Biologics Blog

http://www.biologicsblog.com/

Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes.

Recent Blog Posts

  • High Court Interprets The Biosimilars Statute — What Now? On Monday, the U.S. Supreme Court issued its first interpretation of the biosimilars statute, the Biologics Price Competition and Innovation Act of 2009. The BPCIA, part of Obamacare, introduced an abbreviated pathway for regulatory approval of biosimilars, allowing biosimilars to piggyback on the regulatory data of innovator biologics for their approval. Biosimilars are biologic medicines,... More
  • Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can Be Given at Any Time On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is available to force biosimilar applicants to participate in the BPCIA’s patent dispute resolution procedures (a/k/a the patent dance); but... More
  • Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars This post, Part III, of a three-part series (Part I and Part II) on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA.  These include the naming and labeling for interchangeable products as well as the relationship between multiple interchangeable products for the same reference... More
  • Part II: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars This post, Part II, of a three-part series (Part I) on FDA’s interchangeability draft guidance, highlights the key issues that were raised in the stakeholder comments provided to FDA.  FDA received 52 comments in total from a variety of stakeholders, including patients, physicians, insurers, innovators and biosimilar makers.  The stakeholders were divided in their views... More
  • Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017.  Innovators, biosimilar makers, patients, healthcare providers and other stakeholders have weighed in on the long-awaited guidance.  Interchangeable biosimilars, unlike other biosimilars, may be substituted for the innovator product without the intervention of the healthcare... More
  • Update on Biosimilar Approvals and Pending Applications in Europe and the U.S. Approvals of biosimilar products in Europe continue to outpace those in the United States.  28 biosimilars are currently approved in Europe and five in the U.S.  In 2017, the European Medical Agency has approved six biosimilar applications, including applications for biosimilars to two of the best-selling complex biologics, Humira (adalimumab) and MabThera (rituximab).  EMA is... More
  • The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner early in development.  If the partners make a deal – say the distributor pays for the right to... More
  • 100 Days Plus Under Trump: What They Mean for Biologics President Donald J. Trump has now been in office for just over one hundred days.  Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like immigration and foreign policy. Amidst the hubbub, however, few have commented on how President Trump’s opening moves could affect the multi-billion-dollar... More
  • Republican Healthcare Bill Would Leave BPCIA Untouched In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned.  But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in fact enacted as part of Obamacare — specifically, as Title VII to the ACA.  Although the BPCIA is no longer politically... More
  • District Court Rules that BPCIA Does Not Limit Innovator’s Remedy If Patent Dance Not Followed In a memorandum and order published last Friday in the Janssen v. Celltrion litigation pending in the federal district court in Massachusetts, Judge Mark L. Wolf provided “guidance” that the Biologics Price Competition and Innovation Act (BPCIA) does not limit an innovator’s remedy to a reasonable royalty unless a biosimilar applicant initiates and follows all... More