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

August 26, 2024Patentactive inducement, ANDA litigation, FDA, Federal Circuit, Generic drugs, inducement, method of use patents, paid, patent infringement, pharmaceutical patents, skinny labelDennis Crouch

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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Red Flags Waved Off: Federal Circuit Rejects Overzealous Fee Award against Patentee

August 25, 2024Patentattorney fees, Federal Circuit, paid, patent eligibility, Section 285Dennis Crouch

by Dennis Crouch

While sitting by designation as at the Federal Circuit, Judge Alan Albright has authored an important new opinion on attorney fees patent cases under 35 U.S.C. § 285. The court vacated and remanded a fee award by Colorado Judge Brooke Jackson, finding that Judge Jackson abused her discretion when determining that the case was "exceptional" under the statute. Realtime Adaptive Streaming L.L.C. v. Sling TV, L.L.C., No. 2023-1035 (Fed. Cir. Aug. 23, 2024).

One wild thing about this case is that Sling TV (DISH) was awarded a $3.9 million fee for seven months of pre-trial litigation -- with the defendant on eligibility at the summary judgment stage. (Having requested ~$5 million).

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

August 22, 2024Patentdouble patenting, Federal Circuit, Historical Cases, paid, patent prosecution, PTA, Supreme Court, USPTODennis Crouch

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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ITC Patent Jurisdiction: Roku’s Petition and Contreras’ Critique

August 22, 2024PatentChevron deference, domestic industry, exclusion order, Federal Circuit, Injunctive Relief, ITC, NPE, paid, patent infringement, patent litigation, Roku, Section 337, software patents, Supreme CourtDennis Crouch

by Dennis Crouch

Roku, Inc. has asked the Supreme Court to review 2024 Federal Circuit decision affirming the US International Trade Commission's (ITC) finding of a Section 337 violation based on infringement of a TV-remote patent owned by Universal Electronics, Inc. (UEI). US10593196 (method of configuring user interfaces on home theater devices to control other appliances).

The petition focuses on the ITC's "domestic industry" requirement, and the level of nexus required between substantial domestic investment, the scope of the asserted patent, and any articles that embody the patented invention. The case invites a broader reconsideration of the ITC's role in patent disputes, including its near-automatic issuance of exclusion orders against adjudged infringers.

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Deference to District Courts: Federal Circuit’s New Approach to Venue Transfer Petitions

August 21, 2024PatentApple, Federal Circuit, mandamus, paid, patent litigation, Section 1404(a), Venue, Western District of TexasDennis Crouch

by Dennis Crouch

In a recent order, the Federal Circuit denied Apple's petition for a writ of mandamus seeking yet again to transfer a patent infringement case from the Western District of Texas (Judge Albright) to the Northern District of California. In re Apple Inc., 24-129 (Fed. Cir. 2024).

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Emphasizing Context in Claim Construction

August 21, 2024PatentClaim Construction, Federal Circuit, indefiniteness, IPR, obviousness, paid, patent litigation, patent prosecution, PTAB, Section 112Dennis Crouch

by Dennis Crouch

In Neonode Smartphone LLC v. Samsung Electronics Co., Ltd., the Federal Circuit has reversed Judge Albright's holding that claims of Neonode's US8095879 are invalid as indefinite. No. 2023-2304 (Fed. Cir. Aug. 20, 2024) (non-precedential). The appellate panel concluded that Albright failed to properly consider the full context of the intrinsic record, particularly the prosecution history.

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Apple v. Vidal: APA Compliance in IPR Discretionary Denial Rules

August 20, 2024PatentAdministrative Law, AIA Trials, Amicus Briefs, APA, discretionary denial, Federal Circuit, IPR, judicial review, NHK-Fintiv Rule, Notice-and-Comment Rulemaking, paid, patent litigation, USPTODennis Crouch

by Dennis Crouch

I have written several times about the Chestek case regarding notice-and-comment requirements under the APA. A second notice-and-comment case is also pending before the Federal Circuit, potentially having a much greater impact on patent practice. The case, Apple v. Vidal, focuses on IPR discretionary denials, which the USPTO implemented as policy without any formal rulemaking notice-and-comment.

