Supreme Court Rules That Defendant May Be Liable For Indirect Infringement Despite Good Faith Belief That Patent Is Invalid

(The following is a guest contribution from Thomas A. Lewry of Brooks Kushman P.C., a patent and technology law firm with offices in Detroit and Los Angeles. Thomas has over 30 years of experience in patent litigation. He can be contacted at tlewry@brookskushman.com.) 

In a case at odds with long-standing assumptions about the legal status of invalid patents, the U.S. Supreme Court has ruled that a defendant’s good faith belief that a patent is invalid is not a defense to active inducement of infringement under 35 U.S.C. § 271(b). Commil USA, LLC v. Cisco Systems, Inc., No. 13-896 (U.S. May 26, 2015). Full opinions HERE. The decision raises a number of practical concerns for companies facing potential claims for indirect infringement of process patents arising from the activities of customers and other product end users.

Background:

Commil USA, LLC sued Cisco Systems, Inc. in the U.S. District Court for the Eastern District of Texas, alleging that Cisco infringed U.S. Patent No. 6,430,395 (entitled “Wireless private branch exchange (WPBX) and communicating between mobile units and base stations”). The ‘395 patent claims methods for improved protocols used to hand-off communications between mobile devices and base stations in a wireless network. Commil alleged that Cisco directly infringed the ‘395 patent and also actively induced infringement by causing users of its wifi network products to practice the claimed methods. A jury found that Cisco actively induced infringement and awarded over $60 million in damages.

On appeal to the U.S. Court of Appeals for the Federal Circuit, Cisco challenged the judgment on multiple grounds. Among other things, Cisco argued that the district court erred in excluding evidence that it believed in good faith that the ‘395 patent was invalid. Cisco offered this evidence to prove that it lacked an intent to cause infringement. In a divided opinion, the Federal Circuit vacated the judgment below. The majority agreed with Cisco by holding “that evidence of an accused infringer’s good-faith belief of invalidity may negate the requisite intent for induced infringement.” Commil USA, LLC v. Cisco Systems, Inc., 720 F.3d 1361, 1368 (Fed. Cir. 2013). The Federal Circuit denied Commil’s petition for en banc review, although five judges dissented from that denial.

Supreme Court Decision:

In a 6-2 decision written by Justice Kennedy, the Supreme Court vacated the Federal Circuit’s opinion and remanded. (Justice Breyer did not participate in the case). The principal question presented in the appeal was whether a defendant accused of active inducement may defend by proving that it believed in good faith that the patent at issue was invalid. The Court held that such a belief is not a defense. Rejecting long-accepted patent dogma, the Court rules that an invalid patent can be infringed, but the infringer may raise invalidity as a defense to liability.

First, the Court reaffirmed the high intent standard for indirect infringement established in Global-Tech Appliances, Inc. v. SEB SA, 563 U.S. ___, 131 S. Ct. 2060 (2011). In that case, the Court held that “induced infringement under §271(b) generally requires knowledge that the induced acts constitute patent infringement.” 131 S. Ct. at 2068. The Court rejected Commil’s suggestion that the standard only requires that the defendant know of the patent, not that the induced actions infringe the patent. The Court noted that the defendant in Global-Tech was liable for active inducement not only because it knew of the patent, but because it “knew it would be causing customers to infringe [the] patent.” Slip op. at 8. Thus, indirect infringement requires both knowledge of the patent and knowledge that the induced acts result in direct infringement.

Second, the Court ruled that a belief that a patent is invalid does not negate knowledge that a customer or other third party is infringing the patent. The Court stressed that invalidity and infringement are “different” and “separate” issues governed by provisions in different sections of the Patent Act. Moreover, the Court noted that conjoining the two legal concepts would erode the presumption of validity that each issued patent enjoys: “But if belief in invalidity were a defense to induced infringement, the force of that presumption would be lessened to a drastic degree, for a defendant could prevail if he proved he reasonably believed the patent was invalid.” Thus, the Court concluded invalidity is unrelated to infringement, and consequently irrelevant to a defendant’s intent to cause infringement:

An accused infringer can, of course, attempt to prove that the patent in suit is invalid; if the patent is indeed invalid, and shown to be so under proper procedures, there is no liability. That is because invalidity is not a defense to infringement, it is a defense to liability. And because of that fact, a belief as to invalidity cannot negate the scienter required for induced infringement.

