On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody.  The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the initial dose.  The patent is one of several patents AbbVie owns that relate to its blockbuster autoimmune drug Humira. 
Continue Reading Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication

Student and Math Book

In Shinn Fu Co. of America, Inc. v. The Tire Hanger Corp., Dkt. No. 2016-2250 (Fed. Cir. July 3, 2017), Shinn Fu appealed the Board’s holding in IPR2015-00208 (discussed here), a rare case in which the PTAB granted a motion to amend, and determined that substitute claims 6-10 of USPN 6,681,897 were patentable.  The claims are drawn to methods of changing the wheels of vehicles on lifts without the operator having to bend while supporting the wheel.
Continue Reading PTAB Gets A Math Lesson

“Inurement,” \i-ˈnu̇r-mənt, -ˈnyu̇r\ noun  :in patent law the concept that the action of another may inure to one’s benefit, esp.  where the actions of another in reducing an invention to practice may be attributed to the named inventor for purposes of establishing priority of invention. 
Continue Reading Breadcrumbs Lead Federal Circuit to “Inurement”

Last fall, the Federal Circuit reversed a PTAB decision that affirmed an Examiner’s rejection of various claims in an ex parte reexamination because the Examiner’s interpretation of the claims, which the PTAB upheld, was unreasonably broad. In re Smith International, Inc., Appeal No. 2016-2303 (Fed. Cir. Sept. 26, 2017). The court’s decision is noteworthy because it reinforces the bounds of the broadest reasonable interpretation claim construction standard the Patent Office must apply when assessing patentability, bounds that do not encompass the broadest possible interpretation.
Continue Reading Federal Circuit Again Reminds PTAB that BRI Must Be Reasonable

In CRFD Research Ltd. v. Matal, No. 2016-2198 (Fed. Cir. Dec. 5, 2017), the Federal Circuit determined that the PTAB erred in its obviousness analysis, in part by failing to consider an argument the IPR petitioner made in a ground that the PTAB determined was “redundant” to the instituted grounds.

Petitioner Hulu, LLC, challenged claims of CRFD Research Ltd.’s patent directed to methods of transferring an ongoing software-based session from one device to another, allowing the user to begin a session on one device, such as a cell phone, and then transferring the session to another device, such as a laptop computer.
Continue Reading PTAB Should Have Considered Argument Raised in “Redundant,” Non-instituted Ground

In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB’s factual findings and that the claims should have been held non-obvious.

The two Novartis patents at issue (U.S. Patent Nos. 6,316,023 and 6,335,031) were from the same patent family and are directed to a pharmaceutical composition comprising rivastigmine (Exelon®) and an antioxidant for the treatment of Alzheimer’s disease.  
Continue Reading PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity

The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, alleging that the claims were obvious in view of a combination of references that included prior art considered by the court in the litigation. Our previous post highlighted the potential for inconsistent results that AIA trials may present relative to district court actions concerning the same patent. 
Continue Reading Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB

Two recent Federal Circuit decisions illustrate how an error in construing claims may lead the court to reverse a PTAB final written decision. In Organik Kimya AS v. Rohm & Haas Co., the Federal Circuit determined that the PTAB correctly construed the disputed claim term, “swelling agent,” and therefore affirmed the PTAB’s decisions upholding the patentability of challenged claims directed to processes for preparing emulsion polymers. In contrast, in Owens Corning v. Fast Felt Corp., decided on the same day, the court determined that the PTAB erred in construing the term “roofing or building cover material” too narrowly, and thus reversed the PTAB’s decision canceling claims directed to methods of applying polymer “nail tabs” on roofing and building cover material.  
Continue Reading Error in Claim Construction Leads to Reversal of IPR Decision and Cancelation of Claims

Recent Federal Circuit decisions reversing or remanding PTAB holdings of obviousness have faulted the Board for failing to clearly articulate its reasoning.  See our previous posts here and here.  In In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017), a split CAFC panel vacated a PTAB ex parte appeal decision affirming an obviousness rejection based on “routine optimization” for failing to explain why one of ordinary skill would arrive at the claimed subject matter.
Continue Reading Assertion of “Routine Optimization” Without Additional Reasoning Insufficient to Support Obviousness Conclusion

PTAB rules prohibit raising new arguments in a reply brief, but it can be difficult to distinguish between an improper reply argument and a proper rebuttal. In Idemitsu Kosan Co. v. SFC Co., No. 2016-2721 (Fed. Cir. Sept. 15, 2017), the Federal Circuit determined that the IPR petitioner properly made a rebuttal argument—not a belated, new argument—in its reply brief, and the court affirmed the PTAB’s decision canceling the challenged claims for obviousness.
Continue Reading Petitioner Made Rebuttal Argument in Reply, Not an Improper New Argument