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July 21, 2008

Tummy Ache

Eisai sued Dr. Reddy's Labs and Teva for infringing 5,045,552 after the two filed ANDAs to make a generic version prior to patent expiration. '552 claims a digestive antacid. Eisai overcame obviousness and inequitable conduct arguments to prevail. In its affirmation, the CAFC elucidated the current standard for chemical obviousness.

Eisai v. Dr. Reddy's Laboratories and Teva Pharmaceuticals (CAFC 2007-1397)

Obviousness

In a convenient fiction of jurisprudence, everything put before appellate courts is a legal question, even one that is factual. That gives the court latitude of attitude to suffer no duel of the way it would rule.

Obviousness under 35 U.S.C. § 103(a) is ultimately a legal question, based on underlying factual determinations. See Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997). The factual determinations underpinning the legal conclusion of obviousness 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, also known as objective indicia of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). Thus, in reviewing a district court's summary judgment of non-obviousness, this court reviews the record for genuine issues of material fact without deference, bearing in mind the movant's burden to prove invalidity by clear and convincing evidence. See Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed. Cir. 1998).

Structural similarity is a crucial question in chemical obviousness.

Where, as here, the patent at issue claims a chemical compound, the analysis of the third Graham factor (the differences between the claimed invention and the prior art) often turns on the structural similarities and differences between the claimed compound and the prior art compounds. See Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1377 (Fed. Cir. 2006) (noting that, for a chemical compound, a prima facie case of obviousness requires "structural similarity between claimed and prior art subject matter . . . where the prior art gives reason or motivation to make the claimed compositions" (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc))). Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound. See Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007). In keeping with the flexible nature of the obviousness inquiry, KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), the requisite motivation can come from any number of sources and need not necessarily be explicit in the art. See Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007). Rather "it is sufficient to show that the claimed and prior art compounds possess a 'sufficiently close relationship . . . to create an expectation,' in light of the totality of the prior art, that the new compound will have 'similar properties' to the old." Id. (quoting Dillon, 919 F.2d at 692).

Defendants tried anti-ulcer compounds as obvious.

To the contrary, the district court emphasized the differences between anti-ulcer action and gastric acid inhibition.

In a mutated echo of its earlier, narrower, teaching-suggestion-motivation test, this CAFC reading of KSR posits a "problem-reasoning-predictability" test for chemical obviousness.

This court notes that the district court did not rigidly limit Teva's obviousness arguments by forcing Teva to select a single lead compound. Rather Teva alone selected lansoprazole as the anchor for its obviousness theory, not the district court. In KSR, the Supreme Court noted that an invention may have been obvious "[w]hen there [was] . . . a design need or market pressure to solve a problem and there [were] . . . a finite number of identified, predictable solutions." 127 S. Ct. at 1742 (tense changes supplied to clarify, as the Court stated and as per 35 U.S.C. § 103, that the obviousness inquiry must rely on evidence available "at the time" of the invention, see Takeda, 492 F.3d at 1356 n.2). The Supreme Court's analysis in KSR thus relies on several assumptions about the prior art landscape. First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions. Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound. See Takeda, 492 F.3d at 1357 ("Thus, in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound."). Third, the Supreme Court's analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a "finite number of identified, predictable solutions," 127 S. Ct. at 1742. In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this "easily traversed, small and finite number of alternatives . . . might support an inference of obviousness." To the extent an art is unpredictable, as the chemical arts often are, KSR's focus on these "identified, predictable solutions" may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.

In other words, post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound. Teva cannot create a genuine issue of material fact on obviousness through the unsupported assertion that compounds other than lansoprazole might have served as lead compounds. Further, the record contains no reasons a skilled artisan would have considered modification of lansoprazole by removing the lipophilicity-conferring fluorinated substituent as an identifiable, predictable solution. In sum, the district court properly concluded that the record did not support a case of obviousness of the '552 patent as a matter of law.

Inequitable Conduct

The standard of inequitable conduct, "a high bar" -

Inequitable conduct in prosecuting a patent application before the United States Patent & Trademark Office may take the form of an affirmative misrepresentation of material fact, a failure to disclose material information, or the submission of false material information, but in every case this false or misleading material communication or failure to communicate must be coupled with an intent to deceive. Innogenetics, 512 F.3d at 1378 (citations omitted). Materiality, defined as "what a reasonable examiner would have considered important in deciding whether to allow a patent application," and intent are both questions of fact, and require proof by clear and convincing evidence. Id. To satisfy the "intent" prong for unenforceability, "the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive." Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (citing Norton v. Curtiss, 433 F.2d 779 (CCPA 1970)). Gross negligence is not sufficient. Id. This is a high bar.

Defendants had a five-prong argument. Lack of materiality banished some accusations, while "insufficient proof of intent to decieve" damned the others.

The CAFC praised Judge Gerard E. Lynch of the Southern District of New York:

In a series of thoughtful, thorough opinions, the district court carefully explained its reasoning with respect to both obviousness and inequitable conduct.

Affirmed.

Posted by Patent Hawk at July 21, 2008 2:07 PM | Prior Art

Comments

Hawk, I read the Decision but haven't yet thought a lot about it. I didn't see the claim in suit but presume it is directed to the compound per se (rather than to, for example, a stomach antacid). I thought I would put my obviousness questions to you first. They are: 1) Would the claimed compound still have been non-obvious if it had not "worked" as an antacid? 2) Does the non-obviousness of the claimed subject matter in the USA vary with the antacid effectiveness of the claimed compound? 3) If so, would that be in direct or in inverse proportion? You perhaps see where I'm coming from, namely, European standards for chemical obviousness.
And thanks for the posting.

Posted by: MaxDrei at July 22, 2008 10:21 PM