Small Drug Companies Closely Watching Supreme Court Case On Patents
A Swiss drugmaker is challenging a 2011 change to the law that no longer allows a company to patent an invention if it was for sale for more than a year before filing a patent application. Meanwhile, Congress also plans to focus on the issue of pharmaceutical patents and lawmakers continue to question the industry's pricing decisions. And as Capitol Hill gears up for potential action on drug costs, there may be some lessons to be learned from China.
Stat:
Supreme Court To Decide Patent Case With Implications For Small Drug Makers
In a few months, the U.S. Supreme Court will decide a closely watched case that could lead to patents being canceled more easily and, therefore, chill deals that small drug makers may pursue in hopes of finding larger partners to get their medicines to market. The case turns on disputed language in U.S. patent law, which was overhauled in 2011, that prohibits a company from patenting an invention if it was for sale for more than a year before filing a patent application. The court, which heard oral arguments on Tuesday, must decide whether Congress intended the law to apply only to agreements that are publicly known or also encompasses confidential transactions out of the public eye. (Silverman, 12/6)
Stat:
Democrats Are Eyeing A Valuable Pharma Asset: Its Patents
Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power: the patents the industry holds on its drugs. For years, lawmakers from both parties have shied away to address the industry’s intellectual property. Muck with a drug company’s government-granted monopoly, the thinking goes, and investments in research and development will disappear. Pharma even helped to scuttle a broad, bipartisan patent reform effort in 2015, in part because the industry worried that even small changes focused on bad actors would open the door to bigger ones. (Facher, 12/7)
The Wall Street Journal:
Congress To Drug Makers: Why Stock Buybacks Over Lowered Drug Prices?
Critics of high drug prices are launching a new line of attack against manufacturers of the medicines, faulting the firms for using savings from the tax overhaul to buy back shares rather than lower prices. The attacks began in October, when more than a dozen Democrats in the House of Representatives sent letters to five big pharmaceutical companies saying they had benefited from recent tax cuts but kept charging high prices. The letters singled out certain drugs whose list prices had increased and asked their manufacturers for details about price changes and the costs of research and advertising. (Loftus, 12/6)
The Wall Street Journal:
Solving China’s Drugs-Price Problem Is Hurting Drugmakers
China’s cure for its health-care problems is causing plenty of pain for drugmakers. Just as in the U.S., expensive prescription drugs have long been a headache in China. Government insurance usually doesn’t cover the full price of drugs for patients, so many have to pay a hefty portion out of their own pockets, especially those with serious diseases. In its latest bid to lower medicine costs, the Chinese government recently asked drugmakers to bid for the right to supply hospitals in 11 major cities, including Shanghai and Beijing. The winners will be those willing to accept the lowest prices. Hospitals are the biggest buyers of drugs in China, accounting for 68% of the $200 billion market, according to health-data company Iqvia. (Wong, 12/7)
An EpiPen alternative and newly FDA-approved lung cancer treatment are also in the news —
The Associated Press:
Generic Drugmaker To Sell Alternative To EpiPen Injectors
Generic drugmaker Sandoz announced plans Thursday to start selling an alternative to the EpiPen in the U.S. early next year. The EpiPen injector is used to halt life-threatening allergic reactions to insect bites, nuts and other foods. Brand-name EpiPen, which dominates the market, has been in short supply since spring because of production problems. (Johnson, 12/6)
Reuters:
Roche's Lung Cancer Combo Treatment Wins FDA Approval
Swiss drugmaker Roche Holding AG said on Thursday that its Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer. ... The drug on Wednesday had also won priority review from the U.S. regulator for treating patients with untreated extensive-stage small cell lung cancer. (12/6)
