Proving Written Description with Experimental Data

by Dennis Crouch

Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories Inc., Docket No. 17-02473 (Fed. Cir. 2019) [Decision][En Banc Petition][Opposition by Dr. Reddy’s]

The asserted patents in this case cover a combination dosing of (1) a pain-relief drug (NSAID) with an enteric coating (released in acidic environment) and (2) an uncoated PPI.  U.S. Patent Nos. 6,926,907 and 8,557,285.

1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:

(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and

(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;

wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

Claim 1 of the ‘285.

The defense raised a written description issue – arguing that the original patent filings did not support the “therapeutically effective” limitation.  The district court sided with the patentee, but the Federal Circuit reversed on appeal and held the claims invalid. In particular, the Federal Circuit found that PHOSITA could not tell from the patent document that the compound was “therapeutically effective” as claimed.

Obviousness – Written Description Interplay: The amount of written description needed varies from patent to patent depending upon a number of factors — including the level of skill in the art.  An invention that far-exceeds the state-of-the-art will need more description in order to show possession of the invention.

In this case, the patentee won its obviousness argument by showing PHOSITA would not have reasonably expected the combination to work.  As such, that means that the claim elements must be fully described in the specification.

The Court also explained that the written description requirement does not always require proof that a claimed drug treatment is effective.  The difficulty for the patentee here, is that the treatment’s effectiveness is particularly claimed.

The Patentee has now petitioned the Federal Circuit for rehearing en banc and explained the holding as follows:

The panel accepted Defendants’ argument that, if the prior art would have led a skilled artisan to be skeptical that uncoated PPI would work, the patents must lack written description because they allegedly lack experimental data or a detailed theory to overcome this teaching away and persuade the skilled artisan the uncoated PPI in the claimed invention would be effective. The panel stated, for example, that the inventor failed to show possession of the claimed invention because a skilled artisan “would not have expected uncoated PPI to raise gastric pH.”

The petition argues that this approach is improper:

The panel improperly enacted a new written description standard requiring either experimental data or a detailed theory of why the invention will work, at least for inventions that overcome obviousness based on skepticism in the field or a lack of reasonable expectation of success. In doing so, the panel’s opinion contradicts the very cases it cites, which hold that written description does not require experimental data, working examples, a detailed theory of why the invention will work, or an actual reduction to practice. . . .

This opinion creates a heightened written description standard that contradicts this Court’s precedents stating that a patent specification must only show that the inventor had possession of the claimed invention and does not need to disclose data

Citing Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015) and Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir. 2014).

Following the en banc petition, the Federal Circuit requested a response from Dr. Reddy’s who filed a short brief arguing primarily that Nuvo created a false “parade of horribles” that mischaracterize the Federal Circuit’s opinion.

  • Alan Pollack (Windels Marx) is handing the appeal for Dr. Reddy’s
  • Stephen Hash (Baker Botts) is representing Nuvo Pharma.

 

19 thoughts on “Proving Written Description with Experimental Data

  1. 5

    I got nailed by my examiner for lack of proof, based on utility. The invention was the use of fluoride to prevent birth defects, and the examiner said that without proof, I could not get labeling, and without labeling it would be useless to doctors. *SIGH* I gave up. Here is the logic, such as it is: (#5) link to raygrogan.weebly.com

  2. 4

    In addition to my remarks at #2 below, I think that the other point to note here is that the CAFC has already explained that “[c]ompliance with the written description requirement is essentially a fact-based inquiry that will necessarily vary depending on the nature of the invention claimed.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F. 3d 1313, 1330 (Fed. Cir. 2003) (quoting Enzo Biochem v. Gen-Probe, Inc., 296 F.3d 1316, 1324 (Fed. Cir. 2002)). In other words, the CAFC did not hold here as a matter of law that Nuvo’s patent needed data to satisfy the written description requirement. Rather, they concluded that—as a matter of fact—no reasonable fact-finder could have been satisfied with the adequacy of the written description of this invention, as of this filing date without more (where data could have supplied that missing “more”). In other words, the decision that Nuvo challenges does not actually reach nearly as far as Nuvo complains.

