Category: Not ‘War and Peace’ But Orphan-Drug Applications Are Few

JGrimes
The Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.
FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug […]

noreply@blogger.com (RCoffield@fsblaw.com)
India has become a hot market for multinational drug companies since it revised its patent laws to give more protection to brand-name medicine. But to hear the branded makers tell it, the patent welcome mat has some holes in it, a WSJ report recounts this morning.
The drug makers point to three top-selling […]

noreply@blogger.com (RCoffield@fsblaw.com)
A bunch of the blockbuster drugs that carried the drug industry for the past decade are about to go off patent. As we’ve noted along with everybody else, that’s going to be tough for pharma companies.
(See, for example, the news this week from Pfizer and Bristol-Myers Squibb, which over the next two […]

noreply@blogger.com (RCoffield@fsblaw.com)
Patent deals between generic and branded drug makers have been getting lot of attention lately on both sides of the Atlantic. Today, Pfizer took a turn in the spotlight.
The world’s largest pharma company said it was among those asked Tuesday by European regulators to disclose their patent agreements with generic makers. Pfizer […]

noreply@blogger.com (RCoffield@fsblaw.com)
The latest peace pact in the generics wars has been signed by AstraZeneca and Teva, shielding AstraZeneca’s mega-selling heartburn drug Nexium from Teva competition until 2014. Now the question is whether a similar deal with another generic maker — Dr. Reddy’s Laboratories — is far behind.
AstraZeneca said the deal will allow Teva […]

JGrimes
Editors always worry that a candid remark on a reporter’s story (”This doesn’t make sense!”) will accidentally find its way into print. It happens to us and, as it turns out, it happens to patent lawyers, too.
This Merck patent application inadvertently included some stray notes from an anonymous commenter. “I plan to DELETE […]

JGrimes
Drug makers sue each other all the time for alleged patent violations and yesterday Abbott Laboratories lost a big round in one such case. A federal jury in Texas ordered the Chicago drug maker to pay J&J one of the largest penalties in U.S. history — $1.67 billion — for infringing on patents […]

JGrimes
Ending settlements in which branded drug makers pay generic ones to delay entry into the market, known as “pay-for-delay” settlements, would save consumers $3.5 billion a year, plus “significant savings” for the federal government, according to Federal Trade Commission Chairman Jon Leibowitz.
In his speech to the Center for American Progress today, Leibowitz said […]

JGrimes
Though the mountains divide and the oceans are wide, it’s a small world after all. The problems of Japanese pharma — patent cliffs, troublesome acquisitions — sound mighty familiar to observers of the drug business in the U.S. and Europe.
As the FT points out, Takeda faces patent expiry on its diabetes drug Actos […]

JGrimes
Powerful drugs for schizophrenia and bipolar disorder are now available to treat depression, and the latest is a combo pill of Eli Lilly’s Zyprexa and Prozac called Symbyax.
Lilly said today that the FDA gave the green light to Symbyax after a difficult regulatory road. Symbyax has been on the market since 2003 as […]