Slip op. at 11 (citation omitted). This analysis would appear to apply both to active inducement and contributory infringement based on the legislative history of 35 U.S.C. § 271(b) and (c).

In a dissent, Justice Scalia, joined by Chief Justice Roberts, argued that, “It follows, as night the day, that only valid patents can be infringed. To talk of infringing an invalid patent is to talk nonsense.”

Impact on Patent Practice:

The Commil decision raises a number of practical issues for companies seeking to contain their patent liability risk.

The decision is likely to impact companies that are potential targets for induced and contributory infringement claims. In the past, companies could disprove intent to infringe by relying on an opinion of counsel that a patent of interest was invalid. Although opinions may remain useful, especially since the Court reaffirmed Global-Tech’s high intent standard, such opinions now should focus on noninfringement, not validity. In fact, the Court suggested that a defendant may lack the necessary intent to cause infringement if it relies on a reasonable interpretation of the patent claims that is different from the patentee’s interpretation. Slip op. at 9.

The Commil decision may be particularly problematic for companies accused of inducing customers or other third parties to infringe patents directed to business methods and other abstract computer-implemented processes that appear to be ineligible for patent protection under recent cases including Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. __, 134 S. Ct. 2347 (2014). Many of these patents may claim abstract ideas and thus appear to be invalid as ineligible in light of current law, but the applicable eligibility standards are continuing to evolve. Commil suggests that a defendant may not avoid liability for indirect infringement by pointing out that it reasonably viewed a patent to be invalid at one point in time, if the claimed invention proves eligible under a later standard.

The Court conceded that its decision would increase the risk of liability for indirect infringement claims amid public concern about perceived abuses of the patent system, including infringement actions by patent-assertion entities and deceptive patent demand letters. It pointed out however, that the “proper ways” to challenge patents as invalid are to commence a declaratory judgment action or AIA post-grant proceeding. Besides the obvious expense required, these procedures may not be available in all situations. For example, declaratory judgment jurisdiction requires an actual case and controversy, and AIA inter partes review proceedings only are available for prior art-based validity challenges. Nonetheless, companies should weigh the benefits of proactively challenging the validity of a patent if a noninfringement opinion is unavailable. Furthermore, the Court cited last term’s Octane Fitness decision in again endorsing attorney fee awards as sanctions for frivolous infringement suits:

Nonetheless, it is still necessary and proper to stress that district courts have the authority and responsibility to ensure frivolous cases are dissuaded. If frivolous cases are filed in federal court, it is within the power of the court to sanction attorneys for bringing such suits. Fed. Rule Civ. Proc. 11. It is also within the district court’s discretion to award attorney’s fees to prevailing parties in “exceptional cases.” 35 U. S. C. §285; see also Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U. S. ___ (2014) (slip op., at 7–8). These safeguards, combined with the avenues that accused inducers have to obtain rulings on the validity of patents, militate in favor of maintaining the separation expressed throughout the Patent Act between infringement and validity.

Slip op. at 14.

Finally, the Commil decision creates an apparent tension with current law and practice relating to willful infringement. Although the Court suggested that its decision would prevent the additional discovery and cost of litigating the defendant’s belief as to the validity of the patent in suit, a defendant’s good faith belief of invalidity remains relevant to the Seagate Technology willfulness standard. In re Seagate Technology, LLC., 497 F.3d 1360 (Fed. Cir. 2007). Under that standard, defendants frequently rely on invalidity opinions to disprove willful infringement. If, however, belief as to invalidity is not related to infringement for purposes of indirect infringement, then its role in avoiding willfulness may be open to question in future cases.

Supreme Court To Hear Challenge To Brulotte Rule

On December 12, 2014, the U.S. Supreme Court granted certiorari in the third patent case to be heard this term, this one presenting an issue at the intersection of patent law and antitrust law. In Brulotte v. Thys Co., 379 U.S. 29 (1964), the Supreme Court ruled that a patent license requiring the licensee to pay royalties after the licensed patent expires is a per se violation of the antitrust laws. In addition, the same conduct constitutes patent misuse, and may render a patent unenforceable in a subsequent infringement action. Now, 50 years later, the petitioner in Kimble v. Marvel Enterprises, Inc., No. 13-720, asks the Court to overturn that per se rule. 

