By Dennis Crouch
Novo Nordisk v. Caraco Pharma (Fed. Cir. 2013)
In a divided opinion, the Federal Circuit has affirmed a lower court trial ruling that Novo's diabetes treatment patent is invalid as obvious. The patent covers the use of a combination of repaglinide and metformin to stabilize a patient's glucose level. U.S. Patent No. 6,677,358. (Branded as PrandiMet)
At the time of Novo's application filing in 1997, it was known that both repaglinide and metformin were useful for treating unstable glucose levels. Repaglinide is a secretagogue and combination drug therapies using metformin other secretogogues were already known to be successful. With those factual findings, the district court made the legal conclusion that the combination would have been obvious to one skilled in the art at the time of the invention. On appeal, the Federal circuit affirmed and rejected
We have an interesting setup in that Novo did not challenge the proposition that the combination was obvious to try. Still, the patentee argued that the synergy of the combination was unexpected and that, therefore, the combination was nonobvious. That argument has the potential of winning. However, in this case the Federal Circuit agreed with the lower court that Caraco had established "that the results of the claimed combination therapy said by Novo to be unexpected and unexplainable were, to the contrary, expected and explainable in light of the state of the art as of the critical date."
A key element of the Federal Circuit's decision is that the result flows from the findings-of-fact and findings-of-fact are reviewed for clear error on appeal. Thus, although Novo provided credible evidence that a skilled artisan would have been surprised by the synergistic effect of the proposed combination of drugs, that evidence was insufficient to overcome the clear-error standard.
Of course, this lawsuit is occurring long after the patent issued. However, one quirky element of the case is that the examiner stated in the prosecution history that the evidence of synergy presented during prosecution was the basis of the decision on allowance. In the later lawsuit, Novo argued that the examiner's factual findings (based upon the same studies presented in court) should be given administrative deference. On appeal, the Federal Circuit rejected that argument and flatly concluded that the PTO findings should be given no deference during later litigation.
The initial determinations by the PTO in determining to grant the application are entitled to no deference as they would be in an appeal to this court under 28 U.S.C. § 1295(4)(A) or (absent new evidence) in a district court proceeding under 35 U.S.C. § 145. Rather, we treat the issued patent as having a presumption of validity that must be overcome by clear and convincing evidence. No decision of the Supreme Court or this court has ever suggested that there is an added burden to overcome PTO findings in district court infringement proceedings, and we reject Novo's contrary assertion. Neither are we persuaded that the presence or absence of PTO findings on particular issues affects the basic presumption of validity.
This administrative deference issue is one that is ripening for further Supreme Court review and follows in the wake of the Supreme Court's decision in Kappos v. Hyatt, 132 S. Ct. 1690 (2012).
The majority opinion was written by Judge Prost and signed by Judge Dyk.
Writing in dissent, Judge Newman argued that Novo's "discovery of the synergistic combination of metformin and repaglinide meets the criteria of patentability, and was incorrectly held to be unpatentable on the ground of obviousness, 35 U.S.C. §103."
The combination described and claimed in the patent in suit, U.S. Patent No. 6,677,358 ("the '358 patent"), is eight-fold more effective than the additive properties, and is now apparently a treatment of choice for persons whose Type II diabetes had previously been untreatable. It is a lifesaving combination for such persons, and is valuable to other diabetics, for it permits a more flexible treatment regimen than prior products. The Novo inventors pursued this combination despite the advice of other "experts" that they were wasting time and money. Nonetheless the district court, and now my colleagues on this panel, find the combination obvious to them, and invalidate the patent. I respectfully dissent.
One of Judge Newman's major points here is that – if anything – patents should offer legal protection for practical advances in science and medicine that actually save lives. That patent guarantee in turn would serve to encourage investment in achieving those advances.
= = = = =
The case is interesting to read for the legal-technical arguments made by the patentee against a finding of obviousness. After KSR and the fall of the teaching-suggestion-motivation test it appeared that obviousness had moved to a much more flexible analysis guided by common sense rather than bright line rules. Although unsuccessful here, the patentees arguments are interesting because they show ways in which that flexibility can be corralled.