Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the U.S. District Court of the District of Massachusetts has ruled in favor of Alnylam and has denied Tekmira Pharmaceuticals Corporation’s motion to dismiss certain claims and motion to disqualify Alnylam’s counsel in an infringement suit filed in January 2012. The infringement suit against Tekmira is based upon Alnylam’s allegations that Tekmira has improperly provided lipid nanoparticle (LNP)-formulated small interfering RNA (siRNA) molecules to pharmaceutical collaborators. As announced today, the Court has ruled that Alnylam has standing in suing Tekmira for infringement of several patents that Tekmira has exclusively licensed to Alnylam. In addition, Alnylam announced today that it has expanded the infringement action with a suit in Canada.
“Alnylam has contracts with Tekmira granting us exclusive rights to deploy LNP technologies in the RNAi field, and we are resolute in enforcing our intellectual property against infringement,” said Laurence Reid, Ph.D., Senior Vice President, Chief Business Officer of Alnylam. “In this regard, we are pleased with the ruling of the Federal Court that has confirmed Alnylam’s rights to enforce certain in-licensed patents against infringing activities. In addition, Alnylam has multiple other patents that protect our innovative discoveries, including the patent used in our expanded infringement action against Tekmira in Canada.”
As alleged in the complaint filed in January 2012, Tekmira’s activities are not protected under the exemption from patent infringement for drug development. As described in the complaint, Tekmira has allegedly infringed a number of issued patents related to siRNA and LNP technologies, including: U.S. Patent No. 7,695,902; U.S. Patent No. 6,858,225; U.S. Patent No. 6,815,432; U.S. Patent No. 6,534,484; U.S. Patent No. 6,586,410; and, U.S. Patent No. 6,858,224. Under Alnylam’s contractual right to enforce Isis’ patent U.S. Patent No. 7,695,902, Alnylam joined Isis to the suit as a co-plaintiff.
In addition, Alnylam today has expanded its infringement action against Tekmira to include CA Patent No. 2,359,180. In a complaint filed today in the Federal Court of Canada, Alnylam alleges Tekmira is infringing this patent in its collaboration activities and in its own research and development efforts.About RNA Interference (RNAi) RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.