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Patent Docs: Does the Myriad decision presage a golden age of patent-free personalized medicine?
September 2013
by Kevin Noonan  | 
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The U.S. Supreme Court's Myriad decision has been almost universally hailed as being a great victory for patients, doctors, personalized medicine and research. Indeed, several genetic analysis companies announced plans to offer BRCA gene testing. The natural question to ask is: Are all of these "experts" correct?
 
During oral arguments before the Federal Circuit Court the first time the case came before the appellate court, Gregory Castanias, representing Myriad Genetics, argued that the plaintiffs would not be able to perform genetic diagnostics on the BRCA genes because Myriad's patents contained additional method claims of different scope (other than the claims targeted 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 nucleotide sequence in a suspected mutant BRCA2 allele, which involves comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.  
 
Whether Castanias is correct depends on how the court's Mayo v. Prometheus and Myriad decisions affect the patent-eligibility of these remaining claims. This question should be answered in one of two lawsuits Myriad filed against two of its competitors (Ambry Genetics and Gene by Gene), who announced they were offering BCRA gene testing. Myriad asserted substantially the same claims against both defendants, and these claims are directed both to genetic diagnostic methods and composition of matter claims for oligonucleotide primers and probes.
 
The specific claims Myriad alleges Ambry and Gene by Gene infringed include claim 6 of U.S. Patent 5,707,999:  
 
A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human, which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the provision that said germline alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1, wherein a germline alteration is detected by amplifying all or part of a BRCA1 gene in said sample using a set of primers specific for a wild-type BRCA1 gene to produce amplified BRCA1 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 determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.  
 
Finally, the companies' allegations also include claims from Myriad 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 24 patents and 520 claims, of which only five were invalidated by the Supreme Court," and it clearly intends to assert these claims.
 
 
The method claims asserted by Myriad against Ambry and Gene by Gene differ from the claims invalidated by the U.S. District Court (and affirmed by the Federal Circuit) in the Myriad case, which recited as limitations merely "comparing" an individual's BRCA gene sequence with the "normal" one. Myriad is less likely to be estopped from asserting these claims against defendants. Other claims, particularly those directed to oligonucleotides, are less likely to be successfully asserted; 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 identity of these sequences with naturally occurring sequences, rather than their synthetic nature, the touchstone for patent eligibility.
 
Whether or not Myriad is successful, it is significant that Myriad has decided to assert these patents, and its continued ability to do so illustrates one of the generally unappreciated aspects of the Myriad case. The plaintiffs in that case, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT), and their supporters chose the claims against which to assert their challenge to the validity of Myriad's patents, and those claims did not include the claims Myriad now asserts. The court's Myriad decision not only does not preclude patent-eligibility for these claims, it affirmatively suggests that claims to such applications (particularly when directed to using cDNA) are the type of claims the court believes do not suffer from the deficiencies the court found attached to claims to "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 the female patient plaintiffs are in no better a position than they were before the court's decision. 
 

 
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.

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