May 3, 2013
BNA's Life Sciences Law & Industry Report
By L. Scott Burwell; Jessica L.A. Marks
By L. Scott Burwell and Jessica L.A. Marks
On April 15, 2013, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics Inc.1 The question before the Court was "Are human genes patentable?"2 This question encompassed several concepts, and so the case could determine the patent eligibility of any and all types of human genetic material, including isolated DNA and complementary DNA ("cDNA").3
A final decision is expected before the end of the term in June, but there is plenty of speculation as to what the decision might entail. In the interim, this article will review the history of the Myriad case, analyze the briefs submitted by the parties and selected amici, review cases discussed during oral arguments, and consider the arguments made by counsel and the questions raised by the justices during the arguments. This review suggests that the Court likely will hold that cDNA is patent eligible, but the patentability of isolated DNA appears too close to call.
The Association for Molecular Pathology (AMP) first challenged Myriad's patents in a declaratory judgment action brought in the U.S. District Court for the Southern District of New York.4 Myriad's patents generally are directed to DNA sequences denominated "BRCA1" and "BRCA2," which are associated with an increased risk of developing breast cancer. Myriad markets diagnostic tests that determine whether a person possesses either of these DNA sequences.
Even at the district court level, interest in this case was high, and over 30 amici submitted briefs. The judge found that the question of whether Myriad's claims were patent eligible under 35 U.S.C. § 101 was one of law and granted AMP's motion for summary judgment that Myriad's claims were not patent eligible.
The claims at issue included composition claims to the isolated BRCA1 and BRCA2 DNA sequences,5 method claims comparing or analyzing isolated DNA,6 and method claims for screening for potential cancer drugs by monitoring changes in cell growth rates.7 The district court judge found that the composition claims were "directed to isolated DNA containing naturally-occurring sequences [which] fall within the products of nature exception to § 101."8 Similarly, the claims for methods of comparing or analyzing isolated DNA were found not to be patent eligible because the "claims-in-suit are directed only to the abstract mental processes." 9 Finally, the judge characterized "the essence of the [method of screening] claim, when considered in its entirety, is the act of comparing cell growth rates and concluding that 'a slower growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.' "10 The judge went on to state that the claimed process was "the scientific method itself," and the recited transformative steps were "nothing more than preparatory, data-gathering steps" that "do not render the claimed mental process patentable under § 101."11
Myriad then appealed the decision to the U.S. Court of Appeals for the Federal Circuit.12 Judges Alan D. Lourie, William C. Bryson, and Kimberly A. Moore affirmed the district court's decision that the method of comparing claims were directed to patent-ineligible mental processes but reversed its other rulings.
In particular, the Federal Circuit found that the isolated DNA molecules did not exist in nature and, thus, were patentable under 35 U.S.C. § 101. Judge Lourie's opinion explained that the "Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given 'markedly different,' or 'distinctive,' characteristics."13 Because isolated DNA molecules have chemical identities and characteristics markedly different from the molecules found in nature, the Federal Circuit determined they were patent-eligible subject matter.
As for the method of screening claim, although the claim included "the abstract mental step of looking at two numbers and 'comparing' two host cells' growth rates," it also recited " 'growing' transformed cells in the presence or absence of a potential cancer therapeutic, an inherently transformative step involving the manipulation of the cells and their growth medium."14 The Federal Circuit held the claim was narrow enough to cover a patent-eligible process because it was "tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic."15
After the Federal Circuit rendered its decision, AMP petitioned the Supreme Court to hear the case.16 Shortly thereafter, the Supreme Court issued its decision in Mayo v. Prometheus,17 and the Supreme Court vacated the Federal Circuit's ruling and remanded the case to the Federal Circuit for a new decision in light of Mayo.
Back at the Federal Circuit, the parties were ordered to file supplemental briefs directly addressing the Mayo decision.18 In its revised decision,19 the Federal Circuit confirmed each of its previous holdings, finding that (1) the composition claims to isolated DNA were patent eligible, (2) the method of comparing or analyzing the isolated DNA claims were not patent eligible, and (3) the method of screening claim was patent eligible. The Federal Circuit found that Mayo did not affect the analysis of composition claims; the claimed molecules were not natural products and thus were not mere reflections of a law of nature.20 Furthermore, since Mayo was consistent with the Chakrabarty21 and Funk Brothers22 cases, it did not affect the original analysis based on those two precedents.23
AMP filed a second petition for certiorari, which was granted in part in November 2012 for a single question: "Are human genes patentable?"24
At the Supreme Court, only the composition claims to isolated DNA are at issue.25 Claim 1 of Myriad's U.S. Patent No. 5,747,282 (the '282 patent) ("An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID No. 2.") and claim 1 of U.S. Patent No. 5,837,492 (the '492 patent) ("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.") are representative of the claims at issue.26
AMP broadly construes the term "isolated DNA" to include DNA sequences that are at least 60 percent similar to the recited nucleic acid sequence; DNA that creates proteins that are at least 30 percent similar to the recited amino acid sequence; any fragment of the DNA sequence; DNA that encodes fragments of the amino acid sequence; any form of genetic material, including RNA, cDNA, genomic DNA, and synthetic DNA; DNA with intervening or regulatory sequences; and DNA modified by chemical or biochemical modifications.27
AMP's arguments flow from this construction of the claims. It alleges that Myriad's patents cover the BRCA1 and BRCA2 genes in all forms. AMP essentially views the recitation of a specific sequence as superfluous in light of its proposed definition of DNA. For example, even though SEQ ID No. 2 of the '282 patent is labeled as a cDNA sequence, AMP argues that the court does not need to reach the determination of whether cDNA is patentable given AMP's proposed construction and because Myriad did not argue that its claims were restricted to cDNA.28
In construing claim 5 of the '282 patent, which claims an isolated DNA having at least 15 nucleotides of the DNA of claim 1, AMP goes as far as to allege the claims cover practically all human genes because "[f]ifteen (15) nucleotide sequences from the BRCA1 gene can be found in virtually every other gene in the body."
AMP proposes three different ways to determine whether the claims are drawn to unpatentable natural phenomena: (1) does the composition have markedly different characteristics found in nature; (2) is the patent based on an inventive concept; and (3) does the patent preempt the use of the underlying product or law of nature.29 And, under each of these constructs, AMP finds that Myriad's claims are not patent eligible.
For instance, AMP asserts that isolated DNA does not have markedly different characteristics from DNA in the body because both naturally-occurring DNA and isolated DNA code for a naturally-occurring polypeptide and their use is "storing and transmitting information about a person's heredity."30 AMP also asserts that the claims are not based on an inventive concept because the BRCA genes are naturally occurring and the isolation of DNA was a well-known technique at the time the patents were filed.31 Moreover, AMP asserts that under its construction, the claims "cover all isolated forms of the naturally-occurring genes, whether previously identified or not," and preempt "all uses of the genes in DNA, cDNA, or RNA form and all variants and fragments of the genes."32
Finally, AMP takes the novel position that the claims violate the First Amendment. AMP asserts that by granting a patent over an entire body of knowledge and preventing others from obtaining or sharing information about the claimed genes, the government is allowing control over thought and preventing the dissemination of ideas, which AMP contends violates the First Amendment.33
Myriad's brief begins by reframing the question presented in a light more favorable to Myriad's position.34 Turning to the substance of the case, Myriad's arguments also flow from its interpretation of the term "isolated DNA." Myriad asserts that isolated DNA is a molecule separated from the genetic material that normally accompanies it in the body or a synthetically created molecule, including recombinant, cloned, or synthesized DNA.35 In addition to the limitation that the DNA be isolated, Myriad also asserts that the claims are limited to the recited sequences.36 For example, several of the claims are drawn to cDNA molecules due to their recitation of a cDNA sequence.37
Myriad also disagrees with AMP's application of the three ways of determining patent eligibility. In applying the three frameworks in what Myriad alleges is the correct way, Myriad asserts that all three frameworks support patent eligibility for its claims.
Regarding AMP's "markedly different" framework, Myriad states that AMP improperly focuses on the similarities between native DNA and isolated DNA.38 Under Myriad's view of this framework, isolated DNA is different from what is found in nature because the isolated gene is not physically bound to other genes, nucleic acids, or proteins within the chromosome.39 Myriad further notes that isolated DNA also can be used as a " 'probe' for target DNA in a patient sample or to 'prime' the production of copies of the target DNA in the laboratory," whereas "naturally occurring DNA cannot be used as probes or primers, because they are chemically bound up with other matter."40
Under the "inventive concept" framework, Myriad contends that the claims are based on an inventive concept because one of ordinary skill could not have created the claimed molecules when the applications were filed. Myriad argues that the inventors' approach to sequencing the claimed DNA went against conventional wisdom and was considered a mistake by their peers.41
Finally, Myriad takes issue with AMP's application of the "preemption" framework, stating that the heavy-handed way that AMP applied it would wipe out entire swaths of valid patents.42 In fact, Myriad posits that pre-emption is not a legally sound framework because all "patents are by their nature preemptive—they give their owners the right to exclude others."43 Nevertheless, in addressing AMP's preemption allegations, Myriad notes that over 18,000 researchers have studied the BRCA1 and BRCA2 genes, over 8,000 papers have been published on the topic, and over 130 clinical trials have been conducted since Myriad's patents issued.44
Myriad reiterates throughout its brief the 30 years of precedent in applying Section 101 to find isolated DNA molecules are human-made and patent eligible.45 It also provides an extensive argument on why USPTO's Utility Examination Guidelines46 should be given deference by the Court47 and explains why AMP's expansive construction of the claims are too broad.48 For example, Myriad notes that one of skill in the art would understand that the recitation of DNA in the claims is limited to DNA "having the particular 'SEQ IDs' that are claimed."49
The gist of the amicus curiae brief of the United States50 was that cDNA is patent eligible, but isolated DNA is not. It argued that cDNA is patent eligible subject matter because it is synthesized genetic material that does not occur in nature.51 Because cDNA must be synthesized, it "leaves the public free to exploit the underlying natural substances used to create cDNA."52
On the other hand, the United States also argued that isolated DNA, without further modification, was not patent eligible because it was merely an extraction of a naturally-occurring substance.53 It alleged that the structural differences between isolated DNA and naturally-occurring DNA are "simply the consequences of removing DNA from its natural environment."54 The United States' position also was prompted by its fear that claims to isolated DNA would preempt the use of underlying native DNA.55
The European Patent Office56 asserted that isolated DNA and other isolated nucleic acids (including cDNA) were patent eligible. In its four-page brief, it noted that the "approach adopted by the EU directive is that a nucleic acid corresponding to a complete or part of a gene, even if its structure is identical to that of a natural element, may constitute a patentable invention, if isolated from the human body or otherwise technically produced."57 Before the EPO, "genetic material is not seen as a special case requiring [patent-eligibility] treatment different from chemical compounds and other products."58
The American Intellectual Property Law Association (AIPLA), one of the largest intellectual property bar associations in the United States, submitted a brief supporting affirmance of the Federal Circuit's decision.59 AIPLA's brief focused on the question of patent eligibility, not patentability. It agreed that " 'human genes' as they exist in the body are not 'patent eligible,' " but further noted that they are not patentable under other sections of the patent laws. For example, human genes are not novel under 35 U.S.C. § 102.
AIPLA argued that isolated DNA is a functional biological tool comprising man-made, discrete chemical entities that differ markedly from genes in the human body.60 Therefore, isolated DNA (including cDNA) is patent eligible.
