After Filing Statutory Disclaimer, Constitution Bars Court from Finding Claims Invalid

by Dennis Crouch

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories, Inc. and Fresenius, 2018-1804, 2019 WL 3807979 (Fed. Cir. Aug. 14, 2019)

Judge Shipp (D.N.J.) upheld the validity of several claims of Sanofi’s patent, but found several claims invalid. On appeal, the Federal Circuit vacated the obviousness holding — finding the invalidity judgment barred by the U.S. Constitution (no case or controversy).

Fresenius and several others filed ANDAs to start selling generic versions of Sanofi’s prostate cancer drug Jevtana (cabazitaxel). Sanofi then sued for infringement on U.S. Patents 8,927,592 and 5,847,170.

In parallel proceedings, the PTAB found most of the claims of the ‘592 patent invalid. Sanofi appealed to the CAFC on some of the claims* — but filed a “statutory disclaimer” of claims 7, 11, 14–16, and 26.  Note here that the disclaimer was not filed until December 2017, well after the close of trial, but before the district court issued its bench-trial judgment.

Rather than dismissing those claims from the lawsuit, the district court went ahead and held the claims invalid, including those that had been disclaimed.  The district court found (1) that a case or controversy still existed with respect to the disclaimed claims and (2) that those claims were obvious.

[On the last day of trial] Defendants [stated] that they “continue[d] to ask for a judgment of invalidity on all of the claims that have been a part of the case.” Plaintiffs did not object. In addition, Plaintiffs did not move at any time prior to the conclusion of the trial to voluntarily dismiss their assertion of Claims 7, 11, 14-16, and 26. The current procedural posture of the case also reflects that the claims at issue have not been cancelled [by the PTO]. The Court, therefore, finds that it has subject matter jurisdiction over Claims 7, 11, 14-16, and 26.

Sanofi-Aventis U.S. LLC v. Fresenius Kabi USA, LLC, CV147869MASLHG, 2018 WL 9364037 (D.N.J. Apr. 25, 2018).  The remaining claims that had been rejected by the PTAB were revived by the Federal Circuit in a Feb 2019 decision — ordering the PTAB to consider allowing amendments to the claims. Sanofi Mature IP v. Mylan Laboratories Ltd., 757 Fed. Appx. 988 (Fed. Cir. 2019)(unpublished).

On appeal, the Federal Circuit has vacated this decision — holding that “disclaimer of the disclaimed claims mooted any controversy.” Rather, once the claims were disclaimed the invalidity relief became “both speculative and immaterial to its possible future defenses, and Defendants thus failed to demonstrate an Article III case or controversy.”

Fresenius pointed to the fact that Sanofi is now in the process of amending its claims before the PTAB — and could potentially recaputure some aspect of those claims.  In addition, Fresenius argued that the decision could provide the company with issue preclusion armor in the future.  On appeal, the Federal Circuit found these potential harms too speculative and insufficient to be considered.

The decision here is somewhat surprising to me because we’re talking about a Constitutional question. Would the constitution allow a judgment on these claims — especially taking into account the ongoing litigation, the potential for recapture, and the notion that a patent covers a single invention (even if re-stated in number of claims).  The Federal Circuit did not cite the Supreme Court’s recent, Already, LLC v. Nike, Inc., 568 U.S. 85 (2013).  In that case, Nike sued Already for trademark infringement (Air Force 1) and Already counterclaimed that the mark was invalid.  Prior to judgment, Nike dismissed its side of the lawsuit and also issued a broadly worded “covenant not to sue” Already.

While the suit was pending, Nike issued a “Covenant Not to Sue,” promising not to raise any trademark or unfair competition claims against Already or any affiliated entity based on Already’s existing footwear designs, or any future Already designs that constituted a “colorable imitation” of Already’s current products.

The Supreme Court found that covenant left the case moot and therefor must be dismissed under the U.S. Constitution.  In its decision, the court held that Nike had the burden of showing that it could not “reasonably be expected” to resume enforcement efforts.

The difference between Already and the present Sanofi case is the breadth of the disclaimer. While Nike disclaimed any TM action based upon products already on the market, Sanofi only disclaimed a handful of claims within a patent – and maintained many other family-member claims as well as the ability to amend claims.

 

 

42 thoughts on “After Filing Statutory Disclaimer, Constitution Bars Court from Finding Claims Invalid

  1. 6

    I take it patent law is not your strong suit.

  2. 5

    It is actually not all that unusual for the Fed. Cir. to decide a case on Constitutional grounds, as here, when one considers the handful of IPR decisions that have been remanded for “due process” violations as well appeal refusals of those held mooted for “no case or controversy.”
    [Not to be confused with the very different cases of alleged un-constitutionality of patent statutes enacted by Congress, which have never been successful.]

