Carnival of Biotechnology

Investing and Clinical Trials

PharmaGossip has an illuminating excerpt from The End of Medicine describing a method to invest in drug companies as they progress through clinical trials.

Ted Love, CEO of Nuvelo Inc., explains how biotechnology companies are frequently able to recover from seemingly disastrous clinical trial failures.

Patents

When manufacturers seeking to sell generic drugs challenge patents in order to try and enter the market, the patent holders will sometimes settle out of court and pay the generic company to wait until the patent expires. There is growing opposition in congress to this practice, with some lawmakers calling it anticompetitive.

In order to challenge a patent, a challenger must either have been sued for infringement, or be able to demonstrate that they are likely to be sued for infringement. This can place licensees in a dilemma where they must decide to license a patent they feel is invalid, or infringe a patent and challenge it but risk paying triple damages for willful infringement. A ruling in the case of Medimmune v. Genentech has strengthened the case for licensees, permitting them to pay licensing fees “in protest” and still challenge a patent.

International

The Chinese biotechnology and pharmaceutical sectors are rapidly growing as increasing numbers of expatriates are returning, bringing skills and connections from abroad back home. Chemical Engineering News profiles the Chinese pharmaceutical industry and investigates the challenges it still faces.

Sir Chris Evans, founder of Merlin Biosciences, blames British biotech investors for having a ‘sick garden syndrome’, stating “We keep pulling the flowers up every six months to look at the size of the roots, and ram them back in the ground wondering why they struggle to grow.”

Drug Patent Expirations in March 2007

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in March 2007

*Drugs may be covered by multiple patents

Carnival of Biotechnology

Scientific Advances

The MaRS Blog has a captivating story of Canada’s recent major diabetes discovery. The first discovery, in 1920, elucidated insulin’s central role in diabetes. The most recent discovery, also from the University of Toronto, has found a strong link between diabetes, pain nerves, and inflammation. Researchers were able to prevent and even reverse diabetes in mice modulating the neuroinflammatory mechanism without any serious side effects.

In the Pipeline issues a dose of realism for the overly-optimistic news of a potential anti-cancer drug found by mistakenly using a high concentration of compounds not previously known to have an anti-cancer effect.

Patents and Regulation
I always like a good inequitable conduct case, and the Patent Baristas have got a fresh one! Amphastar and Teva successfully challenged Sanofi-Aventis’s Lovenox patent by convincing the court of deceptive intent by Sanofi.

Eye on Pharma has some recomendations for the FDA. After years of being simultaneously blamed for being too lax on safety and not moving quickly enough on safety, this nine-step plan for change aims to restore the agency’s credibility.

I’ve railed about Michael Crichton’s misguided NYTimes Op-Ed’s before, and his most recent anti-patent screed is as misguided as his previous posts. I rather liked Nobel Intent‘s take on the matter: “It is becoming a truism that if there are two sides to a scientific debate, Michael Crichton can usually be found on the wrong one.”

Marketing

John Mack at Pharma Marketing has another excellent post on what I’d call “excessive creativity” in pharmaceutical marketing. Whereas branded websites providing information on drugs must carefully meter their statements, the same does not hold true for unbranded sites. Through a little investigative journalism, Mack has discovered a thinly veiled promotional agenda for weight-loss drug Alli.

Industry Trends

Yet another industry giant enters the biotechnology fray. Following the path laid by IBM, Motorola, Corning, and others, General Electric is investing in biotechnology – specifically in medical diagnostics.