The Art of Losing Gracefully or How Koki’s appellate loss is truly a win.

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by Dennis Crouch

We have seen lots of ITC action recently. In the new Koki v. ITC decision, the Federal Circuit found that the accused infringer Koki lacked Constitutional standing to bring the appeal  based upon a binding promise not to sue submitted by the patentee Kyocera.

As I discuss at the end of this post, although Koki is the nominal loser, the company substantially advanced its position on appeal because Kyocera was forced to declare (and then clarify) its promise in order to obtain dismissal.

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Omitted Elements and Written Description: Federal Circuit’s Split Decision in Allergan v. Sun Pharma

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by Dennis Crouch

I previously wrote about Allergan USA, Inc. v. MSN Laboratories Private Ltd. (Sun Pharma), No. 24-1061 (Fed. Cir. Aug. 13, 2024), focusing on Federal Circuit's about-face on obviousness-type double patenting.  My original post skipped over an important aspect of the opinion: the court's 2-1 decision favoring the patentee on the written description requirement of 35 U.S.C. § 112(a).  This portion of the case focuses once again on when an element is "essential" to the invention and therefore required in the claims.

Four key takeaways:

  1. We presume that no element is "essential."
  2. Courts should look for indications in the patent documents that the feature is critical, essential, etc.
  3. The court here relied upon broad claims in the priority filing that were later deleted in order to show the inventor possessed embodiments that did not require the element.
  4. The key focus for written description is comparing the specification with the claims.  Although expert testimony may be relevant, it must be directly tied to the intrinsic record.

All of these elements point to the idea that it is the job of the patent drafter and prosecutor to ensure the written description is sufficient, and to avoid pitfalls that might indicate otherwise.

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One Bite at the Apple: WARF’s Second Infringement Theory Gets Precluded

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by Dennis Crouch

In a significant ruling that underscores the importance of strategic litigation planning in patent cases, the Federal Circuit has affirmed a district court's judgment barring Wisconsin Alumni Research Foundation (WARF) from pursuing  doctrine of equivalents infringement claims against Apple after the patentee's failed bid to show literal infringement. Wisconsin Alumni Research Foundation v. Apple Inc., No. 22-1884 (Fed. Cir. Aug. 28, 2024).  The case addresses two separate but related disputes: WARF I, concerning Apple's A7 and A8 processors, and WARF II, involving Apple's A9 and A10 processors. The Federal Circuit's decision hinges on three key legal principles: waiver, issue preclusion, and the Kessler doctrine. In particular, the court expanded the scope of both issue preclusion and the Kessler doctrine in favor of accused infringers.

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Eye-Opening Verdict: Lashify’s Patent Win Curls Industry Expectations

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by Dennis Crouch

This week a unanimous jury in Judge Albright's W.D.Tex. courtroom filled out a very simple verdict form that favored the patentee Lashify over the accused infringer Worldbeauty, who sells drugstore lashes:

Q: Did Lashify prove, by a preponderance of the evidence, that Worldbeauty has directly infringed the asserted claims of the asserted patents?

A: Yes, Yes, Yes (all 3 claims).

Q: Did Lashify prove, by a preponderance of the evidence, that Worldbeauty's infringement was willful?

A: Yes

Q: Did Worldbeauty prove, by clear and convincing evidence that the asserted claims are invalid as obvious in light of the prior art?

A: No, No, No.

Q: What amount did Lashify prove, by a preponderance of the evidence, it is entitled to as damages for Worldbeauty's infringement?

A: $30.5 million in lost profits.

There will certainly be some post-verdict motions, including the adjudged infringer's motion for JMOL as well as the patentee's request for treble damages and attorney fees.  The $90 million potential is certainly enough to blink your eyes at. 

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Rehearing Requested: Hikma Challenges Federal Circuit’s Skinny Label Ruling

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by Dennis Crouch

[A prior version of this article's title mistakenly stated that Amarin had filed the petition]

Hikma's recent petition for rehearing en banc against Amarin asks the Federal Circuit to reconsider its "skinny label" jurisprudence.  Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. 2024)

These cases typically involve the following scenario:

  • a drug formulation with multiple approved uses;
  • the formulation/compound patents are all expired as are patents on one or more uses; but
  • at least one method of use claim is still under patent (e.g., take 100 mg each day to treat hypertension...).

The FDA will approve a generic version of the formulation, but the approved label will only mention the non-patented uses.  Thus, it is a "skinny label" because the patented uses listed on for the branded formulation have been "carved out."

Of course, everyone understands that it is the same drug and will be just as safe and effective as the branded. The generic manufacturer, along with doctors, patients, pharmacies, insurance companies, and hospitals, . . . they all understand the carveout as simply a patent legalese. While technically an 'off label' prescription, it is still for an approved use considered safe and effective. In my experience, these folks typically do not strongly support the patent system and would have no compunction against using the cheaper drug for the patented use -- so long as they do not get tagged.

