Welcome to Winston & Strawn’s Federal Circuit Patent Decision Summaries. This bulletin provides a short summary of, and links to, the precedential patent cases decided by the Federal Circuit last week. We hope that these summaries are useful in keeping you updated on the Federal Circuit’s patent decisions.

A synergistic effect that is predictable renders a claim obvious.

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No. 2011-1223 (Fed. Cir. June 28, 2013).

After being sued for infringement, a generic drug manufacturer sought to invalidate a patent for treating diabetes with the combination of two drugs that have a synergistic effect. Since it was well-known in the art that using two drugs with different mechanisms for attacking diabetes is more effective than one, the District Court invalidated the patent as obvious, explaining that the key obviousness inquiry was “whether the combination yielded an unexpected synergistic effect.” It found the level of synergy predictable since a reasonable artisan seeking to combine the two drugs “would base his expectations upon prior art” involving similar combinations, some of which “produce beneficial and even synergistic results.”

Additionally, the District Court held the patent unenforceable due to inequitable conduct. The author of a study crucial to the prosecution of the patent had submitted an affidavit to the PTO, but omitted skeptical remarks he made elsewhere about the study, and omitted that the results cited were not measured according to his original test plan. Also, the lawyer who prosecuted the patent described the study as “clear evidence” of synergy, whereas the study’s language indicated the results “strongly suggested” synergy. The court deemed the study omissions and the lawyer’s misrepresentation material and intentional.

The Federal Circuit affirmed the obviousness holding, rejecting the patentee’s argument that the court misallocated the burden of persuasion by forcing the patentee to present evidence of unexpected results once a prima facie case of obviousness was established. It also rejected the patentee’s assertion that the lower court did not properly review the scope and content of the prior art and its argument the trial court should have deferred to the findings of the PTO. The Federal Circuit found no error in the lower court's finding that the synergistic effects of treatment using the two drugs were predictable, thereby rendering the combination obvious.

The inequitable conduct finding was reversed because the Federal Circuit found the author’s statements to be generally consistent and did not view the omissions as material since he “disclosed the results of his original protocol to the examiner” and did not “expressly undermine his stated opinion.” And, while “troubling,” the attorney’s misstatement was not material since he otherwise “employed carefully-chosen language which tracked the qualified nature” of the expert’s opinion.

The dissent claimed that the majority had misapplied the law of obviousness because “the question is not whether it would have been obvious to look for synergistic combinations; the question is whether it was obvious that [the claimed combination] would be 800% more effective than the additive effect of the components separately.”

A copy of the opinion can be found here.

In order to prove induced infringement, a patentee must prove that an alleged infringer possessed actual knowledge that the induced acts would constitute infringement or was willfully blind towards this fact. An alleged infringer’s good faith belief that the patent was invalid may negate a finding of inducement.

Commil USA, LLC v. Cisco Systems, Inc., No. 2012-1042 (Fed. Cir. June 25, 2013).

The defendant obtained a partial reversal of a district court’s judgment that it had directly and indirectly infringed a patent. While affirming the district court’s judgment on issues of direct infringement and patent validity, the Federal Circuit reversed the judgment on the induced infringement claim, holding that the district court erred by: (1) giving an erroneous jury instruction that allowed the jury to find induced infringement based on negligence; and (2) precluding the defendant from presenting evidence of its good faith belief that the patent in suit was invalid. 

Prior to trial, the defendant proffered evidence to support its good faith belief that the patent was invalid. Plaintiff filed a motion in limine to exclude the evidence, which the district court granted. On appeal, the Federal Circuit held that excluding this evidence was error. The Federal Circuit noted that although its prior opinions had not yet addressed the issue, a good faith belief of patent invalidity may negate the requisite intent for induced infringement and, therefore, evidence of such good faith should be allowed on the induced infringement claim. 