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Government Opposition to Chestek’s Cert Petition

August 20, 2024Patentadministrative procedure act, Chestek v. Vidal, Federal Circuit, notice-and-comment, paid, patent office rulemakingDennis Crouch

by Dennis Crouch

The U.S. Solicitor General has filed the Government's opposition to Chestek PLLC's petition for a writ of certiorari in a case challenging the USPTO's authority to implement certain procedural rules without notice-and-comment rulemaking. The case has has significant implications for the agency's regulatory powers. In particular, the Federal Circuit's decision frees the agency so that it most situations it can conduct rulemaking without any notice-and-comment. Chestek offers some similarities to another APA case pending at the Federal Circuit, Apple v. Vidal, that similarly questions whether the FINTIV discretionary denial rules should have gone through notice-and-comment.

If you recall, this case center's on the USPTO's attempt to address trademark fraud. One approach that the agency has taken is to require trademark applicants to provide their domicile address (defined as their permanent legal residence or principal place of business) rather than just a mailing address. 84 Fed. Reg. 31,498 (July 2, 2019). The agency found that many of the fraudulent filing were from foreign applicants using a U.S. mailing address. This requirement is designed to help weed those out. Chestek refused to provide her home address to the USPTO because of privacy concerns, leading the USPTO to reject her trademark application.

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EcoFactor Responds: Defending the Federal Circuit’s Damages Ruling Allowing Qualitative Apportionment

August 19, 2024PatentAmicus Briefs, apportionment, comparable licenses, Damages, Daubert, en banc, Expert Testimony, Federal Circuit, judicial review, paid, patent litigation, Patent Valuation, Reasonable RoyaltyDennis Crouch

by Dennis Crouch

This is my third post focusing on Google's en banc challenge to 'loose' damages testimony. The patentee, EcoFactor, has now filed a responsive brief in the ongoing smart thermostat patent dispute which resulted in a $20 million jury verdict against Google. A 2-1 Federal Circuit panel affirmed the verdict and, as you might expect, EcoFactor's en banc response defends the decision, arguing that the case presents a straightforward application of established precedent. At core, EcoFactor argues that Google and amici are seeking to impose new, rigid rules that go beyond existing Federal Circuit precedent. Although some say that hindsight is 20/20, anyone who has undergone a hypothetical damages analysis will understand that the process always involves some degree of guestimation and uncertainty -- adding additional precision and calculation is unlikely to provide any true certainty or predictability.

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No Concrete Plans, No Standing: Federal Circuit’s Latest on IPR Appeals

August 18, 2024PatentAIA Trials, Article III, Case-or-Controversy, Constitutional Law, Dismissal with Prejudice, Federal Circuit, infringement, IPR, judicial review, Kessler Doctrine, obviousness, paid, patent litigation, standingDennis Crouch

by Dennis Crouch

The recent Federal Circuit decision in Platinum Optics v. Viavi Solutions focuses attention once again on the case-and-controversy requirement derived from Article III of the U.S. Constitution, which extends federal judicial power to "Cases" and "Controversies."

The seemingly simple phrase has been the subject of extensive judicial jockeying in the development of the doctrine we know as "standing."

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Defense Side Amici Support for Tighter Reins on Damages Expert Testimony

August 16, 2024PatentAmicus Briefs, apportionment, comparable licenses, Damages, Daubert, en banc, Expert Testimony, Federal Circuit, paid, patent litigation, Patent Valuation, Reasonable Royalty, Rule 702Dennis Crouch

by Dennis Crouch

Google's pending en banc petition in EcoFactor v. Google has drawn significant support from some tech giants, focusing on the application of Daubert standards to patent damages expert testimony. Five amicus briefs supporting Google's position have been filed with the Federal Circuit, each arguing for stricter scrutiny of damages calculations and expert reliability in patent cases. This post discusses the case and the issues presented by the amici army.

