Guide to Biosimilars Litigation and Regulation in the U.S.
Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. provides expert guidance and practical know-how for lawyers working in this burgeoning area of the law. This webinar series provides an opportunity to dive deep into some of the key topics covered in the Guide.
CLE Credit Pending for all in NY, CA, NJ and CT
April 8, 2020
So You Want To Make A Biosimilar? Top Considerations Before You Start
Developing a biosimilar, and successfully bringing it to market, is a complex and expensive process. This webinar provides a broad overview of important strategic considerations that biosimilar makers should take into account before even applying for an aBLA to increase their odds of a successful launch.
May 6, 2020
Biosimilars Patent Challenges at the PTAB
This webinar covers biosimilar patent challenges at the PTAB. We explore topics including:
- The type of biologics patents being challenged at the PTAB and the success rate for each type
- Timing of challenges relative to aBLA filing/litigation
- Number of challenges for given patent/given drug
- Implications of results of these PTAB challenges for biologics manufacturers
- Strategies for biosimilars companies in light of PTAB stats
September 9, 2020
Biosimilars: Navigating the 271(e) “Safe Harbor” and 271(g) Exceptions to Patent Infringement
U.S. patent law provides two exceptions to patent infringement that particularly impact biosimilar manufacturers:
- The law provides a “safe harbor” from infringement when the use of a patented invention is “reasonably related” to developing information to submit to FDA to support approval of a new drug.
- The law provides a carve-out from infringement based on foreign use of a process patent to make an imported product if the product is “materially changed by subsequent processes” before importation into the United States.
This webinar discusses how these important exceptions to infringement apply to biosimilar products, and how courts have determined what potentially infringing activities qualify for the protections.
October 7, 2020
Clinical Trials, Marketing and Labeling: Strategies for Proving and Defending Induced Infringement of Biosimilars
This webinar discusses strategies and considerations on proving and defending patent infringement for developers of branded and follow-on biologics (biosimilars and interchangeables), including how the induced infringement analysis may be impacted by the selection; and, conduct of clinical trials and biosimilar marketing strategy. We discuss the following issues:
- Overview of standard for proving induced infringement
- The relevance of ANDA experience and caselaw on biologics
- How prescribing biosimilars differs from prescribing interchangeables
- Developing caselaw on how labeling may affect the induced infringement analysis
- Impact on induced infringement based on clinical trial and marketing strategies
November 4, 2020
The Rise of State Pharma Laws: Understanding the Current Framework of Settlement Disclosure and Drug Price Transparency Laws
Nearly a dozen states have enacted provisions related to pharmaceutical price transparency and patent litigation settlements. Many of them impose requirements on drug manufacturers that biosimilars companies need to follow.
In this webinar, we provide an overview of these new state pharmaceutical laws along with tips for navigating compliance across company activities.
December 2, 2020
Patent Dance Disclosures: Discovery During the Patent Dance and Beyond
This webinar covers strategies and considerations for discovery provided during pre-litigation disclosures under the BPCIA (the so-called “patent dance”) and in BPCIA litigation. We discuss the following topics:
- Basic overview of disclosures made before litigation during the patent dance, including:
- reference product’s disclosures of what patents it will assert against the biosimilar applicant (the “3A list”)
- detailed statement regarding infringement and response to the biosimilar applicant’s detailed statement regarding invalidity or unenforceability (the “3C statement”)
- biosimilar applicant’s detailed statement (the “3B statement”), list of patents it may assert (the “3B list”)
- How courts have dealt with disputes regarding sufficiency of pre-litigation disclosures
- How patent dance disclosures have been used later in BPCIA litigation and IPRs
- Special issues arising in discovery during BPCIA litigation