Williams

by: Eric

5/14/2009

Very important issue..... EW

Director, University of Florida Genetics Institute

by: Kenneth I. Berns, M.D., Ph.D.

5/14/2009

Patenting of human genes is a bad idea. The argument is made that protection of intellectual property is essential for the development of unique products and that without it biotechnology would be severely hampered.
There is no question that the biotechnology industry has been enhanced tremendously by the Bayh-Dole Act and various interpretations by the U.S. Patent Office. However, there has been consistent concern expressed when the discovery to be patented is a natural component of the human body.
The current process does affect genetic testing, as well as the development of various therapies for the correction of genetic defects. This is the issue of a current law suit by the ACLU and others against Myriad Genetics, which currently must license any genetic test for BRCA 1 and 2 mutations, which essentially deprives patients of choice and undoubtedly drives up the price of health care.
Health care in the U.S. would be enhanced if the ACLU suit prevails.

Partner, Sutherland

by: William L. Warren

5/14/2009

It does seem that the challenges to gene patenting are mounting rapidly. I would note that the ACLU case unexpectedly based its invalidity challenge on claims to unpatentable subject matter (35 USC 101). The Supreme Court recently issued a comprehensive review of what constitutes patentable subject matter in In re Bilski (Oct 2008), with a particular focus on method claims.
The Court cast into doubt the validity of certain diagnostic method claims, but did not at all question the validity of claims to isolated genes themselves, even citing with approval its seminal biotechnology Chakrabarty case. The Supreme Court is very unlikely to open another review of the issue challenged by the ACLU in the present case.
The ACLU might have instead considered challenging the Myriad patents for obviousness. The Court of Appeals for the Federal Circuit has recently taken a much stronger obviousness position against gene patents in In re Kubin (April 2009).

Patent Attorney and Attorney at Law

by: Gerry J. Elman, J.D.

5/15/2009

A casual reader of the complaint might be misled into thinking that the suit is against just the company, Myriad Genetics, which is defined in paragraph 28 as “Myriad.” Reading the sad descriptions of the women suffering from breast cancer who haven’t been able to get state-of-the-art gene tests, one might surmise that singlehandedly the company is callously preventing these women from getting needed healthcare. But a closer look at the complaint reveals that the owners of the various patents named in the suit are The University of Utah Research Foundation, as well as the University of Pennsylvania, the U.S. Department of Health, and a couple of Canadian R&D companies. Thus Myriad Genetics is the exclusive licensee of patents resulting from work performed at and owned by a variety of institutions. By a sleight of hand, the lawyers for the plaintiffs have conflated the foundation trustees at the University of Utah with Myriad Genetics, redefining “Myriad” in paragraph 29 as including them as well as the company. And then at paragraph 30, the plaintiffs’ lawyers play a further shell game by identifying Penn, the Department of Health, and the Canadian companies as co-owners of various of the patents but omitting them from the suit, saying that “Myriad, as the exclusive licensee of all of the patents, is fully capable of representing the interests of all of the patent owners.” Curiously, that paragraph 30 uses the term “Myriad” without reconciling the conflict between paragraphs 28 and 29 as to who is who.

The suit also asserts that the U.S. Patent and Trademark Office has acted unconstitutionally in granting the following categories of patent claims: for natural human genes, for natural human genes with natural mutations, for any method, including nonpatented methods, of looking for mutations in natural human genes.

Last but not least, the suit asserts that patent claims “over the thought that two genes are different or have different effects, including but not limited to the thought that the differences correlate with an increased risk of breast and/or ovarian cancer,” are invalid. This allegation may be an effort to provide the basis for a challenge to this type of claim, which was aborted by the Supreme course in 2006. (see below)

At a time when patent reform bills are pending before Congress (S. 515 and H.R. 1260) it is curious that the plaintiff organizations and their counsel have chosen to assert these arguments in court rather than as testimony before the House and Senate. Perhaps they intend publicity over this suit to reach the ears of Congress as well as the courts and the Administration.

However, litigation over the validity of a patent claim to correlating elevated homocysteine levels with certain Vitamin B deficiencies was taken to the Supreme Court and then dismissed in June 2006 as raising the issue prematurely. But three Justices dissented from that ruling, saying they would have invalidated the pertinent claims. This aspect of the present case seems to be directed to a similar issue, which may now be ripe for determination.

The Court of Appeals for the Federal Circuit (CAFC) decided In re Bilski last year, holding that a patent claim to a “method” isn’t valid unless it is "tied to a particular machine or apparatus" or "transforms a particular article into a different state or thing." More recently, in Classen Immunotherapeutics, Inc. v. Biogen Idec, the CAFC, citing In re Bilski, affirmed a district court decision invalidating the claims in Classen's patent reciting:
1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

biotech employee

by: MFM (prefer to remain anonymous)

5/15/2009

as a woman, I am very distressed by Myriad's policies. As an staff member of a biotechnology company and former paralegal, i fully appreciate the value of intellectual property. Surely there must be a compromise that can be reached; if not, this suit has the potential to thwart new industrial initiatives. On the other hand,Myriad's position compromises women's health.

Science is now business

by: Concerned Citizen

10/1/2009

As a graduate student at the University of Utah, I am sad to realize that science has been lost to to a form of corporate business. Is it absurd to think that patents on nature is just another way for corporations to make more money? What's next patents on the air we breath? I am astonished that the courts can debate on the patentability of nature. It's one thing to patent a companies inventiveness (as in a product that works on nature) and another to claim a patent on something that always existed (but perhaps wasn't fully understood). Those companies didn't create or invent the genes in question. They merely came to understand their importance in the human genome. I would hope that the art of science and all of its mysteries and awesomeness hasn't been lost to corporate usury and greed.