    1. 5.1

      Never…?

      Hmm, I seem to recall some recent Congressional statutes on the Trademark side that appears to contradict your assertion.

      1. 5.1.1

        Which is why the words “patent statute” are in the sentence in question.

        1. 5.1.1.1

          Well certainly, I was NOT talking about the patent statute when I referenced the trademark statute – but that clearly does not take away the point that your sniping from the sidelines entails: Congressional statutes dealing with IP ARE successfully challenged on Constitutional grounds.

          Those of the likes of inte11ectual COWARDS (such as yourself) who are too afraid to actually engage on the merits of discussions before a court makes a ruling have NO room to be such neigh Sayers.

          1. 5.1.1.1.1

            “Those of the likes of inte11ectual COWARDS (such as yourself) who are too afraid to actually engage on the merits of discussions before a court makes a ruling have NO room to be such neigh Sayers.”

            I hate the neigh Sayers [sic; naysayers] too! Just say no to the neigh Sayers!

            1. 5.1.1.1.1.1

              Some just won’t get the layered pun (even if you lead them to water)

  3. 4

    Dennis, this write-up was a little sloppy. To make things a little clearer: shortly after the trial began in DNJ, the PTAB ruled that claims 1-5 and 7-30 of the ‘592 were invalid, and refused to let Sanofi amend any of those claims. Sanofi appealed PTAB’s refusal of permission to amend, but not with respect to claims 7, 11, 14-16 or 26. Sanofi disclaimed those claims after trial at the DNJ but before the DNJ rendered its judgment. All the CAFC said here was that Sanofi’s disclaiming of those claims divested the DNJ of jurisdiction over those claims, because there no longer existed a case or controversy. That conclusion seems straightforward to me.

    The CAFC also said that, while it had remanded the appeal from the PTAB back to the PTAB, and therefore it was theoretically possible that the remaining claims in the ‘592 patent may yet be amended and asserted in court, it would have been speculative of the DNJ to rule on those as-yet-not-effected amended and not-yet-asserted amended claims; and that the defendants would have the opportunity to plead issue preclusion and claim preclusion, if appropriate, when and if the actual amended claims were asserted. This too seems unremarkable.

    I have not yet looked at the ‘592 patent or its history before PTAB, but it will likely be interesting to try to understand why certain claims were disclaimed and others not.

    Considering that the CAFC upheld the DNJ’s conclusion that claims 1 and 2 of the ‘170 patent – the other Orange Book-listed patent asserted in this litigation – were not invalid for obviousness, it would seem that Sanofi will prevail regardless of the fate of the ‘592 patent. But here too, I haven’t looked closely enough to be sure.

  4. 3

    Re: “Fresenius pointed to the fact that Sanofi is now in the process of amending its claims before the PTAB — and could potentially recapture some aspect of those claims.”
    Not validly in the same patent, since there is no post-grant system other than a limited-applicably broadening reissue that does not expressly prohibit claim broadening, and the Fed. Cir. interprets that as broadening in any respect, plus there is the recapture rule, etc.

  5. 2

    the Federal Circuit found these potential harms too speculative and insufficient to be considered.

    ROTFLMAO

    The decision here is somewhat surprising to me because we’re talking about a Constitutional question.

    Dennis, you should be aware by now that the Constitution doesn’t apply to the patent system and can’t possibly be used to constrain patent rights (although it can be used to prevent constraints on patent rights, which are the most important rights ever!)a. That’s especially true of the First Amendment, which definitely doesn’t constrain either the patent or copyright system because (at least according to your beloved commenter Bildo) no human being has ever made a “cogent” argument to the contrary. And probably nobody ever will because, golly, this stuff is sooooo complicated.

    There are many excellent papers about the lack of Constitutional restraints on our IP laws so it’s suprising to hear you even go down this road. You really should spend more time reading Big Jeans and Noonan’s blogs. They are incredibly serious people, and not just a bunch of self-interested m-0-uthbreathing hacks who will literally do and say anything, as is widely believed.

    1. 2.1

      You spin so much, you may want to sit down.

      After you are done being dizzy, maybe YOU can do more than merely mouth “First Amendment” and YOU can try to make a cogent First Amendment argument.

      To “de-spin” your nonsense, I have never said nor indicated that a cogent First Amendment argument could not be made. I merely have consistently noted that YOU have never made one.

      For starters, I would recommend that you actually take a class in First Amendment Law. Going back aways now, but if I recall correctly, that was an optional class in my law school (and one I pulled down the High A in).

      1. 2.1.1

        if I recall correctly, that was an optional class in my law school (and one I pulled down the High A in).

        We got ourselves a True Expert, folks.

        1. 2.1.1.1

          Meh, “folks” would probably enjoy YOU doing more than mouthing “First Amendment” and making an actual cogent First Amendment argument.

