The BPCIA Patent Dance: Recent Trends, Developments and Court Decisions
In Sandoz Inc. v. Amgen Inc. decision, the Supreme Court provided some clarity in the “patent dance” issues under the Biologics Price Competition and Innovation Act (BPCIA). The court unanimously ruled that a biosimilar applicant cannot be enjoined by a biologic sponsor for declining to provide a copy of its application and manufacturing information; and that a biosimilar applicant is permitted to provide 180-day premarketing notice either before or after obtaining FDA approval. While the decision provided the biosimilar industry with a potential boost, it is still important for the members of patent, healthcare and pharmaceutical sectors to remain updated with the recent regulatory trends and developments to effectively grapple with the potential issues, implications and risks.
In this LIVE Webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will provide the audience with an in-depth discussion of the fundamentals as well as updates regarding the latest and significant issues surrounding the BPCIA Patent Dance. Speakers will also offer practical litigation strategies and best compliance practices.
Some of the major topics that will be covered in this course are:
- The BPCIA Patent Dance - An Overview
- Recent Court Decisions
- Emerging Trends and Regulatory Developments
- Challenges, Issues and Implications
- Key Takeaways
- Litigation Tips and Strategies
- Best Compliance Practices
Joanna T. Brougher, Esq., MPH, Owner & Principal
BioPharma Law Group, PLLC
- Overview of Sandoz v. Amgen
- What was the Supreme Court holding? What did the Court leave open?
- What are the various options for biosimilar companies with regard to the Patent Dance
Andrew Wasson, Partner
- I’ve always had the opinion that the “patent dance” is an inefficient and unnecessary feature of the law. Much of the concern that gave rise to such an elaborate mechanism was driven by worries about Orange Book bottlenecks that were created by the 30-month stay provisions of Hatch-Waxman. But there are no 30-month stays in the BPCIA, so ultimately such concerns are unwarranted. Thus, in a happy coincidence, it seems that the Supreme Court’s opinion eliminates for other reasons what is likely unnecessary and counter-productive anyway.
- We have done some empirical research regarding usage of the patent dance provisions in practice. One of the concerns that militated away from an Orange Book-like patent information list was that many more types of patents are applicable to biosimilars. While that may be true, sponsors and biosimilar applicants seem to be litigating patents in a scale similar to Hatch-Waxman. Other than Abbvie, who had an initial list of 61 patents, the majority of sponsors engaged in the patent dance list less than 10 patents. And ultimately only a handful of patents are litigated in practice.
- By holding that a biosimilar applicant may give notice of commercial marketing even before the biosimilar is licensed, the Supreme Court ruling puts a lot of pressure on both sponsors and biosimilar applicants right before launch. From the biosimilar applicant perspective there will be substantial risk on the table because any damages post-launch would not be simply technical infringement, effectively making the analysis an “at-risk” launch analysis. From the sponsor’s perspective, sponsors will likely have to quickly move on preliminary injunction papers. This is not optimal from the court’s perspective either – preliminary injunctions are drop-everything types of proceedings which interfere with the court’s already over-burdened dockets. Thus, notwithstanding the Court’s ruling, all parties may come to private agreements for notice that would minimize risk all-around
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 …
Joanna is the Owner and Principal of BioPharma Law Group, PLLC. She is a patent attorney who focuses her practice on all aspects of services related to patents in the life sciences. Joanna has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act. Joanna is also a former Adjunct Lecturer at the Harvard T.H. Chan School of Public Health and the current Editor-in-Chief of the Journal of Commercial Biotechnology. She regularly speaks or lectures on intellectual property-related topics and is a frequent author of articles related to patent law and healthcare. In 2013, Joanna published a book called Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health which examines the relationship between patents and public health in the context of medical technologies. In 2014, Joanna was selected to the National Law Journal’s list of Boston’s Rising Stars. Joanna received her J.D. degree from Boston College Law School, and is admitted to the Massachusetts and New York State Bars as well as the USPTO.
Joanna is the Owner and Principal of BioPharma Law Group, PLLC. She is a patent attorney who focuses her practice …
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Method of Presentation:
Experience in Patent Laws
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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. The firm was founded in 1997 as Frommer Lawrence and Haug and adopted the Haug Partners name in March 2017.
About BioPharma Law Group, PLLC
BioPharma Law Group, PLLC is a law firm that serves life sciences companies, including biotechnology, pharmaceutical, and medical device companies, at all stages. We provide efficient, focused, and practical legal advice and solutions to enable life science companies to meet their intellectual property and corporate goals and needs.
We represent life sciences companies, with a focus on the biotechnology, pharmaceutical, and medical device sectors. Our list of clients includes innovator and generic/biosimilar companies, sponsor companies and manufacturers, start-ups and mid-stage companies, public and private companies, universities, investors, as well as individual entrepreneurs, scientists, engineers, and physicians.