Opinion ID: 2792379
Heading Depth: 4
Heading Rank: 1

Heading: The Framing of the Obviousness Question

Text: The district court began its obviousness analysis by addressing a dispute between the parties regarding the proper “framing” of the obviousness question. Insite, 2013 WL 5975015, at . Plaintiffs argued that the proper question to be considered by the court was whether it would have been obvious to a person of ordinary skill in the art at the time of the invention to develop a topical ophthalmic formulation containing azithromycin. Sandoz argued for a narrower question: whether it would have been obvious that topical azithromycin could be used to treat conjunctivitis. The district court agreed with the plaintiffs and found no reason to limit the question to conjunctivitis and to azithromycin. The district court found that there were options beyond just azithromycin that were available to a formulator when considering topical ophthalmic treatments, id. at , and that persons of ordinary skill in the art would not have developed formulations that only treated conjunctivitis and not corneal infections, given concerns about the spread of conjunctival infections to the cornea. Id. On appeal, Sandoz argues that the district court erred as a matter of law in its framing of the obviousness inquiry. Sandoz contends that in broadly framing the obviousness inquiry, the district court required Sandoz to prove the obviousness of topical treatments of all manner of eye infections and not merely conjunctivitis with azithromycin. Sandoz contends that this amounts to an 8 INSITE VISION INCORPORATED v. SANDOZ, INC. error of law contrary to bedrock legal principles that “‘[c]laims which are broad enough to read on obvious subject matter are unpatentable even though they also read on nonobvious subject matter.’” Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 n.4 (Fed. Cir. 2008) (alteration in original) (quoting In re Lintner, 458 F.2d 1013, 1015 (C.C.P.A. 1972)). Sandoz also relies heavily on Alcon Research, Ltd. v. Apotex Inc., in which this court held that courts should “look at any motivation [for combining references, even] beyond that articulated by the patent.” 687 F.3d 1362, 1368 (Fed. Cir. 2012). Plaintiffs respond that identifying the problem faced by a person of skill in the art is a factual question, on which the district court properly ruled. Plaintiffs contend that nothing in the district court’s framing of the issue precluded Sandoz from proving that topical treatment of conjunctivitis would have been obvious, but that Sandoz simply failed to carry its burden—a factual issue not a legal question. The district court did not clearly err in framing the obviousness inquiry as it did, based on its understanding of the problem facing those skilled in the art at the time the invention was made. Moreover, the district court, in framing the question, did not foreclose Sandoz from attempting to prove that the claims would have been obvious based on the treatment of conjunctivitis by the topical administration of azithromycin. The obviousness inquiry entails consideration of whether a person of ordinary skill in the art “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and . . . would have had a reasonable expectation of success in doing so.” Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (internal quotation mark omitted) (quoting Pfizer, Inc. v. Apotex, Inc., 490 F.3d 1348, 1361 (Fed. Cir. 2007)); see also Bayer Schering Pharma INSITE VISION INCORPORATED v. SANDOZ, INC. 9 AG v. Barr Labs, Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). “In considering motivation in the obviousness analysis, the problem examined is not the specific problem solved by the invention.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). “Defining the problem in terms of its solution reveals improper hindsight in the selection of the prior art relevant to obviousness.” Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed. Cir. 1998). And, here, the district court recognized that an overly narrow “statement of the problem [can] represent[] a form of prohibited reliance on hindsight, [because] [o]ften the inventive contribution lies in defining the problem in a new revelatory way.” Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377 (Fed. Cir. 2012). Whether a person of ordinary skill in the art would narrow the research focus to lead to the invention depends on the facts. Alcon is not to the contrary. Alcon merely holds that if the prior art would motivate a person of skill in the art to make the claimed invention, even if that was not based on “the same motivation that the patentee had,” the patent would have been obvious. 687 F.3d at 1368. But whether the prior art would so motivate a skilled artisan is a question of fact. Cf. PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (“‘The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact.’” (quoting Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006))). Here, the district court did not clearly err in finding that the problem faced by one skilled in the art was broader than merely seeking to use azithromycin to treat conjunctivitis. The district court found that azithromycin’s characteristics—including that molecules in its class were “known to be bacteriostatic, to have a limited spectrum of activity, and to require multiple doses per day to penetrate tissue,” Insite, 2013 WL 5975015, at — would make it a poor choice for treating ocular infections. 10 INSITE VISION INCORPORATED v. SANDOZ, INC. Furthermore, the district court found “the unique balance of log P, molecular weight, solubility, and charge,” also made it “not a good candidate.” Id. The district court also credited the testimony of plaintiffs’ expert, Dr. Asbell, that, desirably, effective treatment of conjunctivitis would include penetration of the cornea as well as the conjunctiva because of the potential that a conjunctival infection could spread to the cornea. Id. at –8. These factual findings provide sufficient support for the district court’s framing of the relevant question. And the district court’s framing of the question did not prevent Sandoz from attempting to invalidate the asserted claims, which were not limited to the cure of conjunctivitis, by proving that it would have been obvious to use azithromycin in a topical treatment to cure that one infection. The problem for Sandoz, as we will next address, is that its proofs simply failed to carry the day in satisfying its clear and convincing burden.