Everything You Wanted to Know About Biosimilars But Were Afraid to Ask: An Expert Interview

Part One Everything You Wanted to Know About Biosimilars But Were Afraid to Ask: An Expert Interview
April 29, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

This is the first in a two-part interview that BioSpace conducted with Kevin E. Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff, a lawyer who specializes in biotechnology patent law and the issue surrounding it. Noonan particularly interested in the legal issues surrounding biosimilars, as Big Pharma braces for the effects of a recent decision by the U.S. Food and Drug Administration (FDA) to allow Novartis AG to start making the nation’s first biosimilar drug. We talked with Noonan about what he sees becoming the biggest issue for the biotech world’s new biosimilar paradigm.

An experienced biotechnology patent lawyer, Noonan brings more than 20 years of extensive work as a molecular biologist studying high-technology problems in serving the unique needs of his clients. Noonan represents biotechnology and pharmaceutical companies, from startups to Fortune 100 companies, on a myriad of issues, as well as several universities in both patenting and licensing to outside investors. He has filed amicus briefs to district courts, the Federal Circuit and the Supreme Court involving patent issues relevant to biotechnology. Noonan is a founding author of the Patent Docs weblog where he writes frequently, and was recently named Chicago’s Biotechnology “Lawyer of the Year” by Best Lawyers in America 2013 and 2014. In 2010, Noonan was interviewed on 60 Minutes about gene patenting.

1. Briefly discuss new developments in case law over the last few months that affect the biosimilar market?

The most relevant decision in biosimilars law in the last few months was the decision by Judge Seeman in the Northern District of California that permitted Sandoz, Inc. to “opt out” of the patent litigation provisions of the BPCIA (the so-called “patent dance”) in Amgen v Sandoz. Under this portion of the statute, the biosimilar applicant “shall” provide the reference product (biologic drug) sponsor (RPS) with a copy of its application and any information on its manufacturing processes relevant to producing the biosimilar. Sandoz was unwilling to comply because the law permits someone from the reference product sponsor to be privy to this information. This may include trade secrets (relating to general biologic processes etc.) that are not limited to the particular product, and unlike in litigation (where such information is routinely disclosed under a protective order) the law does not limit disclosure to outside counsel. Thus, Sandoz reasonably feared that its closest competitors could become aware of its trade secrets (which provide Sandoz with a competitive advantage) and that the protections of the law were not enough.

Sandoz proffered a creative legal argument that was persuasive to the judge. Specifically, Sandoz argued that the provisions of the law that provided for remedies/punishments for failure to comply with the disclosure provisions (namely, that the reference product sponsor could immediately bring suit and seek an injunction) evinced an intention by the Congress that the disclosure requirements (and other portions of the law) were optional, and that if a biosimilar applicant like Sandoz chose not to comply then the RPS could avail itself of the remedies in the statute.

While this argument is clever, knowledgeable people involved with drafting the law have stated that Congress had no such intent, and it is not up to the Federal Circuit to hear the question on appeal. Canons of statutory construction (“shall” generally means “must,” for example) are expected to trump Sandoz’s arguments.

2. How do you think the U.S. has handled biosimilar law and could that be improved?

The Sandoz case shows a significant limitation in the law, specifically the complexity of the patent dance provisions and the incentives to avoid it. Congress could close the loophole exploited by Sandoz either expressly or by changing who gets to see the biosimilar applicant’s confidential manufacturing information, which would reduce the incentives to creatively lawyer around these provisions. This is important because the intent of the law was for the RPS to get an understanding of which of its patents to assert in litigation, something difficult if not impossible to do without disclosure of the biosimilar application and how the product will be made. This problem will only get worse if current proposals to heighten pleadings requirements in patent litigation are passed by this Congress.

On the other hand, the FDA has recently approved its first biosimilar drug in the U.S. (Sandoz’s filgrastim biosimilar, to be marketed as Zarxio in competition for Amgen’s Neupogen), needing only about 10 months to do so. Generally, FDA has done a good job taking the responsibility the statute gives to them and developing guidances and protocols for evaluating biosimilarity. It has helped that the “first wave” of biosimilar drugs in the U.S. have been approved in Europe over the past decade and this is expected to change as newer drugs become biosimilar “targets.” But for now this portion of the law is working well, and FDA has shown a willingness to work with applicants through the biosimilar approval pathway (which the agency is still developing).

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