Laundry Lists of Parts are Inadequate Written Description for a Explicit Mixture
7 min read
by Dennis Crouch
The pending Supreme Courtroom case of Amgen v. Sanofi focuses on a broadly claimed genus and asks whether or not the disclosure is sufficiently detailed. The Federal Circuit’s current UMN v. Gilead is the flip-side. Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023). UNM’s authentic disclosure is extraordinarily broad with “laundry lists” of parts that may be included in numerous combos; whereas the later-added declare is directed to a extra specific sub-genus mixture. The court docket seemed in useless for some indication within the specification as to why the claimed mixture is essential or significantly prompt. Right here, they disclosed a big forest, however did not disclose the tree that turned out to be invaluable. 
Going ahead, a patentee may keep away from this specific downside with some patent legal professional methods. Relatively than itemizing all potential parts for every useful group and usually suggesting their mixture, an early-stage patentee may need its AI assistant present a hypothetical instance of every attainable mixture, one by one. That state of affairs would supply clear ipsis verbis disclosure and thus extra seemingly survive a written description problem.
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Most U.S. patents assert precedence to at the very least one prior patent utility submitting. The early submitting date helps keep away from would-be intervening and invalidating prior artwork. However, the best to precedence isn’t computerized. Along with the formal paperwork, the unique utility should sufficiently disclose the invention as claimed within the later patent. Sufficiency of disclosure is usually judged beneath 35 U.S.C. §112(a) with the doctrines of enablement and written description.
A patent that improperly claims precedence isn’t routinely invalid. Relatively, the precedence submitting date is rendered void after which we take into account whether or not the invention was nonetheless novel and nonobvious as-of the later submitting date. This setup additionally permits these disclosure points to be thought-about throughout Inter Partes Evaluate (IPR) proceedings which can be statutorily restricted to anticipation and obviousness grounds.
In Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023), the Federal Circuit confronted the difficulty of whether or not the written description present in UMN’s precedence purposes supported the claims within the ensuing US8815830 patent. Right here, the ‘830 patent covers the drug sofosbuvir that has FDA approval for Hep-C remedy. Declare 1 doesn’t merely cowl sofosbuvir, however as an alternative a whole genus of molecules that match the final construction proven above and the place useful teams R1 – R7 are additional outlined throughout the declare. As an illustration, “R3 is hydroxy … R5 is an amino acid …”
UMN’s preliminary patent utility was a provisional filed again in 2004, adopted by a PCT utility in 2005, adopted by a non-provisional utility in 2007 and eventually by one other non-provisional utility in 2013 that led to the ‘830 patent. In 2010, a Gilead patent utility printed (“Sofia”) that discloses the claimed invention. On this setup, UMN’s can disregard Sofia as long as it correctly claimed precedence to at the very least a type of earlier purposes. However, if precedence fails then the ‘830 patent is anticipated.
Throughout the IPR, the Board sided with Gilead — concluding that the precedence filings lacked enough written description and thus that the claims have been invalid as anticipated. On enchantment, the Federal Circuit has affirmed in an opinion by Choose Lourie and joined by Judges Dyk and Stoll.
The patent act requires a “written description of the invention” be submitted within the type of a patent specification. “Judicial gloss” explains this requirement has proving that the inventor “possessed the invention as claimed” on the time of submitting. Written description points most frequently come up in conditions like this one the place the patented claims weren’t discovered within the authentic submitting paperwork; however reasonably have been added later throughout prosecution.
The courts have been significantly laborious on patentees looking for to say protection for a big genus of compounds. In that state of affairs, it’s usually a troublesome endeavor for the patentee to actually enumerate all operable compounds coated by the claims. That degree of disclosure isn’t required, however the patentee should describe “the outer limits of the genus” in addition to “both a consultant variety of members of the genus or structural options frequent to the members of the genus, in both case with sufficient precision {that a} related artisan can visualize or acknowledge the members of the genus.” The court docket will even take into account “blaze marks throughout the disclosure that information consideration to the claimed species or subgenus.” Slip Op., citing In re Ruschig, 379 F.2nd 990 (CCPA 1967).
