OSI Pharma., Inc. v. Mylan Pharma. Inc.

Case Name: OSI Pharma., Inc. v. Mylan Pharma. Inc., Civ. No. 09-185-SLR, 2012 U.S.Dist. LEXIS 60757 (D. Del. May 1, 2012) (Robinson, J.)

Drug Product and Patent(s)-in-Suit: Tarceva^® (erlotinib); U.S. Pat. Nos. 5,747,498 ("the '498 Patent") reissued as U.S. Reissue Patent No. RE41,065 ("the '065 patent), 6,900,221 ("the '221 patent"), and 7,087,613 ("the '613 patent")

Nature of the Case and Issue(s) Presented:  The '065 patent discloses compounds and pharmaceutically acceptable salts of those compounds useful for treating hyperproliferative diseases such as cancer.  The specification recites many preferred compounds according to the invention and erlotinib is identified as one of the specifically-preferred compounds.  The'221 patent relates to a stable form of erlotinib HCl ("polymorph B"), pharmaceutical compositions containing polymorph B, as well as methods of treating hyperproliferative disorders by administering the compound.  The '221 patent specification incorporates the '498 patent in its entirety for its disclosure of erlotinib HCl.

In February 2009, Teva filed an ANDA for generic erlotinib including a Paragraph IV certification against the '498, '221, and '613 patents.  Shortly thereafter, Mylan sent notice to OSI that it too filed an ANDA for generic erlotinib that included a Paragraph IV certification against the same patents.  In March 2009, plaintiffs filed suit against Teva and Mylan.  After the '498 patent reissued as the '065 patent, plaintiffs amended their complaint against Teva and Mylan, alleging infringement of the '065, '221, and '613 patents by Teva and Mylan.  Teva and Mylan each brought counterclaims of non-infringement and invalidity.  At the pretrial conference, Mylan and Teva conceded infringement of certain claims of the '065 and '221 patents.  Teva settled all remaining claims on the eve of trial, and Mylan proceeded on its invalidity defenses during a five-day bench trial.  The Court held that the claims of both patents-in-suit were not invalid.

Why Plaintiffs Prevailed:  Mylan identified a prior art compound described in an example from a European patent application ("Barker") differing from erlotinib only in that it contains an ethynyl group, rather than erlotinib's methyl group, at the 3'-position.  Barker further discloses that its referenced compounds "possess anti-cancer activity."  Mylan's argument therefore was that an ordinary medicinal chemist would have started with Barker, identified the gap in claim coverage as not covering an ethynyl group, recognized the suggestion in the prior art to use a "small, non-polar group" at the 3'-position, and filled the gap by putting an ethynyl group at the 3'-position of the best compounds disclosed in Barker.  But as the Court noted, absent from Barker is any indication regarding useful properties or potent and promising activity for the compounds that Barker discloses.  Since potency drives the research, the Court was not persuaded by Mylan's argument that the ease of synthesis would have led a person of ordinary skill in the art to the prior art compound identified in Barker.  The Court was equally not persuaded by Mylan's argument that the absence of teaching the ethynyl substituent in Barker would have suggested to one of ordinary skill in the art to select it.  To the contrary, OSI presented evidence indicating that the prior art taught away from using ethynyl compounds because they tended "to be toxic" and "led to inactivation of critical liver enzymes."  Moreover, the Court found evidence of secondary considerations, in particular long felt need and unexpected results, that supported its conclusion that the '065 patent was not obvious.

Mylan argued that every element of claim 53 of the '221 patent is disclosed in both the '498 patent abstract and an abstract by Iwata ("Iwata").  According to the Court, however, the '498 patent did not disclose using erlotinib for the treatment of "lung cancer," rather, it references thousands of compounds encompassed by a formula in the treatment of various cancers.  Relying on testimony from OSI's expert, the Court found that an oncologist would not read the '498 patent to teach that every compound disclosed would be a treatment for every disease disclosed.  Mylan also did not meet its burden in showing that Iwata anticipated the '221 patent. Iwata speaks generally of erlotinib as providing a highly targeted cancer therapeutic for a wider range of cancers, but makes no specific mention of a carrier.  Moreover, the experiments Iwata discloses were done on tumor models, not human patients, therefore the concept of "treatment" was missing from the Iwata abstract.  Finally, the Court also found that Mylan did not show by clear and convincing evidence that the '221 patent was obvious.  In particular, "Mylan does not advance a persuasive rationale for why a person of ordinary skill in the art would have been motivated to select erlotinib for the treatment of NSCLC, a specific subset of ‘lung' cancer generally."   As an example, the Court noted that the cells used in Iwata were not NSCLC cancer cells.  For all these reasons, including evidence of secondary considerations concerning unmet needs and failure of others, the Court found that the '221 patent was not anticipated nor obvious.