Category: BPCIA

Today, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register.  Although Janssen’s lawsuit is not the first action under the BPCIA, today marks the first time the FDA published notice of any BPCIA lawsuit.

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.”  In determining the standard and appropriate level of detail required by the disclosures pursuant to the patent dance, looking to analogous disclosure requirements in the Hatch-Waxman context provides helpful guidance.  Gleaning from the Hatch-Waxman context, “detailed statement” disclosures under the BPCIA should have a reasonable basis and establish a prima facie case of invalidity or non-infringement.  Moreover, as in the Hatch-Waxman context, filing “baseless” non-infringement or invalidity positions may risk sanctions as an “exceptional case” that may warrant attorney fees under 35 U.S.C. § 285.

The BPCIA created an abbreviated pathway for FDA approval of biological medicinal products that are “biosimilar” to an already FDA-approved product.  The FDA recently approved the first U.S. biosimilar – Sandoz’s biosimilar of Amgen’s Neupogen – and is currently reviewing at least four other proposed biosimilars.  Many innovators and biosimilars manufacturers are responding to the changing landscape for biologics by developing “biobetters”:  new and improved versions of biologic medicinal products.  While biobetters require discovery and an original Biologics License Application (BLA) with a full complement of pre-clinical and clinical data for marketing approval, they also offer many advantages.  By offering superior and longer-acting medicine, biobetters provide a competitive advantage over biosimilar products.  In addition, unlike biosimilars, they generally would be entitled to patent protection and 12 years of non-patent exclusivity under the BPCIA.  

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of  their dispute over the Biologics Price Competition and Innovation Act (BPCIA).  While both sides received heavy questioning, several commentators have suggested that the panel’s comments favored Amgen, which previously obtained an injunction pending appeal.  There is no timetable for a decision but the appeal is expedited.

On May 13, the FDA released additional draft question-and-answer guidance on the implementation of the BPCIA.  The draft document resurrects a number of the questions from FDA’s original 2012 draft guidance that were omitted from last month’s final version of the 2012 document.  As a result, FDA’s final answers to important questions from three years ago may not be forthcoming for some time. 

In the wake of the Supreme Court’s decision in Daimler AG v. Bauman, some defendants in Hatch-Waxman litigation have contested personal jurisdiction anywhere outside their “home” state.  District courts have universally rejected such arguments, finding personal jurisdiction in the patent owner’s chosen forum on the basis of consent or specific jurisdiction.    The Federal Circuit will consider two of these cases this summer. The lessons learned will be equally applicable to litigation under the BPCIA.  

Medicare Part B covers drugs prescribed and administered in an outpatient setting (e.g., a doctor’s office or outpatient clinic), including many biologic drugs (given that they are often injectable drugs that must be administered by a health practitioner).  In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, the practical impact of Medicare Part B’s reimbursement policy will soon be tested in the marketplace.

On March 6, the Food and Drug Administration (FDA) approved the first biosimilar in U.S. history—Sandoz’s biosimilar of Amgen’s blockbuster drug used to prevent infections in cancer patients, Neupogen. Sandoz, a Novartis company, reaped tremendous savings in cost and time by taking advantage of the new biosimilar pathway rather than submitting a full biologics license application (BLA) to the FDA and undertaking all the studies that Amgen had to perform to obtain approval for Neupogen. The extent to which these savings will be passed on to the U.S. health care system as envisioned by the Obama administration, however, is less clear.

On March 31, the Supreme Court heard oral argument in Commil USA LLC v. Cisco Systems Inc.  The Supreme Court considered the Federal Circuit’s holding that a belief in a patent’s invalidity is a defense to inducing infringement under 35 U.S.C. § 271(b).  The Justices posed tough questions to both sides.  But the ultimate outcome of this case should not impact litigation under the BPCIA where inducing infringement of method of treatment and manufacturing patents offers important protection to innovators since the validity of such patents is typically determined prior to launch of a biosimilar product.

On March 19, Judge Seeborg of the Northern District of California denied Amgen’s motion for a preliminary injunction in Amgen v. Sandoz. Sandoz recently won the first-ever FDA approval for a biosimilar for its product Zarxio, which is based on Amgen’s blockbuster Neupogen. 

Today the FDA announced approval of the first ever biosimilar in the United States, Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim) product.  Although Sandoz has cleared FDA obstacles, when Zarxio reaches the market depends on the outcome of Amgen’s lawsuit under the BPCIA. 

The exclusivity period for biologic drugs has recently become a hot topic in both domestic and foreign policy. At home, the Obama administration’s latest budget proposes reducing the exclusivity period to seven years, down from its current 12. Abroad, the exclusivity period for biologics has developed into a sticking point in negotiations over the Trans-Pacific Partnership.

Welcome to the Biologics Blog, which will track and analyze developments in intellectual property law related to biologic medical products as well as regulatory and legislative changes. Our impetus for starting the blog is the recent onset of regulatory activity and litigation under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created a new regulatory and legal framework for biosimilar and interchangeable biologic products.