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Janssen Seeks Expedited Trial in Janssen v. Celltrion

One week ago, we reported that FDA approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). Today, Janssen filed a letter to the court in Janssen v. Celltrion informing the court that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…

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Sanofi and Regeneron announce positive Phase 3 results for dupilumab and plan FDA application

On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis.  According to Sanofi’s and Regeneron’s press release:  “There are no approved systemic therapies in the U.S….

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PTO Publishes New PTAB Rules

On April 1, the U.S. Patent & Trademark Office published new rules for AIA proceedings before the Patent Trial & Appeal Board, including inter partes reviews (IPRs).  IPRs are becoming an important tool for biosimilar manufacturers to challenge patents on biologic drugs (for example, see here, here, and here). Some of the most…

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Amgen v. Apotex: Federal Circuit Oral Argument Held

Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a…

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TPP Updates: Japan and Canada Begin Deliberations on Trade Deal Ratification

Since the TPP’s signing by twelve Pacific Rim countries this past February, the agreement has been making its way through the “next phase” of its development—ratification through the signatory countries’ “respective domestic processes.”   As we’ve covered previously (see our posts here and here), if enacted, the TPP’s intellectual property provisions…

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