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Policy Considerations: The On-Sale Bar for Secret Processes

August 15, 2024PatentAIA, Federal Circuit, First-to-File, International Harmonization, Metallizing Engineering, On-Sale Bar, paid, Patent Invalidity, patent litigation, patent policy, Patent Term, prior art, Prior User Rights, public disclosure, Secret Prior Art, Trade SecretsDennis Crouch

by Dennis Crouch

In light of the Federal Circuit's recent decision in Celanese v. ITC, it's worth examining the policy implications of maintaining a strong on-sale bar that extends even to invalidate patents on secret processes when the resulting products have been commercialized. This rule is rooted in pre-AIA jurisprudence and is now affirmed under the AIA.

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Family Planning Patent Style: Allergan, Cellect, and the ODP Maze

August 13, 2024PatentAllergan v MSN Labs, Cellect, Continuation Patents, double patenting, Federal Circuit, obviousness, obviousness-type double patenting, paid, Patent Expiration, Patent Families, patent litigation, Patent Portfolio Management, patent strategy, Patent Term, patent term adjustment, patent validityDennis Crouch

by Dennis Crouch

Most U.S. utility patents are (or will eventually be) part of a patent family with at least one other U.S. patent. The recent rise in focus on obviousness type double patenting (ODP) has been unnerving to some, especially with the Cellect decision from 2023 that seemed to greatly expand the risk of family members colliding based upon differing expiration dates due to Patent Term Adjustment (PTA).

The Federal Circuit's new ODP opinion in Allergan USA v. MSN Labs, 24-1061 (Fed. Cir. August 13, 2014), provides some major relief to patent portfolio holders, holding that "a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date." This ruling provides a measure of protection for first-filed patents that receive substantial PTA, shielding them from ODP challenges based on their own continuations sharing the same priority date.

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No Sugar-Coating: Post-AIA Patent on Secret Process Barred by Pre-Filing Sale of Product

August 12, 2024PatentAIA, Artificial Sweeteners, Federal Circuit, Helsinn, International Trade, ITC, On-Sale Bar, paid, Patent Filing Strategy, Patent Harmonization, patent litigation, patent validity, prior art, Secret Processes, Statutory Interpretation, Supreme CourtDennis Crouch

by Dennis Crouch

Although the result could have been guessed, the Federal Circuit has issued an important decision interpreting the scope of post-AIA 35 U.S.C. 102 -- and the meaning of the "claimed invention." Celanese Intl. Corp. v. Intl. Trade Comm'n, 22-01827 (Fed. Cir. August 12, 2024). In particular, the court affirmed the precedent of D.L. Auld -- i.e., the on-sale bar continues to block patenting of an otherwise secret process when the patentee makes pre-filing sales of product made using that process. The ITC had invalidated Celanese' artificial sweetener manufacturing process patent based upon these pre-filing sales. That judgment was thus affirmed on appeal.

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Zebra’s Stripes: Just So Stories about Patent Standing

August 11, 2024PatentArticle III Standing, Cert Petition, exclusionary rights, Federal Circuit, Intellectual Property Finance, litigation finance, paid, patent assignment, patent enforcement, patent law, patent licensing, patent litigation, Patent Ownership, patent rights, Patent Standing, standing, Supreme CourtDennis Crouch

by Dennis Crouch

The newest patent-focused petition for writ of certiorari to the Supreme Court was recently filed by Zebra Technologies, challenging the Federal Circuit's determination that the a patentee had standing to sue for infringement even though a third party separately held rights to assign, license, and enforce patent rights.

The case offers an increasingly common situation in patent litigation finance where the litigation funder is seeking legal assurances and collateral rights, but where those rights potentially risk stripping the patent owner from the exclusionary rights necessary to establish standing.

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Patently-O Updates for Friday, August 9, 2024

August 9, 2024PatentpaidDennis Crouch

by Dennis Crouch

Welcome to August 2024. This post offers a recap of some of the week's events.

