Power to Biotech: Getting What They Want on Patents, Generics

Alicia Mundy in the Wall Street Journal (http://sbk.online.wsj.com/article/SB124917341780899303.html; subscription required) writes how the House Energy and Commerce Committee voted 47-11 to hand the biotech industry a major victory in an amendment to the health reform bill, handing a setback to the Administration.

The industry gets a full 12 years' patent exclusivity for its expensive biologic products, which Obama and other Democratic leaders had hoped to whittle down to 5-7 years before generic competition would be allowed. Many of the worst "evergreening" abuses, by which the brand name drug maker can extend patent rights by making only minor tweaks in a drug, also get the green light under these amendments.

If this is a sign of how likely Congress is to stand up to the Pharma and biotech lobbies to pass meaningful health reform, it is not encouraging.

Prominent Cancer Scientist: Stop Evergreening

HOOKED describes how drug companies commonly engage in "evergreening"--finding ways to renew or extend the patent on a profitable drug that is about to go off-patent and become available generically at a much lower price. Sometimes this involves the belated "discovery" of a "new" drug that is supposedly superior to the old one when in fact the new drug is only a minor chemical variant of the old molecule (such as the substitution of Nexium for Prilosec). In other instances the action is in the courtrooms rather than the lab, when companies simply file nuisance lawsuits against all the generic makers for patent infringement, hoping simply to delay the generics' entry into the market.

Joining the voices condemning evergreening and related patent shenanigans is Brian Druker, the scientist (at Oregon Health and Science University) generally given the major credit for the discovery of the cancer drug, Gleevic (or Glivic outside the U.S.), which ushered in a new generation of less-toxic "designer" anti-cancer drugs.

Druker reviews the history of the development of Gleevic, noting that it involved an extended collaboration between academic and industry scientists. He recalls also how the drug developers had to overcome continued skepticism about the value of their discovery. (His story is rather at odds with the standard Pharma history of the same events. The Pharma side now seems not to recall how skeptical the money managers were, and also believe that almost all the major discoveries were made by in-house industry scientists.)

Druker goes on to complain about the high price now being charged for Gleevic or Glivic. (HOOKED explains how the price chosen had nothing to do with the actual cost of producing the drug, and was for all intents and purposes simply what the market would bear. Within a year or so Gleeevic sales reimbursed its maker, Novartis, for all the costs of research and development.) He complains about the games played with patents and monopolies that result in these high drug prices, that put needed drugs outside the reach of too many patients. He argues that he and his fellow scientists never planned to discover important new treatments for dread diseases like cancer, just to see the drug priced so high as to be unavailable to so many.

In HOOKED, Gleevic is presented as a showcase industry success story. It's a genuinely novel drug, based on a novel biochemical concept, that produced near-magical results in its early trials for patients with a couple of relatively rare sorts of cancer. Further experience with the drug appears to date to have confirmed both its effectiveness and its low side-effect profile--a huge breakthrough in cancer chemotherapy. So, if one wanted to pat the drug industry on the back, it is hard to find a better case to do so than Gleevic. It is therefore especially sad to see even this "wonder" drug drawing this severe criticism, and for good reason.

Druker B. Don't abuse patents: scientists. http://www.livemint.com/Articles/PrintArticle.aspx