On June 13, 2013, the U.S. Supreme Court held that genes are not patentable. It is this commentator’s position that the Court’s Myriad decision should not have been all that surprising based on case law precedent, the exceptions to patentability under 37 U.S. § 101, and the current healthcare “cost concern” landscape. The decision may eventually be viewed as involving merely a narrow carving out of DNA sequence-related patents as being ineligible for patent protection under 35 U.S.C. § 101 for reasons to be discussed below.
Although this blog focuses on the High Court’s June 13, 2013 decision concerning gene patentability, the blog also discusses medical diagnostic method patent claims. In fact the Myriad case originally started out as challenges to both: 1) the patentability of two genes, BRCA1 and BRAC2, known to be indicators of a substantially higher breast cancer risk and ovarian cancer risk, relative to the general population; and 2) the genetics testing methods for evaluating the presence of these genes in patients.
Indeed gene patents such as the ones at issue in the Myriad case generally will have no commercial value unless the claimed gene has some money-making use, for example as a medical diagnostic tool. It is thus not surprising that Myriad Genetics (Myriad), as the applicant for patents on the BRAC1 and BRAC2 genes, also sought patent protection for the resultant genetics testing methods it developed to test for the presence of the genes in patient blood samples. Very recently, these genes and the associated testing methods have been in the main stream news as the result of actress Angelina Jolie’s decision to undergo a double mastectomy due to the test results obtained with Myriad’s patented genetic testing methods.
Around the same time the Myriad case was winding its way through the courts, another case was also being closely watched by the industry. On March 20, 2012, the U.S. Supreme Court in a unanimous decision invalidated two patents licensed by Prometheus Laboratories, Inc. for methods related to treating IBD/Crohn’s disease and other gastrointestinal disorders on 35 U.S.C. § 101 grounds. Mayo Collaborative Science v. Prometheus Laboratories, Inc., 566 U.S. (2012).
No discussion of the High Court’s Myriad decision would be complete without a discussion of its Prometheus decision. For the past several years, both the Myriad and Prometheus cases have occupied the intellectual property legal landscape in the areas of medical diagnostic testing and biotechnology and there has actually been considerable overlap in their respective procedural histories. For example, the High Court initially granted writ of certiorari for the Myriad case, but then on March 26, 2012 remanded the case to the Federal Circuit with directions to reconsider its previous 2011 decision concerning the validity of Myriad’s genetic testing method claims and gene patents in view of the High Court’s Prometheus decision a week earlier. The Federal Circuit’s August 2012 decision reaffirmed its 2011 decision that Myriad’s 1) patent claims for isolated genes were valid; 2) genetic sequence comparison diagnostic tests were invalid; and the 3) tests for evaluating the efficacy of potential breast cancer therapeutics were valid. The High Court then agreed to hear the case on the issue of gene patentability resulting in the decision discussed in this blog. For a detailed analysis of the Federal Circuit’s 2011 Myriad decision, see our previous blog entitled: “The Reach of Bilski: from Biotechnology to Financial Method Patents.”
Due to its length, this blog is divided into the following sections for organizational purposes:
- Background Behind the Myriad case.
- Differences Between an Isolated Gene Sequence and Synthesized cDNA for Those Readers Who Have Little Biotechnology Background.
- The High Court’s Rationale for Invalidating Myriad’s Isolated Gene Patent Claims but Not cDNA Patents Based on its Previous Holdings in Chakrabarty and Funk Brothers.
- Diagnostic Testing Method Claims Under § 101 in View of Prometheus and Myriad.
- The Implications of the Myriad Decision.
- Suggestions for IP Risk Assessment from a 35 U.S.C. § 101 Perspective Earlier than Later by Patent Counsel and Innovators.
1. Background Behind the Myriad case
Finding a specific gene within a DNA molecule comprised of tens of millions nucleotides is, to say the least, technically challenging. Gene isolation and identification have been made possible due to advances in bio-analytical techniques processes. Using techniques that were available at the time, Myriad Genetics (Myriad) discovered the BRAC1 and BRAC2 genes that play a role in a woman’s breast health and also identified the exact two chromosomes on which the 1 and 2 genes are located. Myriad Genetics then developed a test for detecting mutations within both genes for assessing whether a patient has an increased risk of breast cancer.
