Posts Tagged: "cancer"

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

The Commission issued a Final Order that bars the POM marketers from making any claim that a food, drug, or dietary supplement is “effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease,” including heart disease, prostate cancer, and erectile dysfunction, unless the claim is supported by two randomized, well-controlled, human clinical trials. The Order also prohibits misrepresentations regarding any test, study, or research, and requires competent and reliable scientific evidence to support claims about the “health benefits, performance, or efficacy” of any food, drug, or dietary supplement.

The USPTO Roundtable on genetic testing exposed claims that have driven the debate so far to a rare scrutiny.  Perhaps the bonfires being prepared for the accused are premature. One critic condemned universities issuing exclusive licenses as culprits responsible for preventing physician-run laboratories “that are begging to do the test” from offering competing testing services. The underlying notion appears that exclusive licensees who spend millions on test development and clinical validation actually provide shoddy lab work in practice, and that physician-run laboratories could do a better job. If so, no supporting evidence was given.

The Bayh-Dole Act unlocked those discoveries that were made with taxpayer money. It allowed businesses and nonprofits, such as universities, to retain title to their inventions that were made with federal funds and to license them to private companies for commercialization. It was a brilliant piece of bipartisan legislation that set the stage for commercializing hundreds of products, including life-saving treatments to which many of us cancer survivors owe our lives.

The conjugates covered by this patent could enable less frequent and better tolerated dosing of one of the most widely used treatments worldwide for relapsing-remitting multiple sclerosis, interferon-beta-1b. The invention described in the European Patent relates to methods for the preparation of conjugates of poly(ethylene glycol), and derivatives thereof, with interferon-beta-1b. Compared to the corresponding unconjugated bioactive components, the conjugates of the invention have increased stability (i.e., longer shelf life and longer half-lives in vivo). In addition, compared to conjugates of the same bioactive component prepared with polymer chains that are attached randomly to solvent-accessible sites along the polypeptide chains, the conjugates of the invention have increased receptor-binding activity and increased potency.

The mantra of the anti-patent community is nearly in unison on the issue of patented drugs. Of course, everyone wants drugs to be developed, but no one wants to pay the exorbitant prices charged for blockbuster, patented drugs. You can add me to that list of individuals who doesn’t like the prices, but at least there is a benefit. Without appropriate financial incentives in place drugs would not be patented, but then again they wouldn’t be developed either. But what is the justification for scarcity and exorbitant prices of old drugs that are off patent?

While success in Phase I is critical, there are substantial hurdles to overcome yet before this vaccine could reach the market. Nevertheless, such a promising cancer vaccine ought to be heralded by everyone, right? Think again! Inovio actually has the audacity to have patents on its ground breaking innovation, which will lead the anti-patent non-thinkers to be more concerned with blowing up the patent system than rooting on Inovio and others as they attempt to eradicate cancer. Absolutely ridiculous if you ask me!

When it comes to solving complex problems, Geoffrey von Maltzahn, MIT graduate student and biomedical engineer, looks to nature for solutions. Finding inspiration in systems that evolution has produced, von Maltzahn is currently helping to tackle one of society’s biggest challenges: improving tumor detection and therapeutic delivery in order to boost the survival rate of cancer patients. Today, the 28-year-old…