Applying traditional claim construction principles to Myriad's claims, AIPLA asserted that the claims do not cover "human genes," but are restricted to isolated DNA with the recited SEQ ID Nos.61 As such, AIPLA concluded that the Federal Circuit properly interpreted the claims and applied the correct analysis to determine that the claims were patent eligible.62
And, returning to its original focus, AIPLA noted that, although Myriad's claims may be patent eligible, that does not mean they are patentable, and it supported keeping the two concepts distinct.63 Furthermore, broad patent eligibility under Section 101 does not preempt, but rather spurs, advances in knowledge because patents are rewards for scientific developments.64
Several decisions have impacted the interpretation of patent eligibility under 35 U.S.C. § 101, but only the Mayo v. Prometheus,65 Funk Brothers v. Kalo Inoculant,66 J.E.M. Ag Supply v. Pioneer,67 and Diamond v. Chakrabarty68 cases were discussed in the oral arguments. Each of these cases is reviewed below.
Mayo v. Prometheus
A little over a year ago, the Supreme Court decided that Prometheus's patents69 for methods of using thiopurine drugs were not patent eligible. The exemplary claim reviewed by the court was directed to optimizing the treatment of autoimmune diseases by (1) administering a thiopurine drug to a subject, (2) determining the level of thiopurine in the subject, and (3) determining whether the subject needs more or less of the drug by comparing the level of thiopurine in the subject to therapeutic levels. Importantly, the claims only required determining the need for more or less of the drug; they did not require any actual administration of the drug to the subject after determining the correct dosage.
The Court found that the third step was merely a natural law stating the relationship between levels of metabolites in a patient and therapeutic efficacy or toxicity. Both parties agreed that the first two steps were known in the art. As such, the Court found that the first two steps did not "transform an unpatentable law of nature into a patent-eligible application of such a law" because they were well-understood, routine, and conventional activities.70 In essence, the Court held that a natural law is unpatentable and adding elements already known in the art cannot change that fact.
Over 60 years ago, the Court addressed claims alleged to cover natural laws in Funk Brothers v. Kalo Inoculant. The claims of Kalo Inoculant's patent71 were directed to compositions of nitrogen-fixing bacteria that did not inhibit each other when combined. The claims did not require, for example, a specific mixture of particular species, as shown in exemplary claim 4:
An inoculant for leguminous plants comprising a plurality of selected mutually noninhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
The Court noted that it was not presented "the question of whether the methods of selecting and testing the noninhibitive strains are patentable." It could only decide whether the product claims were patent eligible. As such, the Court found that the mixture of naturally-occurring bacteria, whose noninhibition qualities "are the work of nature," was not patent eligible. The bacteria performed in their natural way, and their use in combination with each other did not improve their natural functioning. Discovery of the natural principle that some nitrogen-fixing bacteria would not inhibit each other, and formulating them into an inoculant (a well-known product in the art) was not patent eligible.
J.E.M. Ag Supply v. Pioneer
In J.E.M. Ag Supply v. Pioneer, J.E.M. was accused of infringing Pioneer's patents on inbred and hybrid corn seeds by reselling Pioneer's seed in violation of its limited license. J.E.M. tried to argue that Pioneer's corn seeds, as sexually reproducing plants, were not patent-eligible subject matter under 35 U.S.C. § 101. But, based on its decision in Diamond v. Chakrabarty (discussed below), the Supreme Court found that sexually reproducing plants were patent-eligible subject matter under the extremely broad language of Section 101.
The seminal case concerning the patent-eligibility of biological materials is Diamond v. Chakrabarty. The issue in that case was the Patent Office's refusal to issue a patent on Chakrabarty's genetically engineered bacteria because of its policy of refusing patents on living things. The Court, focusing solely on the language of 35 U.S.C. § 101, found that Chakrabarty's man-made micro-organism constituted a "manufacture" or "composition of matter" within the statute. The statute did not explicitly prohibit the patenting of live organisms, and the Court cautioned that limitations and conditions that the Legislature had not expressed should not be read into the patent laws.72 And, since Congress had intended patent-eligible subject matter to "include anything under the sun that is made by man," Chakrabarty's "micro-organism plainly qualifie[d] as patentable subject matter."
