Merck Process for Stabilizing Antibiotic Compound Invalid as Obvious

Merck Sharp & Dohme Corp. v. Hospira, Inc., No. 2017-1115, (Fed. Cir. Oct. 26, 2017) (Before Newman, Lourie, and Hughes, J.) (Opinion for the court, Lourie, J.) (Dissenting opinion, Newman, J.).

The District of Delaware found that one of two patents asserted by Merck was not invalid and infringed, and the other patent, while infringed, was invalid as obvious. Merck appealed the conclusion of invalidity. The Federal Circuit affirmed.

The relevant patent was directed to a process for preparing a stable formulation of an antibiotic compound by reducing degradation pathways for two unstable portions of the antibiotic compound. The patent accomplished this reduction by minimizing both dimerization and hydrolysis at the two unstable portions. Prior art taught that the same antibiotic compound could be stabilized using dimerization.

The Court agreed with the district court that while three steps of the patent were not “individually taught by the prior art, the ‘recipe’ for the final formulation was disclosed” when the prior art taught dimerization by “reacting the pyrrolidine nitrogen with carbon dioxide to form a ‘carbon dioxide adduct.’”  The “order of the steps, the simultaneous addition of the base, the specific temperature range, and a final moisture content of less than 10%,” were seen as “nothing more than conventional manufacturing steps” and artisans “would have utilized [these steps] via routine experimentation, armed with the principles disclosed in the prior art.”

The Court next looked at Merck’s objective evidence of nonobviousness. The Court found no error in the district court’s conclusion that while there was evidence of commercial success and copying, the evidence was insufficient to outweigh the “strong prima facie case of obviousness.”  The Court pointed to blocking patents as weakening the inference of nonobviousness from commercial success. “[w] where market entry was precluded by another patent and by exclusive statutory rights…the inference of nonobviousness…from evidence of commercial success is weak.”   The Court also found that evidence of copying may be relevant, even though Hatch-Waxman ANDA cases typically require copying, but agreed with the district court that “in any event…the evidence of copying could not overcome the weight of the competing evidence of obviousness.”

Judge Newman dissented, lamenting the “inconsistent treatment of the procedures and burdens in applying the evidentiary factors of obviousness.”  Judge Newman’s view is that the obviousness “question is whether the entirety of the evidence relating to the [patent], including the evidence of [objective indications of nonobviousness], establish obviousness.”  The district court thus incorrectly used “a shortcut … convert[ing] three of the four Graham factors into a self-standing ‘prima facie’ case, whereby the objective considerations must achieve rebuttal weight.”  Judge Newman would have remanded the case to apply the “correct law.”

If the strongest evidence of nonobviousness are objective indicia, it is critical for the patentee to persuade the finder of fact that all four Graham factors need to be evaluated contemporaneously in making an obviousness determination.




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2 comments so far.

  • [Avatar for Peter Kramer]
    Peter Kramer
    November 6, 2017 08:20 am

    I am no longer impressed by the Pieta. Michelangelo simply used a hammer and chisel, the tools of the trade, and therefore, “all experimental details that one of ordinary skill would have utilized.” Thank you Federal Circuit!

  • [Avatar for Dan Hanson]
    Dan Hanson
    November 5, 2017 03:58 pm

    This Merck opinion is the most confusing opinion I’ve read in quite a while. Here are a couple of things that had me scratching my head:

    Various claim limitations were missing from the prior art, but the trial court found the missing limitations to be obvious anyway. It was asserted that the trial court determined that those limitations were within the “knowledge, creativity, and common sense” of a skilled artisan, though it is unclear whether the invocation of “common sense” was that of the appellate advocate or the trial court. The Federal Circuit treated the issue not as a common sense issue but as a routine experimentation issue (which is probably wise, since the issue did not seem to be common sense-related even for a skilled artisan), saying the missing limitations are “all experimental details that one of ordinary skill would have utilized via routine experimentation….” The Federal Circuit curiously made no analysis, however, of the legal principles applicable to routine experimentation (nor to common sense). The recent Honeywell case was not cited or discussed at all. In Honeywell, the Federal Circuit said: “A further point regarding so-called ‘routine testing’ is that § 103 provides that ‘[p]atentability shall not be negated by the manner in which the invention was made.’ 35 U.S.C. § 103 (2012). That provision was enacted to ensure that routine experimentation does not necessarily preclude patentability.” How would the Federal Circuit reconcile its decision in Merck with this passage from Honeywell? That is a fair question, as Judge Lourie is the author of both the Merck and Honeywell opinions.

    The patent holder also proved commercial success and proved that the commercial success was linked to the asserted claims. The trial court determined that the evidence was weak (not irrelevant, but of little weight) because the patent holder held other patents that deterred market entry, thereby enhancing commercial success. The trial court apparently followed precedent, and the Federal Circuit even quoted from one of its earlier opinions that appears to support what the trial court did. And yet, the Federal Circuit criticized the trial court, saying it should not have “discounted” the evidence of commercial success. But then, the Federal Circuit, acting as an appellate court, curiously gave the evidence of commercial success “its full and proper weight” (which the trial court apparently did not do) and concluded that the trial court did not clearly err after all. So wait, was the trial court right? Or was the trial court wrong but the error was harmless? And what the heck would be the “full and proper weight” anyway?