At trial, the district court instructed the jury that it could find induced infringement if Cisco “actually intended to cause the acts that constitute direct infringement and that [it] knew or should have known that its actions would induce actual infringement.” On appeal, the Federal Circuit held that the knowledge requirement for inducement could be satisfied by proving actual knowledge that the induced acts would constitute infringement or willful blindness towards that fact. The Court held that the jury instruction was inconsistent with this standard because it could sustain a finding of inducement on mere recklessness or negligence.

The jury found in plaintiff’s favor on the issues of patent validity and direct infringement, but in the defendant’s favor on the issue of induced infringement. Following the trial, the district court granted the plaintiff’s motion for a partial new trial – on issues relating to induced infringement and damages (but not patent validity and direct infringement) – based on a finding that defense counsel had made certain prejudicial statements during the first trial. A second trial was then held on induced infringement and damages. On appeal, the defendant challenged the district court’s grant of a partial new trial on the issues of only induced infringement and damages, which resulted in separate trials on validity/direct infringement (the first trial) and induced infringement (the second trial). The Federal Circuit found that, based on the record, the district court did not abuse its discretion in granting a new trial, and that separate trials on invalidity and induced infringement did not violate the Seventh Amendment because the defendant’s good-faith belief that the patent was invalid was separate and distinct from the issue of whether the patent was in fact valid. Thus, the Federal Circuit remanded the case for a new trial on the issues of induced infringement and damages, because those were the only issues impacted by the district court’s errors that the Federal Circuit had found.

A copy of the opinion can be found here.

A claim on a molecule is not adequately enabled by a specification with only one working example if one of ordinary skill in the art would be required to synthesize and screen each of at least tens of thousands of candidate compounds to practice the full scope of the claim.

Wyeth et al. v. Abbott Laboratories et al., No. 2012-1223, -1224 (Fed. Cir. June 26, 2013).

Wyeth and Cordis Corporation (“Wyeth”) appealed from the U.S. District Court for the District of New Jersey’s grant of summary judgment that claims 1 and 2 of U.S. Patent No. 5,516,781 and claim 1 of U.S. Patent 5,563,146 are invalid for nonenablement. The patents-in-suit relate to the use of rapamycin for the treatment and prevention of restenosis. The claims relate to a method of treating or preventing “restenosis...which comprises administering an antirestenosis effective amount of rapamycin to said mammal.” See, e.g., ‘781 patent at claim 1. In general, “rapamycin” refers to a class of compounds, and the District Court adopted Wyeth’s proposed construction of “rapamycin” as  “a compound containing a macrocyclic triene ring structure produced by Streptomyces hygroscopicus, having immune-suppressive and antirestenotic effects.”  Based on that construction, the District Court granted defendants’ motions for summary judgment of invalidity for nonenablement.

The Federal Circuit affirmed, holding that there is no genuine issue of material fact that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation. Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice the full scope without undue experimentation. Adopting the District Court’s unchallenged construction of “rapamycin,” the court found the invention to be a new method of use of a known compound (sirlimus) and any other compounds that meet the construction’s structural and functional requirements. The specification only disclosed a single species along with assays that could be used to determine which compounds exhibited the requisite effect. This meant that it would be necessary to synthesize and test each candidate compound using the assays disclosed in the specification to determine whether the potential compound possessed the necessary immunosuppressive and antirestenotic effects. The court found that there was “no genuine dispute that practicing the full scope of the claims would require synthesizing and screening each of at least tens of thousands of compounds” and that effort, which required “a complicated and lengthy series of experiments” represented undue experimentation.

A copy of the opinion can be found here.

If you have questions about the summaries that appeared in this bulletin, or would like to learn more about any of these cases, please contact one of the litigation partners listed here. If you have questions or comments about Winston & Strawn’s Federal Circuit Patent Decision Summaries or would like to be added to the mailing list, please contact one of the editors: Kathleen Barry at (312) 558-8046, Mike Brody at (312) 558-6385, Jim Hurst at (312) 558-5230, or Allan Fanucci at (212) 294-3311.

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