Of course, as with the briefs, the justices spent a significant portion of time considering the differences between patent-eligibility specifically and patentability generally.73 Several justices showed an astute grasp of patent law, noting that a decision that genes were patent eligible would not mean that Myriad's claims were necessarily patentable.74 Chief Justice John G. Roberts's statements provide a prime example. During the argument presented by the United States, the Chief Justice noted that "the basic general approach [in patent law is] we have a very expansive view of what is patent eligible and then we narrow things through . . . issues like obviousness and so on."75 He then asked counsel for the United States to explain its positions on patent ineligibility when "it [would] make more sense to address the questions at issue here in the obviousness realm."76 Justice Sonia Sotomayor also showed a nuanced understanding of patent law in interpreting Judge William C. Bryson's dissent with respect to the cDNA claims in the Federal Circuit decision.77 She understood that he felt that cDNA was patent eligible in general, "but that he had a problem with [Myriad's 15-base cDNA claim] because it included 15 nucleotide long segments or fragments which he says reoccur in nature."78 Thus, she understood that Judge Bryson may find cDNA patent eligible, but that Myriad's broadest claims were not patentable because they were obvious.
At times, some of the discussion during oral argument seemed to muddle the two concepts. For example, Myriad was asked if it thought that the first person to isolate a whole chromosome should have gotten a patent on the chromosome.79 Myriad noted that the question was unclear, because one can only get a patent if the subject matter is (1) patent eligible, and (2) novel and nonobvious.80 After prompting by Myriad, the question was narrowed to patent eligibility by asking whether the first person to isolate a chromosome "could [] have gone to the PTO."81
Nevertheless, the Court seemed to have a better grasp on patent law than many of those submitting briefs. For example, Justice Stephen G. Breyer challenged AMP's interpretation of the claims as covering the entire genes without regard to the recited sequences, noting that the "wherein" clause reciting a specific sequence clearly limited the claims.82 And, although Justice Samuel A. Alito hinted that the case could be decided on other grounds besides the Section 101 issue, the justices in general seemed prepared to decide the patent eligibility issue before them.
Practical considerations, including the incentives provided by various types of claims, the treatment of such claims by the rest of the world, and the reliance of business on the status quo, were at the forefront of the justices' concerns. Regarding the incentives provided by certain claims, several justices asked about claims to the methods for finding, isolating, or using the BRCA1 and BRCA2 genes.83 The justices were trying to determine why Myriad had not simply obtained other types of claim coverage and whether other types of claims would provide companies adequate incentive for finding and isolating genes. Both parties explained that the methods Myriad used to find and isolate the genes were well known in the art and would not have been patentable. As for the incentive provided by claims to the use of the genes, Myriad did not provide a clear response as to why such claims were insufficient and instead returned to its basic argument that the isolated DNA was patent eligible.84 AMP, on the other hand, indicated that scientific curiosity and the recognition of one's peers would be enough for companies to invest in searching for and isolating gene sequences, a position that was swiftly critiqued by the justices.85 Along the same lines, questions arose about the incentives that would be provided if cDNA were found patent eligible but isolated DNA were not patent eligible.86
Justice Ruth Bader Ginsburg also noted that "every other industrialized nation [finds such material] patentable [i.e., patent eligible]," so a decision by the Court to the contrary would leave the United States "in a singular position."87 Counsel for the United States did clarify that some countries only allow patents on isolated genomic DNA for a particular use.88 The benefits of uniformity, this time with respect to uniform application of U.S. patent law across industries, were noted later in the argument by Justice Anthony M. Kennedy.89
The reliance of the biotech industry on the over-30-year-old Chakrabarty decision, the USPTO Guidelines'90 deeming claims to isolated DNA patent eligible, and the large number of granted patents also was a focus of Myriad's arguments.91 Although Justice Ginsburg suggested that the USPTO Guidelines should be given less deference in light of the U.S. government's positions in its amicus brief, Myriad noted that the reliance on it was not affected since the government's new position was only recently made public in the brief.92
All in all, based on the practical considerations, the justices seemed hesitant to strike down all product claims to genes as patent-ineligible due to the incentives they provide to research, the desire to maintain uniformity with other countries, and reliance the industry has on the current system.
