Filer of an ANDA Paragraph III Certification has Standing to Appeal from PTAB in IPR

The filer of a tentatively-approved ANDA with a Paragraph III certification has standing to appeal an IPR decision to the CAFC if the listing of the challenged patent in the Orange Book delays the final approval of the ANDA.

Judge Alan Lourie. ANDA Paragraph III Certification Filer has Standing to Appeal from PTAB

Judge Alan Lourie delivered the panel opinion for the Federal Circuit in Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH.

The Federal Circuit affirmed a decision of the PTAB holding that claims 1-5 and 21-24 of U.S. Patent No. 6,858,650 to UCB Pharma GmbH (the ’650 patent) were not unpatentable as obvious on January 11. See Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH No. 2017-2596 (Fed. Cir. January 11, 2019).

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of the ‘650 patent alleging certain claims were obvious. After institution of the IPR, Amerigen and two other companies joined as parties to the proceeding. After the PTAB’s finding that the challenged claims were not unpatentable, Amerigen—but not Mylan—appealed the decision.

On appeal, UCB asserted Amerigen lacked standing. Specifically, UCB argued that, based on the Paragraph III certification accompanying Amerigen’s abbreviated new drug application (ANDA), the FDA will not approve Amerigen’s ANDA until the expiration of the ‘650 patent, previously upheld in a separate suit in the District of Delaware, in 2022. Consequently, UCB contends Amerigen is foreclosed from infringing the ‘650 patent, and without a possibility of infringement there can be no justiciable dispute.

Standing requires a claimant to have “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc v. Robins, 136 S. Ct. 1540, 1547 (2016). UCB further argued that under the Hatch-Waxman Act “Paragraph IV certification is the fundamental, jurisdictional basis enabling parties to litigate Orange Book- listed patents in Article III courts,” and without that basis there can be no injury in fact.

The Federal Circuit rejected UCB’s argument for several reasons. First, this case did not arise under the Hatch-Waxman Act. Second, Amerigen did not rely a risk of infringement liability as a basis for injury. Rather, Amerigen pointed to a concrete commercial injury that it incurred from the listing of the ’650 patent in the Orange Book, which was only possible so long as the ’650 patent was not found invalid. Specifically, the listing of the ‘650 patent blocked the launch of Amerigen’s tentatively approved ANDA, and invalidation of the patent would advance its drug’s launch.

“We have previously recognized that listing a patent in the Orange Book may create a cognizable injury independent of the prospect of infringement liability,” wrote Judge Alan Lourie for a unanimous panel of the Federal Circuit. “ If Amerigen succeeds in invalidating the ‘650 patent here and having the patent delisted, then it… could launch its proposed drug substantially earlier than it otherwise could. Consequently, by any common-sense measure, Amerigen has a substantial, concrete stake in whether it succeeds in proving the invalidity of the ‘650 patent.” (internal quotations omitted).

Thus, the Federal Circuit concluded that Amerigen had standing to appeal from the PTAB’s decision and proceeded to the merits.

Regarding the merits of Amerigen’s obviousness arguments, the Federal Circuit found no error in the PTAB’s decision. Judge Lourie explained that is was reasonable, based on the dearth of testimony, to weigh the appellee’s expert testimony over the appellant’s expert testimony. Further, even assuming a person skilled in the art would be motivated to modify one of the key compounds of the ‘650 patent, the petitioners failed to prove a skilled person would have made the specific modifications leading to the claimed compounds. Thus, the PTAB finding that the petitioners did not sustain their burden of proof was supported by substantial evidence.

Ultimately, the Federal Circuit affirmed the PTAB’s decision to confirm the patentability of the claims of the ‘650 patent. 


Image Source: Gene Quinn © 2015
Judge Alan Lourie speaking at the AIPLA Annual meeting, October 2015.

The Author

Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Dustin Weeks is a Partner in the intellectual property practice group at Troutman Sanders. His practice spans all areas of intellectual property law, including patent prosecution, patent litigation (including Hatch-Waxman litigation), and client counseling. He represents clients ranging from start-ups and solo inventors to Fortune 500 companies. Dustin works closely with his clients to learn their business objectives so that he can tailor strategies to procure, protect, and enforce their intellectual property. Dustin specializes in post-grant proceedings (e.g. Inter Partes Reviews) before the Patent Trial and Appeal Board (PTAB) where he has extensive experience representing both patent owners and petitioners across a wide range of technologies, including wireless networking, pharmaceuticals, MEMs devices, medical devices, and electro-mechanical consumer devices. Dustin's broad experience in patent prosecution, counseling, and patent litigation uniquely positions him to navigate the blended practice of post-grant proceedings.

For more information or to contact Dustin, please visit his Firm Profile Page.

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