Teva Files Certiorari Petition in "Skinny" Label Case

Attorney: Richard D. Kelly
August 9, 2022

On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.<... Read more

Sure, A Court Can Rewrite Patent Claims. But Can It Change A Disclosure? (Pavo Solutions, Part II)

Attorney: Jeffrey B. McIntyre
August 8, 2022

After discussing a court’s ability to rewrite patent claim language in view of the Federal Circuit’s decision in Pavo Solutions v. Kingston Technology (Pavo Solutions, Part I), my post last week noted that there was more to the story, including the issue of whether a court could rewrite a patent’s disclosure. Here are a few thoughts on that issue.<... Read more

Can A Court Rewrite Claim Language During Claim Construction? If You Don't Ask For It, You'll Never Know (Pavo Solutions, Part I)

Attorney: Jeffrey B. McIntyre
August 3, 2022

In Pavo Solutions v. Kingston Technology (June 2022), the Federal Circuit rewrote claim language in the asserted patent by changing the claim element "for pivoting" from case to cover. The claim element in question read as follows:<... Read more

Obviousness Must Consider Function / Intended Use of Prior Art Device

Attorney: Derek Lightner, Ph.D.
August 2, 2022

On July 22, 2022, the Patent Trial and Appeal Board (PTAB) reversed an examiner’s assertion of obviousness in the case of Ex parte Jaeger (Appeal 2021-002641, USSN 15/559,117). The issue in Jaeger was whether the addition of known element to a prior art device was obvious where the combination was not consistent the purpose / operation of the prior art device.<... Read more

Cardex – Patent Eligibility – It's The Claims That Matter

Attorney: Richard D. Kelly
July 25, 2022

On July 18 the Federal Circuit in Cardex, Inc. v. Eurofins Viracor, Inc., affirmed the district court decision finding that diagnostic method claims directed to detecting organ transplant rejections in U.S.P.s 8,703,652 (‘652), 9,845,497 (‘497), and 10,329,607 (‘607) were not patent eligible. The following claim from ‘652 is representative of the claims on appeal, emphasis in the decision:<... Read more

FDA Stays Juul Ban, Announces Plan To Implement New Policies

Attorney: Elissa Sanford
July 7, 2022

On June 23, 2022, the FDA banned the sale of Juul’s tobacco-and menthol-flavored products. The agency’s reasoning was that Juul’s applications did not have sufficient toxicological evidence to support the marketing of the products as appropriate for protecting public health.  Juul has long since been on the FDA’s radar for past marketing practices including the marketing of their now-discontinued fruit or candy-like flavors, which were viewed as appealing to minors.  The company secured an emergency stay on June 24, asserting that the FDA did not fully consider its 125,000 page application which purportedly contained studies showing how the products expose users to lower levels of harmful toxins as compared to conventional cigarettes.  Juul also cited political pressure as the FDA’s motivation due to an “inappropriate” level of interference from Congress.<... Read more

Supreme Court Denies Certiorari in American Axle

Attorney: Richard D. Kelly
July 5, 2022

On the last day of June to the dismay of many, the Supreme Court denied cert in yet another Federal Circuit patent eligibility decision, American Axle. Many had been hopeful of a grant because the Court had requested the Solicitor General’s view on the petition.  In May the SG provided comments favoring granting cert. A dispassionate viewer would probably not have been surprised by the denial since it’s not apparent how any new decision by the Supreme Court could result in consistency from the Federal Circuit. As Judge Albright noted in deciding Health Discovery Corp. v. Intel Corporation, 6:20-cv-666ADA (WD TX December 27, 2021), he found it difficult to extract a unified theory of Alice’s two steps from the Federal Circuit’s § jurisprudence. The function of a circuit court is to take a Supreme Court decision and derive theory of how one is to apply it.  While different circuit court’s may arrive at different conclusions as to how a decision is to be applied, it is rare for a circuit court to be unable to be consistent in its application of the law as announced by the Supreme Court. Yet this is the position of the Federal Circuit. A situation hardly conducive to “furthering the progress of the useful arts.”<... Read more

Federal Circuit Reverses Novartis Gilyena Negative Limitation Decision

Attorney: Richard D. Kelly
June 22, 2022

On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more

In a Rule 12(b)(6) Motion to Dismiss Patentee's IPR Arguments Doom Its Complaint for Patent Infringement

Attorney: Richard D. Kelly
June 8, 2022

On June 6, Judge Albright granted Meta Platforms. Inc.’s (Meta) 12(b)(6) motion to dismiss a complaint filed by Grecia Estate Holdings LLC in part relying on Grecia’s representations in IPR2016-00789 (IPR) to the PTAB that successfully defeated institution of the IPR.<... Read more

PTAB Overrules Routine Experimentation / Optimization Obviousness Finding

Attorney: Derek Lightner, Ph.D.
May 18, 2022

The Patent Trial and Appeals Board (PTAB) recently overruled an examiner’s finding of obviousness of claims premised on a “missing” moisture permeability feature in a composition designed for moisture absorption.<... Read more