Myriad sought and obtained a number of patents for both the gene sequences themselves and mutation screening tests. The claims for gene nucleotide sequences included claims for complementary DNA exons in the BRAC1 and BRAC2 genes.
At the time it discovered the two BRAC genes, Myriad was not the only entity offering BRCA testing. Genetic testing generally requires the isolation of the gene being evaluated by the genetic testing method. Myriad asserted its patent rights against other entities that were performing BRAC testing. As a result, the other players in the field agreed to stop all allegedly infringing BRAC testing, and Myriad became the only entity providing BRAC1 and BRAC2 genetic testing. Myriad slip opinion at pg. 7.
In 2007, a physician who had previously used another entity for evaluating his patients’ DNA samples for BRAC mutations, along with medical patients, advocacy groups, and other doctors filed a lawsuit seeking declaration that Myriad’s patents were invalid under the products of nature exception of 35 U.S.C. § 101. The case eventually reached the Supreme Court where oral argument took place in April, 2013. In the resulting decision, the Court held that genes, when merely isolated from DNA, are a product of nature ineligible for patent protection. Another type of DNA, known as cDNA, is, however, still eligible for patent protection according to the Court.
2. Differences Between an Isolated Gene Sequence and Synthesized cDNA
To understand the Court’s rationale, a somewhat more detailed discussion on the biochemical differences between an isolated gene sequence and cDNA than that presented in the opinion may be helpful. Isolated gene sequences represent portions of the intact DNA molecule in which the chemical bonds that connect the targeted gene sequence with the rest of the naturally occurring DNA molecule are broken, generally by a chemical reaction known as hydrolysis. Breaking of these bonds releases the gene sequence from the DNA molecule. Such a step is generally necessary to “convert” a DNA-embedded gene into a useful DNA fragment that is suitable for biotechnology and medical diagnostics applications.
In nature, genes are transcribed into messenger RNA (mRNA). This step involves the “reading” of each gene’s code where the code is based on the the sequence of molecules known as nucleotides by specific enzymes (proteins that catalyze reactions) catalyze reactions). Each gene is defined by its specific nucleotide (A, T, C, and G for brevity) sequence. During the transcription process, the genetic code is “read” to produce the corresponding mRNA nucleotide sequence that will subsequently be converted by the cell into the protein coded for in the associated mRNA.
Complementary DNA (cDNA) is DNA that is synthesized from messenger RNA (mRNA) using the enzymes DNA polymerase and reverse transcriptase to catalyze the reaction. The conversion of mRNA to cDNA basically represents the reverse of the transpriction process wherein a DNA gene sequence is transcribed into mRNA. Complementary DNA often used to code eukaryotic genes in prokaryotes and is routinely used in the biotechnology industry for gene cloning or as gene probes.
A gene’s entire DNA sequence, as present in nature, may actually include nucleotides that do not code for the protein or that interrupt the gene-coding sequence of the DNA. These “extraneous” nucleic acids, known as introns, are found in the genes of most organisms and are therefore part of the gene.
As part of this transcription process in which mRNA is synthesized through the “reading” of the gene’s genetic code (i.e., nucleotide sequence), the introns are removed from pre-mRNA to provide the final mature mRNA required for translation of the mRNA code into its corresponding protein, or in this case, for the production of cDNA.
The term exon refers to any nucleotide sequence encoded by a gene that remains present in the final mature mRNA (after removal of the introns). After removal of the introns, the resultant free ends of the remaining nucleotide sequences undergo splicing to join the exons together to produce mature mRNA. From this mature RNA, cDNA can be synthesized. The resultant cDNA differs from its “parent” DNA sequence in that the intron sequences have been deleted.
3. The High Court’s Rationale for Invalidating Isolated Gene Sequences Based on the Chakrabarty and Funk Brothers Cases
Why did the Supreme Court hold that cDNA but not the “parent” DNA BRAC1 and BRAC2 gene sequences are eligible for patent protection? Indeed the petitioners argued that neither cDNA nor its parent gene sequence should be eligible for patent protection under §101.
The seminal case relied on by the High Court was Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). The Chakrabarty decision came out around the time the biotechnology industry was getting started and helped pave the way for the development of a viable, job-producing biotechnology industry.
