Today in Bowman v. Monstanto Co., 569 U.S. __ (2013), a unanimous Supreme Court held that under the doctrine of patent exhaustion,the authorized sale of a patented article only gives the purchaser or any subsequent owner of the patented article the right to use or resell that article. It does not give the purchaser or any subsequent owner the right to make copies of the original article, even when the article being purchased inherently possesses the ability to make copies of itself. Continue reading this entry
The transcript for today’s Supreme Court oral argument in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) has been released, and the importance of the gene patenting debate to personalized medicine was discussed. The Court was well briefed on the issues and questioned the parties and U.S. government regarding why isolated genes should or should not be patent-eligible, the distinctions between DNA probes or primers and claims to full length sequences (isolated genomic DNA and cDNA) and the difficulty in crafting a test that would exclude broadly claimed inventions under Section 101 of the patent act rather than limiting broadly claimed inventions as failing under Section 102 (novelty) and/or Section 103 (obviousness). Continue reading this entry
The patenting of human genes in Australia remains under court review. As reported in the blog Patentology, an appeal of the Australian decision, Cancer Voices et al. v. Myriad Genetics Inc. et al., was filed on March 4, 2013 to a Full Bench of the Federal Court of Australia by the law firm of Maurice Blackburn on behalf of cancer survivor Yvonne D’Arcy. As reported in my February 19, 2013 post, the lower court upheld claims to isolated polynucleotides comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus. The polynucleotides can be RNA, DNA, cDNA and synthetic forms.
The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) recently issued recommendations regarding genetic testing or screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children (“Report”), the AAP and ACMG review the scenarios in which genetic testing or screening of minors may occur and recommend best practices for such testing.Continue reading this entry
The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should expand its jurisdiction to laboratory developed tests (“LDTs) performed by clinical laboratories. Continue reading this entry
Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the decision, as set forth in its Guidance Document distributed to patent examiners. Patent examiners are advised to follow the Guidance Document in examining a process claim (e.g., medical method claim) in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle in the Guidance Document) is a limiting element or step. Thus, a medical diagnostic claim that correlates or relates to a genetic marker or physiological measurement (typical in personalized medicine) is subject to the Guidance Document as the claim necessarily includes an element interpreted by the USPTO as a natural principle. Continue reading this entry
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics licensed applications (BLAs). Continue reading this entry
Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine. A recent report by Thomas Reuters (“Spotlight On … Personalized Medicine, A Pharma Matters Report,” the “Report”) summarizes the technical, regulatory and economic challenges the pharmaceutical industry faces as they move from the traditional drug development model to a personalized approach. Historically, the development of new molecular entities rely on developing drugs with annual sales over $1.0 billion. In contrast, personalized medicine will develop drugs and therapies targeted to smaller patient populations with significantly reduced annual sales. The Report also underscores the benefits of personalized medicine and highlights progress the pharmaceutical industry has made toward providing targeted therapies. Continue reading this entry
The collection, analysis and sharing of large amounts of information, such as genetic data, is an important part of the implementation and management of personalized medicine. Many health care providers are moving applications and other IT infrastructure components into “the cloud” to share and manage this information. However, the use of cloud computing is not without legal risks associated with hosting and accessing clinical data in the cloud computing environment. Continue reading this entry
Following up on my post examining the Myriad gene patenting case, which is heading to the Supreme Court, I had the chance to discuss the subject with Colin O’Keefe of LXBN. In the interview, I discuss the legal and commercial issues at the core of the controversy, and whether or not genes are indeed patented.
On December 3, 2012, Representative Mike Honda of California introduced The Healthcare Innovation and Marketplace Technologies Act (HIMTA), to foster more innovation in the health care industry by removing barriers in wireless health. See HR 6626, attached.
Office of Wireless Health
The bill would establish an Office of Wireless Health at the Food and Drug Administration (FDA) to coordinate with other governmental agencies and private industry, and provide recommendations to the FDA Commissioner on how to develop and maintain a consistent, reasonable, and predictable regulatory framework on wireless health issues. The goal of the Office of Wireless Health, according to Representative Honda’s office, is not to expand the mandate or responsibilities of the FDA, but rather to seek to better clarify and simplify existing regulations while providing sorely needed expertise in this important field.
The bill will also establish an mHealth developer support program at the Department of Health and Human Services to help mobile application developers build their devices in line with current privacy regulations. An array of support resources are envisioned, such as a national hotline, an educational website, and a yearly report that will help translate the wide array of privacy guidelines into common English.
Other goals of the bill include creating a marketplace for innovation by creating a low-interest small business loan program to clinics and physician offices for the purchasing of new health information technologies. It also would create a tax incentive program to allow medical providers to deduct costs related to non-electronic health record information technology. A grant program would also be established to assist medical care providers in retraining their employees into new positions that use health information technology.
Implications for Personalized Medicine
Personalized medicine is more than targeted therapeutics, it also involves direct patient involvement in monitoring and selecting therapies. Smart phones and other mobile devices will lead the way, offering a cost-effective truly mobile means to collect and monitor patient care. This bill, if enacted, should foster innovation in this growing trend in health care delivery and facilitate the coming electronic revolution in health data storage and management.