Democrat VP Nominee Gov. Tim Walz apparently owns no stocks. For those of us that do, this week experienced extremely high price volatility. One of the biggest losers of the week (percentage wise) is Houston based FibroBiologics, Inc. (Nasdaq: FBLG) whose 3rd quarter Q-10 reported "substantial doubt about our ability to continue as a going concern." The filing noted increased R&D costs, delay in clinical trials for their wound healing fibroblast treatments, and financing struggles. The companies 150+ issued/pending patents (global) and are likely the company's largest assets. Currently pending APN 17/757,309 includes what seems to be a very broad claim of administering fibrobrasts to treat or prevent kidney disease:

1. A method of preventing or treating kidney disease in an individual having, or at risk of having, kidney disease comprising administering a prophylactically or therapeutically effective amount of fibroblasts, modified fibroblasts, and/or products derived from fibroblasts.

The examiner has not yet passed judgment on the claim. Melissa Sistrunk at Norton Rose appears to be handling the prosecution.

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Bleak House Revisited: Lemon Bay Cove and the Regulatory Takings Quagmire

August 8, 2024Patentobviousness, paidDennis Crouch

by Dennis Crouch

A recently filed petition for writ of certiorari in Lemon Bay Cove, LLC v. United States highlights the longstanding difficulty in defining regulatory taking as well as determining when a regulatory takings claim becomes ripe for judicial review. The brief was filed by the Pacific Legal Foundation, a public interest law firm that focuses largely on protecting private property against government intrusion and regulation.

Background: Lemon Bay Cove, LLC owns about 6 acres of intercoastal property in Charlotte County, Florida, north of Ft. Myers. In 2012, Lemon Bay applied to the U.S. Army Corps of Engineers for a permit to fill about 2 acres around Sandpiper Key to construct a 12-unit townhome development. After a nearly four-year process, the Corps denied the application with prejudice in 2016.

Lemon Bay then filed suit in the Court of Federal Claims, alleging that the Corps' denial effected a per se regulatory taking under Lucas v. South Carolina Coastal Council, 505 U.S. 1003 (1992), by depriving the property of all economically viable use.

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Means-Plus-Function Claims in Patent Eligibility and Infringement Analyses

August 7, 2024Patent112(f), Abstract Idea, Claim Construction, en banc petition, Google, infringement, means-plus-function, paid, patent eligibility, software, software patentsDennis Crouch

by Dennis Crouch

Means-plus-function claims have generally been disfavored because of the tendency of courts to either (1) narrowly construe their scope when corresponding structure is detailed in the specification or (2) render them invalid as indefinite when the specification lacks sufficient corresponding structure. If Impact Engine's petition is well received, there is a good chance that this historically popular claim style will see a revival.

The Federal Circuit's recent decision in Impact Engine v. Google has again raised the issue of over the proper treatment of MPF, this time regarding patent eligibility and infringement analyses. Appeal No. 22-2291 (Fed. Cir. July 3, 2024). I had skipped a write-up of the non-precedential decision, but now Impact Engine has petitioned for en banc review, arguing that

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Welcome to Patently-O

August 5, 2024PatentDennis Crouch

A few members have had a technical issue with logging in but not having access. We are still tracking down the cause, but the problem is solved by resetting your password: https://patentlyo.com/login-2?action=forgot_password. (more…)

Federal Circuit Narrows AIA Grace Period: Public Disclosure Must Make Invention ‘Reasonably Available’

August 5, 2024Patent35 U.S.C. § 102, AIA, Federal Circuit, grace period, paid, patent law, prior art, public disclosure, safe harborDennis Crouch

by Dennis Crouch

The Federal Circuit's new decision in Sanho v. Kaijet highlights the narrowness of the pre-filing grace period (safe harbor) provision under the America Invents Act (AIA) and serves as a reminder that there are a number of patents that would have been valid under the pre-AIA patent system may no longer be valid under the current law. Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 2023-1336 (Fed. Cir. July 31, 2024).

The basic holding is that the 102(a)(2)/(b)(2) safe harbor triggered by an inventor's pre-filing "public disclosure" of the invention requires that the invention be made "reasonably available to the public." Neither public uses nor private sales satisfy this requirement. This is a long post, because the issues are both important and interesting. In the end, I suggest a panel rehearing in the case because I believe that the Federal Circuit unfairly found forfeiture of key arguments whose resolution would help clarify the law.

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