In Chakrabarty, the inventor had added four plasmids to a naturally occurring bacterium that caused the bacterium to efficiently break down various components of crude oil. This genetically engineered bacterium is now known as pseudomonas putida. Although at the time of the invention several species of oil-metabolizing bacteria were known to exist, the bacteria were not efficient in degrading the oil, for example, that accumulated as the result of an oil spill, either when used alone or in combination with the other oil-metabolizing bacteria. Although it was recognized that the use of more than one type of oil-producing bacterium would improve the efficiency of the oil-breakdown process, the bacteria competed with each other, thereby limiting their applicability.
The bacteria-containing genes required for degrading oil were located on plasmids. Plasmids are small DNA molecules most commonly found in bacteria. Today plasmids are widely used in molecular cloning to drive the replication of recombinant DNA sequences within host organisms. Chakrabarty discovered a way of introducing the four oil-metabolizing genes into a bacterium to produce a stable new organism with efficient oil-metabolizing properties using UV radiation to cross-link the plasmids to the host bacterium’s DNA. The genetically-engineered bacterium also had the very desirable property of not being an opportunistic human pathogen.
The USPTO refused to grant a patent on the invention because the invention involved a living organism that was, according to the USPTO, ineligible for patent protection under 35 U.S.C. § 101. Section 101 provides that “ ‘[w]hoever invents or discovers any new and useful composition of matter, or any new and improvement thereof, may obtain a patent therefor, subject to the conditions and requirement of this title.’ ” Over the years, the High Court has held that “this provision contains an important implicit exception that laws of nature, natural phenomena, and abstract ideas are not patentable.” Myriad slip opinion at 11.
The Chakrabarty matter eventually was decided by the High Court. Finding in favor of Chakrabarty, the Court explained that the modified bacterium was “ ‘not a hitherto unknown natural phenomenon but a non-naturally occurring manufacture or composition of matter – a product of human ingenuity ‘having a distinctive name, character [and] use.’ “ Myriad slip opinion at 12 quoting Chakrabarty at 309-310.
In its Myriad decision, the High Court distinguished its Chakrabarty decision from its decision in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). The patent at issue in Funk Brothers was for a combination if nitrogen-fixing bacteria into a single inoculant for use by farmers. At the time, the nitrogen-fixing ability of nitrogen was well known, and indeed farmers routinely inoculated their crops with various strains of bacteria to improve soil nitrogen levels which in turn improved crops. However, farmers, depending upon the type of crop, ended up using different bacteria with different crops because: 1) different plants used different bacteria; and 2) some bacteria inhibited each other. By mixing the various bacteria together, the patent applicant in Funk brothers had basically eliminated the need to separately inoculate crops with different inoculant preparations. Myriad slip opinion at 13 citing Funk Brothers at 132.
The Funk Brothers Court held that “the composition was not patent eligible because it involved the combination of existing bacteria that were not altered in any way. Moreover, the utility of the mixture was due to the natural property of nitrogen fixation and therefore “fell squarely within the law of nature exception.” Myriad slip opinion at 13 quoting Funk Brothers at 132.
Based on the Funk Brothers holding, had the Chakrabarty patent involved merely mixing together various strains of natural-occurring, oil-metabolizing bacteria, the Chakrabarty Court would have presumably found the mixture ineligible for patent protection. This is because the invention would have been relying on natural phenomena to achieve a result. Under the law of nature exception, a patent on a newly discovered, unmodified strain of oil-metabolizing bacterium would also be patent ineligible because the law of nature exception applies to discoveries of previously unknown natural phenomena. The patentable genetically engineered bacterium in Chakrabarty, however, was created through human ingenuity wherein a new bacterium exhibited the following desirable property: the ability to effectively use all four different oil-metabolizing genes within one organism to effectively overcome the inhibition problem associated with the then-known, naturally occurring oil-metabolizing strains of bacteria. The result? A more efficient way to degrade crude oil through a new composition of matter that happened to be a living organism.
