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Tag Archives: Gene Patenting

Isolated DNA Is Not Patent-Eligible

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Gene Patents; Genetic Testing; Personalized Medicine

Today the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013) (opinion here), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible. Justice Thomas, who delivered the opinion of the Court, stated that claims to isolated DNA (in this case, isolated BRCA1 and BRCA2 genes that are used to determine an increased risk of certain cancers) are excluded for falling within the law of nature exception to patent-eligibility. The Court conceded that Myriad found the location of the BRCA1 and BRCA2 genes, but that this discovery, by itself, does not render the BRCA genes new compositions of matter that are patent-eligible. The Court explained that with respect to isolated DNA molecules:

In this case, … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the Section 101 inquiry. (citing Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).

In contrast to isolated DNA, altered or modified DNA, the Court explained, remain patent-eligible as well as applications of any information gleaned from the isolation of the gene or a new method used to isolate the DNA. The Court in footnote 8 also noted that the possibility that an unusual and rare phenomenon that might randomly create a molecule similar to one created synthetically, such as a synthetic cDNA molecule made through human ingenuity, would not render the synthetic molecule unpatentable.

Thus, the Supreme Court has removed from patent-eligibility a class of discoveries that has been the backbone of the biotechnology industry for the last few decades. Isolated DNA molecules, such as isolated genes that describe the gene as it exists in nature, microRNA and interfering RNA, if claimed as isolated molecules, now fail the Supreme Court’s patent-eligibility test. To meet the new standard, the patent claim must contain an element that explicitly shows human intervention, such as a modification to the DNA sequence or the addition of an element useful in the application of the technology. Unlike the Supreme Court’s Prometheus decision which incorporated patent concepts of novelty and non-obviousness into the patent-eligibility standard, this Myriad decision did not intermix the separate criteria for patentability. Therefore it is likely that if the isolated DNA molecule is novel and non-obvious, the addition of the element showing human intervention into the claim would qualify the claim for patent-eligibility under the new standard.

On the same day that the Supreme Court issued its decision, the USPTO issued guidelines (attached) for its examiners instructing them that isolated DNA molecules that are unaltered should be rejected for failing to satisfy 35 U.S.C. Section 101. Synthetic or altered DNA molecules remain patent-eligible.

Video Interview: Discussing the Supreme Court’s Oral Arguments in Myriad Gene Patenting Case

Posted by Antoinette Konski on Posted in Gene Patents; Personalized Medicine

Earlier this week, I had the opportunity to speak again with Colin O’Keefe of LXBN regarding last week’s oral arguments in Association for Molecular Pathology v. Myriad Genetics. In the interview, I share some quick observations on the oral arguments and offer my thoughts why I believe the Justices will “split the baby” with their ruling.

Personalized Medicine and the Gene Patenting Debate

Posted by Antoinette Konski on Posted in Gene Patents; Genetic Testing; Personalized Medicine

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

Australian “Gene Patenting” Case to be Appealed

Posted by Antoinette Konski on Posted in Gene Patents; Genetic Testing; Personalized Medicine

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.

Myriad Posts Gene Patenting Victory in Australia

Posted by Antoinette Konski on Posted in Gene Patents; Uncategorized

In a companion case to the “gene patenting” dispute presently before the U.S. Supreme Court, Myriad Genetics, Inc. successfully defended the patent-eligibility of “gene patents” in Australia. In Cancer Voices et al. v. Myriad Genetics Inc. et al. [Myriad] the Federal Court of Australia held that a claim that covers an isolated naturally occurring nucleic acid – either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) – is patentable provided that the other requirements for patentability have been met.  

The Challenged Claims

The challenged patent entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene” claims 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 invention also includes detection methods, isolated antibodies, and screening methods.

Legal Analysis

In reaching its holding, the Australian court reviewed the relevant case law in Australia and the United States and its application to the patenting of products of nature. The court highlighted prior decisions where the technology may depend on the operation of natural laws or the natural properties of the materials involved. Similar to Judge Lourie’s reasoning in the companion U.S. case [see prior post of August 16, 2012], the Australian court focused on the isolated nature of genetic material. Isolated or purified nucleic acids, the court reasoned, is the product of human intervention. Moreover, the court placed importance on the long standing practice of patenting isolated DNA in Australia and other countries. The court also determined that it would be difficult, on any rational basis, to confine the holding of this case to patenting in other fields, such as the patenting of pure and isolated chemicals that occur in nature; where the consequences of such are unknown.

Myriad and the biotechnology community now wait for the U.S. Supreme Court’s review of the patent-eligibility of human genes. Oral argument is expected in April. Stay tuned.

Are Human Genes Patentable?