  3. 3

    The patentee: The panel improperly enacted a new written description standard requiring either experimental data or a detailed theory of why the invention will work, at least for inventions that overcome obviousness based on skepticism in the field or a lack of reasonable expectation of success.

    I don’t see what’s “new” about this, much less improper.

    If you are the patentee and you want to argue that your claimed invention is non-obvious because “skilled artisan would have been skeptical about claimed property X flowing from the claimed combination”, then of course you to show possession you need to have in your earliest filing either (1) data in your specification demonstrating that claimed property X was known; or (2) a cogent (LOL) explanation as to why the prior art was mistaken. Otherwise you’d be claiming something that was pure speculation at the time of filing. The game that gets played if this rule isn’t in place is an applicant filing hundreds/thousands of provisional applications (easily affordable) covering different possible “solutions” to a problem and then, after the “correct” solution is obtained, abandoning the applications reciting the “incorrect” (or “unfixed”) concepts.

    What’s more interesting about the CAFC’s decision — and most welcome! — is that it seems to cut very strongly against the CAFC’s ill-considered and relatively recent opinions permitting the use of post-filing “discoveries” of unexpected results to support non-obviousness. What judicial activist 103 decisions giveth, 112 taketh away.

    Kind of a huge deal and a positive improvement to the system, assuming it remains. Thanks for alerting everyone, Dennis.

    1. 3.1

      A minor edit for clarity: of course to show possession you need to have in your earliest filing either (1) data in your specification demonstrating that claimed property X was known…

      And for further clarity, by “known”, I mean “known/proven by the inventor” (not “known in the prior art”).

      1. 3.1.1

        Hmm,

        Does your “known/proven” really mean proven?

        As in, those pesky “effective” functionalities having been proven and passed, oh, say, FDA testing?

        You do know of course just how many things submitted to FDA testing do fail to be proven for that functionality, eh?

    2. 3.2

      Seems like it could have been handled a little more cleanly as a 101 utility issue –No credible utility, as “(ii) Credibility is assessed from the perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record (e.g., test data, affidavits or declarations from experts in the art, patents or printed publications) […]”

      1. 3.2.1

        [I]t could have been handled a little more cleanly as a 101 utility issue…

        Lord have mercy! Why does Title 35 even include provisions beyond §101? Is there any aspect of U.S. patent law that §101 cannot be stretched to cover?

        1. 3.2.1.1

          Hmmmm.

          This may actually be FAR less of a stretch than the Court has so recently rewritten.

          After all, the words of Congress DO provide the following two aspects to 35 USC 101:

          The claimed invention can be written in at least one statutory category, and

          The claimed invention provides utility within the Useful Arts.

          Credibility of utility IS one of the recognized 101 proper rejection basis (i.e., no perpetual motion machines).

      2. 3.2.2

        [I]t could have been handled a little more cleanly as a 101 utility issue…

        Not only would it not have been “more clean” to decide this case on utility grounds, invalidation on such grounds would have been a crazy mess. The claim recites esomeprazole and naproxen. Set aside the “therapeutically effective amounts” limitation because it is a red-herring for purposes of assessing utility. Any amount of naproxen has utility. Any amoung of esomeprazole has utility. Therefore, the claim as a whole—which requires esomeprazole and naproxen—has utility.

        The problem here is not utility. Rather, the problem is a failure of written description. The appeals panel reached the right conclusion for the right reason here.

        1. 3.2.2.1

          Greg: Any amount of naproxen has utility. Any amount of esomeprazole has utility.

          Say what? Claims don’t exist in a vacuum, Greg. This is a blind spot of yours.

          What’s the specific, substantial and credible utility of “A gel capsule comprising between 1 and 2 picograms of naproxen”?

          Please don’t embarrass the world and say “homeopathic remedy.”

          Setting this business aside for the moment, a utility challenge of these particular claims under 101 probably is not “cleaner” than the 112 decision that was actually handed down … but that’s primarily because the case law on “utility” is not developed very well and would have to be created mostly from scratch to “cleanly” address the issues presented in this case.