Ipsis verbis: I discussed above that written description challenges are most frequently profitable in conditions the place the declare scope has modified throughout prosecution. Claims which can be discovered word-for-word within the authentic utility (ipsis verbis) can nonetheless fail the written description requirement, however that result’s a lot much less seemingly. Right here, UMN argued that the unique provisional submitting disclosed the eventual declare in ipsis verbis kind — pointing to a mix of parts of provisional claims 1, 2, 13, 21, 22, 45, and 47 that collectively forming a considerable word-for-word recitation of declare 1 within the ‘830 patent. On enchantment although the Federal Circuit discovered that mixture of this disparate set of claims required a bit an excessive amount of cleverness.
Following this maze-like path, every step offering a number of different paths, isn’t a written description of what may need been described if every of the elective steps had been set forth as the one possibility. This argument calls to thoughts what Yogi Berra, the Yankee catcher, was reported to have stated: “when one involves a fork within the street, take it.” That remark was notable due to its indeterminacy, its lack of path. Equally, right here, all these elective selections don’t outline the meant consequence that’s declare 1 of the ’830 patent.
Furthermore, Minnesota’s argument is akin to that rejected in Fujikawa, the place the applicant “persist[ed] in arguing that its proposed depend [wa]s disclosed ipsis verbis in Wattanasin’s utility.” Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996). Because the court docket defined in Fujikawa: “simply because a moiety is listed as one attainable selection for one place doesn’t imply there’s ipsis verbis assist for each species or sub-genus that chooses that moiety. Had been this the case, a ‘laundry record’ disclosure of each attainable moiety for each attainable place would represent a written description of each species within the genus. This can’t be as a result of such a disclosure wouldn’t ‘fairly lead’ these expert within the artwork to any specific species.”
Slip Op. I might argue that the Federal Circuit erred on this level. The UMN provisional utility’s Declare 1 is directed to the identical normal molecule, however with a lot broader definitions for every of the useful group. Then, the following provisional dependent claims (2, 13, 21, 22, 45, and 47) refine the scope of these useful teams in a fashion that’s similar to that ultimately claimed within the ‘380 patent. Right here, every of those dependent claims are outlined as being dependent upon any of the prior claims. Thus, provisional dependent declare 47 seemingly contains the similar limitations discovered within the ‘830 patent declare 1. Sure, it’s a little bit difficult, however so is chemistry.
It’s not clear that my quibble would change the result of the case since ipsis verbis assist doesn’t essentially lead to enough written description.
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The absence of ipsis verbis assist isn’t deadly, as long as the unique filings sufficiently present possession of the total scope of the claimed invention. In instances involving very broad disclosure (a forest), the courts look rigorously for indications that for disclosure of the actual timber really claimed. However, lengthy lists of parts aren’t enough. Relatively, the solutions – the “blaze marks” — should be clear. Right here, the PTAB discovered the patentee had failed to offer that roadmap and, on enchantment, the Federal Circuit affirmed on substantial proof.
[T]he constructions [disclosed in the provisional] are so intensive and diverse that [they] encompasses a considerably bigger genus than that claimed within the ’830 patent, aren’t sufficiently frequent to that of declare 1 of the ’830 patent to offer written description assist.
Slip Op.
UMN made different arguments that have been all rejected:
- The PTAB ought to have made a credibility willpower or different reality discovering relating to professional testimony. On enchantment although the Federal Circuit concluded that the PTAB isn’t required to handle each facet competition inside its determination.
- The PTAB beforehand issued a call that’s facially inconsistent with this case, and thus is performing in an arbitrary and capricious method. On enchantment, the court docket discovered no downside for the reason that Board isn’t certain by prior panels.
- As a state establishment, UMN is immune from IPR challenges. UMN acknowledged that this argument was beforehand determined by the Federal Circuit. Additional, UMN has already misplaced a case on this argument and so isn’t just certain by precedent but additionally collateral estoppel.
Cancellation affirmed.
