Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... 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

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

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

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

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

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

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

Attorney: Elissa Sanford
December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

NHK-Fintiv Rule - APA Violation?

Attorney: Grace Kim
April 21, 2021

I recently wrote an article (NHK-Fintiv Rule Challenges Look Futile at Federal Circuit) about a Federal Circuit decision that dismissed Mylan’s appeal of a PTAB decision that denied institution of an IPR. The Federal Circuit concluded that although judicial review is available by petition for mandamus and the Federal Circuit may consider Mylan’s request for mandamus, “there is no reviewability of the Director’s exercise of his discretion to deny institution except for colorable constitutional claims.” Mylan Laboratories Ltd. v. Janssen Pharmaceutica. N.V., No. 2021-1071, slip op. at 12 (Fed. Cir. March 12, 2021) (precedential).<... Read more

NHK-Fintiv Rule Challenges Look Futile at Federal Circuit

Attorney: Grace Kim
April 6, 2021

The NHK-Fintiv rule allows the Patent Trial and Appeal Board (PTAB) to deny institution of an inter partes review petition based on the progress of a parallel U.S. district court proceeding of the same patent. The rule was established under former USPTO director Andrei Iancu in 2018, in NHK Spring v. Intri-Plex., No. IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential). As a result of the restrictions opposed by the NHK-Fintiv Rule, many petitioners have been facing increasing challenges in seeking review at the PTAB for patents where there is a parallel district court proceeding.<... Read more

Must a "Human Antibody" Be Entirely Human? Or May It Also Be "Partially Human?"

Attorney: Marina I. Miller, Ph.D.
October 16, 2020

This is a consolidated appeal from two Patent Trial and Appeal Board (“Board”) decisions in inter partes reviews (“IPRs”) of U.S. Patent 8,679,487 (“the ’487 patent”), owned by Immunex Corp. (“Immunex”). Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuti-cals, Inc. (“Sanofi”) challenged the ’487 patent. The Board invalidated all challenged claims in IPR 2017-01884. Immunex appealed, contesting the construction of the claim term “human antibodies.” The Court of Appeals for the Federal Circuit (“the Court”) agreed with the Board’s claim construction and affirmed the invalidity decision.<... Read more