The detailed discussion of the Chakrabarty and Funk Brothers cases is presented because both holdings were relied on by the High Court in reaching the decision that isolated, unaltered gene sequences (as unaltered relates to no difference in nucleotide sequences between the isolated and DNA-embedded gense) are not patentable under § 101. According to the Myriad Court, the BRAC1 and BRAC2 gene sequences, including gene sequences with mutations, represented something that was always present in nature. The fact that both genes’ chromosomal locations and sequences were known prior to the time Myriad applied for its patents does not overcome the natural phenomenon exception to §101.
The High Court further opined that the isolated gene sequences, created by breaking chemical bonds to release the genes from the parent DNA molecule for use in genetic testing by well-known methods, do not represent modified genes eligible for patent protection. This is because the Myriad patent claims were focused on the genetic information encoded within the BRAC1 and BRAC2 genes, and this genetic information (nucleotide sequences) is contained within the isolated gene sequences. The Court was reluctant to find patent eligibility due to the scope of the sequence claims because even a chemically modified molecule that still contained the BRAC1 and BRAC2 gene sequences would be infringing according to the Myriad patent claims. This would be so even if the chemically modified molecule represented a new composition of matter created through human ingenuity and therefore in line with §101 and Chakrabarty. Under this analysis, excised gene sequences do not constitute a composition of matter that is something more than a mere product of nature. Myriad slip opinion at 15.
On the other hand, cDNA that contains the BRAC1 and BRAC2 gene sequences remain patent eligible at least under § 101 according to the High Court providing that the introns present in the isolated “parent” gene have been removed to create a form of DNA that is distinct from that found in nature. Complementary DNA made from short DNA sequences, however, would be patent ineligible if introns were not present due to the short length of the DNA. Myriad slip opinion at 17. Even if the resultant complementary DNA sequence is “dictated by nature” as the petitioners argued, the High Court noted that the “lab technician unquestionably creates something new.” Id.
It is important to note that the High Court’s analysis was based only on patent eligibility under § 101 and did not discuss whether the patents met the other requirements for patent eligibility under 35 U.S.C. §§ 102, 103, and 112. Myriad slip opinion at 17, note 9. The patent eligibility of cDNA sequences under Myriad must still meet the requirements of these non-§ 101 patent eligibility requirements (e.g., novelty and nonobviousness) even if they pass muster under §101.
4. Diagnostic Testing Method Claims Under §101 in View of Prometheus and Myriad
On March 20, 2012, the U.S. Supreme Court in a unanimous decision invalidated two patents licensed by Prometheus Laboratories (6,355,623 issued March 12, 2002 and 6,680,302 issued January 20, 2004) for methods related to treating IBD/Crohn’s disease and other gastrointestinal disorders by lowering or reducing the drug dosage by measuring the level of one or more the drug’s metabolites in patient’s blood sample. The decision overturned the Federal Circuit’s holding that the method claims met the requirements of § 101. The invalidated method claims were for increasing or reducing the dosage of drug for treating Crohn’s disease by measuring the level of one or more the drug’s metabolites in patient’s blood sample and comparing it against a claimed therapeutic range. Mayo Collaborative Science v. Prometheus Laboratories, Inc., 566 U.S. (2012).
Both diagnostic method patents at issue in the Prometheus case were based on the correlation between concentrations of certain metabolites in the patient’s blood resulting from the administration of a thiopurine drug to treat among other things, Crohn’s disease and the resultant beneficial or harmful effect on the patient. The High Court noted that the patents involved information/knowledge that was already understood. That is, as is the case with many drugs, thiopurine’s effective concentration for achieving the desired clinical effect may be accompanied by serious side effects. The ideal drug concentration for any drug is of course the one which achieves the desired clinical result with minimal or at least tolerable side effects.
The High Court also pointed out that at the time the subject patents were filed, the field already understood that thiopurine’s metabolites were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective. Indeed the patents cited a reference by Cuffari, et al, in a 1996 medical journal publication. However, at the time of this discovery, the actual concentrations of the metabolites(s) associated with both efficacy and non-harmful side effects was not known. Prometheus slip opinion at 8.
The High Court used a two-pronged approach to reach its conclusion that both patents were invalid under § 101. First, it determined if the claimed method was an unpatentable law of nature under §101. Second, it determined whether, even if they did include a law of nature, the method claims were sufficiently transformative to render them patentable under the Bilski line of cases.
