Written Description is Not Always Your Friend

Attorney: Richard D. Kelly
November 21, 2022

While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more

Is the Supreme Court Poised to Consider the Federal Circuit's "Possession of the Invention" Definition of Written Description?

Attorney: Richard D. Kelly
October 5, 2022

The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more

Federal Circuit Trumped By Supreme Court On Stay Of Mandate In Gilenya

Attorney: Richard D. Kelly
October 3, 2022

Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.<... Read more

Applications For Patent Term Extension (PTE) Now Easily Searchable at USPTO

Attorney: Richard D. Kelly
September 8, 2022

As part of the USPTO’s effort to make drugs more affordable it is now publishing a list of PTE applications filed within the last five years by filing date as well as a listing all granted PTEs. This is the first time the USPTO has published a compilation of filed but not yet granted PTE applications.  Previously the USPTO published a list of granted PTEs only.  Previously the only way to discover if a PTE had been filed for a patent was to review the patent file history. This required that one first review the FDA Orange Book for patents listed for a newly approved drug and then search the USPTO application file records to determine if a PTE had been filed on one or more of the listed patents. The new list includes the drug name, patent number and PTE filing date; it also links directly to the application making review easy. Since a PTE application must be filed within 60 days of a drug’s approval the new listing will allow generic drug companies to determine the patent exclusivities quickly and easily for the new drug. A link to the PTE extension page is here.  The page has two lists, one for PTEs filed in the last five years and one for all granted PTEs.<... Read more

Federal Circuit Revisits Assignor Estoppel

Attorney: Richard D. Kelly
August 18, 2022

On August 11, 2022, the Federal Circuit issued its opinion in the remand of Hologic, Inc. v Minerva Surgical, Inc. from the Supreme Court’s decision limiting the application of assignor estoppel to where the assignor is taking in litigation a position inconsistent with his prior representations in assigning the patent. In this case the issue was whether the issued claims are materially broader than the claims in the assigned application, Minerva Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298, 2302, 2309 (2021). The Supreme Court in Minerva refused to discard the concept of assignor estoppel but instead held that the concept comes with limits and “reaches only as far as the equitable principle long understood to lie at its core.” The Supreme Court held that assignor estoppel “applies only when an inventor says one thing (explicitly or implicitly) in assigning a patent and the opposite in litigating against the patent’s owner.” Id. at 2304. Stated differently, where the assignor has not any explicit or implicit representations which conflict with an invalidity defense.<... Read more

Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorneys: Richard D. Kelly and Elissa Sanford
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

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

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

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