Maryland Intellectual Property Law Blog : Maryland Intellectual Property Lawyer & Attorney : Brian Wm. Higgins : Serving Baltimore, Columbia, Frederick

   The following cases are reported as being filed in the U.S. District Court for the District of Maryland in May 2010 (source: Justia.com):

• Patent dockets:
  
  • Genzyme Corporation v. Watson Laboratories, Inc., No. 1:2010cv01323 (filed May 24, 2010); this Hatch-Waxman patent infringement lawsuit was brought by Genzyme after Watson sought Food and Drug Administration (FDA) approval to market in the US a generic version of the company's Renvela(R) drug product (sevelamer carbonate).  According to FDA information, Genzyme, based in Cambridge, MA, is the New Drug Applicant for this reference listed drug, which covers oral suspensions and tablet forms.  Renvela is indicated for "phosphate binding," and, according to Genzyme's website, is a "first-line monotherapy for controlling serum phosphorus in patients with Chronic Kidney Disease (CKD) — on dialysis without calcium or metal accumulation."  Genzyme's patent exclusivity reportedly extends until September 16, 2014.  
     
  • MIH International, LLC v. Weber Orthopedic, Inc., No. 8:2010cv01127 (filed May 5, 2010)
  
   
• Trademark dockets:
  
  • Gifford's Dairy, Inc. v. Gifford's Holdings, LLC, Gifford's Ice Cream & Candy Company, Inc., and Deal Metrics, LLC., No. 1:2010cv01294 (filed May 20, 2010); Gifford's Ice Cream & Candy Co., based in Silver Spring, MD, calls itself Washington, DC's oldest ice cream company (with retail stores in Baltimore, Bethesda, Chevy Chase, and Rockville, MD, and downtown DC).  Gifford's Dairy, based in Skowhegan, ME, is the owner of the registered trademarks GIFFORD'S and GIFFORD'S ICE CREAM FAMILY OWNED THE ICE CREAM STAND ICE CREAM

• Copyright dockets:
  • Advanced Education Systems, LLC d/b/a TrainingPro v. MTI Services Corporation d/b/a Mortgage Training Institute, No. 1:2010cv01253 (filed May 18, 2010)

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     35 U.S.C. § 156(d)(1) requires the submission of a patent term extension (PTE) application within 60 days from the date the patentee obtains permission from the FDA to commercially market or use a drug product that is the subject of a new drug application (NDA). This provision was enacted because FDA review of NDAs may take years after a patent covering the drug that is the subject of the NDA has issued by the PTO.

     On June 23, 2008, the U.S. House of Representatives passed by voice vote H.R. 6344, which had been introduced the same day by Rep. Delahunt (D-MA), and is similar to a provision included in the House version of the Patent Reform Act of 2007. The current bill is entitled "To provide emergency authority to delay or toll judicial proceedings in United States district and circuit courts, and for other purposes." Sec. 4 states:

"The Director may accept an application under this section that is filed not later than three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional."

     The bill would retroactively cover Massachusetts-based The Medicines Company, which filed a PTE application for U.S. Patent No. 5,196,404 on the 62d day after FDA approved its NDA for ANGIOMAX, an anticoagulant.

     Status: Received in the Senate and read twice and referred to the Committee on the Judiciary.

     Hat tip to the Anticipate This! Patent and Trademark Law Blog.

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• IP Forum Webinar Announcement: "DELAWARE: Epicenter for U.S. IP Dispute Resolution"
  
       This from a soon-to-be released announcement from my law firm, Blank Rome:  "Join a knowledgeable team from Blank Rome on April 30, 2008 for an in-depth look at the Top 5 Things You Need Know when litigating a patent case in the U.S. District of Delaware Court. Learn why today’s most significant IP matters are being litigated in this jurisdiction from a panel of experts who know how Delaware’s unique rules and procedures work.  J.C. Boggs, Keeto Sabharwal, Steve Caponi, Charles Wolfe, Dale Dubé and Vincent Poppiti will examine several key cases and lead an interactive discussion over the web.  Date: April 30, 2008; time: 1030 to 1200 EDST US."   
  
