Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                          March/April  2015

In This Issue

·    Amgen v. Sandoz

·    News

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Jill M. Browning

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·        California District Judge Ruled Participation In Dispute Resolution Process under BPCIA Optional: A ruling issued March 19, 2015 by the Northern District of California in Amgen v. Sandoz, 14-cv-04741-RS, concluded that the procedure set forth in 42 U.S.C. §262, passed as part of the Biologics Price Competition and Innovation Act (BPCIA), regarding potential disputes over patent validity and infringement is not mandatory.  The dispute resolution process requires a biosimilar applicant and the reference product sponsor to participate in series of informational exchanges directed to narrowing and/or resolving patent disputes.  Amgen has marketed Neupogen since 1991.  On July 7, 2014, the FDA accepted a Sandoz BLA for approval of a biosimilar to Neupogen. Sandoz provided notice to Amgen that it believed it would receive FDA approval around the second quarter of 2015 and that it has opted out of the BPCIA’s dispute resolution procedures.  The court, in interpreting the BPCIA, indicated that the use of the word “shall” did not, in the context of the overall statute, imply that the actions are mandatory in all contexts.  Specifically here, the BPCIA contemplates the scenario where the biosimilar applicant does not comply with a provision, thereby indicating that the activity is not mandatory.  Thus, “a party’s failure to participate permits the opposing party to commence [instead] patent litigation”.

The second dispute the court resolved involved 42 USC §262 (l)(8)(A), which provides that the application “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” (emphasis added).  Amgen argued that use of the past tense “licensed” means that the applicant cannot provide the 180 days notice until after the FDA has granted the approval of the biosimilar.  The court, however,  concluded that the of the past tense “licensed” meant that the FDA must grant approval before the commercial marketing, but not before notice could be provided.

This decision may not be the final word on the interpretations of these provisions of the statute, as the decision will likely be appealed.   


·        US pharmaceutical market may rise to $548bn by 2020: Currently, the pharmaceutical market is at $395bn.  According to research and consulting firm GlobalData, many factors may contribute to the increase of drug/biologic sales, including increased healthcare expenditure, ageing population, rising prevalence of chronic lifestyle diseases (diabetes, obesity), universal and easy access to reimbursement for pharmaceutical product costs and Obamacare, will increase the volume of drug and biologic sales.

·        Amicus Therapeutics planning to file for accelerated approval with the FDA:  The accelerated approval designation targets drugs aiming at serious conditions, allowing them to be approved based on less-stringent criteria. Amicus Therapeutics’ drug, called migalastat, is a potential therapy for Fabry disease (which is characterized by the buildup of fat in the body’s cells). If approved by the FDA, the drug would be the first oral treatment for this rare condition.

·        Maine lawmakers attempting to enact GMO labeling requirement: Maine passed in 2013 a bill that requires food retailers to label products containing genetically modified organisms. However, this law will only come into force if at least four other Northeastern states pass similar laws. As of now, Connecticut and Vermont have approved GMO labeling laws.  Maine is still waiting for Massachusetts and New Hampshire to follow.

·        On the flip side, a bill aimed at blocking state GMO labeling is set for release: The bill provides that labeling GMO food could only be required if there is a “material difference” between the biotech ingredient and its conventionally counterpart. The purpose is to bar the use of the non-GMO label as suggesting that their products are safer than biotech versions.


The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  For more information, contact Jill M. Browning or Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2015 GREENBLUM & BERNSTEIN, P.L.C.