Kimble is the inventor of a "Spiderman" toy that allows children (and perhaps some adults) to shoot foam webs from their wrists. He licensed the patent to Marvel. The license included a royalty based on sales of the toy, but did not provide for the royalties to end when the patent expired. Marvel relied on Brulotte to stop paying post-expiration royalties.

The Brulotte Rule has been widely criticized as outdated. For example, Scheiber v. Dolby Labs., Inc., 293 F.3d 1014 (7th Cir. 2002), Judge Richard Posner criticized the rule as being wrong, lamenting that the Seventh Circuit had “no authority to overrule a Supreme Court decision no matter how dubious its reasoning strikes us, or even how out of touch with the Supreme Court’s current thinking the decision seems.” The U.S. Department of Justice and Federal Trade Commission also have criticized the rule in recent guidelines analyzing anticompetitive provisions in intellectual property license agreements. In recent years, the Supreme Court has modernized its analysis of antitrust concerns relating to intellectual property. See, e.g., Illinois Tool Works, Inc. v. Independent. Ink, Inc., 547 U.S. 28 (2006) (overruling its prior decisions that, in an antitrust tying claim, a patent does not necessarily confer market power upon a patentee). The Kimble case may be a vehicle for it to dispense with the Burlotte rule as well. Oral arguments have not been scheduled.

Myriad Down Under - The Federal Court of Australia has a message for the US Supreme Court: "You were wrong (with respect)!"

© Robert Johnson 

The Federal Court of Australia has recently published its judgment in the case of D'Arcy v Myriad Genetics Inc.: while the issues examined by the Australian court mirror those considered by the US Supreme Court in its landmark decision last year (Association for Molecular Pathology v Myriad Genetics), the outcome certainly does not. In its decision, published on the 5th of September, the Federal Court of Australia openly criticized the Supreme Court's opinion, endorsing, instead, the conclusions reached in the partly-reversed Federal Circuit's decision. The judges found the relevant claims of Australian Patent No 686004 to be patentable, as within the meaning and boundaries of section 6 of the Statute of Monopolies. The dispute primarily concerned the patentability of nucleic acid sequences that have been isolated from the cell nucleus.

The judgment starts with an indication of the theoretical approach of the court to the interpretation of s 6 of the Statute of Monopolies, a provision that is almost 400 years old. First, the judges noted that, in order to define whether an invention is patentable, the interpreter should not focus on the verbal or linguistic meaning of the words 'manufacture' or 'manner of manufacture' (see National Research Development Corporation v Commissioner of Patents), but on whether the invention 'is a proper subject' for a monopoly, in accordance with the principles developed for the application of s 6. The court also warned against the use of metaphors, observing that they can 'blind the eye of the mind by oversimplification': in particular, it took issue with the representation of the process of isolation of the nucleic acid as equivalent to the creation of a metaphorical microscope enabling one to see into a gene and view the exon sequence in the subject person. Finally, it listed the principles and considerations relevant to the applicability of s 6 of the Statute of Monopolies:

First, the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age; rather, the boundaries must be such as to be apt to encompass the development of science and technology, and human ingenuity. This explains the broadening concept of patentability since the first quarter of the 17th century.
Secondly, human intervention that creates an artificial state of affairs that has some discernible effect is essential.
Thirdly, whilst notions of utility, ingenuity and invention have their place after one concludes that the claim is within the field of s 6, such notions also inform the context of analysis of patentability by assisting in describing the claims to processes or products that are claimed new results of principles carried into practice through human intervention and that create some claimed useful result by involving an artificial state of affairs.
Fourthly, expressions such as “the work of nature” or “the laws of nature” are not found in the statute; nor are they useful tools of analysis.
Fifthly, the distinction between discovery of a scientific principle or fact and a deployment of such to a useful end by a procedure is real.

After discussing the scientific background of the invention, the court examined the decision of the primary judge, according to which, Myriad's patent did not concern genetic information per se, but isolated chemical composition, thus advancing no claim in relation to 'naturally occurring DNA and RNA as they exist in cell'. The court engaged in, essentially, a reconstruction of the fine line between discovery and invention: inter alia, the court observed that the distinction between the two concepts is primarily concerned with the creative dimension of an invention ('the suggestion of an act to be done, an act which results in a new product, or a new result, or a new process or a new combination for producing an old product or an old result', according to Reynolds v Herbert Smith & Co Ltd), and that an invention that super-adds something to the existing knowledge is patentable, with the fine line being embodied by the existence of an enabling disclosure that departs from what the public already knows (Hill v Evans).

