchid Chemicals & Pharmaceuticals a patent infringement law suit concerning generic Boniva (ibandronate sodium) tablets, 150mg. originated by Switzerland’s Roche, notes Hyman, Phelps & McNamara lawyer Kurt Karst on the firm’s FDA Law Blog

India-headquartered Orchid Healthcare submitted an Abbreviated New Drug Application to the Food and Drug Administration on or about May 16, 2007 seeking approval to market a generic version of Boniva Once-Monthly, and containing a certification to the then-listed Orange Book patents for NDA No 021455. After having amended ANDA No 078998 with Paragraph IV certifications to the ‘634 and ‘957 patents, Roche sued Orchid for patent infringement. In response to Roche’s First Amended Complaint, Orchid included in its Answer, among other things, a counterclaim pursuant to FDC Act Sec 505(j)(5)(C)(ii)(I) requesting that the court issue an order requiring Roche to correct the PUCs for the ‘634 and ‘957 patents. According to Orchid, “Roche’s use codes do not accurately describe the patented methods of use found in the claims of the 634 and 957 patents, in that they state that the 634 and 957 patent claims cover prevention of osteoporosis,” and “Roche must correct the use code for the 634 patent…from ‘U-642: treatment and prevention of osteoporosis’ to ‘treatment of osteoporosis,’ and correct the use code for the 957 patent…from ‘U-887: treatment and prevention of osteoporosis’ to ‘treatment of osteoporosis.’”

Of course, says Mr Karst, hanging over Orchid’s counterclaim was the Federal Circuit’s 2010 decision in Novo Nordisk vs Caraco Pharmaceutical Laboratories, in which the Court reversed and vacated a 2009 decision from the US District Court for the Eastern District of Michigan (Southern Division). The district court ruled and issued an Order and Injunction requiring Novo Nordisk to change an Orange Book-listed PUC for a patent concerning Prandin (repaglinide) Tablets as a result of Caraco’s FDC Act  Sec 505(j)(5)(C)(ii)(I) counterclaim.