A celebration joined in an inter partes evaluate beneath Part 315(c) has a statutory proper underneath Part 319 to attraction the Board’s remaining written choice, even when the social gathering submitting the unique petition lacks Article III standing to attraction.
The Federal Circuit on February 1 affirmed the Patent Trial and Attraction Board’s ultimate written determination in an inter partes evaluation concluding that the claims of a patent directed to a composition for treating epilepsy usually are not unpatentable. The Federal Circuit first visited the difficulty of whether or not three petitioners—Mylan Prescription drugs, Breckenridge Prescription drugs, and Alembic Prescription drugs, all of whom have been sued for infringement of the patent multiple yr previous to the establishment of the IPR, and all of whom have been joined within the IPR underneath 35 U.S.C. § 315(c)—had standing to attraction the Board’s last choice. The Courtroom held that the petitioners had a statutory proper, underneath 35 U.S.C. § 319 to attraction. The Courtroom additionally mentioned whether or not there was a motivation to mix the “classical isosteres” disclosed in a secondary reference with the lead compound disclosed in a main reference, finally holding that the upper anticipated efficiency of the first reference’s lead compound over the claimed compound wouldn’t create a motivation to mix. Mylan Pharms. Inc. v. Analysis Corp. Techs., Nos. 2017-2088, 2017-2089, 2017-2091, 2019 U.S. App. LEXIS 3282 (Fed. Cir. Feb. 1, 2019) (Earlier than Lourie, Bryson, and Wallach, Circuit Judges) (Opinion for the Courtroom, Lourie, Circuit Decide).
Patent and Claims
The case centered round U.S. Reissue Patent 38,551 (the ’551 patent), owned by Analysis Company Applied sciences, Inc. (RCT). The claims at challenge within the ’551 patent, Claims eight–13, are directed to compounds and pharmaceutical compositions for treating epilepsy and different central nervous system issues. Declare eight is directed to the actual compound (R)-N-benzyl-2-acetamido-Three-methoxypropionamide, in any other case known as lacosamide.
Declare 9 claims “lacosamide in 90 % or larger purity,” Declare 10 claims “therapeutic compositions comprising the claimed compounds” and Claims 11–13 claimed “use of the compounds for treating central nervous system issues.”
Argentum Prescription drugs LLC (Argentum) petitioned for inter partes evaluation of the ’551 patent in November of 2015. Argentum challenged Claims 1–13 on eight grounds. Inside these eight grounds, Floor (1) challenged Claims 1–9 as apparent over the references Kohn and Silverman, and Floor (2) challenged Claims 10–13 over Kohn, Silverman, and U.S. Patent 5,378,729.
The Board instituted Argentum’s petition based mostly solely on these two grounds. Three days after the Board instituted the petition, Mylan Prescription drugs, Breckenridge Prescription drugs, and Alembic Prescription drugs, the Appellants right here, petitioned for evaluation with concurrent motions for joinder. Every of the three new petitioners had been sued by RCT for infringing the ’551 patent, and every have been sued over a yr previous to their petition for IPR. The Board instituted every petition and joined every of the petitions with the Argentum continuing. RCT cancelled Claims 1–7 after the Board’s last choice and earlier than this attraction.
Through the inter partes evaluate, Argentum superior a lead compound evaluation for Floor (1). Argentum provided Kohn—a 1991 article authored by the named inventor of the ’551 patent—as a main reference offering the proffered lead compound. A research in Kohn disclosed (R,S)-2-acetamido-N-benzyl-2-methylacetamide as a lead compound and changed the ?-methyl group with functionalized nitrogen, oxygen, or sulfur substituents. Kohn recognized that “in probably the most potent analogues… a functionalized oxygen atom existed two atoms faraway from the ?-carbon atom.” The reference additionally recognized a compound 31.
