Tuesday, January 27, 2009

Amicus Briefs Filed in Prometheus v. Mayo, an Important Case for Biotechnology and the Future of Personalized Medicine

I have explained in several previous posts (on this blog and on Patently-O) why Prometheus v. Mayo is an important case for biotechnology, with particularly important implications for future innovation in diagnostics and personalized medicine. In Prometheus, the district court invalidated personalized medicine claims under 35 USC 101as patent-ineligible, based on its finding that a correlation between the level of non-naturally occurring drug breakdown products in a patient's body and the optimal drug dosage is an unpatentable “natural phenomenon.” In my view, the district court erred in characterizing a non-naturally drug breakdown product, and the interaction of those breakdown products with the human body, as natural phenomena. If not corrected, this erroneous interpretation of Section 101 could have a profound detrimental impact on patenting and innovation in the life sciences, particular with respect to new technologies relating to preventive and personalized medicine. A copy of Prometheus’s appellant brief is provided here.

Last week, I filed an amicus brief in Prometheus on behalf of myself and several other concerned patent law professors (Law Profs Brief). The brief supports neither party, and ventures no opinion on the ultimate patentability of the claims, but does argue that the rationale set forth by the district court for invalidating the Prometheus claims is incorrect and potentially harmful. It also argues that Bilski has not rendered moot the distinction between natural and non-natural phenomena, and that Bilski’s machine-transformation test will likely prove insufficient and appropriate for many patent claims arising out of the life sciences. It also points out the potential for unintended consequences and uncertainty with respect to a host of claims relating to biotech and pharma, and particularly with respect to the burgeoning field of personalized medicine. It also distinguishes the claims at issue from the oft-discussed claim 13 from LabCorp v. Metabolite, which relates to a correlation involving naturally occurring metabolites as opposed to non-naturally occurring drug breakdown products. Law Profs ask the Federal Circuit to reverse the district court on its determination that the correlation between the level of drug breakdown products in the human body and the optimal dosage of the drug is an unpatentable “natural phenomenon.”

The Biotechnology Industry Organization (BIO Brief) has also filed a brief supporting neither party, but like Law Profs arguing that the district court erred in its application of section 101 to invalidate Prometheus claims.

The American Intellectual Property Law Association (AIPLA Brief) has filed a brief in support of Prometheus, likewise arguing for a reversal of the district court’s judgment that the claims are invalid under Section 101.

I understand that Myriad also filed a brief in support of Prometheus, but I have only seen a draft and cannot definitely confirm that it was filed. As a leading diagnostics company, Myriad obviously has a major stake in the outcome of this case. The draft I saw argued that patents on the inventions claimed in Prometheus and LabCorp are critical for ensuring innovation in diagnostics and personalized medicine.

Law Profs, BIO and AIPLA all join with Prometheus in arguing that the district court erred in characterizing this correlation between a non-naturally occurring drug breakdown product and optimal drug dosage as a natural phenomenon. They also all make the point that if not reversed, the district court's misapplication of Section 101 could have profound unintended negative consequences on future innovation and biotechnology, with particular emphasis placed on the effect on personalized medicine. Law Profs and BIO argue that the Bilski machine-transformation test is not well-suited for determining patent eligibility for inventions arising in the life sciences. BIO and AIPLA argue that in any event, the Prometheus claims satisfy both the machine and transformation prongs of the Bilski test. They also fault the district court for improperly focusing on individual claim elements, rather than the patentability of the claim as a whole, and note the potential for abuse if courts disregard claim limitations as mere “insubstantial post-solution activity.”

8 comments:

canadian52 said...

Great article! Care to share it and any other content on a communal biotechnology blog? The Canadian BioTechnologist 2.0 Blog is a communal effort devoted to the productivity of the Canadian Biotechnology sector and the fine people who take part in this profession. We are inviting bench scientists and technologists to contribute content: posters, tools, research, presentations, articles, white papers, multimedia, music downloads and entertainment, conference announcements, videos etc. Additionally, we are interested in publicizing the work of your organization. Generally, we are looking for 250 - 500 word articles.
Please feel free to visit the blog.
http://cbt20.wordpress.com/

Anna Schafer said...

If not corrected, this erroneous interpretation of Section 101 could have a profound detrimental impact on patenting and innovation in the life sciences, particular with respect to new technologies relating to preventive and personalized medicine. buy waklert

Amanda1245 said...

This increases the patience level of your mind. Waklert has the consequences of cerebrum concoction.(Buy Cheap Waklert)

Rx Meds onDemand said...

If you are looking for an option where you can buy Medicine online cod at the best price, You can compare the prices of the different brands of medicine and then buy one with the lowest price. Your search for medicines cheap price ends with our online pharmacy. Online Pharmacy has online medicine for sale.
buy artvigil 150mg online cod,
Buy Modafinil 200mg Online without prescription,
buy tapentadol 100mg online overnight,
buy tramadol 100mg online overnight

Unknown said...

Whether it’s a mature wife or a woman, you can be sure of one thing. They will love truly with the expectation of being loved back. Hope the above tips help you to win your mature gal’s heart. Relationship with Mature Women
and
As you can see, this process is so simple with just a few clicks. Just try them out and type this all-time emoji within 2 seconds! Hopefully, you follow the steps to add the Emoji in your various system like Mobile Phone and PC and enjoy texting with emoji. Memoji Apps to Make Your Own Memoji

That’s all folks! To date, these are some of the worst anime girlfriends that you will wish that you never see in real life. Worst Anime Girlfriends

Unknown said...

Great Post.
provigil Online 

zendavid said...


If you are suffering from severe insomnia and are looking for a medicine to re-establish your normal sleep cycle then you can buy waklert 150mg online with Cash On Arrival and get it delivered at your doorstep.

henryjohn said...

A popular drug among cognitive enhancers is called Artvigil. It can be used as a replacement for Modafinil, another cognitive enhancer. Sleep Apnea With Obstruction & Narcolepsy Buy Top Sleeping Pills From Top Online Pharmacy. Buy artvigil 150mg online to treat sleep problems. Delivered overnight to your doorstep, Cas On Delivery.