On June 13, 2013, the Supreme Court of the United States unanimously held that isolated, naturally occurring DNAs are not patent eligible, but synthetically produced cDNAs are.[1]  35 U.S.C. § 101 provides that processes, machines, manufactures, and compositions of matter are patent eligible subject matter.  Judicially created exceptions, however, put limits on patent eligibility where patent claims encompass laws of nature, natural phenomena, and abstract ideas.  The Court granted certiorari to consider the sole question of whether human genes are patent eligible under 35 U.S.C § 101.[2]

A. The Facts of Association for Molecular Pathology v. Myriad Genetics, Inc.

This case concerns clinically significant diagnostic methods for detecting genetic mutations in BRCA1 and BRCA2, which are predictive of an increased risk for developing breast and/or ovarian cancer.  Many patients testing positive for such mutations elect surgical removal of their breasts and/or ovaries.

Myriad owns a family of patents that includes claims to isolated DNAs and cDNAs that encode a BRCA1 or a BRCA2 polypeptide sequence.  Medical organizations, doctors, advocacy groups, and patients (collectively, “Petitioners”) filed a declaratory judgment action asserting the invalidity of Myriad’s patents because they claim natural products.  By seeking to invalidate Myriad’s patents, Petitioners hoped to remove them as a barrier to the development of other commercially available laboratory test sites thereby increasing the accessibility and decreasing the price of the test services.

B. The Supreme Court’s Decision

The Court affirmed in part and reversed in part the prior Federal Circuit decision by holding that claims directed to isolated naturally occurring DNAs are not patent eligible because such DNAs fall within the naturally occurring phenomena exception.[3]  But the Court upheld the Federal Circuit decision that claims to cDNAs are patentable eligible.[4]  The judgment acknowledges that the common law exceptions to patent eligibility strike a balance between incentives for innovation and impediments to the public availability of information, especially as it relates to the basic tools of science and technology.

The Court characterized Myriad’s contribution as “uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.”[5]  Referring to Chakrabarty, the Court articulated that the test for patentable subject matter is whether the subject matter of the claim “was new with markedly different characteristics than that found in nature.”[6]  Applying this test, the Court found that a claim to isolated DNA encoding a specific polypeptide is not different than the DNA found in nature; Myriad did not create or alter any of the DNA or any of the genetic information encoded in the BRCA1 and BRCA2 genes.  Although acknowledging that Myriad expended huge research efforts in establishing the role played by the BRCA1 and BRCA2 genes in various forms of cancer, the Court, nonetheless, found that separating the DNA from its surrounding genetic material is not an invention.  The Court recognized that Myriad’s discovery was beneficial and important but maintained that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”[7]

Myriad argued that the isolated DNA from its natural state breaks chemical bonds and changes natural DNA into a non-naturally occurring molecule. The Court was not persuaded.  It reasoned that Myriad neither claimed the subject matter in terms of a chemical composition nor relied on the modified DNA.  The Court speculated that this was because it would be easier for a competitor to design around the claims through insubstantial modification of the claimed sequence.  Recognizing that such a design around would be unacceptable to Myriad, the Court, nevertheless, concluded that the claims center around genetic information expressed in the BRCA1 and BRCA2 genes and “not with a specific chemical composition of a molecule.”

The Court took a different view of cDNA patent eligibility because, in its view, cDNAs do not occur in nature.  The Petitioners countered by arguing that “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician,” thereby making cDNA patent ineligible.”[8]  The Court rejected this argument, concluding that cDNA was not a product of nature because it was new and distinct from the parent DNA even though it retains naturally occurring exons of the parent DNA.  Accordingly, the Court held that cDNA is patent eligible under § 101.  Finally, the Court noted the limits of its decision because the case did not present any issues related to method claims directed to manipulating genes or method of use claims; nor was the Court presented with issues involving patents on altering natural DNA sequence.

C.  Implications of the Supreme Court’s Decision

The impact of the Supreme Court’s decision is best considered in view of holdings in the Court’s Mayo v. Prometheus[9] and the Federal Circuit’s Ass’n Mol. Path. v. U.S.P.T.O.[10] decisions, which, collectively, limit the patent eligibility of diagnostic methods and gene sequences, where claims broadly encompass natural phenomena and products of nature.