        2. 3.2.2.2

          I don’t have comments about the lack evidence of utility/lack of evidence of possession. I just would like to point that utility cannot reasonably be analyzed element by element. Any amount of hats has utility, a fridge has utility, therefore a pile of hats coupled to a fridge would have utility??? No way…

          1. 3.2.2.2.1

            Similarly PiKa, analyzing utility at the claim piece part level may yield each piece part as not having utility, but the claim as a whole having utility.

            This is why 35 USC 101 is a “claim as a whole” thing.

            Note as well, that this does link to my put-down of Malcolm and Malcolm’s “logic” that attempts to NOT take the claim as a whole when he attempts to parse claims (my posts with the Big Box of Protons, Neutrons and Electrons meme).

  4. 2

    The panel got this one right already. I doubt that the en banc court will bite, nor should it.

    In doing so, the panel’s opinion contradicts the very cases it cites, which hold that written description does not require experimental data, working examples, a detailed theory of why the invention will work, or an actual reduction to practice…

    Almost. The prior cases hold that written description may not require experimental data. Some inventions require more description that others, and there are certainly inventions that cannot be adequately described until they are actually reduced to practice. Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). It is scarcely inconsistent with prior precedent to say that some inventions require data to show adequate written description while others do not.

    1. 2.1

      Mr. “High Road” hasn’t taken that case out of context at all, has he?

      (It is an interesting and rather complicated case with competing claims to invention)

  5. 1

    I am actually looking forward to “High Road, I Use My Own Name” Greg DeLassus’s comments on this thread.

    (Let’s throw another thought seed out there: “in a therapeutically effective amount” is functional claiming and is not a singular objective physical structure.

    1. 1.1

      “in a therapeutically effective amount” is functional claiming and is not a singular objective physical structure.

      So much straw, so little time.

      As has been pointed out a zillion times before, this “function” (“therapeutically effective for treating X”) is never the only novel feature recited in the claim (unless both the prosecuting attorney and the Examiner has completely failed at his/her job).

      In addition, the term “singular” in the phrase “singular objective physical structure” seems to come out of left field. There is no existing or proposed requirement that a functional term be limited to a “singular” structure. The problem is with functional terms that have no meaningful structural bounds whatsoever (e.g., the “structures” corresponding to “determining a credit score” or “approving a user”). Every competently drafted pharma application will recite dose ranges in the specification, at least, if not in the claim itself. The point is that there is either an art-recognized “objective structure” corresponding to the “amount” (e.g., a range known in the art), or a stated “objective structure” (e.g., “100-200 mgs”) or else your claim is in deep d00d00, as it should be (assuming the recited “functionality” is relied on to overcome the art).

      None of this is difficult to follow for reasonable people. Basic stuff.

      1. 1.1.1

        Funny how your “pointed out a million times” is actually being pointed out for the first time ever here (as well as how funny it is that you seek to somehow constrain this particular “functionality” as somehow different because “it is not the only”

        The “singular” does NOT come out of left field. It is there because if you want to “cover” more than one “objective physical structure,” you are venturing into the land of ladders of abstraction.

        That may well be a more nuanced point, but certainly is not “out of left field.”

      2. 1.1.2

        The point is that there is either an art-recognized “objective structure” corresponding to the “amount” (e.g., a range known in the art), or a stated “objective structure” (e.g., “100-200 mgs”)

        Hmm, so then all that functional claiming of “effective” has to be:

        Known in the art (gee, you think you might have a problem trying to obtain a patent on such?) or

        Some stated amount (then we use the functional ‘effective’ in the claim at all — just claim that amount…

        Or maybe you have not yet completed your thoughts here.

        Let’s give you that benefit of doubt. Please complete your captivating dissertation.

        1. 1.1.2.1

          …as is typical, putting Malcolm’s drive-by monologue to the test and asking him to provide something substantive yields the same “contribution” from him:

          Nothing.

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