The following guest post was written by Birch, Stewart, Kolasch & Birch Partner Mark J. Nuell, Ph.D.
Myriad Genetics has filed their brief in their appeal of the decision in Assoc. of Med. Pathology et al. v. Myriad Genetics et al. This case is one having effect on patent-eligibility of claims directed to purified natural products and to sequence-based diagnostic methods. Myriad’s brief is a paper of advocacy, and it is persuasive of an asserted lack of jurisdiction. Thus, the Federal Circuit might not even reach the questions of patentability of isolated DNA and of nucleic acid (sequence)-based diagnostic methods. But, should the Federal Circuit choose to consider those questions, it appears that claims to “isolated DNA” meet the standard for patent-eligibility. Despite their arguments to the contrary, some of Myriad’s diagnostic method claims are likely to fail to meet the standard, as falling within the scope of abstract ideas or laws of nature. The other method claims that are challenged, although they can be interpreted to include a “transformative” step and so include a strong clue in favor of patent-eligibility under Bilski v. Kappos, might be deemed ineligible for patent protection because the “transformative” steps represent mere data-gathering steps.
Introduction
On March 29, 2010, in a district court far, far away (from Utah, anyway), Judge Sweet’s decision, by summary judgment, in the Declaratory Judgment action Assoc. of Med. Pathology et al. v. Myriad Genetics et al.[i] upset settled expectations that “isolated DNA” and the like were subject matter eligible for claiming in a U.S. Patent. His decision that diagnostic methods that rely upon comparison of “sequences” of nucleotides to reach a conclusion about the likelihood or prognosis of a disease are also not eligible to be claimed in a U.S. Patent came after a decision (now vacated and remanded) the other way on a similar question presented by Prometheus Laboratories v. Mayo Collaborative Services.[ii]
Plaintiffs had selected only a few claims from among seven different patents[iii], and it is plain that they chose their targeted claims carefully, because the claims that were not challenged did not meet the facts they asserted in support of their position. The Defendants’ claims that were not challenged appear to sufficiently cover their commercialized embodiments of the invention, and so even if Judge Sweet’s decisions are left standing, Defendant Myriad Genetics will be left with enforceable, commercially valuable patent claims.
Nonetheless, Myriad has appealed Judge Sweet’s decisions, and their principle brief in support of their appeal was filed on October 22. Their opening salvo presents three issues for consideration by the Court of Appeals for the Federal Circuit; standing, are composition claims directed to isolated DNA molecules ineligible for patenting under 35 USC § 101 and are diagnostic methods based upon analysis of nucleic acid sequences ineligible for patenting under 35 USC § 101?[iv]
Justiciability
Standing is a threshold issue that must be established for the Court to have jurisdiction. 28 U.S.C. 2201(a) – the Declaratory Judgment Act – provides that the rights and other legal relations of parties to an “actual controvery” may be decided by a Federal Court.[v] Myriad points to Medimmune, Inc. v. Genentech, Inc.[vi] as their articulation of the standard for a justiciable “actual controversy”.
All the circumstances … [must] show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
All of the attorneys in the audience will recall at least one case they read in law school where the judge reached a result that was at odds with the case law on the subject, and the unsurprising lesson that judges sometimes make decisions they feel are right, as in the interests of justice, and then stretch and pull and piece together the rules to justify their opinions. Myriad asserts that is how standing was acknowledged by Judge Sweet.
In essence Myriad asserts that his primary error was to truncate the rule from Medimmune at “controversy”and then this was compounded by his supposition that “all of the circumstances” can include a desire to see a public policy that is at least mildly controversial be considered by the judicial system. Even though it is not likely that the Federal Circuit will support him, this is an at least understandable reason on the part of Judge Sweet to find justiciability.
Myriad then supposes the entire Medimmune rule and points out that Plaintiffs’ evidence of any assertion of their patent claims by Myriad and the University of Utah was at least ten years old. They make the quite persuasive point that, had Myriad actually sued any of the Plaintiffs at the date of filing of the Declaratory Judgment complaint, said Plaintiff would likely have succeeded with a defense of laches, and so Plaintiffs were hardly in a position to assert “sufficient immediacy … to warrant the issuance of a declaratory judgment.”
Myriad also denies the “reality” of the adversity of legal interests of the parties, asserting that none of the parties Plaintiff had ever been communicated with in a manner that could credibly be understood to be a threat of a suit for infringement. In fact, some of the parties Plaintiff had not been communicated with at all. Indeed, Myriad somewhat suggests that Plaintiffs are “reverse trolls”; having no products or services on the market, they nonetheless sue for invalidity of a patent claim.
Any associate charged with writing a “soft” cease-and-desist letter would do well to read these sections of the brief (esp. pp. 20-21).
If Myriad’s characterization of the facts is found correct, then it is quite possible that the Federal Circuit will never reach the more interesting issues.
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[i] Association for Molecular Pathology v. U.S. Patent and Trademark Office, 94 U.S.P.Q.2d (BNA) 1683, ____ F. Supp. 2d ___, 2010 WL 1233416, No. 09 Civ. 4515, (SDNY March 29, 2010).
[ii] Prometheus Laboratories v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009), certiorari granted, judgment vacated and remanded, 130 S.Ct. 3543 (2010).
[iii] The challenged claims are:
| PATENT NO. | LIST OF CLAIMS |
| 5,747,282 | 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. 5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1. 6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2. 7. An isolated DNA selected from the group consisting of: (a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056; (b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385; (c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted. 20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic. |
| 5,837,492 | 1. An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2. 6. An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer. 7. The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1. |
| 5,693,473 | 1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1. |
| 5,709,999 | 1. 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 proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1. |
| 5,710,001 | 1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample. |
| 5,753,441 | 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject. |
| 6,033,857 | 1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises 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. 2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer. |
[iv] Myriad brief, p. 1.
[v] 28 U.S.C. § 2201(a) – In a case of actual controversy within its jurisdiction, except with respect to Federal taxes other than actions brought under section 7428 of the Internal Revenue Code of 1986, a proceeding under section 505 or 1146 of title 11, or in any civil action involving an antidumping or countervailing duty proceeding regarding a class or kind of merchandise of a free trade area country (as defined in section 516A(f)(10) of the Tariff Act of 1930), as determined by the administering authority, any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought. Any such declaration shall have the force and effect of a final judgment or decree and shall be reviewable as such.
[vi] Medimmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007).
Tags: Assoc. of Med. Pathology et al. v. Myriad Genetics et al., Bilski v. Kappos, Declaratory Judgment Act, Federal Circuit, Judge Sweet, justiciability, MedImmune Inc. v. Genentech Inc., Prometheus Laboratories v. Mayo Collaborative Services
Although some gene patent proponents argue that it’s about legal precedent and reliance, I honestly think that this is one of those issues that is largely about one’s politics and policy. Whether or not human genes are legally patentable is a question rather like the “if a tree falls in the forest” hypo. I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones — perhaps because there is no real legal answer. That being the case, although I’d like to read a Supreme Court opinion deciding this issue, perhaps this is really one for Congress to deal with.
http://www.generalpatent.com/media/videos/patent-suits