A quick search of patents issued by the U.S.P.T.O. identified greater than 5,000 patents that claim “isolated DNA.”  While the Court acknowledged Circuit Judge Moore’s observation[11] that patentees rely on prior court decisions[12] and U.S.P.T.O. guidelines[13] when drafting claims to “isolated DNA,” it was, nonetheless, not influenced by that fact.

Clearly, these decisions will have a widespread impact on the biotechnology industry, especially those companies employing genomics technologies to develop predictive methodologies for the safety and efficacy of therapeutic compounds.  Moreover, these decisions leave uncertain whether other biomolecules, such as proteins and antibodies that share structural identity with in vivo molecules, are, like genes, also patent ineligible.  It would be prudent, therefore, to expect that claims covering any biomolecule as it appears in nature, regardless of whether it was isolated, are likely invalid as directed to ineligible subject matter.[14]

Viewed collectively, however, the court decisions do provide substantial clarity about what subject matter is and is not patent eligible.  These decisions should be carefully considered when preparing patent specifications and drafting claims that recite nucleic acids, including cDNAs, genomic DNAs, synthetically produced DNAs having non-natural nucleotide sequences, methods for detecting and using nucleic acids, and new applications of knowledge regarding genetic information.  And they are equally relevant, albeit less illuminating, when considering strategies for protecting other biomolecules such as antibodies and other proteins.  

D.  Practice Tips

With these decisions and their implications in mind, we offer the following recommendations for drafting specifications and claims to new biotechnology inventions and for amending claims in issued patents and pending patent applications.

Issued Patents

Portfolios of issued patents should be reviewed for claims that cover laws of nature, natural phenomena, or products of nature.  Where such claims are identified, patentee should consider pursuing a reissue application with claims amended to escape the exceptions to patent eligibility.  Because such claim amendments are typically narrowing amendments, patentee has until the patent expires to file a reissue and is not limited to the two year period in which a broadening reissue must be filed.

When reviewing issued claims, consider claims that recite nucleic acids and ensure that those claims do not “read on” genetic DNA.  Beware of claims using open-ended comprising language to broaden the scope of protection for short polynucleotides and other gene fragments, including primer and probe sequences.  Where supported by the specification, incorporate size limitations and other clarifying amendments to ensure that the claim does not cover a genetic sequence.

Review claims that are directed to methods for detection and amend those claims to recite assay components and methodologies for performing steps of detecting, measuring, observing, and the like.  If the specification disclosure supports assays and systems for using genetic information in methods for detection, draft claims that specifically recite the components of those assays and systems.  A claim to a method for detecting a genetic mutation by comparing one sequence to another is likely not patent eligible, but a claim that recites the steps of amplifying and sequencing a genetic sequence likely is.

Pending Patent Applications

Pending patent applications should also be reviewed for claims directed to patent ineligible subject matter.  Amend those claims as suggested, above, for issued patents.  Also consider alternative claim strategies to broaden the overall scope and range of patent protection including, for example, pursuing claims in a continuing application that are directed to primer and probe sequences that are used in methods for detecting claims and limit the size of those sequences to ensure that the claims do not inadvertently read on a gene sequence. 

Also consider claims to vectors and plasmids that comprise and direct the expression of gene and cDNA sequences and host cells comprising those vectors and plasmids.  If a composition or method claim recites a gene sequence containing one or more naturally-occurring mutations that are associated with a particular disease or phenotype, consider amending those claims, or pursuing separate claims, to recite cDNA sequences that contain those mutations.

And, if those newly drafted claims are not adequately supported by the specification as originally filed, consider incorporating new subject matter into the specification of a pending application and filing as a continuation-in-part or a separate stand-alone application.

Newly Drafted Patent Applications

When preparing new patent applications, draft specifications that clearly describe structural and functional distinctions between the claimed subject matter that might otherwise be regarded as a natural phenomenon or a law or product of nature.  Describe how newly disclosed biomolecules differ from naturally occurring biomolecules and disclose splice variants of naturally occurring DNAs.  In addition to claims to the cDNAs themselves, also disclose and claim vectors for expression of cDNAs and host cells comprising those expression vectors.

