On June 13, 2013, the Supreme Court issued a unanimous decision holding that “genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material.” See Association for Molecular Pathology v. Myriad Genetics Corp. (AMP), 133 S. Ct. 2107, 2120 (2013). Attorney Sewell’s publication entitled “Unanimous U.S. Supreme Court and Angelina Jolie: BRCA1 & BRCA2 Patentability” is widely disseminated, well-received by his peers, and sparks considerable commentary.
Background
In somewhat of a twist, the Supreme Court’s decision against the patentability of isolated DNA prompted more—not less—litigation by Myriad regarding gene patents. Between 1997 and 2013, Myriad’s revenue from its BRACAnalysis test steadily increased, and totals more than $2 billion. BRACAnalysis is a genetic test that confirms the presence of BRCA1 or BRCA2 gene mutations, responsible for the majority of breast and ovarian cancers. Myriad earned that revenue by carefully guarding its patent rights and preventing others from providing screening tests for the BRCA1 and BRCA2 genes. From the mid-1990s, until the Supreme Court’s AMP decision, Myriad was the lone provider of full-sequence BRCA1 and BRCA2 tests in the United States. Within days of the Supreme Court’s AMP decision, Defendant Ambry Genetics Corporation announced plans to sell tests less expensive than Myriad’s to screen BRCA1 and BRCA2 genes. Ambry Genetics Corporation is a clinical diagnostic and genomic services company in Aliso Viejo, California. Defendant now offers a menu of at least six tests that include screening for BRCA1 and BRCA2: a combined BRCA1/BRCA2 test, BRCAPlus, BreastNext, PancNext, Ova Next, and CancerNext. Defendant’s BRCA1/BRCA2 test is available for $2,200—substantially less than the price for comparable testing offered by Myriad.
Soon after Defendant Ambry made its announcement, Myriad filed a complaint in the District Court of Utah alleging that Ambry’s genetic testing infringes several of Myriad’s patents. Myriad also moved for a preliminary injunction to enjoin Defendant Ambry from sales or offers to sell “genetic tests including a BRCA1 or BRCA2 panel”. Ambry opposed the motion, alleging that the claims were invalid under 35 U.S.C. § 101 et seq. The district court divided the Myriad gene patent claims at issue into the Primer Claims and the Method Claims.
On March 20, 2014, the Utah District Court held that Plaintiffs are not entitled to a preliminary injunction because “although Plaintiffs have shown they are likely to be irreparably harmed if an injunction does not issue, Defendant has raised substantial questions concerning whether any of the patent claims at issue in Plaintiffs’ Motion are directed toward patent eligible subject matter under 35 U.S.C. § 101”. Myriad then appealed to the Federal Circuit the denial of its motion for a preliminary injunction.
U.S. Federal Circuit Court of Appeals
On October 6, 2014, Chief Judge Prost and Judges Dyk and Clevenger of the U.S. Court of Appeals for the Federal Circuit heard oral argument in the interlocutory appeal of the Utah district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. The two main issues that dominated the argument are: 1) the correct implementation of the test for patent eligibility; and 2) the application of this test to probes and primers. The impact on the biotechnology industry was also discussed.
Jonathan E. Singer, counsel for Myriad, began by arguing that both the Federal Circuit and the Supreme Court had previously acknowledged that Myriad was entitled to patent some applications of their newly-discovered gene sequence and tools designed specifically to utilize that sequence. Myriad argues that primer pairs are patent subject matter eligible under 35 U.S.C § 101 because the pairs are structurally and functionally different than a single fragment of DNA. Counsel for Myriad also argued that, as a whole, the method of screening for alterations on the BRCA genes involves steps of the method claims, when considered together, effect an improvement in a technical field – by using Myriad’s probes and primers that Myriad invented.
With respect to the primer claims, Ambry argues that these claims are patent-ineligible because, in addition to reciting patent-ineligible products of nature, the claims fail under Alice because they are a generic component used to amplify a person’s gene sequence to access the sequence information for the patent-ineligible sequence comparison. As for the method claims, Ambry argues that under Alice, “the combination of unpatentable subject matter and a generic physical application is no more patent eligible than a claim reciting only the unpatentable subject matter.” See Ambry Supplemental Brief at page 3.
Conclusion
What is clear from the district and appellate court arguments is that it does not appear likely that Myriad will be successful in its attempts to preliminarily enjoin Ambry. Additionally, the biotechnology industry is looking towards the Federal Circuit for guidance on the correct implementation of patent subject matter eligibility under Myriad, Mayo, and Alice.