Patent no. 6,355,623 provided for the following:
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder compromising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder.
wherein the level of 6-thioguainine less than about 230 pmol . . . indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6 thioguainine greater than 400 pmol . . indicates a need to decrease the amount of aid drug subsequently administered to said subject. Prometheus slip opinion at 9.
The High Court concluded that the method claims merely set forth laws of nature. Prometheus slip opinion at 8. That is, the relationship between a drug’s metabolite’s concentration is a natural indicator that the metabolite’s concentration can be used to establish the optimal dosage of a drug where optimal means that concentration which produces the desired effect with minimal serious side effects. Furthermore, this relationship of cause and effect is the result of the natural metabolic path ways by which drugs compounds are metabolized in the body. Drug metabolism is thus a natural process constituting a law of nature, and any patent that “simply describes that relation sets forth a natural law.” Id.
As with its cases involving laws of nature, natural phenomena, and abstract data, the High Court then determined whether the Prometheus claims did something substantially more than “simply describe” a natural relation. If so, the claims would qualify as patent-eligible processes that are not in and of themselves natural laws, but actually apply natural laws.
The Court found that the steps recited in the claims did nothing to convert them into patentable subject matter. For example, the “administering” step is simply telling doctors to administer thiopurine to the patient. The “determining” step is telling “doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” Prometheus slip opinion at 10.
Relying on its decision in the seminal Bilski v. Kappos case which involved an abstract idea, the Court also emphasized that the prohibition against patenting a law of nature [or an abstract idea as in Bilski] cannot be circumvented by attempting to limit the use of the application of a natural phenomenon to, in this case, a particular drug.
Finally, the Court dismissed the argument that Prometheus’ claims were patent eligible because the “claimed process involved transforming the human body by administering a thiopurine drug and transforming the blood by analyzing a thiopurine drug and transforming the blood by analyzing it to determine metabolite levels.” The Federal Circuit had used this reasoning to uphold the Prometheus claims based on the High Court’s reasoning in previous cases, including Bilski, that “transformation and reduction of an article to a different state or thing is the clue to the patentability of a process claim that does not include particular machines.” Prometheus slip opinion at opinion at 9
The High Court found the “transformation” argument unpersuasive given the nature of the steps involved because the relationship between the drug and its metabolites exists in principle apart from any human action. Prometheus slip opinion at opinion at 9 and 19. At best, the steps in the Court’s opinion were minimally transformative. The Court further emphasized that the Federal Circuit had misinterpreted its wording in the Bilski decision that stated that the “machine or transformation test is an important and useful clue to patentability” in finding that the Prometheus method claims were valid. In actuality, the Court had never used the test to trump the “law of nature exclusion.” Prometheus slip opinion at 19. For a detailed discussion on the “transformation” test relied on by the Federal Circuit relied on originally in the 2011 decision, see our previous blog entitled: “The Reach of Bilski from Biotechnology Patents to Financial Method Patents.”
The USPTO initiated another argument in favor of the Prometheus patents by arguing that “virtually any step beyond a statement of a law of nature itself should transform any unpatentable law of nature into a potentially patentable application to satisfy § 101’s demands.” The rationale was that the statutory provisions of U.S.C. § 102 would perform the screening function of weeding out weak transformative claims for “lack of novelty.” Prometheus slip opinion at 20.
The Prometheus Court disagreed because such an approach would render the “ ‘law of nature’ exception to § 101 patentability a dead letter, ”and would be inconsistent with prior law where the holdings were based on a §101 analysis only. The Court also pointed out that §§ 102 and 103 say nothing about “treating laws of nature as if they were part of the prior art when applying these sections.” Furthermore, “shifting the patent-eligibility to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that are not equipped to do.” Prometheus slip opinion at 21.
The High Court’s opinion also addressed the public policy issues raised by Prometheus and several amici on the one side and various medical professional groups on the other side. Prometheus and its proponents argued a decision to invalidate its patents would have a negative impact on the ability of medical researchers to make valuable discoveries in the area of medical diagnostic research which includes research leading to the discovery of laws of nature. Such expensive research has made the United States the world leader in this field and requires patent protection. Prometheus slip opinion at 22.
Opponents argued that the diagnostic patents such as the one at issue that such patents will “ ‘will result in a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.’ ” Prometheus slip opinion at 23.
