Patent Docs: Does the Myriad decision presage a golden age of patent-free personalized medicine?

The U.S. Supreme Court's Myriad decision has been almost universally hailed as beinga great victory for patients, doctors, personalized medicine and research.Indeed, several genetic analysis companies announced plans to offer BRCA genetesting. The natural question to ask is: Are all of these "experts" correct?

During oral arguments before the Federal Circuit Court thefirst time the case came before the appellate court, Gregory Castanias,representing Myriad Genetics, argued that the plaintiffs would not be able toperform genetic diagnostics on the BRCA genes because Myriad's patentscontained additional method claims of different scope (other than the claimstargeted by plaintiffs in their lawsuit) that Myriad could assert. For example,Claim 1 of U.S. Patent No. 6,033,857 is illustrative of the invalidated claims:

A method for identifying a mutant BRCA2 nucleotidesequence in a suspected mutant BRCA2 allele, which involves comparing thenucleotide sequence of the suspected mutant BRCA2 allele with the wild-typeBRCA2 nucleotide sequence, wherein a difference between the suspected mutantand the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

Whether Castanias is correct depends on how the court's Mayov. Prometheus and Myriad decisions affect the patent-eligibility of theseremaining claims. This question should be answered in one of two lawsuitsMyriad filed against two of its competitors (Ambry Genetics and Gene by Gene),who announced they were offering BCRA gene testing. Myriad assertedsubstantially the same claims against both defendants, and these claims aredirected both to genetic diagnostic methods and composition of matter claimsfor oligonucleotide primers and probes.

The specific claims Myriad alleges Ambry and Gene by Geneinfringed include claim 6 of U.S. Patent 5,707,999:

A method for detecting a germline alteration in a BRCA1gene, said alteration selected from the group consisting of the alterations setforth in Tables 12A, 14, 18 or 19 in a human, which comprises analyzing asequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing asequence of BRCA1 cDNA made from mRNA from said human sample with the provisionthat said germline alteration is not a deletion of four nucleotidescorresponding to base numbers 4184-4187 of SEQ ID NO:1, wherein a germlinealteration is detected by amplifying all or part of a BRCA1 gene in said sampleusing a set of primers specific for a wild-type BRCA1 gene to produce amplifiedBRCA1 nucleic acids and sequencing the amplified BRCA1 nucleic acids.

The companies also include claim 16 of U.S. Patent No.5,747,282:

A pair of single-stranded DNA primers for determinationof a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, thesequence of said primers being derived from human chromosome 17q, wherein theuse of said primers in a polymerase chain reaction results in the synthesis ofDNA having all or part of the sequence of the BRCA1 gene.

Finally, the companies' allegations also include claims fromMyriad patent Nos. 5,654,155; 5,750,400; 5,753,441; 5,837,492; 6,033,857;6,051,379; 6,951,721; and 7,250,497.

As Myriad states in its complaint, the company "has 24patents and 520 claims, of which only five were invalidated by the SupremeCourt," and it clearly intends to assert these claims.

The method claims asserted by Myriad against Ambry and Geneby Gene differ from the claims invalidated by the U.S. District Court (andaffirmed by the Federal Circuit) in the Myriad case, which recited as limitations merely "comparing" an individual'sBRCA gene sequence with the "normal" one. Myriad is less likely to be estoppedfrom asserting these claims against defendants. Other claims, particularlythose directed to oligonucleotides, are less likely to be successfullyasserted; this is because these claims have other patentability issues, e.g., on novelty grounds, and because the Supreme Court's Myriad decision could be interpreted to make the identityof these sequences with naturally occurring sequences, rather than theirsynthetic nature, the touchstone for patent eligibility.

Whether or not Myriad is successful, it is significant thatMyriad has decided to assert these patents, and its continued ability to do soillustrates one of the generally unappreciated aspects of the Myriad case. The plaintiffs in that case, the American CivilLiberties Union (ACLU) and the Public Patent Foundation (PUBPAT), and theirsupporters chose the claims against which to assert their challenge to thevalidity of Myriad's patents, and those claims did not include the claimsMyriad now asserts. The court's Myriad decision not only does not preclude patent-eligibility for theseclaims, it affirmatively suggests that claims to such applications(particularly when directed to using cDNA) are the type of claims the courtbelieves do not suffer from the deficiencies the court found attached to claimsto "merely" isolated genomic DNA.

In view of these considerations, it should be clear that any"victory" claimed by the ACLU or PUBPAT is of the Pyrrhic variety, and thefemale patient plaintiffs are in no better a position than they were before thecourt's decision.

Kevin Noonanis a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP andrepresents biotechnology and pharmaceutical companies on a myriad of issues. Aformer molecular biologist, he is also the founding author of the Patent Docsweblog, http://patentdocs.typepad.com/.