Novo Nordisk v. Caraco: Federal Circuit Gives No Deference to Examiner's Finding of Synergy in Obviousness Determination | Practical Law

Novo Nordisk v. Caraco: Federal Circuit Gives No Deference to Examiner's Finding of Synergy in Obviousness Determination | Practical Law

In Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., a divided panel of the US Court of Appeals for the Federal Circuit affirmed the district court's finding that claim 4 of Novo's U.S. Patent No. 6,677,358, directed to a method for treating Type II diabetes with combination therapy using repaglinide and metformin, was invalid as obvious. The Federal Circuit unanimously reversed the district court's determination that the '358 patent was unenforceable due to inequitable conduct.

Novo Nordisk v. Caraco: Federal Circuit Gives No Deference to Examiner's Finding of Synergy in Obviousness Determination

by PLC Intellectual Property & Technology
Published on 24 Jun 2013 • USA (National/Federal)
In Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., a divided panel of the US Court of Appeals for the Federal Circuit affirmed the district court's finding that claim 4 of Novo's U.S. Patent No. 6,677,358, directed to a method for treating Type II diabetes with combination therapy using repaglinide and metformin, was invalid as obvious. The Federal Circuit unanimously reversed the district court's determination that the '358 patent was unenforceable due to inequitable conduct.
On June 18, 2013, the US Court of Appeals for the Federal Circuit issued an opinion in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. affirming the district court's holding that claim 4 of Novo's U.S. Patent No. 6,677,358 ('358 patent) is invalid as obvious. Claim 4 is directed to a method for treating Type II diabetes with combination therapy using repaglinide and metformin. After multiple previous rejections based on obviousness during prosecution, the USPTO patent examiner finally allowed the claim after Novo submitted, through a declaration, the results of a study that Novo's patent counsel argued provided clear evidence of the combination's synergistic results.
The district court determined that Caraco had established that:
  • It was obvious to try the combination therapy.
  • The results of the combination were expected in light of the prior art.
On appeal, in a divided opinion, the majority (Judges Dyk and Prost) concluded that Caraco proved by clear and convincing evidence that an artisan would have expected the level of synergy Novo found when it combined the two compounds.
Notably, the majority rejected Novo's argument that the district court should have deferred to the USPTO examiner's finding of synergy. It noted that in a district court challenge to an issued patent, the USPTO's initial determination on whether to grant an application is entitled to no deference as it would be in either:
  • An appeal to the Federal Circuit from a decision of the Patent Trial and Appeal Board under 28 U.S.C. § 1295(A).
  • A proceeding under 35 U.S.C. § 145 concerning optional review in the US District Court for the Eastern District of Virginia of decisions from the USPTO rejecting patent applications in the first instance, absent new evidence.
The majority also rejected Novo's arguments that:
  • The district court misallocated the burden of persuasion by forcing Novo to overcome Caraco's prima facie case of obviousness with evidence of unexpected results.
  • Even if the burdens were properly allocated, Caraco's evidence insufficiently supported the court's ultimate obviousness findings.
Judge Newman dissented, arguing that Novo's discovery of the synergistic combination of metformin and repaglinide was incorrectly held to be unpatentable as obvious because, among other reasons:
  • The prior art did not show that it would have been obvious that the claimed combination would produce results superior to the additive effect of the compounds separately.
  • The claimed compound need not provide clinical results superior to those produced by the closest prior art.
The Federal Circuit also unanimously reversed the district court's finding that the patent was unenforceable due to inequitable conduct, finding that certain representations and omissions made by a Novo scientist and its patent counsel during the '358 patent's prosecution did not qualify as "but for" material under Therasense.
This is the third time the case has been before the Federal Circuit. The case, which stems from an Abbreviated New Drug Application filed by Caraco in 2005, previously went up to the US Supreme Court to determine whether a generic drug manufacturer can file a counterclaim in a Hatch-Waxman patent litigation to require a branded drug manufacturer to correct Orange Book patent use code information (see Legal Update, Generic Drug Manufacturer May Force Correction of Inaccurate Orange Book Patent Information: Supreme Court).
Court documents: