Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                               May-June 2012   

In This Issue

·    Supreme Court Caraco Decision

·    News

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Jill M. Browning

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The United States Supreme Court ruled on April 17, 2012, in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk, A/S, (Case No. 10-844), that a generic manufacturer may counterclaim against the name brand to force correction of an Orange Book “use  code” that inaccurately describes the brand’s patent as covering a particular method of using a drug.

The FDA requires the New Drug Application (“NDA”) holder to list the patents that it believes cover the reference drug product in what is commonly referred to as the “Orange Book”.  The NDA holder must also include a “use code,” which is a brief description of the scope of the patents that are listed.  The FDA uses this information, when evaluating an Abbreviated New Drug Application (“ANDA”) submitted by a generic drug manufacturer, to determine whether the ANDA would infringe the NDA’s listed patents or may be approved. 

In the present case, the FDA approved three “uses” of the active ingredient (repaglinide) to treat diabetes, namely, use of the active ingredient alone, in combination with metformin, or in combination with another drug. The Novo Nordisk Orange Book listed patent covers only the use of the active ingredient with metformin – but Novo Nordisk changed the use code to cover all three “uses.”  Thus, Caraco’s ANDA, which was directed to using the active ingredient alone, fell within the scope of the use code, permitting the NDA holder to sue Caraco under the Hatch-Waxman statutory scheme. 

Caraco brought a counterclaim seeking to require Novo Nordisk to amend its use code to reflect the active ingredient and metformin, which would permit FDA to approve its ANDA.  The lower court granted Caraco’s request, but the Federal Circuit reversed. 

The Supreme Court sided with Caraco, reversing the Federal Circuit and concluding that a counterclaim may be filed whenever the Orange Book listed patent does not claim a method of use for which the ANDA applicant seeks to market the generic drug.   


·         BIOSIMILAR UPDATE FROM FDA: FDA held a public hearing on May 11, 2012 regarding the Draft Guidance documents related to the development of biosimilar products.  There were multiple presenters.  The topics discussed included: (i) requiring clinical trials; (ii) determining what constitutes a  “protein” on a case-by-case basis; (iii) naming strategies for biosimilars; (iv) trade secret protections; (v) 12 year market exclusivity; and (vi)  using non-US reference comparator products in biosimilar applications.  An archive of the webcast may be found at the FDA website at

·         Baxter International is collaborating with Chatham Therapeutics to develop a hemophilia B gene therapy treatment.  Baxter paid $25 million to advance the program through early clinical trials, with additional money to be paid in view of development/commercial milestones.

·         GSK continues its efforts to take over Human Genome Sciences Inc.  HGS rejected a $2.6 billion hostile takeover bid by GSK May 17, 2012.  GSK extended its unsolicited tender offer of $13 per share of HGS to June 29, 2012.

·         Amylin has rejected a $3.5 billion buyout offer from Bristol-Myers.  It remains to be seen whether Bristol-Myers will try to increase its offer or whether AstraZeneca, Sanofi, Merck and Takeda will try to bid for Amylin.     


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 at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C.