The most interesting part of the decision, however, concerns the court's discussion of the decisions of the Supreme Court and of the Federal Circuit in the similar US case. The analysis moved from the observations made by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd, where their Honors noted that, in the US, 'composition claims to a naturally occurring deoxyribonucleic acid (DNA) segment, focusing on the genetic information encoded in two genes associated with certain cancers, have been held to claim subject matter falling within the exception [to patentability], even though such important and useful genes had never before been located, or isolated from surrounding genetic material' (emphasis added). Then the court turned its attention, in particular, to the decision of the Federal Circuit, reversed, in part, by the landmark decision of the Supreme Court. It found that Judge Lourie, who had delivered the opinion for the Court of Appeals for the Federal Circuit, had properly identified (i) the economic significance of the isolated genes as diagnostic tools, (ii) the distinction between products/laws of nature and products of man, (iii) the difference, in chemical structure and potential use, between naturally occurring and isolated DNA sequences. The court explained that the reasoning of the Federal Circuit, which distinguished between a product and the information contained therein, was 'consistent with patent law, and persuasive', as well as in line with the teaching of National Research Development Corporation v Commissioner of Patents.

The judges established that Myriad's claims concern tangible materials, specifically isolated chemicals, whose structure, uses or functions are different from those of the chemicals in situ. They added that genetic code, in itself, is not claimed in the patent, noting the distinction 'between a claim to an isolated nucleic acid comprised in part of a sequence of nucleotide bases and a claim to a written sequence of nucleotides which may be identical to the corresponding sequence in the natural cell'. In particular, they highlighted that, while the gene that contains the mutation exists in nature, it cannot be used to identify the mutation until it is isolated, a situation that, according to the court, 'reflects a difference between the gene in its natural state and after isolation'.

Tackling the different interpretation given by the US Supreme Court, the judges critically observed that the US decision erred in (i) relying on an analysis of similarities/differences in the location and order of the nucleotides, rather than in the chemical structure, (ii) interpreting Myriad's claim as directed to information contained in the genetic sequence, (iii) finding that the isolated nucleic acid was a product of nature. The relevant passages are reproduced below:

It is difficult to reconcile that Court’s endorsement of the reasoning in Chakrabarty, with its rejection of isolated nucleic acid as eligible for patentability. With respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful. 

[...] Following Chakrabarty and NRDC, the isolated nucleic acid has ‘markedly different characteristics from any found in nature’; Myriad did not merely ‘separate that gene from its surrounding genetic material’. It should make no difference that in Chakrabarty there was an “addition” (of the plasmids) to the natural product (the bacterium); this is not the appropriate test. Myriad’s claim, properly considered is not, as the US Supreme Court considered, concerned ‘primarily with the information contained in the genetic sequence [rather than] with the specific chemical composition of a particular molecule’.

The reasoning of Lourie and Moore JJ of the Federal Circuit is persuasive. It accords with the High Court’s reasoning in NRDC and Microcell. The US Supreme Court accepted that cDNA is patentable. It rejected the isolated nucleic acid of claim 1 because it accepted wrongly, with respect, that the isolated nucleic acid is a “product of nature”. In any event, that exclusion is not in accordance with the principles of patent law in Australia and has been specifically rejected as a reason for exclusion in NRDC.

Thus, the court concluded that Myriad's claim is a patentable invention and the proper subject of letters patent. The isolated nucleic acid 'has resulted in an artificially created state of affairs for economic benefit', and the related invention is as worthy of reward as inventions that use other synthetic versions of DNA (e.g. cDNA, which the US Supreme Court held to be patentable, as a non-naturally occurring DNA sequence, due to the removal of the non-expressing portion of the sequence).

Who bears the burden of proof in declaratory judgments of non-infringement? The patentee, answers the US Supreme Court

On Wednesday, the US Supreme Court published its decision in the case of Medtronic Inc. v Mirowski Family Ventures LLC, ruling that, when a licensee brings an action for declaratory judgment of non-infringement of a licensed patent, the patentee bears the burden of persuasion on the issue of infringement. The Supreme Court unanimously reversed the judgment of the Federal Circuit, as suggested by the briefs submitted by the Solicitor General (here), and by a number of law professors (here).

