Federal Circuit confirms validity of patent for UCB’s Vimpat®

Vimpat® 100mg. By Yahia.Mokhtar. Licensed CC BY-SA 4.0 International.

On May 23, 2018, the Federal Circuit issued a decision in UCB, Inc. v. Accord Healthcare, Inc. (Before Prost, C.J., Bryson, and Stoll, J.)(Opinion for the court, Stoll, J.), a case arising under the Hatch-Waxman Act. The Appellees UCB, Inc. et al own and/or license U.S. Patent No. RE38,551., titled Anticonvulsant enantiomeric amino acid derivatives. The ‘551 patent covers lacosamide, an anti-epileptic drug for the treatment of epilepsy and other central nervous system disorders. UCB holds New Drug Applications (“NDAs”) that cover its lacosamide anti-epileptic drug approved by the Food and Drug Administration (“FDA”) and marketed under the tradename Vimpat®. The ‘551 patent is listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) as covering Vimpat®.

Appellants were generic drug manufacturers who filed Abbreviated New Drug Applications (“ANDAs”), seeking approval for generic versions of Vimpat®. Pursuant to applicable Hatch-Waxman provisions, Appellants certified in their ANDAs that the ‘551 patent was invalid, unenforceable, or that their proposed generic lacosamide products would not infringe the ‘551 patent.


Consequently, as is their right under Hatch-Waxman, UCB sued Appellants for patent infringement in the United States District Court for the District of Delaware. Appellants stipulated to infringement of claims 9, 10, and 13 of the ‘551 patent but maintained that these claims are invalid for obviousness-type double patenting, obviousness, and anticipation.

Following a bench trial, the district court made exhaustive fact findings based on the trial evidence and concluded that the asserted claims of the ‘551 patent were not invalid. Appellants appealled that decision, arguing that the district court misapplied the legal standards for obviousness-type double patenting, obviousness, and anticipation, and that the prior art anticipates and/or renders the ‘551 patent obvious.

The Federal Circuit held that the district court applied the correct legal standards in its obviousness-type double patenting, obviousness, and anticipation analyses, and found no clear error in its underlying factual findings. As a result, the Federal Circuit affirmed the district court’s ultimate conclusion that the asserted claims were not invalid.

“We are pleased with the CAFC decision,” said Anna Richo UCB’s Executive Vice President and General Counsel. “This confirms the strength of our intellectual property for Vimpat®
and maintains UCB’s exclusivity position until March 2022.” This decision supports UCB’s commitment to epilepsy patients and UCB’s ability to deliver Vimpat® to patients.

Obviousness-Type Double Patenting

The Federal Circuit did not disturb the district court’s finding of no obviousness type double patenting, because UCB failed to show that a chemist would have been led to modify the compound described in the ‘301 patent, to create lacosamide according to the ‘551 disclosure. More specifically, no reference disclosed any anticonvulsant data for any compound comprising a methoxymethyl group at R3, including lacosamide.

Obviousness

The district court applied a two-part “lead compound analysis” to evaluate whether the new chemical compound would have been prima facie obvious over a known compound: 1) whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds or starting points; and 2) whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.

Accord argued that the chemistry here, which concerned purifying a mixture, does not require a lead compound analysis. The Federal Circuit agreed but stipulated that no authority prohibited a lead compound analysis either. The lower court did not erroneously find that a person of ordinary skill would not have been led to select a lead compound from the references, because there was a lack of data supporting them, and expert testimony discouraged their use.

Anticipation

The Federal Circuit further found that the claims were not anticipated, because a broader genus of compound cited in the prior art reference did not disclose separation into the more narrow species cited in claim 9 of the ‘551 patent.

Chief Prost dissenting

Chief Judge Prost disagreed with the majority’s obvious-type double patenting analysis. While she noted the majority’s recognition of substantial evidence against a reasonable expectation of success in creating a functionalized amino acid (“FAA”) with anticonvulsant activity by selecting an unsubstituted benzyl for R and unsubstituted methyl for R1, she also noted experiments to the contrary that the majority ignored. Further, the contrary experiments were comparable or more promising than others tested. Prost also wrote that the majority failed to include one of the references in its obvious-type double patenting analysis.

Take Away

It was not reversible error for the district court to apply a lead compound analysis to evaluate the obviousness of a compound obtained by purifying mixtures. In that type of analysis, the prior art must provide a reason to modify a known lead compound, in order to obtain the claimed compound with a reasonable likelihood of success.

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and founder of IPWatchdog.com. Gene is also a principal lecturer in the PLI Patent Bar Review Course and an attorney with Widerman Malek. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Gene Quinn

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.

Gene Quinn

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.

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  1. Santh June 6, 2018 12:39 am

    Have you read “The captured economy”? It’s by polisci profs out of Johns Hopkins and looks at four segments of the economy, one of which is IP law and how, quote: “Patent protection, some of which can more fairly be described as patent trolling, raises new companies’ cost of doing business, with questionable and perhaps even nonexistent benefits for innovation overall” (from the atlantic article on the book, politics aside). Could be a good read.

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