In the specification, set out definitions for terms such as “synthetic,” “percent identity,” “complementary,” “conservative substitution,” and “recombinant,” which can be used in claims to distinguish the subject matter over natural products.  When drafting new claims, avoid certain terms, such as “discovered,” “found,” “identified,” “located,” “isolated,” and “purified,” which were specifically called out as potentially problematic by the Court when discussing Myriad’s patent.[15]  Instead, claims should reference cDNA sequences and use terms, such as “created,” “synthetic,” and “derived,” which were adopted by the Court when discussing why a cDNA is patent eligible.[16]  Further, a DNA sequence, if derived from a genomic sequence, must have at least one intervening intron removed.[17]

In addition to composition claims, also remember to disclose and claim commercial embodiments of those compositions and to claim methods of detection, use, and manufacture.  Support those method for detection claims by disclosing methodology for amplification, hybridization, sequencing, and the like that will be, or could be, used in those methods and disclose the sequences of suitable primers and probes used in detection steps.  In addition to claims to the methods themselves, also claim the components used in those methods, such as probes, primers, and kits comprising those probes and primers.  Also consider including claims that are directed to methods for identifying candidate therapeutics based on cell systems that express gene and cDNA sequences.

If a protein or antibody having a native amino acid sequence will become a commercial product, consider how that protein or antibody will be expressed and whether that expression system will confer structural modifications that do not naturally occur in vivo.  Disclose those predicted changes in glycosylation patterns or other post-translational modifications and recite them in composition claims that are directed to those proteins and antibodies.

* * * * *

The recent decisions from the U.S. Supreme Court and Federal Circuit will have a tremendous effect on the protection of biotechnology inventions.  Viewed collectively, those decisions provide substantial insight and guidance on what claims are directed to patent eligible subject matter and what claims are not.  We recommend that you carefully consider those decisions when developing strategies for protecting your valuable inventions to ensure that your patents don’t run afoul of the judicially created exceptions to the patent eligible subject matter recited in 35 U.S.C. § 101.

[1] Ass'n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, 2013 U.S. LEXIS 4540, at *6 (U.S. June 13, 2013).
[2] Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 694 (2012).
[3] Ass'n for Molecular Pathology, 2013 U.S. LEXIS at *6, *22.
[4] Id. at 30.
[5] Id. at 22.
[6] Id. at 23.
[7] Id.
[8] Id. at 30.
[9] Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012).
[10] Ass’n for Molecular Pathology v. U.S.P.T.O., 689 F.3d 1303 (Fed. Cir. 2012). 
[11] Id. at 1343 (Circuit Judge Moore, concurring in part, “Congress has, for centuries, authorized an expansive scope of patentable subject matter.  Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries.  There are now thousands of patents with claims to isolated DNA, and some unknown (but certainly large) number of patents to purified natural products or fragments thereof.  … I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved.
[12] See, e.g., Amgen v. Chugai, 927 F,2d 1200 (Fed. Cir. 1991) (upholding the validity of claims directed to “[a] purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin”) and In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (“[t]he isolation and sequencing of a human gene that encodes a particular domain of a protein” is “a classic biotechnology invention.”).
[13] See, e.g., and U.S.P.T.O. Utility Examination Guidelines, 66 Fed. Reg. 1092 (2001) (“A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature.  Thus, the concern that a person whose body ‘includes’ a patented gene could infringe the patent is misfounded.”)
[14] Id. at 27-28.  “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.”  The Court implies that if claims are directed to a chemical structure and a change in chemical structure from the compound as it exists in nature is relied upon, then those claims might cover eligible subject matter.  The question remains what is meant by “reliance on chemical changes?”  While this statement may be beneficial to certain biomolecules that depend heavily upon their chemical structure, this strategy is limited when applied to DNA sequences in view of the Court’s following statement: “If the patent depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ‘282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair.”  
[15] “Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.”  Id. at 27.
[16] “That may be so, but the lab technician unquestionably creates something new when cDNA is made, but it is distinct from the DNA from it was derived.  As a result cDNA is not a ‘product of nature’ and is patent eligible under §101 . . . .” Id. at 30.
[17] “As a result cDNA is not a ‘product of nature’ and is patent eligible under §101, except insofar as very short series of DNA may have not intervening introns to review when creating cDNA.  In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”  Id. at 17.  “As already explained, creation of cDNA sequence from mRNA result in an exons-only molecule that is not naturally occurring.  Id. at 30.