Personalized Medicine Bulletin The source for business, legal, and regulatory developments shaping an evolving industry

Category Archives: Genetic Testing

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.

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

“Human Genes” and Patents

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

At 10:00 A.M. on April 15th, the U.S. Supreme Court will entertain oral arguments in the dispute now known as the human “gene patenting” case. The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) is likely the highest profile patent dispute before the Supreme Court in recent history, arguably because it touches on issues concerning invention, innovation, investment, property rights and the delivery of health care. Arguing against the patenting of “human genes” and reversal of 30 years of U.S. patenting precedent is Christopher A. Hansen (on behalf of the American Civil Liberties Union (“ACLU”) and plaintiffs-petitioners). Gregory A. Castanias is representing defendants-respondents Myriad Genetics Inc. et al. (“Myriad”), arguing for the continued patent-eligibility of isolated human genes, cDNA and functional fragments of DNA. Solicitor General Donald B. Verrilli, Jr. is arguing on behalf of the U.S.government as amicus, supporting neither party in full.

What is a “Human Gene?”

“Are human genes patentable” is the sole question before the Supreme Court. Hidden within this deceptively simple question is what is specifically meant by the phrase “a human gene.” During this dispute, the patent claims at issue have been argued to cover a complete human gene (including contiguous coding and non-coding regions), artificial, human-generated, contiguous DNA sequences (cDNA and recombinant DNA) and functional gene fragments being identical to portions of a human gene. In its recent Reply Brief, the ACLU argues that the term “a human gene” includes isolated human DNA, cDNA and fragments, but excludes recombinant DNA. The ultimate construction of the term “a human gene” is key to whether or not gene patents preempt the use of laws and products of nature; a policy issue that has been heavily briefed and argued by the parties and amici.

Naturally-Occurring Genes

In its Reply Brief, the ACLU responds to Myriad and its amici’s concern that a ruling in petitioner’s favor might prevent useful patents on tests, drugs, other DNA-related compositions such as recombinant DNA, or patents limited to particular uses by opining that the question before the Supreme Court does not touch recombinant DNA (DNA that results from choosing fragments from genes or chromosomes that do not appear together in nature and “stitching them together”), recombinant therapeutic proteins, or genetically engineered antibodies. (Page 2 of Reply Brief.)

The ACLU argues that in contrast to recombinant DNA, DNA isolated or purified from a human (complete gene sequences and fragments of genes) should not be patent-eligible because the acts of finding, separating and characterizing a DNA molecule do not present structural distinctions between the DNA or gene as it exists in the human body. The ACLU also dismisses Myriad’s new uses of isolated DNA over DNA in the human body, on the ground that these arguments only speak to methods for using materials (relevant only to method or use patents) and not patents claiming compositions such as isolated DNA.

Patent-Eligibility of cDNA

The ACLU takes the position that the patent-eligibility of cDNA is not at issue, but should the Supreme Court decide to take on this issue, it should find that cDNA is not patent-eligible. cDNA (an abbreviation of complementary DNA) is synthesized in a laboratory from a messenger RNA (“mRNA”) template. Certain of Myriad’s patent claims at issue are limited to cDNA by reference to a specific nucleotide sequence which was determined by a process of reverse transcribing messenger RNA. The ACLU first takes issue with Myriad’s construction of the cDNA claim because, in its opinion, the claim does not identify the sequence as cDNA. The ACLU opines that thus, the claim arguably covers any isolated DNA with that nucleotide sequence. Moreover, the act of creating cDNA is, in the ACLU’s opinion, as simple as linking the mRNA fragments to form one template that codes a functional protein like magnets on a string.

Interestingly, in the ACLU’s view, cDNA is distinct from recombinant DNA, “which is created when a geneticist selects cDNA or DNA fragments from different sources and intentionally stitches them together. (Page 10 of Reply Brief). Any cDNA that “simply mirrors naturally-occurring mRNA is a product of nature and a basic scientific tool” and therefore is argued to be patent-ineligible. (Page 10 of Reply Brief).

A Question of Claim Construction

The history of this dispute is unusual in that the patent claims at issue were never construed, a process by which the parties and at times the court interpret patent claims to determine their scope and meaning. Indeed, any patent analysis, whether to determine patent infringement or patent invalidity, requires a construction of the patent claims. Construction of Myriad’s patent claims would have served as clear notice to the amici and public as to what subject matter was objectionable and why. Without this fundamental analysis, the parties and amici have appeared to struggle with what is clearly at issue here – the patenting of any DNA that has some sequence identity to a human gene or only purified whole gene sequences? Indeed, one sensible approach for the Supreme Court would be to remand for construction of the patent claims.  

The ACLU in its Reply Brief has moved from its prior policy-heavy arguments of preemption and public health to a more traditional analysis of the claim language and whether that language satisfies the statute that governs patent-eligible subject matter. Whether and how the Supreme Court handles the same issue will be telling as to its ultimate decision and more importantly, the effect if any, of the possible exclusion of human DNA or genes from the U.S. patent system.

