Purdue Pharma Products v. Par Pharmaceutical (CAFC 2009-1553, -1592) nonprecedential

After a five-day bench trial, the district court held that Par's proposed generic tramadol product literally infringed the asserted patents, that the asserted patents were not unenforceable, but that the asserted claims were invalid for obviousness. Purdue Pharma Prods. L.P. v. Par Pharm., Inc., 642 F. Supp. 2d 329 (D. Del. 2009). With regard to invalidity, the district court held that the asserted claims would have been obvious in light of (1) U.S. Patent 5,580,578 ("Oshlack"), which describes formulations of opioid analgesics, including tramadol, for once-daily dosing and (2) what was known in the art about tramadol and once-daily formulations. The court reasoned that the Oshlack patent taught the use of tramadol as one of fourteen different opioid analgesics to be used and that any differences in incorporating tramadol as the active ingredient in a once-a-day formulation would have involved only routine experimentation. Id. at 369-73. The court then rejected Purdue's claims of secondary considerations, finding evidence of copying not compelling in the ANDA context where bioequivalency is a prerequisite to FDA approval, and that Purdue's evidence of commercial success was "underwhelming." Id. at 373-74.

The high bar to finding inequitable conduct continues.

With regard to unenforceability, the district court found that Par had failed to prove intent to deceive by clear and convincing evidence. Specifically, while finding that the applicants had withheld material experimental data and had submitted a materially misleading declaration ("the Malkowska declaration"), the district court found plausible the inference that the applicants were merely overly aggressive in trying to put a positive spin on the experimental results without intending to deceive the United States Patent and Trademark Office ("PTO"). In reaching that conclusion, the district court relied, inter alia, on the credibility of Ms. Malkowska's testimony and the applicants' later disclosure of the more pertinent Napp repeat experiments generated for a foreign litigation. Id. at 375-79.

Obviousness

While the ultimate question of obviousness under 35 U.S.C. § 103 is a question of law, reviewed de novo, it is based on several underlying factual determinations, which we review after a bench trial for clear error. Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054, 1058 (Fed. Cir. 2004). The relevant factual determinations include 1) the scope and content of the prior art, 2) the level of ordinary skill in the art, 3) the differences between the claimed invention and the prior art, and 4) evidence of secondary factors. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).

Oshlack easily rendered the Purdue patents obvious.

Purdue's main argument is that a person of skill in the art would not have selected tramadol out of the myriad other possible active ingredients for use in a once-daily formulation. But Oshlack makes that very selection; it lists tramadol as one of fourteen different opioid analgesics to use in a controlled-release formulation that provide effective blood levels for twenty-four hours. As such, Oshlack itself renders the selection of tramadol obvious regardless whether or not the patent lists tramadol as a preferred embodiment. See Perricone v. Medicis Pharm. Corp. 432 F.3d 1368, 1376 (Fed. Cir. 2005) ("This court rejects the notion that one of [14 listed] ingredients cannot anticipate because it appears without special emphasis in a longer list."); see also Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that the prior art's disclosure of a multitude of combinations failed to render any particular formulation less obvious).

Inequitable Conduct

This court reviews the district court's inequitable conduct determination under a two-tier standard; we review the underlying factual determinations for clear error but the ultimate decision on inequitable conduct for an abuse of discretion. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008). A conclusion of inequitable conduct requires an accused infringer to show that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) did so with intent to deceive the PTO. Id. Both materiality and intent to deceive must be proven by clear and convincing evidence, after which the court must balance the equities to determine whether the conduct was egregious enough to warrant holding the entire patent unenforceable. Id.

We agree with Purdue and affirm the district court's decision of no inequitable conduct. Even assuming that the applicants withheld material data and submitted a materially misleading declaration, as the district court found, Purdue Pharma, 642 F. Supp. 2d at 378, we find no clear error in the district court's finding that Par failed to present clear and convincing evidence of intent to deceive, id. at 379. Specifically, the fact that the applicants later submitted to the PTO the Napp repeat experiments strongly suggests that the applicants did not act with deceptive intent when they omitted similar data from the Malkowska declaration or when they submitted the Malkowska declaration with its omitted data to the PTO. Cf. Cargill, 476 F.3d at 1366 (finding intent to deceive when applicants repeatedly omitted highly relevant test data). In fact, the Napp repeat experiments were even more pertinent than the withheld data as they revealed dissolution rates that fell directly within--rather than near--the claimed rates. Therefore, another reasonable inference is that the applicants believed (rightly or wrongly) that the withheld data were irrelevant, either because the experimental conditions did not replicate those of the prior art or because they did not replicate those in an earlier Malkowska declaration.

Any inference of deceptive intent in the preparation of the declaration itself is further undermined by the fact that the applicants prepared the Malkowska declaration, not to respond directly to a rejection by the PTO, but for an EPO proceeding regarding a related patent. Cf. Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181, 1193 (Fed. Cir. 2006); Paragon Podiatry, 984 F.2d at 1191. That further diminishes the reasonableness of inferring that any omission or misleading statement in the preparation of the declaration was made with the specific intent of deceiving the PTO. See Star Scientific, 537 F.3d at 1366. Because intent to deceive is not the single most reasonable inference that can be drawn from the evidence, id., we affirm the district court's determination of no inequitable conduct.

Affirmed.