PTAB Reverses §101 and §103 Rejections for Plant Extract

Attorney: Grace Kim
December 13, 2022

Update by Grace Kim and Sara Pistilli, PharmD.

On December 6, 2022, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim to a plant extract based on patent ineligible subject matter (Appeal 2022-001062). Claim 1 of the application US 15/521,212 (the 212 Application) is directed towards:<... 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

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

Does Claim Construction For Patent Opinions Now Require a Crystal Ball? (Pavo Solutions, Part III)

August 16, 2022

In my first post about Pavo Solutions v. Kingston Technology a few weeks ago, I noted that 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

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

Biogen v. Mylan Written Description - What Does The Federal Circuit's Decision Really Mean?

December 8, 2021

Following up on my post last week (Dec 1.), I have read commentary about how the Federal Circuit’s decision in Biogen v. Mylan was incorrect. Is it really the case that the decision was wrong and that the Federal Circuit needs to address it en banc (or that the Supreme Court needs to address it)? <... Read more

A Digital Camera (A Mechanical/Electronic Device) is Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
July 6, 2021

Yu sued Apple for infringement of the claims of U.S. Patent 6,611,289. The district court granted Defendants’ motion to dismiss on the basis that the asserted claims were invalid under 35 U.S.C. § 101. Yu appealed. The Federal Circuit (“the Court”) found no error and affirmed.<... Read more

In re Rudy and the PTO 101 Guidance

Attorney: Richard D. Kelly
April 22, 2021

The USPTO 101 Guidance document has been under a cloud when Judge Brinkema refused to follow the guidance in Cleveland Clinic Found. V. True Health Diagnostics LLC., affirmed at 760 F. App'x. 1013, 1020 (Fed. Cir. 2019). Cleveland Clinic relied on Guidance example 29, claim 1 to assert that its claims were patent eligible since they were drafted in the same manner. The Federal Circuit in rejecting the argument found the 101 Guidance example 29, claim 1 to be "strikingly" similar to claim 1, see760 F. App'x. at 1020, which the Federal Circuit held was patent ineligible. The guidance teaches that example 29, claim 1 is patent eligible. The USPTO has not responded to the Court's criticism and example 29 continues to appear in the Guidance unchanged.... Read more

Indefiniteness: Bad Translation/Lack of Definition Redux

Attorney: Daniel J. Pereira, Ph.D.
April 15, 2021

            I previously wrote about a Federal Circuit Opinion that affirmed a lower court ruling that the term “half-liquid” was indefinite despite the apparent mis-translation of the original Italian term “semiliquido” https://www.lifesciencesipblog.com/indefiniteness-bad-translation-lack-of-definition-or-both. On March 1, 2021, the losing party (IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc.) filed a petition for writ of certiorari in the U.S. Supreme Court and so I thought it would be interesting to take another look at this case. Indeed, the petitioner presented a novel question for review of the lower courts’ decision of indefiniteness of the term at issue. The question presented in the petition is:<... Read more