The Supreme Court's Decision in Myriad – a Sea Change for U.S. Biotechnology Patents

On June 13, 2013, the Supreme Court rendered its unanimous decision in the long and storied Myriad case (569 U.S. ____ (2013)). The Myriad decision greatly impacts biotechnology in the U.S. and adds to the difficulties putative inventors now face due to 35 U.S.C. § 101.

The Decision

Underlying the Myriad case is Myriad Genetics, Inc.'s discovery of the precise location and sequences of what are now known as the BRCA1 and BRCA2 genes. Individuals with mutations in these genes have an increased risk of developing breast and ovarian cancer.

All of the nine Myriad claims at issue include the preamble "[a]n isolated DNA." See Claims 1, 2, 5, 6 and 7 of U.S. Patent No. 5,747,282; Claim 1 of U.S. Patent No. 5,693,473; and Claims 1, 6 and 7 of U.S. Patent No. 5,837,492. Claim 1 of U.S. Patent No. 5,747,282 is an exemplar: "An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2."

The Supreme Court sought to resolve "whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U.S.C. § 101 by virtue of its isolation from the rest of the human genome" and held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."

Practical Implications of the Myriad Decision

Claims that can be read to encompass a naturally occurring DNA, but for the isolation of a recited sequence, may be held unpatentable. Claims directed to nucleic acid molecules that are not naturally occurring, e.g., cDNA, are likely to remain patentable. Applicants will need to adjust their prosecution strategies accordingly. Owners of patents containing claims that are potentially impacted by the decision should consider the validity of those claims before enforcing a patent and may wish to consider whether a reissue application could improve their position.

Summary of the Court's Rationale

Justice Thomas noted that 35 U.S.C. § 101 has long been held to contain an important implicit exception: Laws of nature, natural phenomena and abstract ideas are not patentable. "It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. . . . Myriad did not create anything." The Court found that the subject matter of Myriad's claims falls "squarely within the law of nature exception" and is not patent eligible. The Court noted that "extensive effort alone is insufficient to satisfy the demands of § 101."

The Supreme Court also addressed "the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins." The Supreme Court held that "cDNA is patent eligible because it is not naturally occurring." The Supreme Court noted that "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived" and, thus, is not a product of nature.

The Supreme Court noted that no method claims were before the Court and that the case did not involve applications of knowledge about the BRCA1 and BRCA2 genes. The Supreme Court made clear that they were not considering the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. "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."

The PTO's Response

The Deputy Commissioner for Patent Examination Policy issued a memorandum to the Patent Examining Corps on June 13, 2013, regarding the Myriad case. The memorandum states that "Myriad significantly changes the Office's examination policy regarding nucleic acid-related technology. . . . As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now 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. Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible." Andrew H. Hirshfeld Memorandum dated June 13, 2013 (emphasis original).

The memorandum concludes by indicating that the PTO is closely reviewing the Myriad decision and will issue "more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations."

Considerations for Patentees and Applicants after the Myriad Decision

The exact impact of the Myriad decision will unfold in the courts for years to come and may be shaped by activity of Congress. In the interim, consideration should be given to both prosecution and enforcement activities.

Prosecution

While the Myriad decision offers some comfort regarding the patent eligibility of cDNA claims, be aware that the Supreme Court noted cDNA is generally patent-eligible "except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA." When drafting, consider distinctions from natural DNA.

While the Myriad decision explicitly notes that "there [were] no method claims before this Court," the PTO's memorandum states that "[o]ther claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under existing guidance in MPEP 2016."

The Myriad decision also makes overt that "this case [did] not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . . [and many] of [Myriad's] unchallenged claims are limited to such applications." When drafting, consider ways in which to highlight the application of genetic information.

As for mutations, deletions, additions and substitutions, the Myriad decision also makes overt that "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered" was not considered and "presents a different inquiry." Thus, it may prove worth the effort and expense to determine how many and what type of alterations may be made without sacrificing function and claims can be directed to the altered form(s).

As for a possible emphasis on chemical composition claims, the Myriad decision comments 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 results from the isolation of a particular section of DNA." The decision also notes that Myriad's claims are concerned with information contained in the genetic sequence and "not with the specific chemical composition of a particular molecule." This may signal an invitation to capture what would have traditionally been a sequence-based claim as a chemical composition claim – one that highlights chemical changes that have occurred.

Protein claims, including antibody claims, need to be considered carefully. If the claims are directed to proteins or antibodies as they exist in nature, one should consider alternative claims.

Like protein claims, claims directed to a host cell, vector or plasmid should be considered carefully. However, included within Myriad's unchallenged claims are host cell, vector, expression system, primer and kit claims.

Implications for Litigation and Business Value

A quick search of issued U.S. patents on the PTO website revealed 2,849 issued U.S. patents with the phrase "isolated DNA" and 6,749 issued U.S. patents with the phrase "isolated nucleic acid" contained in at least one claim. If you own patents containing claims directed to "isolated" DNA sequences that would read on a natural sequence but for the isolation, you should realize you need not do anything. The existence in a patent of a claim that is not valid does not affect the validity of the other claims and you need not actively disclaim the claim. However, you should consider the validity of any claims in light of the Myriad decision before asserting a potentially impacted claim.

If you assessed business opportunities based upon the assumption that isolated DNA claims are patent eligible, you should revisit those assessments. As a former potential infringer, you may now have more room to operate. As a former potential plaintiff in an infringement action, you may now have lost some claims.

Reissue Applications

For those who own patents containing claims that recite "isolated DNA," thought should be given as to whether one or more reissue applications should be filed. Depending on the nature of the case, it may be possible to rephrase "isolated DNA" language into language not hindered by the Myriad decision. Recall that a narrowing reissue may be filed at any time during the life of the patent, but a broadening reissue may only be filed within two years after issuance of the patent. In many cases, a reissue application to correct claims in light of the Myriad decision may be filed without broadening the claims.

Stay Tuned

Taking the Myriad case into account, Buchanan's full-service IP team of prosecutors, litigators, and interference and post-grant specialists, with the input of its in-house FDA group, can assist you in obtaining, enforcing and challenging U.S. patents.