Advertisement

July 25, 2014

Batting Practice with DNA Patents at the U.S. Supreme Court

The Supreme Court heard oral arguments on April 15, 2013 in Association of Molecular Pathology vs. Myriad Genetics (Docket 12-398) regarding the patent eligibility of isolated DNA sequences. More specifically, they probed both parties in search of the line demarcating the patent eligibility of recombinant DNA (rDNA), complementary DNA (cDNA) and isolated DNA sequences. The Supreme Court's decision in this case could impact not just the patentability of DNA sequences but also that of any composition derived from a naturally occurring product.

The Justices were concerned about the effect of broad patents on the DNA sequences and their possible preemptive effect. Justice Kagan questioned the patentability of an isolated DNA sequence, and whether one could have patented an isolated chromosome under the current "patent happy" United States Patent and Trademark Office. Several Justices sought to understand the extent of human manipulation required to make a product found in nature patent eligible. An oft-used analogy was a bat that does not exist in nature but is derived from a natural product – a tree. They sought to understand the point at which a composition of matter stops being a "product of nature" and becomes a product of human manipulation.

But the Justices' unease with the patent-eligibility of isolated DNA sequences appeared to be tempered by the understanding that making any DNA sequence patent-ineligible could have chilling effects on biotechnological innovations. Early in the arguments, Justices Kagan, Kennedy and Scalia pointedly asked about the incentives for a company, like Myriad, to spend millions of dollars to develop a product that lacked patent protection. They also sought to understand the difference in value of patents directed to isolated DNA sequences and those directed to cDNA. Moreover, they inquired whether there would be sufficient value in process and use patents if even cDNAs are held patent-ineligible. Justice Sotomayor observed that isolation of DNA sequences may not have value until applied to a particular use.

Stepping beyond the questions regarding patent law, scientific questions were raised about the distinctions among recombinant DNA, cDNA and isolated DNA. The Justices struggled with appropriate analogies: a baseball bat carved out of a limb, chocolate chip cookies, isolating compounds extracted from a plant in the Amazon forest, and removing a plant from the forest. A bat does not exist in nature but is a product of human manipulation of a natural product. Using this analogy, the Justices were questioning the nature of cDNA – whether creating cDNA was just snipping off the branches of the tree or just fashioning a bat from the branch. Justice Sotomayor, who started off asking the most scientific questions, drew a very simplistic analogy using a chocolate chip cookie made of natural ingredients like salt and flour. She questioned whether cDNA sequence was akin to the salt and flour or to the chocolate chip cookie.

Some Justices appeared receptive to the Solicitor General's position that patent-eligibility should start with cDNA sequences and not isolated DNA sequences. Justice Breyer noted that cDNA does not exist in nature, and does not contain uracil nor introns. If he were to take a super microscope, Justice Breyer noted, the cDNA sequence would look different from anything found in nature and have a different function. The Justices then probed the amount of manipulation necessary to make a product found in nature patent eligible.

As Justice Breyer indicated, patent law is filled with uneasy compromises. Although the Justices appeared uneasy about the patent eligibility of isolated DNA sequences, they recognized that cDNA is a result of human manipulation bringing it closer to patent eligibility. The Justices' concern regarding the effects of their decision on investments in biotechnology will likely temper any changes to the patent eligibility requirement they may make with their decision in this case.

These are simply impressions from the batting practice at the Supreme Court. Let's see what happens when the Justices step up to the plate and deliver their decision at the end of this term.

Heather M. Khassian, registered patent attorney w/ Bracewell & Giuliani law firm
Associate

Heather Khassian is a registered patent attorney who counsels and represents clients in intellectual property matters, including patent prosecution, patent drafting, agreements, opinion work, patent strategy, and IP litigation. She is experienced in a broad range of technologies including chemicals, polymers, biotechnology, pharmaceuticals, medical devices, wireless communications, and semiconductors. In addition, Heather has experience with USPTO Interference practice.

Prior to joining Bracewell, Heather was intellectual property counsel for LyondellBasell Industries and...

713-221-1120

Boost: AJAX core statistics

Legal Disclaimer

You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's  Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only. Any legal analysis, legislative updates or other content and links should not be construed as legal or professional advice or a substitute for such advice. No attorney-client or confidential relationship is formed by the transmission of information between you and the National Law Review website or any of the law firms, attorneys or other professionals or organizations who include content on the National Law Review website. If you require legal or professional advice, kindly contact an attorney or other suitable professional advisor.  

Some states have laws and ethical rules regarding solicitation and advertisement practices by attorneys and/or other professionals. The National Law Review is not a law firm nor is www.NatLawReview.com  intended to be  a referral service for attorneys and/or other professionals. The NLR does not wish, nor does it intend, to solicit the business of anyone or to refer anyone to an attorney or other professional.  NLR does not answer legal questions nor will we refer you to an attorney or other professional if you request such information from us. 

Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. Attorney Advertising Notice: Prior results do not guarantee a similar outcome. Statement in compliance with Texas Rules of Professional Conduct. Unless otherwise noted, attorneys are not certified by the Texas Board of Legal Specialization, nor can NLR attest to the accuracy of any notation of Legal Specialization or other Professional Credentials.

The National Law Review - National Law Forum LLC 4700 Gilbert Ave. Suite 47 #230 Western Springs, IL 60558  Telephone  (708) 357-3317 If you would ike to contact us via email please click here.