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Federal Circuit Affirms PTAB Ruling That Prior Art and FDA Skepticism Supports Non-Obviousness Finding

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“The PTAB discovered that proof of business skepticism, together with the skepticism of the FDA throughout Eli Lilly’s medical trials, supported a conclusion of non-obviousness.”

federal circuitThe U.S. Courtroom of Appeals for the Federal Circuit just lately affirmed the Patent Trial and Attraction Board’s (PTAB) determination upholding the patentability of Eli Lilly & Co.’s patent claims directed to decreasing toxicity of a chemotherapy agent. In so holding, the Federal Circuit cited the Meals and Drug Administration’s (FDA’s) skepticism of the efficacy of the strategies as proof supporting non-obviousness. See Neptune Generics, LLC v. Eli Lilly & Co., Nos. 2018-1288, 2018-1290, 2019 U.S. App. LEXIS 12492 (Fed. Cir. Apr. 26, 2019) (Earlier than Moore, Wallach, and Hughes, J.) (Opinion for the Courtroom, Moore, J.)

Neptune Generics, LLC, Fresenius Kabi USA, LLC, and Mylan Laboratories Ltd. (collectively, the Petitioners) filed three petitions for inter partes evaluate (IPR) towards claims 1-22 of U.S. Patent No. 7,772,209 (the ?209 patent) owned by Eli Lilly & Co. The ?209 patent usually pertains to strategies of administering folic acid and a methylmalonic acid (MMA) decreasing agent, reminiscent of vitamin B12, earlier than administering pemetrexed disodium, a chemotherapy agent, to scale back the poisonous results of pemetrexed. The PTAB discovered that the ?209 patent was not unpatentable as apparent as a result of it was not recognized within the artwork to pretreat pemetrexed with vitamin B12 together with folic acid and the skepticism of others, particularly the FDA, supported a conclusion of non-obviousness. The Federal Circuit discovered that substantial proof supported the PTAB’s findings and affirmed.

Petitioners filed three IPR petitions towards the ?209 patent, every asserting a special mixture of references. All petitions, nevertheless, asserted the identical two references: a 1998 summary by C. Niyikiza et al. (Niyikiza I) and European Patent Software zero 595 005 A1 (EP005). The Board discovered that the ?209 patent was not apparent as a result of a talented artisan wouldn’t have been motivated to manage an MMA decreasing agent resembling vitamin B12 along with folic acid to scale back the poisonous results of pemetrexed. The PTAB discovered that it was recognized within the prior artwork that pretreatment with folic acid reduces the toxicity related to administration of pemetrexed as a result of folic acid deficiency is related to elevated ranges of homocysteine, which itself is a predictor of pemetrexed toxicity. Nevertheless, there was no proof within the prior artwork of any relationship or correlation between elevated ranges of MMA—which is related to vitamin B12 deficiency—and pemetrexed toxicity. In different phrases, there was no proof within the prior artwork of any understanding or correlation between administering an MMA decreasing agent akin to vitamin B12 and decreased pemetrexed toxicity. Consequently, an individual of bizarre talent within the artwork wouldn’t be motivated so as to add an MMA decreasing agent corresponding to vitamin B12 along with folic acid to scale back pemetrexed toxicity. The Board’s conclusion that there was no motivation within the prior artwork to pretreat with each folic acid and vitamin B12 to scale back pemetrexed toxicity was supported by substantial proof, and, thus, the Federal Circuit affirmed.

Eli Lilly’s Statements to the FDA

Petitioners additionally argued that the Board erred in failing to think about Eli Lilly’s statements to the FDA relating to pretreatment with folic acid and vitamin B12 and by failing to preclude Eli Lilly from taking opposite positions in the course of the IPRs. Throughout medical trials for Eli Lilly’s chemotherapy agent, Eli Lilly “inform[ed] the FDA that the prior artwork instructed that pretreating with folic acid and B12 was a no-risk, predictable strategy to decrease pemetrexed-induced fatalities by decreasing pretreatment homocysteine ranges.” Petitioners argued that these statements have been indicative of the state-of-the-art and the background information of a talented artisan on the time the ?209 patent was filed. The Federal Circuit deferred to the Board’s factual willpower and declined to seek out error, noting that “[w]hile, a patent proprietor’s personal disclosures to the FDA could also be thought-about in assessing the state of the prior artwork, . . . a reality finder should not permit its evaluation to be distorted by hindsight bias.” As a result of the Board’s determination to not contemplate Eli Lilly’s statements was not error, the Federal Circuit affirmed.

