Laundry Lists of Parts are Inadequate Written Description for a Specific Mixture

by Dennis Crouch

The pending Supreme Court docket 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 latest 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 elements that could be included in varied combos;  whereas the later-added declare is directed to a extra explicit sub-genus mixture.  The courtroom regarded in useless for some indication within the specification as to why the claimed mixture is essential or notably advised.  Right here, they disclosed a big forest, however did not disclose the tree that turned out to be precious.

Going ahead, a patentee may keep away from this explicit drawback with some patent lawyer tips.  Somewhat than itemizing all potential elements for every purposeful group and customarily suggesting their mixture, an early-stage patentee might need its AI assistant present a hypothetical instance of every potential mixture, separately.  That state of affairs would offer clear ipsis verbis disclosure and thus extra seemingly survive a written description problem.

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Most U.S. patents assert precedence to not less than one prior patent software submitting.  The early submitting date helps keep away from would-be intervening and invalidating prior artwork.  However, the correct to precedence is just not automated. Along with the formal paperwork, the unique software should sufficiently disclose the invention as claimed within the later patent.  Sufficiency of disclosure is usually judged underneath 35 U.S.C. §112(a) with the doctrines of enablement and written description.

A patent that improperly claims precedence is just not routinely invalid.  Somewhat, the precedence submitting date is rendered void after which we contemplate 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 of throughout Inter Partes Assessment  (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 problem of whether or not the  written description present in UMN’s precedence functions 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 a substitute a whole genus of molecules that match the overall construction proven above and the place purposeful teams R1 – R7 are additional outlined inside the declare.  As an example, “R3 is hydroxy … R5 is an amino acid …”

UMN’s preliminary patent software was a provisional filed again in 2004, adopted by a PCT software in 2005, adopted by a non-provisional software in 2007 and at last by one other non-provisional software in 2013 that led to the ‘830 patent. In 2010, a Gilead patent software revealed (“Sofia”) that discloses the claimed invention.  On this setup, UMN’s can disregard Sofia as long as it correctly claimed precedence to not less than a type of earlier functions.  However, if precedence fails then the ‘830 patent is anticipated.

In the course of the IPR, the Board sided with Gilead — concluding that the precedence filings lacked adequate written description and thus that the claims have been invalid as anticipated. On attraction, the Federal Circuit has affirmed in an opinion by Decide 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 notably laborious on patentees searching for to say protection for a big genus of compounds.  In that state of affairs, it’s sometimes a troublesome endeavor for the patentee to actually enumerate all operable compounds coated by the claims.  That stage of disclosure is just not 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 courtroom may even contemplate “blaze marks inside 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 software (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 type — pointing to a mixture of components 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 attraction 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 various paths, is just not a written description of what might need been described if every of the optionally available steps had been set forth as the one possibility. This argument calls to thoughts what Yogi Berra, the Yankee catcher, was reported to have mentioned: “when one involves a fork within the highway, take it.” That remark was notable due to its indeterminacy, its lack of path. Equally, right here, all these optionally available selections don’t outline the supposed end result 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 rely [wa]s disclosed ipsis verbis in Wattanasin’s software.” Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996). Because the courtroom defined in Fujikawa: “simply because a moiety is listed as one potential alternative for one place doesn’t imply there’s ipsis verbis help for each species or sub-genus that chooses that moiety. Have been this the case, a ‘laundry record’ disclosure of each potential moiety for each potential 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 explicit species.”

Slip Op.  I’d argue that the Federal Circuit erred on this level. The UMN provisional software’s Declare 1 is directed to the identical basic molecule, however with a lot broader definitions for every of the purposeful group. Then, the next provisional dependent claims (2, 13, 21, 22, 45, and 47) refine the scope of these purposeful 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 isn’t clear that my quibble would change the end result of the case since ipsis verbis help doesn’t essentially end in adequate written description.

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The absence of ipsis verbis help is just not 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 truly claimed.  However, lengthy lists of elements aren’t adequate. Somewhat, the recommendations – the “blaze marks” — have to be clear.  Right here, the PTAB discovered the patentee had failed to offer that roadmap and, on attraction, the Federal Circuit affirmed on substantial proof.

[T]he constructions [disclosed in the provisional] are so in depth and different 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 help.

Slip Op.

UMN made different arguments that have been all rejected:

1. The PTAB ought to have made a credibility dedication or different reality discovering concerning skilled testimony.  On attraction although the Federal Circuit concluded that the PTAB is just not required to deal with each  aspect competition inside its choice.
2. The PTAB beforehand issued a choice that’s facially inconsistent with this case, and thus is performing in an arbitrary and capricious method.  On attraction, the courtroom discovered no drawback because the Board is just not certain by prior panels.
3. 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 is not only certain by precedent but additionally collateral estoppel.

Cancellation affirmed.