Posted by Antoinette Konski on Posted in Diagnostic Methods; Gene Patents; Personalized Medicine

As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?” The issue arises from the long-running dispute among a consortium of plaintiffs, led by the American Civil Liberties Union (collectively “ACLU”) who sued Myriad Genetics, Inc. and the Directors of the University of of Utah Research Foundation (collectively “Myriad”) challenging the patentability of composition and method claims related to human genetics. The Supreme Court’s opinion has the potential to overrule over 30 years USPTO practice that supported the growth of the U.S. biotechnology industry. Continue reading this entry

Amici Urge Reversal of “Gene Patenting” Decision

Posted by Antoinette Konski on Posted in Genetic Testing; Personalized Medicine

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.

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Myriad Responds: ACLU Asks The Wrong Question

Posted by Antoinette Konski on Posted in Gene Patents; Personalized Medicine; Prometheus

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

Genetic Data, Patents, and Trade Secrets

Posted by Antoinette Konski on Posted in Gene Patents; Genetic Testing; Infringement; Personalized Medicine

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.

Policy Options

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)

Personalized Medicine After the ACLU “Gene Patenting” Decision

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Diagnostic Methods; Gene Patents; Personalized Medicine; Prometheus

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

ACLU “Gene Patenting” Case Argued at Federal Circuit

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Gene Patents; Genetic Testing; Prometheus

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

Gene Patents and Diagnostics: The Economics of Innovation

Posted by Antoinette Konski on Posted in Gene Patents

The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael Hopkins and Stuart Hogarth argue in the recent issue of Nature Biotechnology. “Biomarker patents for diagnostics: problem or solution?” Nature Biotechnology, Vol. 30(6): 498-500. Consistent with the biomedical model, many innovators have relied on patents and the temporary monopoly patents provide to recoup the cost of innovation, but the appropriateness of this model is being challenged. Whether are not patents covering diagnostic medical tests support or spurn innovation was considered in the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus, Inc., decision, (see our March 20th post) and is currently under review by the U.S. Patent and Trademark Office (see our January 25th post). The issue also is central to the ACLU’s challenge to the patenting of isolated DNA now before the Federal Circuit in the Association for Molecular Pathology v. Myriad Genetics et al. or the ”gene patenting case” recently sent back to the Federal Circuit for reconsideration in light of the U.S. Supreme Court’s Mayo decision (see our March 26th post.) Patents for this technology are argued to be unnecessary as the cost of providing the tests are low and could prevent clinical scientists in hospital laboratories from developing and offering their services.

A Missed Opportunity

The co-authors suggest that whatever judgments are made against gene patents, the debate thus far has missed an opportunity to consider the wider issue of diagnostic patents and their role in innovation. The conclusions drawn by the co-authors were informed by a seminar convened in London in 2010 by the Human Genetics Commission, whose membership included hospital staff, diagnostic and pharmaceutical firms, research funders, lawyers and ethicists. The co-authors also note that the context of the debate differs between Europe and the United States. However, several important points are raised by the co-authors that are relevant to the ongoing debate in the United States.

Changing Regulations

For too long, the co-authors note, the gene-patenting debate has been framed by an innovation model that assumes low regulatory barriers to market entry and an easy path to market and clinical adoption. Recent evidence suggests that low-cost and therefore easy market entry is no longer the norm. Test developers are now being asked to provide more evidence, not less, and more quickly, and conventional business models do not support large-scale trials of the utility of new biomarkers. In addition, as noted in our January 24th post, the U.S. Food and Drug Administration will begin regulating laboratory developed tests offered as companion diagnostics.

The SACGHS Report

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) for the U.S. Department of Health and Human Services has often been cited by those who oppose the patenting of this technology. The SACGHS committee concluded that the exclusivity provided by patents or licenses had not been necessary to ensure that tests were developed and made available to patients. What is lost in the discussion but noted by Hopkins and Hogarth is that the evidence informing the SACGHS report and conclusion was mainly limited to tests for the diagnosis of rare genetic disorders. Tests related to, for example, infectious agents and drug metabolism were neglected in the SACGHS analysis. The co-authors report that the approach SACGHS took on framing the issues and evidence split their committee, with dissenters writing that the burden of regulatory compliance and the need for clinical utility were pushing up R & D costs for test development. IP was therefore required to incentivize companies to invest in this technology.

Who Will Pay for Personalized Medicine?