Three types of gene claims were discussed: claims to genes that were only loosely tied to particular sequences; claims to isolated DNA; and claims to cDNA.
AMP argued that because the specification defined DNA broadly to include "all forms of mutations" and to include RNA, cDNA, genomic DNA, and synthetic nucleic acids, Myriad's claims should be interpreted as generally covering the BRCA genes.93 This interpretation generally was dismissed by other parties, and Justice Breyer questioned how AMP could come to such a construction given the case law on claim interpretation.94 Since AMP's position was not seriously considered by the Court, it is unlikely that the decision will address claims to genes that do not include specific sequence information.
It is more likely that the decision will come down to whether isolated DNA and/or cDNA is patent eligible. Both of these types of DNA were at issue because Myriad had claims directed to both cDNA sequences and genomic DNA sequences.95
Justices Sotomayor, Scalia, Kennedy, and Breyer's questions suggested support for the patent-eligibility of cDNA. For example, Justice Breyer noted that cDNA was not found in nature, and Justice Kennedy said that cDNA had unique functions such as being easier to tag.96 Justices Roberts and Kagan focused on the patentability of isolated DNA without much attention to the patentability of cDNA, so their positions are more difficult to discern. Regardless, it appears that a majority of the Court supports the patent-eligibility of cDNA.
As for isolated DNA, the outcome is murky. Many illustrative comparisons were posed in an attempt to understand the degree of human ingenuity involved in creating isolated DNA. Isolated DNA was compared to a baseball bat "isolated" from a tree,97 gold extracted from rocks,98 leaves or trees removed from the middle of the Amazon forest,99 and the isolated ingredients of salt, flour, eggs, and butter used to make cookies.100 There was disagreement as to whether isolated DNA's use as a primer or probe constituted different functionality than DNA in the body.101
The comments regarding isolated DNA often were disparaging. Justice Sotomayor found it "very, very difficult to conceive how you can patent a sequential numbering system by nature," leading her to ask "how [the sequence to isolated DNA] add[s] to nature when all you are doing is copying its sequence?"102 Justice Kennedy felt that it takes more human invention to create a baseball bat from a tree than it does to create isolated DNA because all you do is "snip off the top and you snip off the bottom and there you've got [isolated DNA]."103 Justice Kagan indicated that isolating DNA was similar to uprooting a tree from the middle of the Amazon forest and that presumably neither was patentable.104 Justice Breyer likened isolating DNA to removing a liver from the body and trying to patent it, alleging that Myriad was trying to find "everything under the sun" to be patent eligible.105
Justice Alito appeared to be the strongest supporter of finding isolated DNA patent eligible, stating early in the arguments that ''[i]solated DNA has a very different function from the DNA as it exists in nature. And although the chemical composition may not be different, . . . it certainly is in a different form.''106 By the end of the arguments, it was unclear whether Justice Alito's apparent support had waned.
Thus, although it appears that cDNA will be found patent eligible, the future of isolated DNA patent-eligibility seems less clear.
Justice Alito questioned why the Court should decide the case on Section 101 issues, hinting that it might be more prudent for the Court to decide the case on other grounds.107 Justice Alito's comments followed a series of questions about deciding the patentability of genes with respect to obviousness.108 It is possible that the Court could hold that genes are not patentable because they are all obvious. But such a decision inherently would include a determination that genes are patent eligible, for patent-eligibility is a preliminary issue decided before obviousness can be considered. Such a sweeping decision on the obviousness of an entire category of subject matter would be unprecedented and appears highly unlikely. At most, if the Court wished to find Myriad's patent invalid because it claimed obvious subject matter, it would hold that the subject matter was patent eligible, but also find that Myriad's particular claims were obvious, similar to its decision in Bilski v. Kappos.109
So where does all of this analysis lead? It appears that the Court likely will find gene claims patent eligible in some form or another. Most likely, the Court will give its blessing to claims to specific cDNA sequences, but claims to isolated DNA may not fare as well.
