Tag Archives: patent infringement

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

August 30, 2024PatentCovenant Not to Sue, Federal Circuit, ITC, Mootness, paid, patent infringement, standingDennis Crouch

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

August 27, 2024PatentDamages, paid, patent infringement, patent litigation, willful infringementDennis Crouch

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

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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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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Presumption of Injunction: How the RESTORE Act Aims to Re-Empower Patent Holders

July 31, 2024PatentConstitutional Law, eBay v. MercExchange, Equity, Federal Circuit, Injunctive Relief, innovation policy, intellectual property, legislation, NPEs, obviousness, paid, patent infringement, patent law, patent litigation, Patent Remedies, patent rights, RESTORE Act, Supreme CourtDennis Crouch

by Dennis Crouch

For the vast majority of American history, a judgment of patent infringement (by a court sitting in equity) led almost directly to injunctive relief barring ongoing infringement. This construct was flipped by the Supreme Court's 2006 decision in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), a case which served as the first major step of weakening patentee rights over the past two decades. Now, a new bipartisan bill aims to restore the pre-eBay status quo. The Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024, introduced by Senators Coons (D-Del.) and Cotton (R-Ark.), with a House companion bill from Representatives Moran (R-Texas) and Dean (D-Pa.), seeks to reshape and repair the availability of injunctive relief for patent holders. As you'll see, one nice element of the Bill is that it simply adds 1 sentence - creating a rebuttable presumption

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Patently-O Bits and Bytes

June 4, 2024Patentpaid, patent agent, patent attorney, patent damages, patent drafting, patent eligibility, patent examiner, patent infringement, patent law, patent litigation, Patent Office, patent office comment period, patent office fees, patent office leadership, patent office policy, patent office regional office, patent prosecutionDennis Crouch

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PREP Act Immunity and its Silent Treatment of Intellectual Property Rights

May 14, 2024Patentcountermeasures, COVID-19, immunity, paid, patent infringement, PREP ActDennis Crouch

by Dennis Crouch

Although the Federal Circuit has dismissed Copan v. Puritan on jurisdictional grounds, I use the case to talk through COVID-19 immunity under the PREP Act, and whether patent infringement is included within its scope.

The 2005 Public Readiness and Emergency Preparedness (PREP) Act provides immunity for

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Patent Rights and Cell-Free DNA cancer testing

April 2, 2024Patentcancer detection, cell-free DNA, obviousness, paid, patent infringement, patent litigation, preliminary injunctionDennis Crouch

by Dennis Crouch

I have been following the ongoing case of Natera v. NeoGenomics that is currently on appeal before the Federal Circuit. Docket No. 24-1324. The technology in these cases has amazing potential and I have several friends who have used these techniques to detect early stage cancer.

The particular litigation here centers on Natera's US Patent No. 11,519,035 issued on December 6, 2022 that covers a method of detecting cancer through analysis of cell-free DNA (cfDNA) obtained from blood samples. The basic idea is that small fragments of DNA that are released into the bloodstream by cells, including cancer cells. High throughput extraction and sequencing technologies can then be used to detect mutations and their potential associated risk factors, including the presence of cancer and the specific type of cancer. cfDNA cancer screening has lots of advantages, most notably, it is almost non-invasive (blood sample) and provides potential early across the entire body. It can be particularly effective for detecting reemergence of cancer for someone in remission because the particular mutation is already known. This is known as a "tumor-informed" test.

Natera's '035 patent is directed to methods for amplifying and sequencing cell-free DNA (cfDNA) to detect cancer. The claimed invention involves three key steps: (1) tagging cfDNA with universal adaptors, (2) amplifying 25-2,000 single nucleotide polymorphism (SNP) loci in a single reaction volume, and (3) performing massively parallel sequencing. Each of these steps were known in the prior art, but the combination of all three appears to be new. NeoGenomics is accused of infringing through its use of its RaDaR, an independently developed cancer-detection test that purportedly employs a similar process for analyzing cfDNA to provide highly sensitive detection of cancerous mutations. NeoGenomics disagrees, arguing the claims require the tagging and targeted amplification to occur in separate PCR reactions with different primer sets, and that its approach combines this process.

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A New Horizon: Design Patent Practitioner Bar Proposed by USPTO

May 15, 2023Patentdesign patent, intellectual property, notice-and-comment, paid, patent eligibility, patent infringement, patent law, patent litigation, patent prosecution, USPTO, USPTO DirectorDennis Crouch

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Attorney Fees on Undecided Inequitable Conduct Issues

May 8, 2023PatentAffirmed Without Opinion, Damages, en banc, Ethics, Federal Circuit, Inequitable Conduct, paid, patent infringement, patent law, patent litigation, patent prosecutionDennis Crouch

by Dennis Crouch

United Cannabis Corp (UCANN) vs. Pure Hemp Collective, --- F.4th --- (Fed. Cir. 2023)

The UCANN vs. Pure Hemp patent case has come to a close with the Federal Circuit affirming the district court's decision to deny attorney fees to Pure Hemp. The original infringement lawsuit was filed in 2018, with UCANN suing Pure Hemp for infringing US Patent No. 9,730,911, covering various high concentration cannabis and CBD extract formulations. During the litigation, UCANN filed for bankruptcy, causing the case to be stayed, and eventually, the parties stipulated to a dismissal of the infringement claims with prejudice. However, the stipulated dismissal did not include any discussion of attorney fees -- leading to the current appeal.

Following the dismissal, Pure Hemp moved for attorney fees and sanctions, arguing that UCANN's counsel committed inequitable conduct during patent prosecution and that UCANN's litigation counsel had a conflict of interest. The district court sided with UCANN and denied attorney fees, stating (1) that Pure Hemp was not the prevailing party and (2) that Pure Hemp did not prove that the case was exceptional. The Federal Circuit has now affirmed the decision, finding that the district court did not abuse its discretion in finding the case unexceptional. Although district court the district court erred in not finding Pure Hemp to be the prevailing party, the error was harmless.