Business Models for Personalized Medicine

Posted by Antoinette Konski on Posted in Economics of Innovation; FDA; FDA Guidelines; Genetic Testing; Personalized Medicine; Reimbursement

Personalized medicine is moving from concept to reality, fueled in part by advances in sequencing technology and data analysis. However, significant business challenges remain that hinder growth and adoption of personalized health care. One such challenge how to is pay for the research and development of new diagnostics and therapies when the target patient population does not fit the traditional pharma “block buster” model. Thus, the health care industry is searching for viable business models to fund personalized therapies and companion diagnostics. How does one attract investment? How does one navigate the regulatory pathway? Will payors reimburse the diagnostic? How does one price the product and service?

The Personalized Medicine Business Summit will tackle these issues on May 14th, in San Francisco. Industry heavyweights such as Steve Burrill, Dr. Elizabeth Mansfield of FDA and Ronnie Andrews of Life Technologies will share their experience and insights on evolving business models for personalized medicine.  Further information is provided at www.personalizedmedicinesummit.com.

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.

Preparing to Comply With the HITECH Final Rule

Posted by Antoinette Konski on Posted in Genetic Testing; Health Care IT; Privacy

As reported in my January 24th, 2013 post, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued an omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). In addition to finalizing proposed regulations set forth in a proposed rule dated July 14, 2010, it also addressed other HIPAA provisions. It also finalized a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA). Continue reading this entry

Genetic Testing and Screening of Children: Ethics and Best Practices

Posted by Antoinette Konski on Posted in Genetic Testing; Genomics; Privacy; Uncategorized

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

Petitioners File Supreme Court “Gene Patenting” Brief

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

Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. (“Myriad”) were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)(“Mayo”). A copy of the brief is attached [MyriadPetitionersMeritsBrief].Continue reading this entry

HIPAA/HITECH Regs Implement GINA Genetic Privacy Provisions

Posted by Antoinette Konski on Posted in Genetic Testing; Privacy

On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued the long-awaited omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). Most of the Rule finalizes numerous proposed regulations set forth in a proposed rule dated July 14, 2010 (the Proposed Rule), which focused on the HITECH Act but also addressed other HIPAA provisions. The Rule also finalizes a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA).

Foley & Lardner, LLP provides an Executive Summary of the Rule and recommendations for preparing to comply. To learn more click here.

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.

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)

Patent Pool Simplifies Development of Personalized Medicine

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

One argument often cited against patenting is that multiple patents can cover one product, its preparation and use, creating a so-called “patent thicket” that must be unwound like a bowl of spaghetti before a new technology is free of potential liability. Cooperation and collaboration among patent holders in the form of a patent pool is one means to provide a one-stop-shop for coordination and management of patented technology. A patent pool is an agreement among patent holders to provide access to patented technologies based on an agreed-upon fee structure. Patent pools have been used in high technology and other fields but typically not in technologies supporting health care.

The National Institutes for Health announced the formation of a patent pool to provide a one-stop shop for worldwide access to diagnostic discoveries for personalized medicine. The pool is managed by MPEG LA and available under the name “the Librassay.” MPEG LA promotes the Librassay as a landmark collaboration among the National Institutes of Health (NIH) and other leading health care innovators, such as Johns Hopkins University, the Ludwig Institute for Cancer Research, Memorial Sloan-Kettering Cancer Center, Partners HealthCare, The Board of Trustees of the Leland Stanford Junior University, The Trustees of the University of Pennsylvania and the University of California, San Francisco.

This and similar collaborations are supportive of the advancement of personalized medicine and underlying technologies. For example, simplified and coordinated access to numerous patented technologies would support whole genome sequencing, which sequences and identifies numerous genetic markers simultaneously.

More on Myriad — “Gene Patenting” Debate Continues

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Diagnostic Methods; Gene Patents; Genetic Testing; Personalized Medicine
As promised in my earlier post, today our firm issued its review of the much anticipated decision regarding the “gene patenting” case (formally known as The Association For Molecular Pathology. et al. v. USPTO et al.) The case was before the Federal Circuit on remand from the U.S. Supreme Court’s March 20, 2012 decision in Mayo Collaborative Services v. Prometheus, Inc. The same three-judge panel heard the case on remand, and the judges reached essentially the same results on the interpretation of  the patent-eligibility of claims under 35 USC § 101 as their earlier decision on the issues. Judge Lourie wrote the opinion for the court, Judge Moore concurred in the result, and Judge Bryson concurred in part and dissented in part. Read Foley & Lardner’s review and analysis here and Courtenay Brinckerhoff’s PharmaPatents post.

Federal Circuit – Non-Naturally DNA Patent-Eligible

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

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.

