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

The PTAB Weighs in on Obviousness-Type Double Patenting and PTA

Attorney: Richard D. Kelly
May 16, 2022

Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period.  Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue.  The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and MitsubishiMagna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more

XML Format Effective July 1, 2022 For PCT Sequence Listings

Attorney: Richard D. Kelly
May 16, 2022

WIPO has announced that as of July 1, 2022, all sequence listings must be submitted in XML format. Information on the standard and a tool for complying is found at https://www.wipo.int/standards/en/sequence/.<... Read more

Written Description and Creating Ranges from Examples

Attorney: Richard D. Kelly
April 7, 2022

At the close of last year, the Federal Circuit affirmed a decision by the PTAB in IPR2019-00329 that a claimed range created from examples was not patentable because it lacked written description in the application as filed. In its decision the PTAB “second guessed” an examiner’s ex Parte decision that the claimed range had written description in the application as filed.  Written description was at issue because the patent challenged, U.S. Patent 9,687,454 (‘454), filed January 6, 2016, needed benefit of its parent application serial number 12/537,571 published on February 10, 2011, as 2011/0033541 (‘541), to avoid ‘541 from being prior art otherwise, most of the ‘454 claims were anticipated by ‘541. The ‘454 claim 1 is directed to a mucoadhesive film comprising about 40 wt.% to about 60 wt.% of a water-soluble polymeric matrix and claim 7 to a range of from about 48.2 wt.% to about 58.6 wt.%. Neither range was found in the ‘454 patent as filed; the claims were added during prosecution. The ‘454 describes the film as “may contain any desired level of self-supporting film forming polymer”; in “one embodiment, the film forming composition” may be at least 25 weight per cent of the composition; alternatively, at least 50 weight per cent of the composition. No upper limit was described.<... Read more

Patent Invalidation Under Section102(b)'s On-Sale Bar Based on a Letter Including Commercial Terms Sent Before the Critical Date

Attorney: Marina I. Miller, Ph.D.
March 28, 2022

Mr. Junker, the named inventor of U.S. Design Patent No. D450,839, sued Medical Components, Inc. and Martech Medical Products, Inc. (“MedComp”) for infringement of the D’839 patent. The parties filed cross-motions for summary judgment, debating whether a letter sent before the critical date was a commercial offer for sale of the claimed design, rendering the claim invalid under the on-sale bar, 35 U.S.C. § 102(b). The district court granted Mr. Junker’s motion for summary judgment of no invalidity under the on-sale bar. MedComp appeals the district court’s summary judgment of no invalidity under the on-sale bar, the judgment of infringement, and the damages award.<... Read more

Plural Unreduced Selections with Unpredictable Effect Not Necessarily Routine Optimization

Attorney: Derek Lightner, Ph.D.
March 8, 2022

The PTAB in Ex parte Sturgis (Appeal 2021-002857; USSN 15/696,282) reversed an examiner’s obviousness rejection of claims for failing to sufficiently establish obviousness via routine optimization The reversal was mainly based upon plural selections being claimed without any particular directions on choosing in the prior art and an unpredicted effect based on the cited art.<... Read more