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A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

Legal Experts Weigh in on BPCIA Severability

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars

The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.

PIRG Files Amicus Brief in Support of Humira Plaintiffs

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

Meier Explains FTC's Power to Pursue Antitrust Activity

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

California's Governor Signs Bill for State to Produce Its Own Biosimilars, Insulins

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

FTC's Markus H. Meier Talks About Restraint of Trade in the Biosimilar Marketplace

The FDA's Office of Therapeutic Biologics and Biosimilars balances a large number of biosimilar development projects with limited resources and is making progress, says Eva Temkin, acting director of policy.

FDA's Eva Temkin Discusses Biosimilar Approvals at ACI

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

Goodwin Attorneys Discuss Hospira-Amgen Infringement Case

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Rep Grothman Introduces Bill for Automatic Insulin Biosimilar Interchangeablity 

April E. Weisbruch is a partner at McDermott, Will, & Emery LLP. She focuses her practice on intellectual property (IP)  matters, particularly in managing large-scale IP litigation and counseling. She works with clients in wide-ranging technology sectors, including pharmaceuticals, software applications, medical devices, organic chemistry and ballistics. April represents clients in all phases of patent litigation, from the filing of a complaint through appeal, as well as in the highly specialized post-grant proceedings before the United States Patent Trial and Appeal Board (PTAB). She has extensive deposition, hearing and trial experience in US district courts throughout the country, as well as in the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit, and the PTAB. Her litigation experience includes traditional "competitor" litigation, litigation against nonpracticing entities, ANDA litigation under the Hatch-Waxman Act and §1498 litigation against the United States of America.

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

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