Association for Molecular Pathology v. United States Patent and Trademark Office: Meet the Plaintiffs

By Jake Meyer

Earlier this week, a lawsuit organized by the American Civil Liberties Union was filed challenging the validity and constitutionality of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad Genetics.  The plaintiffs in this case include: women who wish to have testing for the BRCA1 and BRCA2 genes; researchers who have the capabilities to offer testing for these genes but are unable to because of Myriad's patents on the BRCA1 and BRCA2 genes; medical organizations; and women's health organizations.

The presence of the certain mutations in the BRCA1 or BRCA2 genes is associated with a predisposition to breast or ovarian cancer.  Women who have these mutations are much more likely to develop these cancers and men who have the mutation can pass the mutation to their daughter.  Women who learn they have these mutations will often opt for drastic surgeries, such as a mastectomy or oopherectomy (removal of the ovaries) to avoid a battle with breast or ovarian cancer.  However, Myriad Genetics owns patents that cover both the BRCA1 and BRCA2 gene sequences and mutations of the genes, which grant Myriad a monopoly over the gene sequences (for an example of one of Myriad's patents click here). Myriad is the only company that offers genetic testing for BRCA1 and BRCA2 in the U.S. and therefore women cannot get second opinions before making decisions about major surgery.  Also, since Myriad has a monopoly on testing, it can charge whatever it wishes for the testing – currently the test costs over $3,000.  Many insurance plans don't cover this testing and many people can't afford the out of pocket cost of the test – so testing isn't available to them.  Further, according to a 2006 study, Myriad's test can miss certain mutations that help cause the disease.

The plaintiffs in this case include researchers who would engage in research on and offer testing for BRCA1 and BRCA2 but are unable to because of Myriad's patents.  Dr. Arupa Ganguly, Associate Professor of Genetics at the Hospital of the University of Pennsylvania, received a cease-and-desist letter from Myriad that forced her to abandon her research and clinical practice on breast cancer.  If the BRCA1 and BRCA2 patents were invalidated, researchers would be free to offer testing and engage in further research.  Competition from other researchers and labs offering testing would also make the test more affordable, available for women.  For example, plaintiff Dr. Harry Osterer is the Director of the Molecular Genetics Laboratory of NYU Medical Center, one of the largest academic genetic testing laboratories in the U.S., and the lab has the ability to evaluate BRCA1 and BRCA2 genes using custom-designed tests that may be more cost-effective than Myriad's tests.  With multiple labs offering BRCA1 and BRCA2 testing, women could get second opinions, and the competition among the labs would lower the cost and improve the quality of the testing.

The plaintiffs in this case also include medical organizations and women's health organizations.  The medical organizations are suing on behalf of their members, who include researchers that would engage in medical research and clinical practice on the BRCA1 and BRCA2 genes if the Myriad's patents are found invalid.  For example, the American Society for Clinical Pathology is a not-for-profit entity that represents 130,000 members who work as pathologists and laboratory professionals.  Members of the ASCP design and interpret tests that detect disease, predict outcomes, and determine the proper treatment.  If Myriad's patents are invalidated members of the ASCP would be able engage in research and provide testing for BRCA1 and BRCA2.  Breast Cancer Action is a not-for-profit breast cancer advocacy and educational organization.  Members of Breast Cancer Action have had their BRCA1 and BRCA2 genes analyzed and also provide information to the public about genetic testing.  Breast Cancer Action would be able to provide this information to the public without fear of infringement in Myriad's patents are found invalid.

Comments

[Discount cycling jerseys]

I'm unclear why this patent shouldn't be honored any differently than are other patents.

Pharmaceutical companies don't have their arms twisted to make their patented products available to everyone. When and where there is no honoring of patents, the incentive to be innovative diminishes.

[PHILLIPS26Shirley]

One acknowledges that men's life seems to be high priced, but people need cash for different issues and not every person earns enough money. Thus to receive fast credit loans and term loan will be a correct way out.

[Consignment]

How-do-you-do, just needed you to know I have added your site to my Google bookmarks because of your extraordinary blog layout. But seriously, I think your site has one of the freshest theme I've came across. It really helps make reading your blog a lot easier.

[Generic Risperdal]

Not a lot - after all, Bilski is limited to method claims, and the composition of matter claims should be fine.

As for the method claims, I agree that under the Classen/Bilski line there is cause for concern (coupled with Metabolite), but the entire method of diagnosing type of claim is so questionable right now I wouldn't bet either way.

[Cheap Air Jordan]

*You live on in each new day.

[air jordans]

* be happy together is good enough. I am not asking for things that I could never get.

[essay writing services]

The article is good, it is worth to think about. Comparison with dignity, to dream of bigger and embody - super!

[loan]

A lot of specialists state that credit loans help a lot of people to live their own way, because they are able to feel free to buy needed things. Moreover, some banks present collateral loan for young and old people.

[CitiLoan Mod]

Well written discussion. Happy to find a website with covering an interesting point, and a great writing style as well. Keep on blogging and publishing and I will continue to keep browsing for sites like this.

A patent is a patent. They paid for the research, etc. Why issue any patents, then, if they are not enforceable?

[Merchant Cash Advance]

Interesting article and one which should be more widely known about in my view. Your level of detail is good and the clarity of writing is excellent. I have bookmarked it for you so that others will be able to see what you have to say.

[Merchant Cash Advance]

I recently came across your post and have been reading along. I thought I would leave my first comment. I don't know what to say except that it caught my interest and you've provided informative points. I will visit this blog often.

[essay writing company]

Extremely interesting and useful. When I "Comb thought, " I understand what he taught me, and now I've learned to set goals correctly. Thank you!

[sex and submission]

Very good and interesting article. I hope that you will write something like this every day.

[Proactol]

I have very high rate of metabolism and I am hypoglycemic.. That means I need to eat as often as I could, more meat so It does not get digested easily so I don't get hungry easily too, and furthermore I need a lot of food, and this is the reason I use Proactol.

[Unique Hoodia]

One acknowledges that men's life seems to be high priced, but people need cash for different issues and not every person earns enough money. Thus to receive fast credit loans and term loan will be a correct way out.

[Capsi]

I think it is wrong that they had to halt their research due to this cease and desist. The research they were doing was needed to find the cure to breast cancer.

[Coach outlet]

wow,I like this article. And this topic in general. I remember when I came back to the US after three month in India.
She prefers ooVoo, though, because you can have a whole gaggle of friends in on the experience.

[term papers for sale]

very interesting article! I will follow your themes.
Can I subscribe to your posts on Twitter or on your Facebook profile?

[Triactol]

It is a good post i had searched in many of the blogs but not found like this one anyway cheers to all..

[fabric blinds]

i had searched in many of the blogs but not found like this one anyway cheers to all..

[ps3 jailbreak]

very interesting article! I will follow your themes

[HGH Releasers]

Some time later i found out what made this error appear. When you have a lot of entities and therefore a huge mapping, it can take quite a long time to process your hbm file.

[Celebrex]

Celebrex (celecoxib) belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body. Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis.

[tenis supra]

I recently came across your blog and have been reading along. I thought I would leave my first comment. I don't know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.

[Capsiplex]

Can I just say what a reduction to find somebody who truly knows what theyre speaking about on the internet. You undoubtedly know find out how to carry a problem to mild and make it important.