Skepticism Helps Non-Obviousness

The Board additionally discovered that proof of business skepticism, together with the skepticism of the FDA throughout Eli Lilly’s medical trials, supported a conclusion of non-obviousness. In response to a variety of fatalities throughout medical trials, Eli Lilly steered supplementing administration of pemetrexed with folic acid and vitamin B12. The FDA was skeptical, noting that the proof cited by Eli Lilly “doesn’t seem to help the addition of nutritional vitamins.” The Federal Circuit rejected Petitioners’ arguments that to help non-obviousness, the proof should recommend that a proposed answer is “technically infeasible,” “unworkable,” or “inconceivable.” The Federal Circuit famous that “

Additional, the Federal Circuit rejected Petitioners’ argument that the ?209 patent was directed to patent ineligible material, noting that the subject material that may be asserted in an IPR petition is restricted to invalidity based mostly on 35 U.S.C. §§ 102 and 103. As a result of patent ineligibility beneath 35 U.S.C. § 101 just isn’t a floor that may be raised in an IPR, the Federal Circuit declined to think about whether or not the ?209 patent was invalid on that floor.

Lastly, the Federal Circuit affirmed the Board’s non-obviousness willpower as to the ?209 patent’s dependent claims, regardless that the Board didn’t instantly tackle their patentability in its choice.

The ruling demonstrates that a patent proprietor’s statements to administrative our bodies such because the FDA may be thought-about in figuring out the state of the prior artwork, although it does increase the danger that the courtroom or Board’s evaluation might be contaminated with hindsight bias.  Proof that others have been apprehensive, skeptical, or stunned about an invention can help a non-obviousness willpower, although “proof that third events thought the invention was unattainable is perhaps entitled to extra weight.”


Dustin Weeks

Dustin Weeks

is a Companion within the mental property follow group at Troutman Sanders. His apply spans all areas of mental property regulation, together with patent prosecution, patent litigation (together with Hatch-Waxman litigation), and shopper counseling. He represents shoppers starting from start-ups and solo inventors to Fortune 500 corporations. Dustin works intently together with his shoppers to study their enterprise goals in order that he can tailor methods to acquire, shield, and implement their mental property. Dustin focuses on post-grant proceedings (e.g. Inter Partes Evaluations) earlier than the Patent Trial and Attraction Board (PTAB) the place he has in depth expertise representing each patent house owners and petitioners throughout a variety of applied sciences, together with wi-fi networking, prescription drugs, MEMs units, medical units, and electro-mechanical shopper units. Dustin’s broad expertise in patent prosecution, counseling, and patent litigation uniquely positions him to navigate the blended follow of post-grant proceedings.

For extra info or to contact Dustin, please go to his Agency Profile Web page.

Dustin Weeks

Robert Schaffer & Joseph Robinson


Robert Schaffer is an mental property companion at Troutman Sanders. Bob applies greater than 30 years of expertise to IP counseling and litigation. His work consists of patent procurement, strategic planning and transactional recommendation, due diligence investigations, district courtroom patent instances, and Federal Circuit appeals. He commonly handles complicated and high-profile home and worldwide patent portfolios, mental property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed courtroom instances Bob’s work consists of representing and counseling shopper in ANDA litigations, complicated patent infringement instances and appeals, and multidistrict and worldwide instances. In disputed Patent Workplace issues his work consists of representing and counseling shoppers in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For extra info and to contact Bob please go to his profile web page on the Troutman Sanders web site.

Joseph Robinson has over 20 years of expertise in all features of mental property regulation. He focuses his apply within the pharmaceutical, life sciences, biotechnology, and medical system fields. His follow encompasses litigation, together with Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in quite a lot of patent and trademark disputes in many various jurisdictions, and has additionally served as appellate counsel earlier than the Courtroom of Appeals for the Federal Circuit. Joe additionally focuses on complicated inter partes issues earlier than the united statesPatent and Trademark Workplace, inventorship disputes, reexaminations and reissues. His expertise consists of quite a few interferences, a specific benefit in new U.S. Patent and Trademark Workplace post-grant proceedings. He additionally counsels on patent–associated U.S. Meals and Drug Administration points, together with citizen petitions, Orange E-book itemizing, and trademark points. For extra info and to contact Joe please go to his profile web page on the Troutman Sanders web site.

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