Thursday, July 9, 2009


Twelve More Years

In a story that is perhaps related to the nexus between certain companies and certain Congressfolk, Ted Kennedy has proposed doubling patent exclusivity for at least some biotech drugs. Here is the story:

It is perhaps interesting to speculate whether this is part of wider negotiations, which seems likely, or something else. Personally, I have favored extending exclusivity for drugs that require an unusually arduous approval process and/as a kind of "reward" for superlative regulatory compliance, particularly in the arenas responsible completion of phase IV studies and responsible promotion.

Kennedy's proposal is so out of synch with what the administration has proposed that it will be "interesting" to see where the middle turns out to be.


  1. It is disappointing that Sen. Kennedy is supporting long exclusivity periods for biologic drug-makers.

    The American people need to know why he would support such exclusivity when it is “twice the time urged by President Barack Obama ,” and counters Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, who warned:

    “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs.”

    The President’s goal is to cut the cost of healthcare, not to help pharma’s bottom line.

    It is clear that reform will be a hard fought battle.

  2. I think that if the biologics actually cured the disease than they should get a twelve year patent life as this owuld certainly help to recoup investments being made in order to bring th biologic to market.

    The story behind this story is perhpas that Amgen has pledged 5 million dollars towards the Edward Kennedy Institute....It will be annexed to the JFK Library in Boston....

    I dunno, maybe it is a bribe of some sort????

  3. I’ll bet it has EVERYTHING to with the $5 million and the preservation of the Kennedy name.


Note - Due to a time out issue with Blogger, you may receive a message that requires you to resend your comment. This will not affect its contents.