        2. 2.1.1.2

          He’s also the only person in the world who understands innovation.

          1. 2.1.1.2.1

            Now you are sharing straw with Malcolm…?

            They say politics makes strange bedfellows, so there goes your proof.

      2. 2.1.2

        “Going back aways now, but if I recall correctly, that was an optional class in my law school (and one I pulled down the High A in).”

        My God, that’s impressive. What was the Professor’s name?

        1. 2.1.2.1

          1. 2.1.2.1.1

            Ohhh, so it was one of those _imaginary_ classes. So why only a High A? Why didn’t you get an A plus plus squared to the infinity power?

            1. 2.1.2.1.1.1

              Your attempt to play the “out yourself” is just one more of your very obvious silly games.

              Don’t you have some examining to do for your bi-week quota, Shifty?

              1. 2.1.2.1.1.1.1

                “out yourself ” as in exposing another of your _imaginary_ classes? That ship sailed long ago, snowflake.

                1. reply caught in filter – basically, you are not doing yourself any favors with noting that your “out yourself” game has sailed long ago.

                  Adding in, calling me “snowflake” does nothing for you, even as you might think yourself clever for engaging in that type of mindless and misaimed ad hominem.

                  The other part of the reply made note of your consistently OFF penchant for things like legal reasoning and use of historical pseudonyms. You seem to be ALWAYS short of reality, and yet (apparently) thinking yourself to be rather clever. You simply are not clever at all.

                2. How sad that your reply got caught, snowflake. I’m sure it would have been devastating. Have you tried Subway? They have the greatest Sandwich Artists (TM) in the world! Subway.

                3. – again, your gamey “snowflake” is as mindless as the Subway reference.

                  Please clean up after you are done pleasing yourself.

                4. Ever stay at Red Roof Inn, snowflake? Use promo code 605422 when booking online. Pets stay for free! Red Roof Inn.

                5. Have you tried Tinactin, snowflake? Tough actin’ Tinactin, for all your anti-fungal needs! At your local pharmacy.
                  Tinactin.

                6. “You know, WHY this site is even here?”

                  Per Wikipedia: “In 1997, he received his B.S.E. in Mechanical and Aerospace Engineering from Princeton University, where he also earned a certificate in engineering management systems. In 2003, he received his J.D. from the University of Chicago Law School,[2] and passed the Illinois bar examination and was admitted to practice in Illinois in the same year.[1] He also passed the USPTO registration examination, most likely in 2003, and was registered to practice as a patent agent in February 2004 and as a patent attorney in August 2004.[5][6] He runs the “Patently-O Patent Blog”,[7] a patent law blog that features analysis on current Federal Circuit law and other subjects.”

                7. Per Wikipedia: “This article is about the attorney. For the bassist, see Dennis Crouch (bassist).”

                8. Why the site is even here is NOT an invitation to discuss the site’s author, Prof. Crouch.

                  And certainly not about the bassist Crouch.

                9. The reason why this site is even here is NOT an invitation to discuss Prof. Crouch (nor the bassist Crouch).

                10. Snowflake, ever try Dr. Scholl’s® Corn Removers with Duragel® Technology? Removes corns fast and provides all-day cushioning pain relief! Ask for it by name. Dr. Scholl’s® Corn Removers.

                11. It’s fascinating how you are forced to “respond” to every comment, even (or especially) when you have nothing to say.

                12. There is nothing “forced.”

                  I ENJOY POSTING.

                  As for “when you have nothing to say” – why don’t you look in the mirror? YOU are really stretching to post something – even if that something IS nothing.

                  It’s as if you so desire relevancy that you think that engaging me somehow brings relevancy to you.

                  Psssst: even as I engage you, you remain irrelevant.

                13. The use of that phrase is inapposite to the current discussion.

                  Had you actually made it through law school, you would have realized that.

                14. The key here is that it is YOU doing the estimating, which renders your view of your own estimating to be a quintessential example of irrelevance.

  6. 1

    The decision makes perfect sense to me. Once the claims were canceled/disclaimed, the claims ceased to exist. You can’t have a case or controversy steaming from infrigment of a non-existing claim. Any opinion as to the validity of non-existing claims would be merely advisory.

    1. 1.1

      Also 35 USC 288 and the first sentence of 25 USC 253 specifically applies to a situation like this.

    2. 1.2

      Once the claims were canceled/disclaimed, the claims ceased to exist.

      Yes, the claims as associated with this specific patent “cease to exist” but the patent family is still pending and this disclaimer is very specific to the particular patent. Presumably our super awesome Constitution (LOL) will step right in to immediately destroy any effort by the patentee to seek coverage of claims that are broader in scope or identical in scope to the disclaimed claims.

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