Background on the Amarin case: Amarin markets Vascepa (icosapent ethyl), which was initially approved by the FDA  in 2012 to treat severe hypertriglyceridemia (triglycerides ≥500 mg/dL). In 2019, Amarin obtained a second FDA-approved indication for Vascepa to reduce cardiovascular risk in certain patients. Amarin holds method patents on this cardiovascular (CV) indication. Hikma sought approval for a generic version of Vascepa, but with a "skinny label" that carved out the patented CV indication under 21 U.S.C. § 355(j)(2)(A)(viii). After launching its generic, Hikma issued press releases referring to its product as the "generic version of Vascepa" and noting Vascepa's total sales figures, which were largely attributable to the patented (but unmentioned) CV use.  None of Hikma's statements direct others toward the patented CV use, but conspiracy minded jurists could quickly connect these dots. If you know what I mean, nudge nudge, wink wink.

The basic question in the case is whether these actions by Hikma qualify as the "clear expression or other affirmative steps taken to foster infringement" typically required by precedent.  Quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (en banc in relevant part).

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Venue Transfer Games Continue: Rafqa Star v. Google

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by Dennis Crouch

Rafqa Star LLC v. Google LLC, No. 6:22-cv-01207-ADA, 2022 WL 3747666 (W.D. Tex. Aug. 17, 2022).

Google is one of the largest companies in the US with extensive ties not just to every state, but virtually every household in the entire country.  Still, the company regularly argues that it would be too unfair and inconvenient to litigate patent cases in states such as Texas. In a recent decision, Judge Alan Albright (W.D.Tex.) denied Google's motion to transfer venue. In his 40-page order, Judge Albright provided an in-depth analysis of the private and public interest factors that, based upon prior precedent, govern transfer under 28 U.S.C. § 1404(a).  The relevant statute reads as follows:

For the convenience of parties and witnesses, in the interest of justice, a district court may transfer any civil action to any other district or division where it might have been brought or to any district or division to which all parties have consented.

Id.  Before analyzing this case, I want to step back and recognize that the current legal test for patent venue transfer has departed significantly from the statutory language declaring the goals of convenience and justice. The public and private factor analysis mandated by current precedent does not actually focus on real inconvenience to parties or witnesses. For instance, the location of documents and witnesses gets weight when almost everything is cloud based. And the 100-mile rule makes little sense in an age of national air travel and remote work.  This is especially true for patent cases that will have nationwide impact.

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“Intent Engine” Claims Fail 101 for Lack of Technological Inventive Concept

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by Dennis Crouch

USC IP P’ship, L.P. v. Meta Platforms (Facebook), 22-1397 (Fed. Cir. August 30, 2023)

In a non-precedential opinion authored by Judge Pauline Newman, the Federal Circuit has affirmed USC IP Partnership's asserted patent claims are all invalid.  Back in 2020, USC IP sued Facebook for infringing its U.S. Patent No. 8,645,300.  The arguably pro-patentee Judge Alan Albright served as the district court judge.  Like Judge Newman, he had also found the claims invalid as unduly directed to an abstract idea. USC IP P’ship, L.P. v. Facebook, Inc., 576 F. Supp. 3d 446 (W.D. Tex. 2021) (granting summary judgment of ineligibility).

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Taylor v. Hunton Andrews Kurth LLP: A Cautionary Tale for Inventors and Startups

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The Harris County Texas appellate court recently affirmed summary judgment favoring the Hunton Andrews Kurth law firm and its attorneys. Taylor v. Hunton Andrews Kurth, LLP, 14-22-00410-CV (Tex. App.--Hous. [14th Dist.] July 13, 2023).  Taylor and his companies WPEM and W2W had sued the firm for legal malpractice after first losing its infringement lawsuit and being stuck with the defendants attorney fees. The case offers a few key takeaways for entrepreneurs delving into the patent system.

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Double Patenting and Patent Term Adjustment

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by Dennis Crouch

The Federal Circuit recently issued an important decision in In re: Cellect, LLC (Fed. Cir. Aug. 28, 2023) regarding how Patent Term Adjustment (PTA) interacts with terminal disclaimers and obviousness-type double patenting (ODP). This case establishes binding precedent that a terminal disclaimer cuts off any extended patent term granted through PTA.

This holding contrasts with the court's prior rulings regarding Patent Term Extension (PTE), where the extended term is calculated from the disclaimed expiration date, not the original expiration date. Thus, PTE extends beyond a disclaimed term, while PTA does not.

This result was expected by many patent experts, although some in the pharmaceutical industry had pushed for PTA to extend beyond disclaimed terms similarly to PTE. In the end, the statutory language expressly addressing disclaimers in the context of PTA proved decisive. This precedent will apply to all patents already in-force as well as those issued in the future.  Thus, applicants will want to carefully consider PTA and terminal disclaimer strategy for patent families.

If I were the judge, I would

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Publicly Traded International Patent Firm IPH Continue Growth through Acquisition

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by Dennis Crouch

The publicly traded Australian company IPH Limited continues expanding its global intellectual property services empire. IPH's latest acquisition is the Canadian IP firm Ridout & Maybee for $65 million Canadian dollars. This comes just 10 months after IPH purchased Canada's largest IP firm, Smart & Biggar.

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