US-based Allos slaps patent violation case on Dr Reddy's

Alleges that generic version of cancer drug Folotyn planned by Dr Reddy’s infringes on three of its patents

Hyderabad: US-based Allos Therapeutics Inc., has recently slapped a lawsuit against Dr Reddy’s Laboratories Limited, alleging that the city-based pharma major’s generic version of Folotyn cancer treatment drug violates three of its patents.

Allos, which markets Folotyn in the US market, filed the case along with three non-profit research organisations in New Jersey federal court last month. In its petition, the Colorado-based pharma company, a subsidiary of Spectrum Pharmaceuticals, Inc., alleged that an abbreviated new drug application (ANDA) filed by Dr Reddy’s with the US Food and Drug Administration (USFDA) violated its marketing exclusivity for the pralatrexate drug used to treat patients with relapsed or refractory peripheral T-cell lymphoma. The non-profit bodies which own the patents and are parties to the lawsuit include New York-based Sloan-Kettering Institute for Cancer Research, Alabama-based Southern Research Institute and Sri International, Inc with headquarters in California.

“Dr Reddy’s submitted the ANDA No 206183 to the FDA, seeking approval to market vials of pralatrexate with 20 mg/1 mL vial and 40 mg/2 mL vial dosages. The pralatrexate vials described in Dr Reddy’s ANDA are herein referred to as Dr Reddy’s Products”, Allos said in its complaint. The petition further said:“Dr Reddy’s has necessarily represented to the FDA that Dr Reddy’s Products have the same active ingredient as Folotyn, have the same routes of administration, dosage forms, and strengths as Folotyn, are bioequivalent to Folotyn, and have the same or substantially the same proposed labeling as Folotyn”.

The three research institutes, which hold patents to the drug, had granted exclusive license over the patents related to the lymphoma treatment to Allos. Subsequently, the USFDA granted Allos’ new marketing application for Folotyn on Sept 24, 2009, giving the company seven years orphan-drug marketing exclusivity over the drug. That exclusivity is not set to end until September 26, 2016, Allos maintained.

The company also made it clear in the petition that Dr Reddy’s informed it through a letter on or around May 27, 2014 about the ANDA. Dr Reddy’s also attached a memorandum stating that it had

“included a certification in the ANDA, pursuant to 21 USC §355(j)(2)(A)(vii)(IV), that the ‘071, ‘470, and ‘078 patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Dr. Reddy’s Products”, the petition added.

However, Allos and the patent holders claim in their three-count complaint that approval of the generic would violate the patents, asking the court to delay approval of the ANDA filed by Dr Reddy’s until at least May 31, 2025, the day the patents expire. The petitioners also sought attorneys' fees from Dr Reddy’s, describing the case as an ‘exceptional one’.

However, officials of Dr Reddy’s were not available for comment on this issue.