PTAB Issues Two New Precedential and One Informative Opinions on Section 325(d)

Attorney: Lisa M. Mandrusiak
April 17, 2020

The PTAB recently designated two decisions as precedential and one decision as informative with respect to 35 U.S.C. § 325(d). These cases discuss the Board's process for deciding when to use their discretion to deny institution because a Petition raises issues that the Patent Office previously considered in other proceedings (e.g., during prosecution, prior reexams).... Read more

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

Attorney: Lisa M. Mandrusiak
March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Not-So-Safe Harbor for Hospira's Erythropoietin Biosimilar

Attorney: Lisa M. Mandrusiak
December 19, 2019

This week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision... Read more

Think Before You Sign: Protecting IP Rights with MTAs

Attorney: Lisa M. Mandrusiak
October 23, 2019

Material transfer agreements (MTAs) are contracts that allow one party to perform research using the materials of another party. These agreements provide a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in the research community. Although these are admirable goals in principle, MTAs have a bad reputation with some researchers and institutions for being overly complex and, in fact, hindering research. Nonetheless, MTAs are important for defining the rights, responsibilities, and obligations of the parties with respect to research collaborations and need to be carefully considered, particularly with respect to ownership of IP rights implicated by the transferred materials.... Read more

Thinking Outside the (Utility Patent) Box – Don't Overlook Design Patent Protection in the Life Sciences

Attorney: Lisa M. Mandrusiak
August 30, 2019

Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined in scope by the content of the drawings rather than the words of a set of claims. Further, design patents have a 15 year term, as opposed to 20 years from filing for utility patents.... Read more

Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?

Attorney: Lisa M. Mandrusiak
July 2, 2019

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details.... Read more


Category: PTAB 101

PTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for Generics

Attorney: Lisa M. Mandrusiak
May 9, 2019

The PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here.... Read more

Biologic Patent Transparency Act - New Bill Aimed at Biologics

Attorney: Lisa M. Mandrusiak
March 12, 2019

A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks.... Read more

Hedge Your Bets in TC 1600 PGRs

Attorney: Lisa M. Mandrusiak
November 30, 2018

Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date.  Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more

PTAB Confirms It Will Apply Broad Petitioner Estoppel Post-SAS

Attorney: Lisa M. Mandrusiak
November 8, 2018

The IPR estoppel provision was originally intended as a check against patent challengers attacking patents serially in the USPTO or other forums based on grounds that were raised or "reasonably could have been raised" in the original IPR. Although the Federal Circuit has interpreted estoppel narrowly, district courts were split, and estoppel's impact has remained in flux for several years.... Read more