In 1991, Medtronic and Mirowski concluded a licensing agreement, which allowed the former to implement, in its products, patented technologies held by the latter, in exchange for royalty payments (the facts of the case are described in detail here). A supplementary agreement (Litigation Tolling Agreement), signed in 2006, established that, if Mirowski believed that one of the products manufactured by Medtronic infringed one of its patents, the licensee could either (i) pay the additional royalties due, or (ii) seek a declaratory judgment of non-infringement, continuing to pay royalties into an escrow account (upon conclusion of the declaratory judgment action, these royalties were to be assigned to the prevailing party). These provisions essentially prevented the licensor from filing a counterclaim for infringement, as, even in case of alleged infringement, the agreement would remain in force.

In 2007, Mirowski gave Medtronic notice of infringement, in relation to two patents allegedly violated by several Medtronic products. As established under the agreement, the licensee filed a declaratory judgment action of non-infringement, paying all the relevant royalties into an escrow account. The District Court found that the patentee had failed to prove infringement, noting that the burden of proof of infringement fell upon Mirowski, even if it was the defendant in the action. The Court of Appeals for the Federal Circuit disagreed, acknowledging that the patentee normally bears the burden of proving infringement, but carving an exception for cases in which the patentee (i) is a defendant in a declaratory judgment action, and (ii) cannot file a counterclaim for infringement due to the continued existence of a license. The Federal Circuit essentially considered that, in such exceptional cases, the patentee is merely assuming a passive position, as the licensee is the only party seeking to disturb the status quo ante:

The contract at issue here required MFV to identify products it believed were covered by the contract. After MFV identified those products, Medtronic was required to either pay royalties on them, or sue for declaratory judgment that the products were not covered. Medtronic is unquestionably the party now requesting relief from the court: it already has a license; it cannot be sued for infringement; it is paying money into escrow; and it wants to stop. In contrast [...] MFV seeks nothing more than to be discharged from the suit and be permitted to continue the quiet enjoyment of its contract. In other words, it is Medtronic and not MFV that is asking the court to disturb the status quo ante and to relieve it from a royalty obligation it believes it does not bear. Consistent with the above, for the court to disturb the status quo ante, Medtronic must present evidence showing that it is entitled to such relief. 

The Supreme Court reversed the Federal Circuit's decision (for a discussion of the first part of the court's decision, which dealt with issues of jurisdiction, see here). The court observed that, according to settled case law, the Declaratory Judgment Act has merely limited procedural purpose (Skelly Oil Co. v. Phillips Petroleum Co.), and leaves substantive rights unchanged (Beacon Theatres Inc. v Westover). Therefore, as the burden of proof is a substantive aspect of a claim (Raleigh v Illionois Department of Revenue), the Declaratory Judgment Act cannot alter the general rule valid in patent infringement actions, under which the burden of proving infringement rests upon the patentee (Under Sea Industries Inc. v Dacor Corp.).

The judges noted that 'shift[ing] the burden depending upon the form of the action could create postlitigation uncertainty about the scope of the patent', highlighting that the Restatement (Second) of Judgments expressly acknowledges the possibility of relitigating an issue in a subsequent suit, when the burden of persuasion has shifted. The infringement issue could thus potentially remain unresolved, if the alleged infringer loses the declaratory judgment action, and the patentee similarly loses a subsequent infringement action brought against the former:

Suppose the evidence is inconclusive, and an alleged infringer loses his declaratory judgment action because he failed to prove noninfringement. The alleged infringer, or others, might continue to engage in the same allegedly infringing behavior, leaving it to the patentee to bring an infringement action. If the burden shifts, the patentee might lose that action because, the evidence being inconclusive, he failed to prove infringement. So, both sides might lose as to infringement, leaving the infringement question undecided, creating uncertainty among the parties and others who seek to know just what products and processes they are free to use.

