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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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Old Dog, New Tricks: Government Defends 200-Year-Old ODP Doctrine Even Under Modern Statutes

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by Dennis Crouch

The debate over obviousness type double patenting continues.  Most recently, the U.S. Government has filed its brief in opposition to certiorari in Cellect v. Vidal. 

In its decision, the Federal Circuit ruled that the Congressionally mandated "patent term guarantee" that adjusts patent term to account for undue USPTO delay (known as PTA) triggers a risk that a later-expiring patent will be invalidated due to obviousness-type double  patenting (ODP). The Government brief consistently defends and agrees with the CAFC's decision -- arguing primarily (1) that ODP is an ancient patent tradition (much like eligibility) and (2) applying ODP to PTA is supported by the statute.

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The Phantom Menace: Federal Circuit Upholds Judge Connolly’s Investigative Powers Even After Dismissal

Patent

by Dennis Crouch

In Backertop Licensing LLC v. Canary Connect, Inc., the Federal Circuit addressed the scope of a district court's inherent authority to investigate potential litigation misconduct. Chief Judge Connolly of the District of Delaware had initiated an inquiry into dozens of patent infringement cases filed by plaintiff LLCs associated with IP Edge, a patent monetization firm, and Mavexar, an affiliated consulting shop. The district court was concerned that the real parties in interest may have been concealed, that fictitious patent assignments were filed with the USPTO to shield those parties from liability, and that the plaintiff LLCs' attorneys may have violated the Rules of Professional Conduct by taking direction from Mavexar without their formal-clients' informed consent.

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Without Undue Experimentation vs Without Any Experiments

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by Dennis Crouch

I was rereading the Supreme Court's recent enablement decision of Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) and was struck by the Supreme Court's statement that its 19th Century decision of Wood v. Underhill, 46 U.S. 1 (1847) "establish[ed] that a specification may call for a reasonable amount of experimentation to make and use a patented invention."  This statement from Amgen is surprising because Chief Justice Taney's decision in Wood includes a seemingly contrary statement that bars any experimentation

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Guest Post: Where Are the Patent Judge Shoppers Going?

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By Paul R. Gugliuzza and J. Jonas Anderson

In the past few weeks, more and more people outside of patent law have learned about ‘judge shopping’—quirks in procedural rules that allow plaintiffs to pick not just a court but the individual judge who will hear their case.

Republican state attorneys general and conservative activists have been exploiting those rules to challenge federal government policies on abortion, immigration, gun control, transgender rights, and more in front of sympathetic, Republican-appointed judges, primarily in Amarillo and Wichita Falls, Texas.

Last month, the Judicial Conference of the United States (a group of judges who oversee the operation of the federal courts) issued a new policy urging courts to adopt case assignment procedures that prevent judge shopping, especially in cases challenging federal law.

Predictably, the beneficiaries of judge shopping—namely, Republicans—decried the new policy as politically motivated and urged district courts to ignore it. Democrats, for their part,

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USPTO Fees: Targeted Higher Fees to Push for Compact

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by Dennis Crouch

The United States Patent and Trademark Office (USPTO) recently proposed a new fee structure for fiscal year 2025, which includes significant increases in various patent fees. [Read the Notice of Proposed Rulemaking] While incremental fee adjustments are common, the proposed changes for FY2025 are particularly noteworthy due to their magnitude in certain targeted areas and potential impact on applicant behavior. Many filers will likely change their practices based on the new higher fees. The USPTO appears to be using these fee adjustments as a tool to shape patent prosecution strategies, encouraging more compact patent applications and smaller patent families.  However, the USPTO is also seeking ways to ensure that the agency remains financially solvent and able to perform its statutory duties in the face of inflation and the Unleashing American Innovators Act of 2022 which reduced patent fees for small and micro entity applicants. The USPTO's proposed fee increases are largely unchanged from the plan announced last year.

One of the most striking changes in the proposed fee structure . . .

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Banning TikTok: Protecting Americans from Foreign Adversary Controlled Applications Act

Patent

by Dennis Crouch

Along with my work in intellectual property, I also spent a lot of time focusing on internet law issues and their interrelation with AI, privacy, speech and security.  We have seen growing calls for action surrounding Section 230 modifications and social media censorship, and several pending Supreme Court cases could reshape the legal landscape governing online platforms.

Banning TikTok: The U.S. House of Representatives passed a bill this week, with a vote of 352-65, that could potentially ban TikTok in the United States. The bill, called the Protecting Americans from Foreign Adversary Controlled Applications Act, would require TikTok to divest from its China-based parent company ByteDance or face consequences such as being cut off from app stores and hosting services in the U.S.

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No Contradiction ⇒ No Indefiniteness

Patent

by Dennis Crouch

The Federal Circuit recently issued a decision in Maxell, Ltd. v. Amperex Technology Limited, No. 2023-1194 (Fed. Cir. Mar. 6, 2024), reversing Judge Alan Albright's finding that certain claims of Maxell's patent covering rechargeable lithium-ion battery indefinite under 35 U.S.C. § 112, ¶ 2 (112(b)). U.S. Patent No. 9,077,035.

The case provides important cover for patent prosecutors who inelegantly add narrowed limitations from the dependent claims into the independent claims without rewriting or deleting the corresponding broader element descriptions already there.

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No Patent for Robot Inventions: UK Supreme Court Rules on AI Inventorship in Thaler v. Comptroller-General

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by Dennis Crouch

Thaler v. Comptroller-General of Patents, Designs and Trade Marks, [2023] UKSC 49. 

In a December 20, 2023 decision, the UK Supreme Court has agreed with American courts that an inventive machine is not deserving of patent rights.  The underlying case will be familiar to many with Dr. Stephen Thaler of St. Louis seeking to patent a thermal-mug designed by an artificial intelligence machine that he created.  Thaler has argued that the AI (called DABUS) conceived of the particular invention in question and also identified its practical utility.  The UK Supreme court based its holding upon the text of the UK Patents Act of 1977 as it reached the same ultimate conclusion as the Federal Circuit in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022), cert. denied, 143 S. Ct. 1783 (2023).

These Thaler cases showcase that under the current patent law regime, autonomous AI systems cannot qualify as inventors entitled to patent rights, irrespective of their creativity. For AI-generated inventions to become patentable, intervention by policymakers to amend inventorship laws would likely be necessary. However, the arguably bigger questions of immediate importance surround collaborative human-AI inventions where both human and machine contribute in creation of a new invention. Thaler expressly disclaimed any human input into DABUS’s inventions, but going forward mixed human-AI inventor teams seem inevitable. Neither the UK Supreme Court’s decision nor the parallel US rulings provide direct guidance on the requisite threshold quality or quantity of human participation in such collaborative inventions to satisfy legal inventorship requirements. Thus, for instance, an open issue remains whether token perfunctory human approval of an AI-devised invention would suffice, or if substantive intellectual contribution is needed. And for primarily AI-driven inventions, are minor tweaks by a human collaborator enough? Or must the human contributor objectively supply the novel concept?

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