Preferring engagement to extreme censure, the U.S. Trade Representative (USTR) hopes to work with officials in China and India this year to create a more even playing field for U.S. medical products in those markets.
Preferring engagement to extreme censure, the U.S. Trade Representative (USTR) hopes to work with officials in China and India this year to create a more even playing field for U.S. medical products in those markets.
Despite pressure from biopharma and other industries to single out India as the worst of the worst in not honoring intellectual property (IP) rights, the U.S Trade Representative (USTR) declined to name the world's biggest exporter of drugs a Priority Foreign Country (PFC), the strongest censure the U.S. can give a trading partner in the annual Special 301 Report.
The Supreme Court opened the door Tuesday to more awards of attorney fees in patent infringement suits when it unanimously reversed the Federal Circuit in Octane Fitness LLC v. Icon Health & Fitness Inc.
Billions of dollars may be riding on when the FDA finalizes a draft guidance that would make more fixed-dose combination (FDC) drugs eligible for five-year new chemical entity (NCE) exclusivity.
Drugmakers hoping to compete with a monoclonal antibody (MAb) granted a seven-year orphan drug exclusivity have final guidance on what they need to do to differentiate their MAbs to get around the exclusivity.
What with federal Sunshine reporting, state transparency rules and a Medicare data dump, drugmakers are awash in a sea of data that could come back to swamp them.
Hoping for a checkmate, generic drugmakers petitioned the Supreme Court Monday to either clear the board for a late May launch of generic versions of Copaxone or force Teva Pharmaceuticals USA Inc. to post a hefty bond to reimburse them for their losses if its final patent on the multiple sclerosis (MS) drug remains struck down on appeal.
In striking down Roche AG's method of osteoporosis treatment claims for once-monthly Boniva, the Federal Circuit may have raised the bar for using a life cycle approach to protect blockbuster drugs from generic and biosimilar competition.
The U.S. Patent and Trademark Office (PTO) is looking to the power of the crowd to strengthen the quality of patents by weeding out claims that aren't innovative.