Argentum provided Silverman to provide a motivation to switch the amine of compound 31’s methoxyamino group with a methylene hyperlink, as present in lacosamide, “to yield a extra secure, synthetically accessible, pharmaceutically widespread and acceptable moiety.” Silverman is a e-book chapter on drug design, and the reference offered an inventory of classical isosteres: –CH2–, –NH–, –O–, –S–, and –Se–. Argentum argued that, of those classical isosteres, “solely methylene would end in a extra pharmaceutically widespread and acceptable compound and resolve the potential stability and synthesis considerations introduced by the methoxyamino moiety.” In line with Argentum, Silverman would have motivated an individual of talent within the artwork to switch the methoxyamino in compound 31 to create lacosamide, and one would have an inexpensive expectation of success in doing so.
The Board Guidelines
The Board disagreed with the petitioners with respect to Floor (1). The Board discovered “that changing the methoxyamino group would have been seen as undesirable as a result of the compounds in Kohn 1991 and not using a methoxyamino or nitrogen-containing moiety on the ?-carbon had lowered exercise.” The Board credited proof suggesting that the methoxyamino group of compound 31 can be anticipated “to confer vital exercise to the compound.” The Board concluded its evaluation by holding that the petitioners failed to satisfy their burden to show by a preponderance of the proof that Claims 1–9 would have been apparent, i.e., the petitioners failed to determine a motivation to mix.
As for Floor (2), the Board didn’t handle the deserves particularly. The Board reasoned that, because it held Declare 1 isn’t apparent over the references, the dependent claims wouldn’t be apparent. The unique petitioner, Argentum, didn’t attraction the Board’s choice; nevertheless, Mylan, Breckenridge, and Alembic, the joined petitioners, all did attraction.
The Courtroom first addressed the difficulty of standing. RCT argued that the three joined petitioners lacked standing as a result of they did “not fall inside the zone of pursuits of 35 U.S.C. § 319.” RCT argued that, since RCT introduced infringement actions towards the three Appellants a yr earlier than this IPR petition was filed, every Appellant’s petition was time-barred. Moreover, RCT argued that the “statutory scheme right here… doesn’t authorize Appellants to hunt federal courtroom evaluation” as a result of the unique Petitioner would have lacked Article III standing, i.e., it was merely an “company matter.”
The Courtroom dismissed RCT’s standing arguments by conducting a quick “zone of pursuits” evaluation. The Courtroom first famous 35 U.S.C. § 315(c) offers that the director “might be a part of as a celebration to the inter partes evaluate any one that correctly information a petition beneath part 311 that the Director… determines warrants the establishment of” an IPR. Moreover, Part 319 states that a “social gathering dissatisfied with the ultimate written choice” of the Board “might attraction the choice pursuant to sections 141 by way of 144. Any celebration to the inter partes evaluation shall have the suitable to be a celebration to the attraction.” The Courtroom held that, as said within the statute, any celebration has the appropriate to attraction the Board’s choice in an IPR, and this should embrace joined events, or else the phrase “get together” in Part 315 would have a special which means than the phrase “get together” in part 319. Accordingly, the Courtroom held that the three joined Petitioner/Appellants had standing to attraction.
The Courtroom then proceeded to the deserves of the case. The Courtroom agreed that the Board’s findings have been supported by substantial proof. The Courtroom discovered the proof that the anticipated efficiency for lacosamide was lower than the anticipated efficiency of compound 31 to be persuasive. Accordingly, the Courtroom agreed that one in every of talent within the artwork wouldn’t have been motivated to switch the amine of compound 31’s methoxyamino group with a methylene hyperlink, as present in lacosamide.
The Courtroom additionally held that the Board didn’t err in concluding that the Appellants didn’t meet their burden of building obviousness for the dependent claims (Claims 11–13), as a result of “[d]ependent claims, with added limitations, are usually not apparent when their father or mother claims will not be.”
Lastly, as a final various, the Appellants requested the case be remanded in mild of SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018). The Courtroom held that the celebration’s request was waived as a result of the request was made greater than six months after the SAS determination.
In rejecting the Appellant’s arguments that the Board erred in its non-obviousness conclusion, the Courtroom affirmed the Board’s conclusion that claims eight–13 wouldn’t have been apparent on the time of the invention.
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 elements of mental property regulation. He focuses his follow within the pharmaceutical, life sciences, biotechnology, and medical gadget fields. His apply 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.
is a Companion within the mental property apply 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 aims 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 Critiques) 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.