Monday, April 15, 2013

Patenting... Real. Comfortable. Genes II ? Judgment Day


Last December, I reported that the U.S. Supreme Court agreed to hear the appeal in ASSOC. FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS, INC. to decide whether isolated human genes are patentable under the U.S. Patent Act (35 U.S.C. § 1 et seq.)   Today, is "judgement day" {well, sort of} as the Supreme Court hears oral arguments on whether isolated human genes are patentable.  The true "judgement day" will come when the Court issues a decision, expected to be by the end of the Court's session in June.  Many have strong opinions either for or against gene patents. In order to have an intelligent, informed debate, it is important to consider why we have a patent system at all.

The Framers of the United States Constitution knew of the importance of technological progress.
The Congress shall have the power...
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. (U.S. Constitution, Article I, § 8, clause 8).
This provides inventors with an incentive to create new products and processes. It also gives companies and investors (e.g. venture capitalists and stockholders), incentive to invest capital looking for a return on their capital investment.

Congress has limited the duration of the monopolistic protection. In return for the protection, the inventor must disclose his or her invention to the Patent Office which, in turn, discloses the information to the general public.

The Patent Act was drafted to accomplishes two goals. First, it encourages innovation and discovery through its incentive of limited monopoly Second, the patent system promotes the disclosure of useful technology to the general public by putting it in the public domain.

Opponents of gene patents say, "Keep your hands off my genes." They argue that human genes are naturally occurring, not the creation of human hands, and thus, not the subject of patents. Therefore, opponents say that genes are in the public domain for all to use. Further, some opponents believe that patenting genes stifle innovation of other researchers who fear lawsuits for patent infringement from the patent owner if they conduct their own research pertaining to the patented gene. In addition, some proponents believe that for public policy reasons and pubic health concerns, physicians should not be prevented from access to the best diagnostics and therapeutic treatments which may include the gene discoveries of another.

Proponents of gene patents assert that biotech and pharmaceutical companies need patent protection for isolated genes. These companies spend millions (or even billions) of dollars to isolate genes and to discover the role that these genes play in disease or in the therapeutic treatment of disease. Absent patent protection, anyone could use the million/billion dollar discovery without having to invest a single dime. Further proponents of patenting genes say that no one would invest in companies if anyone could use their discoveries for free. As a result, biotech companies would cease to develop new diagnostics and therapeutic treatments predicated on isolated gene sequences. Therefore, without the financial incentive of patent protection, new genetic diagnostics and therapeutic treatments will never be made. Without patent protection for gene discoveries, entire industries will be lost and/or negatively impacted. Accordingly, proponents argue that patenting genes accomplishes the two goals of the Patent act, offering both economic development and providing a pathway for new discoveries of disease diagnostics and therapeutic treatments.

© Stephen J. Weyer, Stites & Harbison, PLLC, 2012
Send email feedback- sweyer@stites.com


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