In Fight Over Recombinant Blood Clotting Factor, PTAB Denies Motion to Submit Supplemental Information

Jun 16, 2017

Reading Time : 2 min

Patent owner Novo Nordisk Healthcare AG owns U.S. Patent No. 9,102,762 B2, entitled “Virus filtration of liquid factor VII compositions.” Factor VII (“FVII”) is a polypeptide involved in blood clotting. It is dissolved in blood plasma and circulates freely until it is attracted to a site of injury and converted to its active form, Factor VIIa (“FVIIa”). Novo Nordisk markets synthetic, recombinant FVIIa under the name NovoSeven. The claims of the patent relate to methods of removing viruses from a composition of recombinant FVII, using a nanofilter with a pore size of 80 nm or less and “where 50-100% of the Factor VII polypeptides . . . are in an activated form (FVIIa) prior to nanofiltration.”

Pursuant to 37 CFR § 42.123(a), once a trial has been instituted, a party may file a motion to submit supplemental information, provided that the party does so within one month of the date trial is instituted and the information is relevant to a claim for which trial was instituted. Petitioner Laboratoire Francais sought to submit several items as supplemental information: a chapter of a French book, a supplemental declaration from its expert, and two journal articles that cite the book as a reference in order to show that the chapter was publicly accessible before the December 2003 filing date.

While Laboratoire Francais’ submission was within the one-month deadline, the PTAB denied the motion. Citing to prior PTAB decisions, the panel noted that “the provision for submitting supplemental information is not intended to offer a petitioner a routine avenue for bolstering deficiencies in a petition raised by a patent owner in a preliminary response.” In other words, a petitioner cannot wait and see what facts and arguments the patent owner comes back with in its response to then introduce new prior art in the proceeding.

Although Laboratoire Francais tried to argue that the book chapter was only recently uncovered in a search of prior art, the PTAB was not convinced. The book chapter was authored by Thierry Burnouf, who was an employee of Laboratoire Francais, a colleague of Laboratoire Francais’s expert, Dr. Chtourou, and the author of another reference that was submitted with the IPR petition. Unfortunately for petitioner, the two journal articles submitted as proof that the book was available as of the filing date cut against the motion; the PTAB cited them as proof that the book was not an obscure reference, but was widely disseminated and available to persons skilled in the art.

Laboratoire Francais du Fractionnement et des Biotechnologies S.A. v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper 22 (June 13, 2017).

Share This Insight

Previous Entries

IP Newsflash

July 1, 2025

In an appeal from an inter partes review, the Federal Circuit recently clarified that the enablement inquiry applied to prior art references in the context of an anticipation defense differs from the enablement inquiry applied when evaluating the claims of a patent.

...

Read More

IP Newsflash

June 26, 2025

The Northern District of Ohio denied a motion to compel the plaintiff to produce test results referenced in its initial disclosures and complaint. The court found that because the “test results are not facts but rather are opinions,” the information was protected as work product. Furthermore, because that testing would not be used as evidence in the litigation, the defendant was not prejudiced.

...

Read More

IP Newsflash

June 6, 2025

In a precedential opinion, the Federal Circuit definitively held that the Patent Trial and Appeal Board has jurisdiction over IPRs that concern expired patents.

...

Read More

IP Newsflash

June 6, 2025

In a patent infringement litigation in the U.S. District Court for the Eastern District of Texas, Judge Rodney Gilstrap denied a joint motion to stay the litigation pending resolution of inter partes review when it was uncertain that all defendants would be bound by the statutory estoppel provision of 35 U.S.C. § 315(e).

...

Read More

IP Newsflash

May 30, 2025

A district court recently dismissed a patent infringement complaint for improper venue under 28 U.S.C. § 1400(b), finding that the storage and distribution of products from an Amazon warehouse was not sufficient to establish that warehouse as a regular and established place of business in the district.

...

Read More

IP Newsflash

May 27, 2025

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that statements made during prosecution of a parent application before the asserted claims were allowed amounted to a prosecution disclaimer that extended to subsequent patents in the family. In reaching this conclusion, the court rejected an attempt by the patentee to resurrect the claim scope through a unilateral, self-serving statement made in later applications in the family.

...

Read More

IP Newsflash

May 13, 2025

The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The Federal Circuit concluded that, where both the original and reissued patents claimed a drug product under regulatory review, using the issue date of the original patent to calculate PTE comports with both the purpose of the Hatch-Waxman Act and the related statutory context.

...

Read More

IP Newsflash

May 12, 2025

The Patent Trial and Appeal Board recently declined to institute a petition for IPR that was filed on the same day that the petitioner filed another petition challenging the same claims of the same patent. The board was not persuaded by petitioner’s arguments that a second petition was needed due to alleged claim construction issues or the number, length or scope differences of the challenged claims.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.