The co-authors also argue that extensive evidence is necessary for a biomarker’s acceptance by drug regulators and health care providers. Such evidence includes, for example, that the biomarker accurately and reliably identifies the target population. If the biomarker is tied to a drug under development by a pharmaceutical company, the drug company has the economic incentive to fund the necessary research.  IP can serve additional strategic roles – stakeholders such as diagnostic developers, pharmaceutical companies and regulators are increasingly eager to control who provides diagnostic tests in the future, because safe, speedy and effective prescription of drugs will depend on reliable diagnostics. However, if the test is not tied to the company’s drug, incentives to fund the development of the diagnostic are less obvious. Hopkins and Hogarth cite the case of Roche’s AmpliChip CYP450 as an example of a test that has been approved by the FDA but not widely adopted because follow-up studies to establish its clinical utility were not completed. Although Roche shepherded the test through the FDA, it did not invest in the necessary clinical studies demanded for wide-spread adoption of the technology. The co-authors note that Roche holds no patents or exclusive licenses on the genes encoding CYP450 and that therefore any investment it makes in building the clinical evidence would also benefit rival companies who have entered the CYP450 market or are preparing to do so.

No Easy Answers

Hopkins and Hogarth provide no simple solution to the question of what should be done to ensure that well-validated diagnostics are made available to patients. They encourage continued public debate by all stakeholders to address the contentious issues that surround funding of research and development to generate evidence on the safe and effective use of diagnostics with clinical utility. In concluding this informative report, the co-authors argue that one point is clear: supporting innovation in the diagnostics sector while ensuring patient access to valuable new tests will require different strategies for different circumstances. Even previously controversial options, such at patented diagnostics and exclusive licenses that restrict market entrants, may have a part to play.

Gene Patenting Case Heads Back to Federal Circuit

Posted by Antoinette Konski on Posted in Companion Diagnostics; Gene Patents; Genetic Testing

The U.S. Supreme Court has sent the ACLU “gene patenting” case back to the Federal Circuit for reconsideration in light of its unanimous decision in  Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012). For a review of the issues, please see Foley & Lardner’s client alert “Supreme Court Tells Federal Circuit to Reconsider Patent Eligibility of Isolated DNA Claims.”

 

U.K. Supreme Court in HGS v. Eli Lilly Determines “Gene Patent” Meets European “Industrial Application” Requirement

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Gene Patents; Genetic Testing; UK/EP Patent Cases

On November 2, 2011, England’s highest court issued an important decision, Human Genome Sciences v. Eli Lilly, relating to biotechnology and claims directed to genes in particular, and consequently personalized medicine. Interestingly, claims at issue in this U.K. case are very similar to the type of compositions claims at issue in the U.S. Myriad “gene patenting” case. See our previous posts on Myriad, such as our August 9, 2011 post. Specifically, in both cases, claims relate to “isolated DNA” encoding a particular amino acid sequence. 

That said, the U.K. case resolves around whether the patent is valid under the requirement that an invention be “susceptible of industrial application” under Articles 52 and 57 of the European Patent Convention (the EPC). This EPC requirement mirrors the U.S. “utility” requirement under 35 U.S.C. §101, rather than subject matter eligibility under §101 at issue in Myriad. The U.K court reversed the lower court to find that HGS’s patent satisfied the industrial application requirement. 

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U.S. Patent Reform – USPTO Solicits Public Comment Regarding Genetic Testing Study

Posted by Jackie Wright Bonilla on Posted in Biomarkers; Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic Testing; Patent Reform

As most in the patent community know, last Friday, September 16, 2011, President Obama signed into law the long-awaited patent reform bill, known as the Leahy-Smith America Invents Act (“AIA”). There are many moving parts to this complicated piece of legislation—many consider it to implement the most sweeping changes to U.S. patent law since enactment of the 1952 Patent Act.

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Federal Circuit Denies ACLU’s Petition for Panel Rehearing in Myriad “Gene Patenting” Case

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Gene Patents; Petitions for Rehearing

For those of you closely following Assn. Molec. Path. et al. v. USPTO et al., otherwise known as the Myriad “gene patenting” case, you already know that both sides petitioned the Federal Circuit for a rehearing by the three-judge panel (not en banc), albeit for different reasons. Specifically, on August 25, 2011, on behalf of Plaintiffs/Appellees, the ACLU filed a Petition for Panel Rehearing on the merits, while Myriad/Appellant filed its own Petition for Panel Rehearing on the standing issue four days later. Both parties filed petitions in response to the precedential decision by the Federal Circuit on July 29, 2011. The latest update is that yesterday, September 13, 2011, the Federal Circuit denied ACLU’s petition, although we still await word on Myriad’s petition.

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U.S. Patent Reform – What Does It Mean To Personalized Medicine?

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic Testing; Patent Reform

Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action by President Obama, who has already promised to sign the bill.

Most provisions in the bill impact U.S. patent practice generally, including moving towards a first-to-file system, expanding prior user rights as a defense to infringement, eliminating interference proceedings, and creating new USPTO proceedings for post-grant review. One aspect of the bill, however, in a section entitled “Study on Genetic Testing,” impacts the personalized medicine industry in particular.  See previous discussion on this provision on our June 26 post and August 3 post.

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