by Dennis Crouch
Back in 2017, I published an article condemning Federal Circuit’s ramped-up practice of issuing R. 36 judgments in cases on appeal from the USPTO. Rather than simply arguing about policy, I looked at the statute and concluded that Section 144 of the Patent Act requires the Federal Circuit to issue its opinion, not just judgments. Dennis Crouch, Wrongly Affirmed Without Opinion, 52 Wake Forest L. Rev. 561 (2017). Over the past two years many petitioners have raised this argument to both the Federal Circuit and the U.S. Supreme Court. However, neither court has responded (denying those petitions without opinion).
Now comes Senju Pharmaceutical Co., Ltd., et al. v. Akorn, Inc., No. 18-1418 (Supreme Court 2019) with the following two questions:
- Whether 35 U.S.C. § 144’s directive that the Federal Circuit “shall issue … its mandate and opinion” in all appeals from the Patent and Trademark Office precludes the Federal Circuit from resolving such appeals through a Rule 36 judgment of affirmance without opinion.
- Whether, under this Court’s decisions in Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Patent Trial and Appeal Board must consider all relevant evidence, including any objective indicia of non-obviousness, when assessing whether a patent is invalid under 35 U.S.C. § 103.
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Senju’s U.S. Patent 6,114,319 claims an emulsified difluprednate (DUREZOL) used in a eye dropper to treat inflammatory eye disorders. The claimed composition includes castor oil, and polyoxyethylene (20) sorbitan monooleat.
At the time of the invention (2000), difluprednate was known for the treatment of eye ailments; and the prior art also taught how to formulate steroids in emulsions in ways recited by the patent document. However, Senju argued against any motivation to combine the prior art by migrating known steroidal suspensions into an emulsion. In addition, Senju presented objective evidence of non-obviousness: including unexpected results and industry praise. Senju also asked the court to draw an inference from the fact that no other steroid emulsion has been approved by the FDA:
If [Akorn’s] argument that the teachings of Ding made emulsions an obvious choice were correct (which it is not), then one would expect to see several other FDA-approved emulsions after Ding was published—but we do not. . . .
[I]f a steroid eye drop emulsion were obvious in light of the prior art, then some industry player—including the assignees of the scientists whose inventions supposedly rendered petitioners’ invention obvious—would have chosen that formulation. The fact that none did is strong objective evidence of non-obviousness.
These secondary consideration arguments were ignored by the PTAB (although others were considered). On appeal, the Federal Circuit affirmed without opinion and denied Senju’s petition for rehearing en banc.
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