Ortho-McNeil Pharmaceutical v. Mylan Labs (Fed. Cir. 2008)
Ortho-McNeil’s anti-convulsant Topamax is expensive and brings in over $1,000,000,000.00 each year. Hoping to produce a generic version, Mylan Labs filed an Abbreviated New Drug Application (ANDA) with the FDA along with arguments that the Topamax patent is invalid and not infringed.
AND vs OR: Mylan’s primary argument relies on a specific construction of the word “AND.” According to Mylan, AND should be construed logically as a conjunction. (i.e., AND = AND). Ortho, on the other hand, argues that its AND is not so restrictive. (I.e., AND = OR).
As you might guess, according to the courts, AND does indeed mean OR.
The problem with Mylan’s argument is that it turns the claims into nonsense. In particular, a conjunctive AND would require the claimed R groups (above) to be both independent spurs and, at the same time, joined as ring groups.
In the 2004 Chef America case, the CAFC allowed such a non-sensical construction — holding that the claim should be interpreted “as written, not as the patentees wish they had written it.” Here, however, Judge Rader distinguished Chef America — noting that here, the claim intrinsic evidence points toward the “alternative” interpretation:
“In Chef America, the only possible interpretation of the claim led to a nonsensical result. This situation is distinguishable because claim 1 can and should be interpreted as the patentees intended, with the meaning of and connoting alternatives.”
Because AND means OR, the claim properly covers the active ingredient topiramate.
KSR and Unpredictable Arts: In what may become an oft-cited decision, Judge Rader outlines how the supreme court’s KSR decision should have little impact on the “unpredictable arts” such as the development of pharmaceuticals.
Apparently, the anti-convulsive properties of topiramate were discovered by a researcher (Maryanoff) looking searching for FBPase inhibitor for diabetes. Oddly, both Mylan and the Court focused on whether the actual decisions of the researcher were logical, blocked by obstacles, or helped by serendipity.
“In retrospect, Dr. Maryanoff’s pathway to the invention, of course, seems to follow the logical steps to produce these properties, but at the time of invention, the inventor’s insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted.”
Of course, under 35 U.S.C. 103 patentability is not to “be negatived by the manner in which the invention was made.”
A Flexible TSM Test: Focusing on KSR, the court promotes its new flexible TSM test:
“The TSM test, flexibly applied, merely assures that the obviousness test proceeds on the basis of evidence – teachings, suggestions (a tellingly broad term), or motivations (an equally broad term) – that arise before the time of invention as the statute requires. As KSR requires, those teachings, suggestions, or motivations need not always be written references but may be found within the knowledge and creativity of ordinarily skilled artisans.”
On the facts, the CAFC found agreed that the invention is clearly nonobvious.
“In this case, the record amply supports the district court’s finding of nonobviousness. . . . As noted above, the challenges of this inventive process would have prevented one of ordinary skill in this art from traversing the multiple obstacles to easily produce the invention in light of the evidence available at the time of invention. Of particular importance beyond the prima facie analysis, this court also detects evidence of objective criteria showing nonobviousness. Specifically, the record shows powerful unexpected results (anticonvulsive activity) for topiramate. The record also shows skepticism of experts and copying – other respected sources of objective evidence of nonobviousness – as well as commercial success. As this court has repeatedly explained, this evidence is not just a cumulative or confirmatory part of the obviousness calculus but constitutes independent evidence of nonobviousness.”
Notes:
- Judge Rader wrote this opinion and was also a member of the 2004 Chef America panel