Summary
As stated in a Thu 19 Mar 2009 press release, OSI Pharmaceuticals (OSIP), in protection of its TARCEVA cancer drug, has filed separate lawsuits against each of Teva and Mylan. As the innovator company for TARCEVA [a FDA Orange Book Prescription (Rx) Referencle Listed Drug (RLD) Product with 3 listed patents - 5747498 6900221 7087613 - and with New Chemical Entity (NCE) exclusivity 5-year expiration date of 18 Nov 2009] OSIP has now started its formal Hatch-Waxman patent offense against the Paragraph (iv) ANDA Filers, Teva and Mylan. At the commercial level, TARCEVA is manufactured for OSIP by Schwarz Pharma and it is distributed by Genentech. TARCEVA is an extremely important revenue source for OSIP; in a recent SEC filing (Form 10K Annual Report filed 27 Feb 2009) OSIP indicates that approximately 88% of its total 2008 revenues are TARCEVA-related.
Analysis
TARCEVA's Active Product Ingredient (API) is erlotinib hydrochloride and it is available in 3 strengths - 25 100 150 mg of erlotinib base, each as a tablet for oral administration. The corresponding umbrella of patent protection covers (a) the API iself, methods of API synthesis, and methods of treatment (5747498); (b) crystalline polymorphs of the API and related methods of treatment (6900221); and (c) methods of monotherapy for various cancers using crystalline polymorphs of the API (7087613). Because (a) OSIP and Pfizer OSIP are co-owners of 5747498; and (b) Genentech is a licensee under each 1 of these 3 patents; - the indicated Plaintiffs in each lawsuit are OSI Pharmaceuticals, Pfizer, and Genentech. The Teva lawsuit [US Delaware District Court Case No. 1:09-cv-00185-UNA, filed 19 Mar 2009] relates to Teva's ANDA No. 91-059. Likewise, the Mylan lawsuit [US Delaware District Court Case No. 1:09-cv-00186-UNA, filed 19 Mar 2009] relates to Mylan's ANDA No. 91-002. Each of Teva and Mylan included Paragraph (iv) patent certifications against all 3 listed patents - 5747498 6900221 7087613 - in their respective ANDAs. Neither case yet has an assigned judge and consolidation of these 2 cases into a single case is likely.
