Teva Pharmaceutical Industries Ltd. (TEVA) may face competition to its top-selling multiple sclerosis drug Copaxone a year earlier than analysts expected after a mixed U.S. court ruling on the patents covering the medicine.
Four patents that expire in May 2014 were upheld July 26 by the U.S. Court of Appeals for the Federal Circuit in Washington, while other patent claims on the drug were invalidated. One of those invalidated patents expires in September 2015.
Teva said it will appeal the decision on the 2015 patent. The company can ask that the case be heard before all active judges or seek review before the U.S. Supreme Court.
Copaxone, Teva’s largest branded medicine, generated $1.1 billion in sales in the first quarter for the Petach Tikva, Israel-based company and accounted for almost a fifth of its revenue last year. The drug, which had made up about 40 percent of the MS market, already is facing competition from Biogen Idec Inc. (BIIB:US)’s Tecfidera treatment, which won U.S. approval in March.
Momenta Pharmaceuticals Inc. (MNTA:US), which is developing a generic version with Novartis AG (NOVN)’s Sandoz, said in its annual report that it’s counting on the generic Copaxone to help the company return to profit.
Chief Executive Officer Heather Bresch of Mylan Inc. (MYL:US), another challenger, said Friday in a statement that the Canonsburg, Pennsylvania-based company expects to begin sales of generic Copaxone on May 25, 2014.
The Federal Circuit ruled that the invalidated patents didn’t clearly outline what Teva claimed was invented. There are ambiguities that make it unclear what molecular weights were used to develop the product, the court ruled.
The case is Teva Pharmaceuticals USA Inc. v. Sandoz Inc., 2012-1567, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court cases are Teva Pharmaceuticals USA Inc. v. Sandoz Inc., 08cv7611 and 09cv8824, U.S. District Court for the Southern District of New York (Manhattan).
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Copyright Can Be Transferred Electronically, Court Says
U.S. copyright ownership can be transferred electronically without a hand-written signature, a federal appellate court said.
The case involves Metropolitan Regional Information Systems Inc., a company that compiles real-estate listings into a fee-based, online database for brokers. MRIS, which operates what is known as a multiple listing service, claimed that American Home Realty Network, a competitor that aggregates real estate information for consumers at no charge, infringed its copyrights by using its photos.
The U.S. Court of Appeals in Richmond, Virginia, acknowledged in its July 17 ruling that “There is little authority regarding the application of e-signatures to instruments conveying copyrights.”
The court found that although the federal Copyright Act doesn’t address whether an electronic agreement to transfer ownership is sufficient without a written signature, the federal Electronic Signatures in Global and National Commerce Act, known as the E-Sign Act, makes contracts binding when signed only by electronic signature.
“To invalidate copyright transfer agreements solely because they were made electronically would thwart the clear congressional intent embodied in the E-Sign Act.”
L. Peter Farkas, an attorney with Farkas & Toikka in Washington who represented American Home Realty, said in a telephone interview that the “decision has some problems and we are trying to figure out what to do. The court assumed things that weren’t in the record.”
Margaret Esquenet, an attorney with Finnegan, Henderson, Farabow, Garrett & Dunner LLP in Washington who represented MRIS, didn’t respond to an e-mailed request for comment.
The case is Metropolitan Regional Information Systems, Inc. v. American Home Realty Network, Inc., No. 12-02102, U.S. Court of Appeals for the Fourth Circuit (Richmond, Virginia).
Copyright Matters Lecture Series to Hold Forum on the U.K.
The U.S. Copyright Office, as part of its series “Copyright Matters” will hold a forum today in Washington at 10 a.m. The meeting, to discuss U.K. copyright law, will feature John Alty, chief executive officer and comptroller general of the Intellectual Property Office of the United Kingdom, as well as Neil Feinson, director of international policy, and Adam Williams, deputy director of international policy.
In a conversation with Register of Copyrights Maria A. Pallante and senior officials of the U.S. Copyright Office, the panelists, according to the Copyright Office website, will discuss current copyright policy issues facing the U.K. and the U.S., such as orphan works, extended collective licensing, small claims and recent efforts in both countries to update the copyright legal system for the digital age. The free event is open to the public.
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Clorox Seeks to Block Imports of Copycat Pine-Sol From Mexico
Clorox (CLX:US) filed a trademark-infringement case against Mexico’s Industrias Alen SA at the U.S. International Trade Commission in Washington on July 25.
The complaint claims that Alen is selling laundry and cleaning products that mimic its Clorox and Pine-Sol brands. Alen sells bleach, detergent, cleaners and disinfecting wipes under names “Cloralex” and “Pinol” names.
The company said in a statement that it seeks “a permanent limited exclusion order against the sale of such products.”
In its complaint, the company claims Alen’s names are intended to increase sales in U.S. market, and as such are “an assault on the iconic Clorox and Pine-Sol American household brands.”
An Alen spokesman couldn’t be reached for comment on the complaint.
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