Patenting Natural Compounds

Patenting Natural Compounds

Effect of Association for Molecular Pathology v. Myriad Genetics, Inc. Supreme Court Ruling on Gene Patents

The U.S. Supreme Court’s June 13, 2013 ruling in Association for Molecular Pathology v. Myriad Genetics, Inc.[1] (“Myriad”) — that naturally occurring DNA sequences are not patentable — may have serious, and perhaps unintended, consequences on issued patents, pending patent applications and future biotechnology inventions.  In Myriad, the unanimous Court ruled that DNA sequences found in nature, such as isolated genomic DNA, are not patentable subject matter under Section 101 of the Patent Act, as codified in 35 U.S.C. §101 (“Section 101”). 

Until Myriad, the United States Patent and Trademark Office (USPTO) Utility Examination Guidelines allowed that “[a]n isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent … .”[2]  Under this policy, by the end of 2010 the USPTO had granted over fifteen thousand patents containing claims to isolated nucleic acids with naturally occurring sequences, with an estimated excess of eight thousand such patents still in effect as of May 2013.[3]  These patents cover nucleic acids relevant to many fields, including medicine, agriculture, energy and food and beverage manufacturing.  After Myriad, claims to nucleic acids with naturally occurring sequences are now at risk of invalidation.  Of equal concern is that, immediately following Myriad, Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld directed the Patent Examining Corps to “reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101,”[4] thereby putting potentially hundreds of pending patent application claims in jeopardy of rejection.

Concerns have also been raised as to the scope of the Myriad holding.  According to Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), the Myriad decision could “create business uncertainty for a broader range of biotechnology inventions.”[5]   For example, Myriad leaves unanswered the questions of whether isolated non-nucleic acid natural compounds are patentable and, if so, under what conditions?

Whether Myriad is narrowly applied only to nucleic acids or broadly interpreted to apply to all naturally occurring biomolecules is an unresolved question with significant implications for biotechnology innovation. [6]  The Myriad Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”[7]  Although Myriad did not address naturally occurring compounds other than DNA, its emphasis on the non-patentability of isolated naturally occurring compounds raises concerns that it could be applied to invalidate claims to isolated naturally occurring small compounds, proteins, polypeptide sequences, antibodies, lipids, steroids and other naturally occurring biomolecules.  Indeed, the words “natural” or “naturally” appear 34 times in the opinion and words with the root “isolate” appear 34 times.

Between 1981 and 2010, 19% of new chemical entities (NCEs) approved by the FDA were isolated and purified natural products or biotechnologically produced peptides or proteins, some of which may be identical to natural compounds.^[8]  Thus, application of Myriad to isolated naturally occurring compounds other than DNA could potentially affect the patentability of therapeutic agents that are widely used in medicine, in addition to compounds used in other fields.  On the other hand, Myriad does not exclude the possibility that an isolated natural compound may be patentable if it is shown to be “new and useful” and not merely a natural phenomenon.  Under Section 101 of the Patent Act, “[w]hoever invents or discovers any new and useful … composition of matter, or any new and useful improvement thereof, may obtain a patent therefor … .”[9]  Nonetheless, as the Myriad Court reiterated, laws of nature, natural phenomena, and abstract ideas are long-held exceptions to patentable subject matter – exceptions that are “not without limits” and, in determining whether subject matter is patentable, a balance must be struck between incentivizing invention versus removing the basic tools of scientific invention, such as natural phenomena, from the public domain.[10]

Applying these principles, the Myriad Court found that Myriad’s discovery of the location and sequence of the BRCA1and BRCA2 genes “fell squarely within the law of nature exception.”[11]  Moreover, the Court found that “separating [a] gene from its surrounding genetic material is not an act of invention.”[12]  As the Court explained, Myriad’s claims were “focus[ed] on the genetic information encoded in the … genes”[13] and did not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”[14]  Thus, applying this reasoning, the Court held that Myriad’s claims to “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”[15]

Assuming that Myriad is applicable to isolated naturally occurring compounds other than DNA, Myriad can still be interpreted to mean that such compounds are patent eligible if the inventors reveal some characteristic distinguishing them from their natural counterparts, thereby demonstrating a “new and useful … composition of matter.”[16]  Indeed, the Myriad Court acknowledged that the process of isolation of a segment of genomic DNA creates a nucleic acid compound chemically distinct from the naturally occurring gene.  However, the Court found that this structural difference was not adequate to confer any “new and useful” property on the isolated nucleic acid sequence.  That is, both the isolated and natural DNA sequence bear the same informational properties and Myriad failed to demonstrate any additional properties beyond that which were “useful.”

The patentability of isolated natural compounds having “new and useful” characteristics is consistent with prior jurisprudence.  In a Federal court decision from 1911, Parke-Davis & Co. v. H.K. Mulford Co.[17], Judge Learned Hand explained that purified adrenaline “became for every practical purpose a new thing commercially and therapeutically,” because the purified adrenaline had properties distinct from the compound in situ.  Later courts similarly found patentable purified naturally occurring compounds.^[18]  These compounds were determined to be patentable even though the claimed products were isolated from nature because the isolated and purified compounds possessed some property that provided a therapeutic advantage compared to the natural compounds.  That is, isolation alone did not render the claimed product patentable; the fact that it had some “new and useful” property compared to the naturally occurring compound made it patentable.

Whether Myriad will be applied broadly to isolated naturally occurring compounds other than DNA, and what constitutes a sufficient “new and useful” property to render an isolated naturally occurring compound patentable, will remain unclear until courts apply Myriad in future litigations.  Until then, the uncertainty currently surrounding what constitutes a patentable invention, in the wake of Myriad, may have the unintended consequence of dampening innovation and stifling discovery of new medicines.