IP Update, Vol. 11, No. 3 (24 June 2013)

Editors: Marc S. Weiner, Esq. and Nicholas P. Godici

The Sky Is Not Falling - Even Post-Myriad, a Myriad of Biotech Claims are Still Patentable

"Rumors of my demise have been greatly exaggerated."  Mark Twain.

Similarly, while the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics on June 13, 2013 will have consequences and will alter patent practice, the decision should not lead to a conclusion of great damage or death to the U.S. biotech industry. Many types of subject matter are still patentable and the negative consequences should not be as far reaching as some have predicted. The Court's opinion rather narrowly concluded that unmodified naturally existing gDNA sequences are not patent eligible, but non-naturally existing sequences (such as cDNA), and modified sequences (if the claims recite the modification) are still patent eligible.

The Supreme Court Decision

The unanimous holding of the Supreme Court marks a significant change in the common practice and application of the Statute, 35 USC §101. For some time patent claims have been granted to polypeptide and polynucleotide sequences reciting the same sequence as present in nature, but with the simple recitation that the sequences are "isolated." The mere recitation of the term "isolated" has been considered sufficient by the USPTO and by the Federal Circuit to distinguish those sequences from the naturally occurring products, making the claims patent eligible under 35 USC §101. The Supreme Court has now determined that simply reciting the term "isolated" in a claim is not sufficient to make the subject matter patent eligible under §101. But the decision should be considered to be somewhat narrow. The Court succinctly stated in the last substantive statement of Justice Thomas' opinion: 

"We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."  (Slip Op. at 18)

Although Myriad had urged that the "isolated DNA" claims should be patent eligible because the methods for isolating DNA from the human gene cause changes in the chemical bonds to create a molecule not found in nature, the Court found that "Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA."  (Slip Op. at 14)

In reaching its conclusion, the Court reviewed the two most relevant prior Supreme Court decisions, namely Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). The Court found that Myriad's claims to mere "isolated" naturally occurring DNA were more similar to the claims found invalid in Funk Brothers.  The Court noted that in Chakrabarty the patent claims were directed to bacteria that had been modified by the insertion of four plasmids, so the modified bacterium were not naturally occurring and had "markedly different characteristics from any found in nature." 447 U.S. at 310. Funk Brothers, on the other hand, related to patent claims to a mere mixture of naturally occurring strains of bacteria. There the Court found the claimed composition to not be patent eligible because the patent holder did not alter the bacteria in any way. Referring to the claims found invalid in Funk Brothers, and comparing them to the Myriad claims, Justice Thomas noted that "His (the Funk Brothers applicant) patent claim thus fell squarely within the law of nature exception. So do Myriad's." (Slip Op. at 13) 

Thus, in the context of the claims of nucleotide sequences, the Supreme Court has now drawn a clear distinction between naturally existing DNA sequences (i.e. gDNA) as compared to cDNA. While the Court found that gDNA sequences are not patent eligible simply because they have been "isolated from the surrounding genetic material", the Court specifically found that "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments".  (Slip Op. at 16) The Court recognized that cDNA sequences are the result of removing the non-coding regions (introns), are thereby represent "an exons-only molecule that is not naturally occurring."  (Slip Op. at 16)

The Court's decision, therefore, is a relatively narrow one, although with consequences to a large number of patent claims.  The decision simply holds that "genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material." But many other types of sequence claims can be drafted that define the sequences with more than simply the term "isolated", and those claims should still be patent eligible, even under the Myriad reasoning.

Please see the memorandum from the USPTO regarding the decision.

Summary provided by Leonard R. Svensson.