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Lynn
What are your thoughts considering the Federal Circuit’s decision this week (Dec 17) in affirming the invalidity of a number of additional genetic testing claims? Unsurprisingly, the court found that the DNA primer claims before the court -claims directed to short, synthetic single-stranded DNA molecules that bind specifically to target nucleotide sequences – were not patent eligible because the primers are “not distinguishable from isolated DNA” and are not similar to complimentary DNA, which was found to be patent-eligible.
More specifically, the Court rejected Myriad’s arguments because single-stranded DNA is not found in the human body, and primers have a fundamentally different function when extracted as compared to when they are part of a DNA strand. The Court read Myriad as holding that “neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”
Following the Supreme Court decision in Myriad, the Federal Circuit arguably narrowed the patent eligibility of biotech inventions in this decision. This most recent development still leaves much to be explained for the correct implementation of patent subject matter eligibility under Myriad, Mayo, and Alice.
Good luck to courts trying to interpret 101 patentability requirements especially considering that in recent years, the number of patents to isolated DNA has been declining while researchers are focusing more on proteins, peptides, RNAs, and transformed organisms containing exogenous cDNA, and their associated methods of use.
It is very likely that the patentability of DNA sequences will continue to be a topic for judicial consideration and it would not be surprising if this decision were considered by the Federal Circuit en banc and/or appealed to the Supreme Court.
This opinion may also affect the biotechnology industry by putting at risk many biotech patents relating to natural occurring products and diagnostics. This is because according to the court, for the DNA primer to be eligible for patent protection under 35 U.S.C. § 101, it must have a different structure, or by implication, a “significantly new function.
Considering that this decision came right after the USPTO issued a revised guidance for examiners on how they should evaluate claims to determine patent protection under § 101, I wonder if the PTO will re-evaluate its interim subject matter eligibility requirements. While the PTO interim guide was mainly consistent with the most recent opinion, the Fed Circuit’s analysis on primers and their function in nature vs in the invention may need to be revised.
Mitchell
Myriad wasn’t the only controversial U.S. Supreme Court case qualifying patentable subject matter. Under 35 U.S.C. § 101, “any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof” is considered patentable subject matter. Of course, there are certain exceptions to this list under which the USPTO will issue patents. Claims to abstract ideas, natural phenomena, and laws of nature are not entitled to patent protection. For many years, these exceptions could be overcome by claiming a specific application of those concepts. Industries relied on these exceptions-to-exceptions in order to maximize their patent protection. However, beginning in 2010, the U.S. Supreme Court began reshaping patent subject matter eligibility under Section 101 through opinions such as Bilski, Mayo, Myriad, and Alice.
Bilski
On June 28, 2010, in its Bilski v. Kappos decision, the Supreme Court held that the claims to “how buyers and sellers of commodities in the energy market can protect, or hedge, against the risk of price changes” were not patent-eligible.” The claims were considered abstract ideas. The court held that an abstract idea that is “[limited] . . . to one field of use or [by] adding token postsolution components” does not make it patentable.
Mayo
On March 20, 2012, the Supreme Court, in Mayo Collaborative Services v. Prometheus Laboratories Inc., held that a method for optimizing drug dosing based on concentrations of metabolites in the blood to be a “law of nature” and therefore patent-ineligible. The Court determined that a law of nature could be patent-eligible only if the nature of the claim is transformed into a patentable application. The invention must include something more than “well-understood, routine, conventional activity previously engaged in by researchers in the field.” Similarly, the invention cannot be “purely conventional or obvious.”
Myriad
As described in the above blog post, on June 13, 2013, the Supreme Court, in AMP v. Myriad Genetics Corp., held that claims on genes are not patent eligible “simply because they have been isolated from the surrounding genetic material.”
Alice
The decision in Alice Corporation Pty. Ltd. v. CLS Bank International (June 19, 2014) was important in that the Supreme Court held that a two-step eligibility analysis, stemming from Mayo, is applicable to any Section 101 analysis, not just the law of nature exception. A claim may be patent eligible if:
(1) it is an abstract idea, natural phenomena, or law of nature, and
(2) the nature of the claim is transformed into a patentable application.
As mentioned in blog, it’s not perfectly clear how to apply this test, or the other holdings on patent subject matter eligibility. The effect of these Supreme Court opinions has a significant impact on the biotechnology and biopharmaceutical groups. Developing a new bio-product can require investments of billions of dollars and normally take up to fifteen years for research and development. Obtaining strong patent protection enables innovator companies to raise prices higher than the production costs, making profits that compensate for the investment in research and development. Furthermore, since strong patent protection assures innovators that these costs can be recovered, thoroughness and quality research are incentivized. Within the biotechnology and biopharmaceutical industries, many believe the new Supreme Court standards under Section 101 disincentivize innovation. If that is true, than the entire patent system, which was created to inspire innovation, is absolutely counter-productive and an utter waste.