On November 30th, 2012, the U.S. Supreme Court will conference and consider whether to review the patent-eligibility of isolated DNA sequences. Our prior post of September 25, 2012 addressed Petitioners’ brief and request for review of the Federal Circuit’s decision that upheld the patent-eligibility of isolated DNA. On October 31st, 2012, Myriad Genetics, Inc. et al. responded and filed its brief in opposition to Supreme Court review (see our post of November 14, 2012). Seven “friend of the court” briefs were filed in support of Petitioners’ request for review and reversal of the Federal Circuit’s decision.
Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material.
The Draft provides provides that only legal entities established by law in China may engage in the collection and preservation of human genetic material. Foreign entities can conduct research with the cooperation of a Chinese entity. Such cooperation shall be subject to the approval of Ministry of Science and Technology of P.R.C (MOST). In addition, the foreign entity shall ensure that staff from the Chinese entity take part in the substantive research and development activity during the collaboration. Though the Draft does not provide that the Chinese party will retain title to any intellectual property developed from the collaboration, the Chinese entity is required to provide a report to MOST regarding the research and development activities within three months from the ending of the international cooperation. The Draft allows the ownership of intellectual property generated from the collaboration to be decided by agreement between the Chinese and foreign entities.
The Draft also notes that the export of human genetic resource sourced from the territory of China shall be subject to the approval of MOST. Because the Draft prohibits trading of human genetic resources, the foreign receiving unit must be the foreign party to the international cooperation approved by MOST. Human genetic resource material imported into China shall be registered with MOST.
A copy of the Draft Regulation on Human Genetic Resources 2012 is attached.
Special thanks to Foley & Lardner’s Max Lin for summarizing the Draft regulations. Max is resident in Foley’s Shanghai office.
On October 31, 2012, Myriad Genetics, Inc. et al. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or “ACLU”) quest for U.S. Supreme Court review in the ongoing legal battle over whether isolated DNA is patent-eligible subject matter. Myriad argued that U.S. Supreme Court review is not warranted, and that if it is, the question for the Supreme Court is not whether human genes are patentable, but whether isolated DNA molecules that were identified and defined by human inventors are patent-eligible subject matter in the United States. Continue reading this entry
Patents protect proprietary information but are of limited duration. After expiration, the patented technology becomes part of the public domain. Trade secrets, in contrast, never expire and therefore are not accessible to the public as long as the information remains secret. Thus, the authors of “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?“ argue that trade secret protection of genomic data is inappropriate because it impedes the free flow of information that is necessary to advance personalized medicine.
Myriad’s Proprietary Technology – Patents and Trade Secrets
In positioning their argument, the authors take aim at Myriad Genetics (“Myriad”), the provider of BRCA1/2 diagnostic testing. Through its diagnostic services, Myriad has tested nearly one million patients and compiled genetic data from the tests. In most instances, the authors argue, the test results are simple to interpret — whether or not the patient sample contains the wild type or variant version of the gene. In a minority of cases, however, sequence differences from wild type are difficult to interpret. These are variations of unknown significance (termed “VUS”) and are valuable to those tested and to other researchers who are trying to interpret the unknown variations. This information, which Myriad for the most part has chosen to maintain as a trade secret, creates an economic inequality that, the authors argue, was created through its patent monopoly. While Myriad has access to public databases in interpreting mutations, outsiders do not have access to Myriad’s data and analytic algorithm. Thus, the authors argue, Myriad’s proprietary database gives Myriad an indefinite exclusivity independent of patent protection unless and until others can repeat Myriad’s sequencing and analysis of patient samples.
Comprehensive databases of genetic information such as VUS data exist, but Myriad has not consistently contributed to them. The objectives of these databases and research consortia, the authors state, are to accumulate data and to refine interpretive methods in order to create publicly available information for improving clinical interpretation of genetic testing. The authors acknowledge that as public resources accumulate data, the value of proprietary databases will erode. In the meantime, however, health plans will pay for many genetic tests that cannot be accurately interpreted based on publicly available information. Several options for encouraging the sharing of this information are suggested.
One option is that free access be a prerequisite to publication. Those having access to genetic information should be required to share data and algorithms as a prerequisite to publication of that information. However, only those who choose to publish would be required to share the data.
Another option would require that databases that list mutations or availability of genetic tests (e.g., the NIH’s nascent Genetic Testing Registry) mandate that test providers share sequence data and interpretive algorithms as a condition of listing their tests.
Another option would rely on the power of payors and regulators. Health plan payors currently reimburse bundled genetic tests and interpretive services. Payors, it is argued, could demand the evidence underlying the clinical determinations when interpretations cannot be independently verified. Payors could also refuse payment unless clinically relevant data are shared and subject to independent verification.
The authors alternatively suggest that national authorities that regulate genomic tests mandate public disclosures as a condition of pre-market approval. Yet further, national and international institutions could fund research to re-create the data in proprietary databases by ensuring that results of genetic analysis be incorporated into large databases. Finally, national health systems could craft payment policies to create incentives for disclosure of data needed to interpret genetic tests – e.g., establishing payment codes for public deposit and interpretation of genomic data.