  
• Rockville, MD-based Nabi Biopharmaceuticals announced on April 3, 2008, that it had settled a patent lawsuit it had filed against Ohio-based Roxane Laboratories over its drug product PhosLo(r). According to a Nabi statement, Nabi had filed the lawsuit on September 27, 2005, under the Hatch-Waxman Act in response to a Paragraph IV Certification letter submitted by Roxane to Nabi concerning Roxane's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration to market a generic version of PhosLo GelCaps.  Nabi sold its PhosLo drug product to Fresenius USA Manufacturing, Inc. in 2006. 
  
  
• The Baltimore Business Journal announced Wednesday that Sarah Djamshidi, a University of Maryland business development official, was named Executive Director of the Chesapeake Innovation Center, which is an Annapolis-based incubator that assists startups developing homeland security technologies.
  
  
• Conference announcement: "Copyright Monopoly: Playing the Innovation Game"

     This from the Center for Intellectual Property, University of Maryland University College (UMUC):  "Since 2001, the Center for Intellectual Property (CIP) has provided premier conferences focusing on the intersection of copyright, technological innovation, and higher education. In its Eighth Annual Symposium, the CIP continues its tradition of convening a rich conversation on copyright policy that includes voices from higher education, business and industry, law, policy, government, and nonprofit sectors, and that also spans the spectrum of opinion and perspective."  8th Annual Symposium, May 28-30, 2008, in Metro Washington, D.C.

• Kevin O'Keefe at LEXBLOG provided a State of the AmLaw 200 blogosphere, March 2008, a few weeks ago, in which he noted that over 25% of the AmLaw 200 law firms (53) now have blogs. The Maryland Intellectual Property Law Blog (a "non law firm branded" blog) is counted among the total. According to Kevin's statistics, there were only 39 blogs being published by the AmLaw 200 in August 2007.

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     In Wyeth v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc., No. 07, Civ. 0632 (D. Md Sep. 11, 2007), the District Court for the District of Maryland denied Baltimore-based Lupin Pharmaceuticals, Inc.'s (LPI) motion to dismiss an action against it and its parent, Mumbai, India-based Lupin Ltd. (Lupin), brought by pharmaceutical giant Wyeth. In reaching its decision, the District Court concluded that "when a wholly-owned U.S. subsidiary of a foreign corporation exists to distribute foreign-produced generic drugs in the U.S. and is actively involved in the ANDA process, the subsidiary also 'submits' an ANDA application" making it subject to the Hatch-Waxman Act like its parent.

     This case began when Lupin filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to market a generic version of EFFEXOR® in the U.S. Under the Hatch-Waxman Act, the filing of an ANDA is an act of infringement. Accordingly, Wyeth, which owns U.S. Patents 6,274,171; 6,403,120; and 6,419,958 for venlafaxine hydrochloride (marketed by Wyeth as EFFEXOR® XR capsules), sued LPI and Lupin within the statutory 45-day period after receiving Lupin's "Paragraph IV" Notice Letter on January 30, 2007.

LPI's Motion to Dismiss

     LPI moved, under F.R.C.P. Rule 12(b)(6), to dismiss the complaint against it, arguing that under the Hatch-Waxman Act, the only act of direct infringement under 35 U.S.C. § 271(e)(2)(A) was Lupin's filing of the ANDA with the FDA. Wyeth sought to maintain LPI in the lawsuit, arguing that there is no “one-defendant-per-ANDA” rule under the Hatch-Waxman Act. LPI, Wyeth said, acted in concert with Lupin to violate Wyeth’s patents.

     The District Court began its analysis by noting that Lupin had made the same arguments, unsuccessfully, in Aventis Pharma Deutschland GMBH v. Lupin Ltd., 403 F. Supp. 2d 484, 494 (E.D. Va. 2005). In that case, the district court found:

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