The court also argued that the patentee is 'in a better position than an alleged infringer to know, and to be able to point out, just where, how, and why a product (or process) infringes a claim of that patent'; shifting the burden of persuasion would force the licensee to negate 'every conceivable infringement theory'. Reciting MedImmune Inc. v Genentech Inc., the Supreme Court further noted that imposing the burden on the licensee would create a significant obstacle to the use of declaratory judgments actions in similar cases:

In [MedImmune], we wrote that the "very purpose" of that Act is to "ameliorate" the "dilemma" posed by "putting" one who challenges a patent’s scope "to the choice between abandoning his rights or risking" suit. [...]. In the absence of the declaratory judgment procedure, Medtronic would face the precise dilemma that MedImmune describes. Either Medtronic would have to abandon its right to challenge the scope of Mirowski’s patents, or it would have to stop paying royalties, risk losing an ordinary patent infringement lawsuit, and thereby risk liability for treble damages and attorney’s fees as well as injunctive relief. [...] As in MedImmune, the declaratory judgment action rescues Medtronic from this dilemma.

These reasons were deemed sufficient to justify an exception to the basic rule described in Schaffer v Weast, where the court had ruled that plaintiffs normally bear 'the risk of failing to prove their claims'. The judges also explained that the public interest favors the maintenance of a well-functioning patent system, but requires, at the same time, that 'patent monopolies [be] kept within their legitimate scope' (Precision Instrument Manufacturing Co. v Automotive Maintenance Machinery Co.). The latter objective would be hindered, if the rules on the burden of proof effectively discouraged licensees from filing declaratory judgment actions. Thus, '[t]he general public interest considerations are, at most, in balance', and suggest retaining the general rule imposing the burden of proving infringement upon the patentee.

In reversing the Federal Circuit's decision, the Supreme Court rightfully took into consideration a series of theoretical (e.g. the nature of the declaratory judgment action and its objectives) and practical issues (e.g. the difficulty, for the licensee, to prove non-infringement under any conceivable infringement theory, and the risk of an unresolved dispute in case of relitigation), which undoubtedly support its conclusion. The court did not discuss other controversial aspects of the case, for example the risk of an abusive use of non-infringement declaratory judgment actions by licensees (the judges merely commented that 'litigation can occur only in the presence of a genuine dispute, "of sufficient immediacy and reality", about the patent's validity or its application'), or the possibility, for the patentee, to bring a counterclaim seeking a declaratory judgment of future infringement under T. Lang et al. v Pacific Marine and Supply Co. (in which the Federal Circuit taught that '[i]f the controversy requirement is met by a sufficient allegation of immediacy and reality, we see no reason why a patentee should be unable to seek a declaratory judgment of infringement against a future infringer when a future infringer is able to maintain a declaratory judgment action for noninfringement under the same circumstances').

It is interesting to note, as observed by Professor Cotter here, that the path taken by the Supreme Court mirrors the approach employed by German courts ('the patentee always has the burden of proof with regard to the infringement issue, even in negative declaratory actions' - for a similar principle applied by Italian courts, see this case), but differs from the ruling of the Court of Appeal for England and Wales in the recent case of Generics [UK] Ltd v Yeda Research and Development Co Ltd & Anor ('the burden of establishing non-infringement fell on [the plaintiff that brought the declaratory judgment action'). The latter case, however, should probably be read in conjunction with Baxter Healthcare Corporation et al. v Abbott Laboratories, where the patentee was required to plead its case, even if the burden of proof remained on the plaintiff (see IPKat post here). From this point of view, even jurisdictions which provide for a shifting of the burden of proof are likely to introduce additional requirements, in order to identify the perimeter of the underlying infringement dispute that prompted the licensee to file the declaratory judgment action.

Supreme Court To Decide Patentability of Human Genes

On November 30, 2012, the U.S. Supreme Court granted certiorari in Assn for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398.  In that case, the plaintiffs challenge the eligibility of Myriad’s patents covering isolated human gene sequences corresponding to the BRCA1 and BRCA2 genes, which when mutated are associated with a high risk of developing breast and ovarian cancer, and diagnostic processes using the genes. The U.S. Court of Appeals for the Federal Circuit ruled in August that Myriad’s patent claims covering isolated genes were patent-eligible under Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S.Ct. 1289 (2012). See Assn. for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. Aug. 16, 2012).

The Court's grant of certiorari is limited to a single question presented in the plaintiffs’ petition:

“1. Are human genes patentable?”