In considering both arguments, the Court recognized the tension between the two view points, but ultimately refused to make an exception for medical diagnostic tests such as the ones at issue in Prometheus and which the Court deemed as representing laws of nature. Prometheus slip opinion at 23-24. As we have seen, similar arguments were made in the Myriad case, eventually culminating in the final decision by the High Court that isolated gene sequences are not patentable.
It is this commentator’s opinion that the High Court invalidated the patents at issue in Prometheus for a number of other reasons beyond a strict § 101 analysis. First, it was bothered by the fact that the relationship between the drug’s efficacy and its metabolite levels was known at the time the patent applications were filed even if the precise therapeutic range was not known. Prometheus slip opinion at 8. Second, the Court emphasized that the claims were directing doctors to engage in a “well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” Prometheus slip opinion at 10. Third, the “determining step” of the method claims was also so broad that it “tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use.” Yet the optimal concentration range of the metabolite specified in the claim was based only on the “research data” obtained from one type of well-known analytical procedure, reversed phase high performance liquid chromatography (HPLC). Id.
Furthermore, based on the prior art as indicated in the patent specification itself, it is even rather “odd” that the patents were even granted under §§ 102 and 103 quite apart from the § 101 issue that formed the basis for invalidation of the patents by the High Court. Indeed, not only was the “drug efficacy” relationship between the drug (6-thioguanine) and its metabolites known, but the HPLC to quantify the drug and its metabolites was well known. Prometheus slip opinion at 8.
After the High Court’s decision in Prometheus, the Federal Circuit reaffirmed its 2011 holding that Myriad’s method claims relating to comparison of gene (nucleic acid sequences) in tumor and normal cells were ineligible for patent protection under §101 because the methods represented nothing more than a patent ineligible abstract mental process, another exception to § 101 on August 16, 2012. Myriad (CAFC) slip opinion at 55. It further reaffirmed its holding that another claim involving a method of screening for a useful cancer therapeutic on the basis of its effect on the growth rate of host cells containing the cancer-causing mutations of the BRAC1 gene was, however, upheld under § 101 because the method requires the man-made transformation of a naturally-occurring cell to a cell with incorporated gene mutations. The method is used to assess cancer therapeutic effectivity as measured by the therapeutic’s effect on the mutated cell’s growth rate. Id.
The take home point from the High Court’s decisions in Myriad and Prometheus and the Federal Court’s most recent Myriad decision as they apply to diagnostic method claims, when read together, is that the medical diagnostics patent claims must involve something more than what may arguably be an abstract mental process (e.g., comparing gene sequences) or a law of nature (claiming a therapeutic range of naturally occurring drug metabolites to make medical decisions concerning drug dosage). In addition, any claimed reagent for performing the test that originates in nature should be a reagent that has been altered or transformed by the inventor(s) (e.g., host cells manipulated by man to contain cancer-causing mutations or a naturally occurring gene sequence that has been chemically linked to, for example, another bio-molecule). Such claims should continue to pass muster under a § 101 analysis.
5. The Implications of the High Court’s Myriad Decision
What exactly does the decision mean for the biotechnology industry? Certainly the Myriad decision is interesting from a political perspective. Indeed the United States argued before the Federal Circuit and the High Court that isolated DNA was not patent eligible but that cDNA was patent eligible. This fact caused the High Court to disregard Myriad’s argument that the High Court should “uphold its patents so as not to disturb the reliance interests of patent holders like itself.” Myriad slip pinion at 16, note. 7. The Court further opined that it was up to Congress to address reliance issues stemming from previous USPTO decisions that have been overturned by the courts. Id.
It is axiomatic that the biotechnology industry has created millions of jobs over the years and in many instances resulted in innovations in various industries ranging from healthcare to energy. Will the Myriad decision hurt the industry, perhaps by, for example, reducing R&D expenditures and thereby reducing jobs? Even the Myriad Court noted that “[w]e have recognized before that patent protection strikes a delicate balance between creating “ ‘incentives that lead to creation, invention, and discovery’ ” and “ ‘impeding the flow of information that might permit, indeed spur invention.’ ” Myriad slip opinion at 11 quoting Mayo Collaborative Science v. Prometheus Laboratories, Inc., 566 U.S. (2012).
