PTAB Declines Request to Review Method of Treating Lymphoma Claim

Oct 12, 2017

Reading Time : 1 min

In rejecting petitioner’s anticipation and obviousness challenges, the panel found that several asserted references were not publicly accessible and, therefore, did not qualify as “printed publications.” First, although a clinical study consent form was distributed to approximately 40 prospective patients, there was no evidence that it was distributed to ordinarily skilled artisans, rather than patients. There was also no evidence to show that an interested party would have known to visit a particular oncology website to look for the consent form. Second, although petitioner’s expert testified that a clinical study protocol was “freely disseminated to any referring doctor or patient,” the panel found this testimony insufficient to establish public accessibility because the expert “[did] not identify any particular instances or the timeframe of its dissemination.” Finally, the panel held that petitioner failed to show that the rituximab label was publicly accessible. In rejecting petitioner’s assertion that the rituximab label was made publicly accessible “when Rituxan was approved,” the panel explained that petitioner failed to provide any documentary or testimonial evidence showing that the label was included in the packaging of a disseminated drug product.

The panel also rejected petitioner’s obviousness challenge because it found that the asserted references failed to disclose the particular treatment regimen and dosing amount limitations recited in the challenged claim. In reaching its decision, the panel rejected the assertion that a skilled artisan would have sought to treat low grade non-Hodgkin’s lymphoma patients with the same dosing regimen employed in a study of a wholly different patient population – namely, elderly patients having aggressive non-Hodgkin’s lymphoma. Nor did petitioner sufficiently explain why an ordinarily skilled artisan would have usedarituximab dose of 375 mg/m2, given the reference’s teachings that “doses up to 500 mg/m2” had been used and that “the best dose and schedule of rituximab remain to be established.”

Celltrion, Inc. v. Biogen, Inc., IPR2017-01093 (PTAB October 6, 2017)
[Franklin, Snedden, Harlow (opinion)]

Share This Insight

Previous Entries

IP Newsflash

November 3, 2025

The Federal Circuit recently clarified the requirement for work disclosed in a reference to qualify as “by another” under pre-AIA Sections 102(a) and (e), holding that there must be complete inventive identity between the information disclosed in the asserted reference and the inventors named on the relevant patent. 

...

Read More

IP Newsflash

October 31, 2025

The District Court for the Northern District of California recently granted a defendant’s motion to bifurcate, ordering that issues related to PGR estoppel should be decided in a bench trial, while the remaining issues in the case should proceed to a jury trial.

...

Read More

IP Newsflash

October 31, 2025

The Northern District of Iowa recently held that a defendant’s motion for partial summary judgment of invalidity was barred after the PTAB issued final written decisions, regardless of when the motion was filed. The defendant filed its motion before the final written decisions were issued, but the court rejected the defendant’s argument that the timing of the motion insulated it from estoppel.

...

Read More

IP Newsflash

October 1, 2025

In a recent final written decision, the PTAB determined that a reference patent was not prior art, despite the petitioner’s post‑filing attempt to correct its petition. While the petitioner argued that it intended to rely on the patent application’s earlier date of publication, both the corrected petition and the expert declaration continued to reference the issued patent rather than the published application.

...

Read More

IP Newsflash

September 30, 2025

The USPTO Director recently granted a petitioner’s request for rehearing of the decision discretionarily denying institution of inter partes review, ultimately vacating the original decision, and referring the petition to the board for an institution decision.

...

Read More

IP Newsflash

September 25, 2025

In considering claims to a method of reducing cardiovascular events, the Federal Circuit held that the term a “clinically proven effective” amount did not render the claims patentable over the prior art. Specifically, the Federal Circuit held that the “clinically proven effective” amount, whether limiting or not, could not be used to distinguish the prior art because the claims also specified the exact amount of the drugs to be administered in the method. The Federal Circuit also rejected patentee’s evidence of unexpected results because that evidence was tied solely to the “clinically proven effective” limitation.

...

Read More

IP Newsflash

September 24, 2025

The Federal Circuit reversed a district court’s denial of judgment as a matter of law on non-infringement, thereby setting aside a $106 million jury verdict, after holding that prosecution history estoppel barred the patentee from asserting infringement under the doctrine of equivalents.

...

Read More

IP Newsflash

September 17, 2025

A magistrate judge in the District of Delaware issued a Report and Recommendation, that found the sole asserted claim was a “single means” claim and therefore invalid for lack of enablement. In reaching that conclusion, the magistrate judge rejected the patentee’s argument that the preamble of the claim disclosed a second element that satisfied the combination requirement of Section 112, paragraph 6 because the preamble simply recited a descriptor of the very apparatus that was the subject of the means-plus-function limitation in the body of the claim. The district court judge presiding over this case has scheduled a hearing to review the magistrate’s ruling.

...

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.