As for Myriad's particular claims, at least some of them could be found invalid. Since some of Myriad's claims are to isolated DNA, they may not be valid if the Court only finds cDNA patent eligible. Even Myriad's cDNA claims could be in a tenuous position, especially those to only 15 nucleotides, if the Court decides to rule on the obviousness of the claims.
Since the Court traditionally issues all of its decisions before the end of a term, we should know by the end of the summer where the patent-eligibility of genes stands.
Endnotes
1 No. 12-398 (S. Ct. April 15, 2013).
2 Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 694 (Nov. 30, 2012); Petition for a Writ of Certiorari, 133 S. Ct. 694 (Sept. 25, 2012) (No. 12-398).
3 cDNA is DNA synthesized from a messenger RNA template. Since the cDNA is synthesized from RNA, cDNA contains only the exons (gene coding regions) of the original DNA. cDNA can be used as gene probes or in gene cloning.
4 Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
5 Claim 1 of U.S. Patent No. 5,747,282 is representative of the composition claims at issue: "An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2."
6 Claim 1 of U.S. Patent No. 5,709,999 is representative of the method of comparing or analyzing claims at issue: "A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a 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."
7 Claim 20 of U.S. Patent No. 5,747,282 is representative of the method for screening claims at issue: "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."
8 Ass'n for Molecular Pathology, 702 F. Supp. 2d at 220.
9 Id. at 234.
10 Id. at 237.
11 Id.
12 Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (2011).
13 Id. at 1351.
14 Id. at 1357.
15 Id. at 1358.
16 Petition for Writ of Certiorari, Ass'n for Molecular Pathology v. Myriad Genetics Inc., 132 S. Ct. 1794 (2012) (No. 11-725).
17 Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289 (2012).
18 Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 467 Fed. App'x 890 (Fed. Cir. 2012).
19 Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012).
20 Id. at 1331.
21 Diamond v. Chakrabarty, 447 U.S. 303 (1980) (citing United States v. Dubilier Condenser Corp., 289 US 178 (1933)).
22 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
23 Ass'n for Molecular Pathology, 689 F.3d at 1333-34.
24 Ass'n for Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 694 (2012).
25 The rulings on the nine composition claims in three patents are challenged at the Supreme Court level: claims 1, 2, 5, 6, and 7 of U.S. Patent No. 5,747,282; claims 1, 6, and 7 of U.S. Patent No. 5,837,492; and claim 1 of U.S. Patent No. 5,693,473. Brief for Petitioners at 11-16, Ass'n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (S. Ct. Jan. 23, 2013).
26 USPTO requires that patent applications that disclose nucleotide and/or amino acid sequences contain a separate list of the sequences, called a "Sequence Listing." In that listing, each sequence is assigned a sequence identifier, or a "SEQ ID No." The applicant subsequently may refer to the sequence by its "SEQ ID No." without reciting the entire sequence.
27 Brief for Petitioners, supra note 25, at 13-14.
28 Id. at 25.
29 Id. at 23-24.
30 Id. at 35.
31 Id. at 37.
32 Id. at 41.
33 Id. at 55-58.
34 Brief for Respondents at i, Ass'n for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (S. Ct. Mar. 7, 2013) ("The question presented is: Did the Federal Circuit correctly apply 35 U.S.C. § 101 to conclude that these particular molecules are 'product[s] of human ingenuity having a distinctive name, character [and] use,' particularly where the general legal rule followed by courts for 30 years has been to allow such patent claims, where the U.S. Patent and Trademark Office ('USPTO') has issued similar patents since at least 1982 and confirmed in the 2001 Utility Guidelines that such isolated molecules are patent-eligible as human-made inventions under § 101, where investors and technology companies have placed significant reliance in these settled property rights over the last 30 years, where the alternative dividing line is indefensible under law or science, and where the challenged claims do not preempt or preclude the use of alternative technologies to identify a patient's cancer predisposition.").
35 Id. at 2.
36 Id. at 11.
37 Id. at 11-12.
38 Id. at 39-41.
39 Id. at 7.
40 Id. at 7-8.
41 Id. at 9.
42 Id. at 45.
43 Id. at 46.
44 Id. at 10.
45 See, e.g., id. at 34-39.
46 Utility Examination Guidelines, 66 Fed. Reg. 1,092 (Jan. 5, 2001), available at http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf.
