Categories: 101 Date: Dec 27, 2014 Title: In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit.: Couterpart Claims of those In Myriad Also Invalidated under 101.
|Title||In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit., No. 2014-1361, -1366 (Fed. Cir. Dec. 17, 2014).|
|[I: Composition of Matter Claims] The four composition of matter claims now on appeal are directed to primers, which are “short, synthetic, single-stranded DNA molecule[s] that bind specifically to . . . intended target nucleotide sequence[s].” J.A. 13. The court held these were likely patent ineligible because they claim so-called products of nature—that is, they claim the same nucleotide sequence as naturally occurring DNA.|
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit., at *5.
|[II: Method Claims] Ambry argues that Mayo is directly on point because the method claims here, as there, simply identify a law of nature (the precise sequence of the BRCA genes, and comparisons of the wild-type BRCA sequences with certain mutations of those gene sequences found in the test subject) and apply conventional techniques. |
Id. at *13.
|[I: Composition of Matter Claims] We do not read the Supreme Court’s opinion in Myriad as conferring patent eligibility on composition of matter claims directed to naturally occurring DNA strands under such circumstances. A DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature. Myriad, 133 S. Ct. at 2116–17 (citing Chakrabarty, 447 U.S. at 309–10). Primers do not have such a different structure and are patent ineligible.|
Id. at *9.
|[II: Method Claims] We need not decide if Mayo is directly on point here because the method claims before us suffer from a separate infirmity: they recite abstract ideas. […] [Furthermore, under the Alice analysis,] [t]he non-patent-ineligible elements of claims 7 and 8 do not add “enough” to make the claims as a whole patent-eligible [because the language only identifies the technique used to compare two gene sequences].|
Id. at *13 and *17 (text added).
|Procedural History||In 2010, Stryker sued Zimmer, alleging that Zimmer’s Pulsavac Plus devices infringed various claims of the ’329, ’807, and ’383 patents. The district court grant- ed partial summary judgment in favor of Stryker, finding infringement of the ’807 and ’383 patents’ asserted claims. The question of whether Zimmer infringed the single asserted claim of the ’329 patent, as well as Zimmer’s invalidity defenses against all of the asserted claims, went to trial. The jury found that the products infringed claim 2 of the ’329 patent and that all the asserted claims were valid. The jury also awarded $70 million in lost profits. It further found that Zimmer had willfully in- fringed all three patents. […] In August 2013, the district court issued an order re- jecting Zimmer’s motions for judgment as a matter of law (“JMOL”) on various issues, affirming the jury’s verdict, awarding trebled damages for willful infringement, find- ing an exceptional case and thus awarding attorneys’ fees to Stryker, and imposing a permanent injunction. The district court subsequently entered final judgment pursu- ant to its order.|
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit. at *3-4.
|Legal Reasoning (DYK, Prost, Clevenger)|
|Relationship with Myriad Case Patents||The Supreme Court has addressed some of the patents at issue here in its June 13, 2013, opinion in Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013) (“Myriad”), as has our court in Association for Molecular Pathology v. United States Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011), vacated, 132 S. Ct. 1794 (2012), and Association for Molecular Pathology v. Myriad, 689 F.3d 1303 (Fed. Cir. 2012), aff’d in part, rev’d in part, 133 S. Ct. 2107 (2013). This case involves claims of those patents not previously considered by the Supreme Court or by this court. |
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit., at *3.
|I. Composition of Matter Claims|
|Representative Claim 16||Claim 16 of the ’282 patent is representative. It is directed to:|
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 par
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit., at *6.
|Same Reasoning as Myriad||The primers before us are not distinguishable from the isolated DNA found patent-ineligible in Myriad and are not similar to the cDNA found to be patent-eligible. Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature.|
Id. at *7.
|Myriad and Isolated Claims||The Court held ineligible the isolated DNA claims, explaining: “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, 133 S. Ct. at 2116. Rather, “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA[ genes].” Id. Even if Myriad made a “[g]roundbreaking, innovative, or even brilliant discov- ery,” id. at 2117, that is not enough. With respect to the isolated DNA, “Myriad did not create anything. To be sure, it found an important and useful gene, but separat- ing that gene from its surrounding genetic material is not an act of invention.” Id. The Court held that “[g]enes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.” Id. at 2120.|
Id. at *7.
|Synthetically Replicated Sequence of Naturally Occurring Sequence Ineligible||Contrary to Myriad’s argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible. Id. at 2117. After all, as the district court in the earlier Myriad case and our opinion in Myriad made clear, isolated DNA is routinely synthetically created. […]|
Id. at *8 (internal citations omitted).
|Separating DNA from Surrounding Material Not Enough||Myriad argues that primers are in fact not naturally occurring because single-stranded DNA cannot be found in the human body. But, as the Supreme Court made clear, “separating [DNA] from its surrounding genetic material is not an act of invention.” Myriad, 133 S. Ct. at 2117. The Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, the same length as the primer claims at issue here, suggesting that even short strands identical to those found in nature are not patent eligible. […]|
Id. at *8.
|II. Method Claims|
|Claim 7, revised to include the language of claim 1, from which it depends, provides:||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[,]|
wherein a germline nucleic acid sequence is com- pared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detect- ing the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit., at *10.
|Claim 8, revised to include the language of claim 1, from which it depends, provides:||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[,]|
wherein a germline nucleic acid sequence is com- pared by amplifying all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids.
Id. at 10-11.
|Alice Analysis: Claims directed to an Abstract Idea||We have already addressed the first paragraphs—the comparison step—in our own 2012 Myriad decision. Claims 7 and 8 at issue here depend from claim 1. Claim 1, which is the first paragraph of claims 7 and 8, is the comparison step.3 In our 2012 decision, we held that claim 1 was patent ineligible because it claimed an abstract mental process of ‘comparing’ and ‘analyzing’ two gene sequences. Myriad, 689 F.3d at 1334. We found:|
[The] claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: one looks at the first position in a first sequence; determines the nucleotide sequence at that first position; looks at the first position in a second sequence; determines the nucleotide sequence at that first position; determines if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alteration; and repeats the process for the next position.
Id. at *14-15.
|Alice Analysis: Claims do Not add Sufficient Structure to Abstract Idea to Meet 101||The non-patent-ineligible elements of claims 7 and 8 do not add “enough” to make the claims as a whole patent-eligible. The district court found, and Myriad does not challenge, that the elements of the second paragraphs of claims 7 and 8 “set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent applications.” J.A. 93 (internal capitalization removed). Moreover, “[a]ny scientist engaged in obtaining the sequence of a gene in a patient sample would rely on these techniques.” J.A. 95. Myriad does not challenge the district court’s finding that “the claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of BRCA1 and BRCA2 sequences in those processes.” Appellants’ Rep. Br. 5 (quoting J.A. 93–94) (alterations omitted).|
Id. at *17.
|The claims on appeal are directed to ineligible subject matter in violation of 35 U.S.C. § 101. Therefore, the district court properly denied Myriad’s motion for prelim- inary injunction. We remand to the district court for an entry of an order consistent with this opinion.|
In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Lit. at *19.