In re Brimonidine Patent Litigation (CAFC 2010-1102, -1103) precedential; Judges Bryson, Dyk (author), and Prost

Allergan got a pass from because Apotex's defense counsel didn't know how to argue invalidity. Then again, neither did Allergan's counsel argue properly.

With respect to the four "related patents," we reach a different conclusion. Neither party argued its validity case to the district court on a claim-by-claim basis and neither presents a claim-by-claim argument to this court. Apotex stipulated to infringement of all asserted claims of the related patents, so the injunction stands unless Apotex can demonstrate that all of the 69 asserted claims are invalid. For purposes of Apotex's appeal, we therefore focus on the narrowest claims, as they are the least vulnerable to Apotex's validity challenge. Based on our careful review of the proceedings at trial, we reject Apotex's argument that as to each of the asserted claims of those patents, the district court erred in concluding that Apotex failed to overcome the presumption of validity by clear and convincing evidence.

More evidence that Apotex counsel was slack -

Apotex's final argument relates to post-trial issues. After trial, both Apotex and Allergan submitted their proposed findings of fact and conclusions of law. In those filings, Apotex made obviousness arguments based on references that were admitted into evidence but that Apotex did not support with expert testimony or otherwise rely on at trial. The court granted Allergan's motion for judgment of a matter of law with respect to Apotex's obviousness arguments made on those references. Apotex contends that it was entitled to make post-verdict arguments that the claims would have been obvious in light of two of these references because (1) the references were admitted into evidence, and (2) the references were incorporated by reference in the patents in suit.

There is no invariable requirement that a prior art reference be accompanied by expert testimony. E.g., Wyers v. Master Lock Co., 616 F.3d 1231, 1242 (Fed. Cir. 2010) ("expert testimony is not required when the references and the invention are easily understandable"). But it is well within a trial judge's discretion to require expert testimony supporting technical references that are relied on to establish obviousness. That the references at issue in this case were incorporated by reference in Allergan's asserted patents means only that they are treated as if set forth in their entirety in the patents; the incorporation of those references is not relevant to whether the district court erred in disregarding them because of the lack of supporting testimony. We hold that the district court did not abuse its discretion in refusing to consider those references in its obviousness analysis in light of the absence of testimony explaining their relevance to the obviousness issue.

One down, but Apotex still lost.

In partial dissent, Judge Dyk would have found the related patents invalid as well. More than anything, the divergence of opinions indicates how unsettled case law is with regard to obviousness under the highly subjective Obzilla (KSR) standard. Hand-waving conjecture, reading the invention into the prior art, is a common occurrence. Here, the conjecture is over what would have been "obvious to try."

A finding of obviousness under the "obvious to try" standard "does not require absolute predictability of success . . . all that is required is a reasonable expectation of success." In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)) (emphasis altered). I think that standard was satisfied here. It is undisputed that all asserted claims of the related patents read on a combination of Alphagan® and Refresh Tears®. The undisputed evidence further establishes that, at the time of the invention, a person having ordinary skill in the art ("PHOSITA") would have known that: (1) Alphagan® had common side effects, two of which included eye irritation and dry eye (known to be exacerbated by its bezalkonium chloride ("BAK") preservative); (2) the higher pH of Refresh Tears®, nearer to that of the human eye, would likely reduce irritation; (3) the "gentle" stabilized chlorine dioxide ("Purite®") preservative in Refresh Tears® would likely be less harmful than Alphagan's® "toxic" BAK preservative; (4) inclusion of Refresh Tears'® carboxymethylcellulose ("CMC") viscosity agent would likely further reduce eye irritation; and (5) physicians were routinely prescribing Refresh Tears® to glaucoma patients on Alphagan® to help alleviate irritation and dry eye, two of Alphagan's® known side effects.

Under these circumstances, I think a PHOSITA would have found a combination of these two commercially successful products "obvious to try." KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007).

Judge Dyk does have solid reasoning, however valid the conclusion may or may not be. A deeper historical perspective is required to truly judge obviousness under such circumstance, and the court record does not reflect that perspective, for lack of expert testimony, at the least.

Exela took a different tack, arguing non-infringement. There was some legal cleverness to the approach taken; complements to Hal Wegner of Foley & Lardner, lead counsel on appeal.

The infringement provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A), states that it is an act of infringement to submit an ANDA that describes "a drug claimed in a patent." The infringement action is a hypothetical case that asks the factfinder to determine whether the drug that will be sold upon approval of the ANDA will infringe the asserted patent. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1249 (Fed. Cir. 2000). In Abbott Laboratories v. TorPharm, Inc., we explained that "[b]ecause drug manufacturers are bound by strict statutory provisions to sell only those products that comport with the ANDA's description of the drug, an ANDA specification defining a proposed generic drug in a manner that directly addresses the issue of infringement will control the infringement inquiry." 300 F.3d 1367, 1373 (Fed. Cir. 2002).

The pH of Exela's drops, tending to acidity, acted as an infringement buffer.

Exela argues that the district court erred by assuming that Exela would manufacture a drug outside of the parameters of the ANDA. In support of the district court's judgment, Allergan argues that in an infringement action provoked by the filing of an ANDA, the court may consider not only the proposed drug as described in the ANDA, but also other relevant information, including the pH drop that the court identified.

We agree with Exela. In Bayer AG v. Elan Pharmaceutical Research Corp., we considered an analogous situation in a different procedural posture. 212 F.3d at 1247-50... The highest pH at which Exela will manufacture and sell its proposed product is 6.7 or Exela will not, legally, market anything at all.

Exela infringement reversed.