The Federal Court’s own invalidation of Myriad’s genetic testing methods for evaluating patient blood samples will likely now also cause other companies to offer genetics testing for the BRAC1 and BRAC2 genes, probably resulting in more competitive pricing. As discussed above, such tests were offered many years ago before Myriad started exercising its right to exclude others from using the claimed genes as the patent owner of the gene sequences.
The Myriad decision may, however, in the long run actually have little impact on patent claims on § 101 grounds for genes utilized in novel, nonobvious diagnostic methods and therapeutic protocols where the genes are altered to serve as a man-made test/protocol reagent. As the High Court implies, genes altered via human intervention to convert them to “something other” than the form found in the gene, are patent eligible under § 101. Also, as stated in the last sentence of the opinion, the holding is actually arguably narrow because the Court “merely [held] that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.” Myriad slip opinion at 18. Yet the Court also noted that “[h]ad Myriad created an innovative method of manipulating genes while searching for the BRAC1 and BRAC2 genes, it could have possibly sought a method patent.” Myriad slip opinion at 17.
As for other claims contained within the Myriad patents, the High Court noted that the case did not involve patent claims on new applications of knowledge about the BRAC1 and BRAC2 genes. Myriad’s patents did in fact include claims on new applications of the BRCA1 and BRAC2 gene sequences were not challenged by the petitioners. Myriad slip opinion at 17.
Although the High Court’s decision has caused concern within the biotechnology industry, whether or not Congress will get involved in passing legislation to offer some sort of protection to the discoverer of naturally occurring gene sequences is a good question. Even the High Court noted that there is no question that Myriad Genetics engaged in extensive [and expensive] research efforts to locate and sequence the BRAC1 and BRAC2 genes, and this knowledge has assisted thousands of women and their doctors in making difficult healthcare decisions based on objective data. Yet, the Hihg Court also noted that Myriad’s gene patents have also prevented others from using the patented isolated gene sequences in other applications that may lead to further useful discoveries without threat of an infringement lawsuit.
As a compromise between the High Court’s “no protection” decision versus pre-Myriad available protections, perhaps Congress could consider carving out a special category for gene patents wherein the patent protection term is for a substantially shorter period than the current terms for utility patents (generally 20 years from the filing date subject to modification under patent law’s term adjustment term provisions) and design patents (14 years from the grant date). This approach would award those biotechnology companies some level of protection as a “special type” of intellectual property right for their efforts.
6. Suggestions for IP Risk Assessment Earlier than Later by Patent Counsel and Innovators
In conclusion, what can patent practitioners and innovators learn from the High Court’s and Federal Circuit’s “invalidating” Myriad and Prometheus holdings? That ideally the practitioner and/or management should be “brought in” early on in the R&D cycle to help educate the inventors and management as to important considerations concerning patentability. By understanding the requirements up-front, the innovators will have a much better understanding of what it will take to meet the requirements of a § 101 analysis.
Furthermore, risk analysis as it applies to getting patent protection should be an integral part of the innovation commercialization cycle so that steps can be taken early on to address potential patent-defeating issues. If the invention could conceivably fall into one of the exceptions to patentability under § 101, it is important that the risk analyzers critically determine if the invention is sufficiently transformative in view of the holdings of the line of cases from Bilski to Myriad so as to withstand a rejection under § 101.
The suggested approach is may be even more important now that the United States is a first-inventor-to-file country. Finally, the risk analysis might also include an assessment of the potential value of trade secret protection as an alternative to obtaining patent protection either in full or in part.
THE FOLLOWING IS NOT LEGAL ADVICE NOR SHOULD YOU CONSIDER IT AS SUCH. IT IS FOR INFORMATIONAL PURPOSES ONLY AND YOUR READING OF THIS BLOG DOES NOT CONSTITUTE AN ATTORNEY-CLIENT RELATIONSHIP. IF YOU ARE CONSIDERING AN ACTION THAT HAS LEGAL CONSEQUENCES, YOU SHOULD CONSULT WITH AN ATTORNEY OF YOUR CHOOSING.
© 2013 by the Attorneys at Troy & Schwartz, LLC, All Rights Reserved.
