Supreme Court Hears Oral Arguments on Affordable Care Act: Will Biosimilars Survive?

Attorney: Lisa M. Mandrusiak
November 10, 2020

Today the Supreme Court heard arguments in Texas v. Azar that the Affordable Care Act (ACA)’s individual coverage mandate is unconstitutional.  According to the ruling in the underlying case, in the absence of the individual mandate, the rest of the ACA cannot stand.<... Read more

Where Have All the Bio/Pharma IPRs Gone?

Attorney: Lisa M. Mandrusiak
October 27, 2020

The IPR program in general has been wildly successful in its intended purpose of providing a lower-cost alternative to patent litigation, and the number of filings has remained relatively steady (though there were somewhat less in 2019 and 2020 as compared to previous years). The same is not true of IPRs filed in the TC 1600 space.<... Read more

Amgen Wins Right to Market Mvasi™ — Federal Circuit Interprets BPCIA Provision Regarding Notice

Attorney: Lisa M. Mandrusiak
July 7, 2020

In 2013, the U.S. enacted the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262 to allow for abbreviated biologics license applications (“aBLA”) to be filed for complex products which are biosimilar to/interchangeable with FDA-licensed biologics.<... Read more

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