Oona Johnstone

Oona Johnstone focuses her practice on U.S. and foreign patent prosecution, IP due diligence, client counseling, and post-grant proceedings, including inter partes review (IPR), in the areas of biotechnology, pharmaceuticals and cleantech. Her expertise spans a wide range of technologies including RNA-based therapeutics, transgenics, antibodies, immune-modulating agents, metabolic engineering, systems and synthetic biology, and drug delivery.

Recent Posts

Generics Go Three for Three at the PTAB in Multiple Sclerosis Blockbuster Dispute

Posted by Oona Johnstone on Sep 9, 2016

Oona Johnstone

In the last two weeks, the PTAB has invalidated three patents covering Copaxone®, a multiple sclerosis drug marketed by Teva with annual sales of over $3 billion. Challenged by generic manufacturers Mylan and Amneal, the patents specifically covered a long-acting form of Copaxone®, known as “3-times-a-week COPAXONE® 40 mg/ml,” which Teva developed when the original version of Copaxone® was coming off patent protection.

These IPR decisions highlight the usefulness of post-grant proceedings for generic and biosimilar manufacturers, particularly for challenging follow-on patents, such as those covering specific dose regimens, as we discussed in earlier posts.   

Read More

Topics: BioPharma, Biosimilars

Early IPRs Challenging Biologic Patents: What We Know

Posted by Oona Johnstone on Jun 17, 2016

Oona Johnstone

Multiple IPRs challenging patents covering brand-name biologics have now been filed by biosimilar developers, for reasons we recently discussed, as well as by other entities. Institution decisions in these early IPRs and a small number of final written decisions suggest that broad mechanistic claims as well as follow-on patent claims—such as those covering methods of treating specific patient populations or specific dose regimens—will be vulnerable to obviousness challenges at the PTAB. However, a tougher time should be expected in challenging composition-of-matter patents.

Read More

Topics: BioPharma, Biosimilars

For Biologics and Biosimilars, Don’t Forget Post-Grant Proceedings

Posted by Oona Johnstone on May 19, 2016

Oona Johnstone

Initially, biopharma represented a small percentage of post-grant proceedings; however, that percentage is increasing. In particular, generic and biosimilar manufacturers are recognizing advantages of this pathway. The high success rates achieved so far are compelling: For biopharma IPR petitions that have reached a final written decision, 66 percent have resulted in some or all of the challenged claims being invalidated.

Read More

Topics: BioPharma, Biosimilars

PTAB v The Untouchables: Widely Validated Biotech Patent to be Reviewed

Posted by Oona Johnstone on Feb 12, 2016

Oona Johnstone

The Cabilly patent family (including Cabilly I, II and III) is likely the most famous patent family in biotechnology. With claims that cover basic steps in generating therapeutic antibodies, these patents are gatekeepers in an industry that has shown unprecedented growth—currently, half of the 10 top-selling drugs in the world by sales are therapeutic antibodies. Through licensing to antibody manufacturers, Genentech—one of the owners of the Cabilly patents—is expected to reach a billion dollars in royalties from this patent family by 2018.

Read More

Topics: BioPharma, Biosimilars

Wolf Greenfield's Post-Grant Blog

Here, the Post-Grant Proceedings Group
at Wolf Greenfield keeps you up to date
on the latest decisions and best practices, and what they mean for you. Learn more about the group and its members.

New Call-to-action
New Call-to-action
New Call-to-action

Subscribe to Email Updates

Recent Posts

Follow Us

This blog is intended to promote thought and debate on developing areas of the law. The opinions, commentary and characterizations of cases provided on this blog are not legal advice and do not represent the opinions of Wolf Greenfield or its clients.