The BPCIA Patent Dance: What’s Old and What’s New in 2018
In its recent Amgen v. Sandoz decision, the Federal Circuit has ruled that the innovators’ initiation of Biologics Price Competition and Innovation Act (BPCIA) pre-litigation information exchanges, known as “patent dance,” is unenforceable under state law. This is in addition to its June 2017 decision which held that patent dance cannot be enforced under the federal law, either. Thus, innovators seeking for biosimilar makers’ disclosures, may have no other option but to sue for infringement.
Recent decisions, such as this, clearly impact the BPCIA litigation landscape. Biosimilar makers and innovator companies eyeing patent litigation should keep themselves abreast of key biosimilar developments in 2018 and beyond.
In this LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will discuss the fundamentals as well as updates regarding the latest and significant issues surrounding the BPCIA Patent Dance. Speakers will also give insights on practical BPCIA litigation strategies and the economic implications of patent protection from biosimilar competition as they delve into in-depth-analysis of recent court rulings in a rapidly evolving legal climate.
Key topics include:
- BPCIA Patent Dance: Recent Trends and Developments
- Notable Court Rulings
- Best Litigation Strategies in Light of Updates--To Dance or Not To Dance?
- Economic Implications of Biologic Patents and Litigation Strategies
- Outlook on Regulatory and Litigation Activities
Andrew Wasson, Partner
- Patent Dance
- Notice of Commercial Marketing
- Freedom-to-Operate and Due Diligence
- Inter Partes Review
Following the Supreme Court and Federal Circuit decisions in Amgen v. Sandoz last June and December, respectively, the courts have held that there is no remedy to require biosimilar applicants to engage in the patent dance contemplated by the BPCIA. Before the decisions, the majority of BPCIA litigations involved parties that engaged in the patent dance. Post-Amgen v. Sandoz, this trend may change, as early empirical data has already begun to show a higher percentage of applicants not dancing (albeit the sample size is still small). There are strategic considerations involved in whether or not to follow through with the patent dance procedures, as will be discussed in detail.
The Supreme Court’s decision allowing biosimilar applicants to provide notice of commercial marketing before licensure also empowers biosimilar applicants – by granting them greater control over the timing of litigation and the possibility of earlier market entry. In Amgen v. Adello, filed March 8, 2018, Adello both opted out of the patent dance procedures and provided notice of commercial marketing shortly after FDA accepted its aBLA for review. Going forward, we will continue to see biosimilar applicants availing themselves of these options in a way that will expedite the pace of litigation.
BPCIA litigations filed in the past year have involved a far greater number of patents than was seen initially. When BPCIA was enacted there was an expectation that the lawsuits would involve many patents. Interestingly, this was not the case for BPCIA cases. However, over the last year the reality seems to be meeting the initial expectations – the last six cases filed have involved at least 17 patents each. The reason for this may be that the earliest batch of biosimilars implicated older patent estates that had largely expired, while the more recent cases may provide a greater number of patents to choose from. Freedom-to-operate searches and due diligences will continue to be extensive and challenging and especially compared with those done under the Hatch-Waxman framework. Not only are the sheer numbers of patents greater, there is no Orange Book-like patent listing to help guide your search.
Now that IPRs are here to stay after the Supreme Court’s decision in Oil States Energy Services v. Greene’s Energy Group, they will undoubtedly play a big role in future BPCIA litigations, as we are already beginning to see. IPRs are an attractive option for biosimilar applicants to “clear the path” to market. Many patents currently being litigated under the BPCIA are also being challenged at PTAB – in many instances by multiple parties, not solely the biosimilar applicant.
Richard A. Mortimer, Managing Principal
- Economic incentives impacting IP litigation for biologics versus traditional Hatch-Waxman (small-molecule) patent cases
- "Patent Dance" vs. Orange Book listing for identifying patents at issue
- 180-day exclusivity provisions for Hatch-Waxman but not BPCIA
- 30-month automatic stay for Hatch-Waxman but not BPCIA
- Differences in regulatory exclusivity
- Generic versus biosimilar competition and implications for IP litigation
- Generic entry and the so called "patent cliff" creates strong economic incentives impacting patent litigation
- Biosimilar entry is typically less stark, but evidence is early and varied
- Brand and biosimilar strategic decisions in biologic IP litigation
- Biosimilar decision of whether to launch at-risk (i.e., prior to conclusion of patent litigation)
- Brand arguments for a preliminary injunction to prevent biosimilar launch
- Factors potentially impacting future biosimilar IP litigation
- IP challenges will target newer and potentially more complex biologics
- How will biosimilar competition evolve?
Who Should Attend:
- Biotech and Pharma Lawyers
- Senior Management from Biotech and Pharma Industries
- In-House Counsel
- Patent Attorneys
- Patent Agent
- Patent Licensing Attorneys
- Patent Counsel
- Patent Litigators
- IP Counsel
- Biotech and Pharma Companies
- Other related/interested Professionals and Organizations
Andrew Wasson is a partner in the New York office of Haug Partners. Andrew has a broad range of experience in both the brand and generic side of pharmaceuticals, especially with respect to issues involving intellectual property law and regulatory law. Having grown up with a father who is a patent lawyer, Mr. Wasson has been involved in patents in one way or another for the better part of his life and has the advantage of being able to deal with complex patent law concepts in a very natural way. Mr. Wasson is registered to practice before the U.S. Patent and Trademark Office and has published extensively in both scientific and legal literature. Mr. Wasson also serves on the Editorial Advisory Board for FDLI's Update Magazine.
Andrew Wasson is a partner in the New York office of Haug Partners. Andrew has a broad range of experience …
Dr. Mortimer specializes in health economics, industrial organization, microeconomic theory, and econometrics. He has provided economic analyses in numerous matters involving questions of market power, pricing, and market exclusion and foreclosure. He has also provided analyses and expert testimony on behalf of health care clients related to litigation (including IP-related matters), and government investigations. In addition to his work in litigation, Dr. Mortimer has undertaken research in the area of health care policy, and has authored several public policy studies. These studies include the potential cost savings from passage of legislation developing an accelerated pathway for biosimilar entry, and the appropriate data exclusivity periods for biologics. His research has been published in leading peer-reviewed journals, including Health Affairs, Nature Reviews Drug Discovery, The Journal of Industrial Economics, and the Journal of Medical Economics.
Dr. Mortimer specializes in health economics, industrial organization, microeconomic theory, and econometrics. He has provided economic analyses in numerous matters …
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Experience in patent infringement litigation
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About Haug Partners
Haug Partners is a full-service, national law firm that provides integrated multidisciplinary legal services for life science and technology companies. Our service offerings include: (i) Antitrust Litigation and Counseling; (ii) Commercial Litigation and Strategic Counseling; (iii) Due Diligence; (iv) FDA Compliance and Counseling; (v) Intellectual Property Enforcement; (vi) Intellectual Property Procurement and Strategy; (vii) International Trade Commission; (viii) Investigations, Compliance, and Risk Mitigation Services; (ix) Licensing and Transactions; and (x) Trademarks and Unfair Competition. With offices in New York, Washington, D.C., and Boston, and through relationships with firms in Germany, China, Japan, and other key international markets, Haug Partners has the resources, technical expertise, legal acumen, and business judgment to consistently deliver optimal outcomes for clients.
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