Patents, Trade Secrets and Public Benefit
One of the benefits of patents is their limited duration. After the patents expire, the technology is placed into the public domain in a manner that allows the public to reproduce the technology. Those involved in the debate over patenting genes (brought to the fore by the challenge to Myriad’s BRCA gene and testing patents, see for example, my prior post of September 25, 2012) have cautioned that removing the ability to protect intellectual property with patents could result in companies deciding to protect the information by the use of trade secrets, rather than patents. Thus, as noted by the authors, the public ultimately loses as the technologies may never enter the public domain.
While the authors pose some interesting solutions to gain access to Myriad’s technology, they never consider that if Myriad had chosen to patent the technology, the patents would expire and the technology would eventually become publicly available. Indeed, Myriad’s patents on the BRCA1/2 technology will expire in a few years. In addition, most patent applications are published prior to grant, thereby disclosing the technology 18 months after filing.
Myriad’s patents did not give rise to its expansive database, it was access to patient samples and Myriad’s expertise in analyzing that information and creating value from it. It is well documented that patents do not impede genetic research. In a recent letter to the journal Nature Methods, Jim Greenwood of the Biotechnology Industry Organization, reports that the number of reported patent lawsuits involving gene patents is practically nonexistent. “Gene patents do not hinder academic research” Nature Methods, Vol. 9(11), page 1039. He states:
“A 2008 study identified only six instances in which such patents had been briefly asserted against clinical diagnostic testing, and none against basic research. This finding is consistent with earlier reports by the US National Research Council and Walsh et al., [citation omitted] which found little empirical evidence to support the notion that patents created obstacles to biomedical research… Gene patents, like other patents, are critical to the development of basic research inventions into cures and therapies for patients as well as drought- and pest-resistant crops and renewable sources of energy. Encouraging the notion that scientists today routinely incur legal liability whenever they conduct genetic research may inflame public debate over ‘gene patents’ but it has nothing to do with a realistic appraisal of the role of patents in academic research. The likelihood that a researcher will infringe a technology patent by using a smartphone is much higher than the risk of infringing a ‘gene patent’ by doing benchwork.” (Embedded citations omitted)
The delivery of health care is in a period of intense transition as information garnered from the sequencing of complete genomes is being integrated into the development and delivery of clinical care. This information is necessary for the advancement and continued development of personalized medicine. As many parties touch this data, e.g., the laboratory technician, the research hospital, the drug developer and the clinician, the patient and her family is vulnerable to unauthorized access to and misuse of that information. Continue reading this entry
The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit’s decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16th post, the same three judges (Lourie, Bryson and Moore) held that isolated DNA and cells transformed with the DNA are patent-eligible. Claims that broadly claim detecting alterations in a gene, in this case the BRCA1 gene, were held to be patent-ineligible. The Ass’n for Molecular Pathology et al. v. USPTO, et al., No. 2010-1406 (Fed. Cir. 2012). In addition, the court determined that the plaintiffs had standing to maintain the action. This decision validates that the tools (DNA and isolated naturally occurring materials) underlying personalized medicine are still patent-eligible. Moreover, the court’s evaluation of the claimed methods are informative to those seeking to patent medical diagnostic tests because the court compared and contrasted a patent-ineligible claimed method to a patent eligible one.Continue reading this entry
Today, in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012), the Federal Circuit held that non-naturally occurring DNA is patent eligible as well as the use of a transformed, non-naturally occurring cell for screening drug candidates. Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent-ineligible. A copy of the Federal Circuit’s decision is attached Federal Circuit Myriad Decision. A detailed analysis by Foley & Lardner, LLP and this blog post will follow.
Advances in information technology, such as high-performance computing, enables the collection, analysis and sharing of information between patients and medical providers. Computer technology makes possible the sequencing and analysis of huge data sets of genomic information. It also connects clinical and genomic information to support personalized health care. As a result, life science companies and health care providers are incorporating hardware and software into the delivery of healthcare and the management of patient information. These technologies are patentable as business methods, provided the technologies satisfy the criteria for patentability: patent-eligibility, novelty, non-obviousness and adequacy of disclosure.Continue reading this entry
On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to isolated DNA, in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012) (“Mayo”). In Mayo, the U.S. Supreme Court held that that certain diagnostic inventions cannot be patented under 35 USC Secion 101 because they effectively claim a law of nature.Continue reading this entry
The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are advised to follow the Guidance Document in examining process claims in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a “natural principle” in the Guidance Document) is a limiting element or step. The revised procedure is effective as of its date of issuance, July 3, 2012.Continue reading this entry
In my June 10th, 2012 post, I noted a report on the current debate whether or not patents promote or impair innovation in the diagnostic field. Last week at the 2012 Biotechnology International Organization (BIO) International Convention, Joseph Damond, vice-president for international affairs at BIO reportedContinue reading this entry
The U.S. Patent Office recently announced that it will not be delivering its report on Genetic Testing as required under Section 27 of the America Invents Act (“AIA”) by the June 16, 2012 deadline.Continue reading this entry