« Hooking | Main | Whoopspool »
February 28, 2009
Biological?
The
Hatch-Waxman Act created an
accelerated pathway
to chemical generic drugs, by virtue of piggy-backing on previous testing
done by the patent holder. Biologic drugs are a different scenario altogether.
Made from living organisms, such as bacteria, not chemical formulation,
biologics are extremely difficult to replicate precisely.
On Wednesday, an spokesperson let loose that President Obama's budget has buried within it a proposal for approving generic biologic drugs. On that news, the morons commonly known as stock market investors promptly sent the share prices of all major drug makers into a tailspin. Who in their right mind owns stocks now anyway? In it for the long haul? As Depression-era economist John Maynard Keynes so keenly observed: "in the long run, we are all dead."
Naturally, generic drug makers jumped for joy. "This is enormous," tooted Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association, a trade cabal. "If a bill with this passes, it will mean huge savings for payers and insurance companies, patients, and state and local governments" as well as federal programs.
The U.S. market for biologics is projected to hit $100 billion by 2011. Biologics are used to treat cancer, hepatitis, arthritis, and in making beer, not to mention, for the seriously health inclined, tofu.
Rep. Henry Waxman, who just took the chair of the House Energy and Commerce Committee, a long-time advocate for generic drugs, was also pleased. While the Judiciary committee generally mauls patent law, Waxman's committee deals with health issues.
Obama's proposal is likely to face a spirited battle in Congress, which has already been wrestling with regulations for approving generic biologics for the past few years. Which is to say that not enough money has sufficiently tilted Congress to act, considering the deep pockets of those major drug companies that stand to lose from generic biologics.
If Obama gets a dog, will stocks of puppy chow go through the roof? You betcha.
Posted by Patent Hawk at February 28, 2009 8:49 PM | The Patent System