47 Id. at 49-50.
48 Id. at 50-55.
49 Id. at 53.
50 Brief for the United States as Amicus Curiae in Support of Neither Party, Ass'n for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (S. Ct. Jan. 31, 2013).
51 Id. at 9.
52 Id. at 12.
53 Id. at 9.
54 Id. at 12.
55 Id. at 20.
56 Brief of Amicus Curiae The Institute of Professional Representatives Before the European Patent Office (EPI) in Support of Neither Party, Ass'n for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 at 3 (S. Ct. Jan. 31, 2013).
57 Id. at 2.
58 Id. at 3.
59 Brief for the American Intellectual Property Law Association as Amicus Curiae in Support of Affirmance but in Support of Neither Party, Ass'n for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (S. Ct. Jan. 31, 2013).
60 Id. at 2.
61 Id. at 6, 9-10.
62 Id. at 10-13.
63 Id. at 14.
64 Id. at 18-19.
65 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).
66 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
67 J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l Inc., 534 U.S. 124 (2001).
68 Diamond v. Chakrabarty, 447 U.S. 303 (1980).
69 U.S. Patent Nos. 6,355,623 and 6,680,302.
70 Mayo Collaborative Servs., 132 S. Ct. at 1297-98.
71 U.S. Patent No. 2,200,532.
72 Diamond v. Chakrabarty, 447 U.S. 303 (1980) (citing United States v. Dubilier Condenser Corp., 289 U.S. 178 (1933)).
73 See, e.g., id. at 23, 61 (Roberts, C.J.); 26, 29, 30 (Ginsburg, J.); 28 (Alito, J.); 19, 31, 62 (Sotomayor, J.).
74 See, e.g., Transcript of Oral Argument, Ass'n for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (S. Ct. Apr. 15, 2013), 26 (Roberts, C.J.); 26, 30 (Ginsburg, J.), available at http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398-amc7.pdf.
75 Id. at 26.
76 Id.
77 Id. at 62.
78 Id.
79 Id. at 52.
80 Id. at 52-54.
81 Id. at 53.
82 Id. at 22.
83 See, e.g., id. at 4 (Roberts, C.J.); 6 (Scalia, J.); 9, 48 (Kennedy, J.); 48 (Breyer, J.); 5, 33, 34 (Sotomayor, J.); 13, 32, 53 (Kagan, J.).
84 Id. at 34-37.
85 Id. at 12-15.
86 Id. at 14 (Scalia, J.); 20 (Kennedy, J.); at 61 (Sotomayor,J.); 13, 25 (Kagan, J.).
87 Id. at 29.
88 Id. at 29-30.
89 Id. at 57-58.
90 Utility Examination Guidelines, 66 Fed. Reg. 1,092 (Jan. 5, 2001), available at http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf.
91 See, e.g., Transcript of Oral Argument, supra note 74, at 33.
92 Id. at 51-52.
93 Brief for Petitioners, supra note 25, at 13-14.
94 Transcript of Oral Argument, supra note 74, at 22.
95 Id. at 37.
96 Id. at 21 (Scalia, J.); 20, 58 (Kennedy, J.); 22 (Ginsburg, J.); 18 (Breyer, J.); 17 (Sotomayor, J.).
97 Id. at 41.
98 Id. at 4-5.
99 Id. at 7-8, 43-45.
100 Id. at 35-36.
101 Id. at 8, 46.
102 Id. at 34.
103 Id. at 41.
104 Id. at 45.
105 Id. at 56.
106 Id. at 8.
107 Id. at 28.
108 Id. at 25-28.
109 Bilski v. Kappos, 130 S. Ct. 3218 (2010).
Reproduced with permission from BNA's Life Sciences Law & Industry Report, Vol. 7, No. 512, 05/03/2013. Copyright © 2013 The Bureau of National Affairs, Inc. (800-372-1033) www.bna.com. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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