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

What’s Patentable After Prometheus? USPTO Issues Interim Response

Posted by Antoinette Konski on Posted in Diagnostic Methods; Genetic Testing; Prometheus

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

Status Update on the Genetic Testing Study

Posted by Antoinette Konski on Posted in AIA; Diagnostic Methods; Genetic Testing; Personalized Medicine

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

Myriad Urges Dismissal of “Gene Patenting” Case

Posted by Antoinette Konski on Posted in Gene Patents; Genetic Testing; Genomics

Yesterday Myriad urged the Federal Circuit to dismiss the “gene patenting” case on the ground that subject matter jurisdiction no longer exists. Myriad argued that in the alternative, the case should be remanded to the district court to address whether declaratory-judgment jurisdiction exists under the current facts of the dispute. 

Continue reading this entry

Patent-Eligibility of Diagnostic Patents Reconsidered in Canada

Posted by Antoinette Konski on Posted in Diagnostic Methods; Gene Patents; Genetic Testing

The Canadian Patent Office released today practice guidelines regarding the patent-eligibility of medical diagnostic methods and medical methods. The practice guidance are in effect immediately and until further notice, and in place of any contrary guidance presently in the Canadian Manual of Patent Office Practice (MOPOP, the Canadian equivalent to the US MPEP, setting forth examination criteria for patent applications).

Diagnostic Methods

The guidance document indicates that many diagnostic methods can be thought of as comprising two distinct aspects: data acquisition steps and data analysis steps. A claim often contains one or more data acquisition steps, such as a step for determining, measuring, identifying, assaying, etc. which may be implicit or explicit. Diagnostic methods are patentable before the Canadian Patent Office if the claim describing the method satisfies all the requirements of patentability, i.e., novelty, inventive, useful, sufficiently disclosed and unambiguously defined and contains an inventive concept that is statutory.

In order to be patentable, the inventive concept of the diagnostic method claim must provide a solution to a technical problem and either have physical existence or manifest a discernible effect or change. If the claim includes at least on step of physically acquiring data from an analyte (such as a substrate, marker, tissue, body, for example) then the inventive concept is statutory. However, where a known analyte had been previously assessed using the same or similar technique to those in the claim, the inventive concept may therefore be limited to the significance, understanding or interpretation of the acquired data. In these situations, the claim is not statutory because the inventive concept is limited ot the interpretation of the acquired data.

Medical Uses

The guidance also emphasizes that medical methods are not statutory in Canada, while medical use claims are permitted, as long as do not equate to medical or surgical methods and they satisfy all other requirements of patentability.

For patent-eligibilty, the inventive concept of a medical use claim must provide a solution to a technical problem and have either physical evidence or manifest a discernible effect or change. If a claim to a medical use includes a dosage regime or range for the purpose of defining patentability, the inventive concept does not need to include that dosage regime or range if the use itself meets all the requirements for patentability. In contrast, if the inventive concept requires a dosage regime or range, then the inventive concept is considered to be a methods of medical treatment, and therefore not patent-eligibility.

Similarly, where the inventive concept necessary to support patentability only serves to instruct a medical professional “how” or “when” to treat a patient, rather than “what” to use, this may not be patent-eligible as the claim would encompass a method of medical treatment.

Prometheus’ Claims in Canada

As those in the medical industry reconsider US patent strategies in light of Prometheus and the expected US PTO guidance for examiners for medical diagnostic methods, (see our posts of March 20, 2012 and March 25, 2012), the patenting of similar technologies in other jurisdications is of concern as global patenting strategies adopt to the uncertainty of the application of Prometheus by the US PTO.

Canada’s recent guidance appears to follow the US Supreme Court holding that such claims are not patent-eligible for failing to claim a patent-eligible method.

The  “determining” step of the Prometheus claims was stated by the US Supreme Court to add nothing of signficance to the art, and merely told doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field. In interpretating the “determining” element under the Canadian guidelines, the inventive concept would be limited to significance, understanding or understanding of the acquired data (as stated by the “wherein” clause of the claim) because the element was previously assessed using the same or equivalent analytical techniques known in the art.

The “wherein” clause would also fail to rescue the claim under the Canadian guidelines as it could be argued to be an expression of the understanding of the discovery of the significance of the acquired data. 

Finally, the “administering” step also was admitted to be known to those in the art and could be precluded from the claim in Canada as being directed to claiming a method of medical treatment.

However, if a diagnostic method is tied to the use of a therapeutic and that use would meets all the other requirements of patentability then the claim is more likely to possess the requisite inventive concept. In addition, if the “determining” step of the claim utilizes analytical techniques unknown to the skilled artisan, the claim is more likely patent-eligible.

A copy of the practice guidelines is available here.

Video Interview: Discussing Mayo v. Prometheus With LXBN TV

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

The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts on what this means for the Myriad “gene patenting” case.

Presidential Commission to Study Management of, and Access to, Human Genome Sequencing Data

Posted by Antoinette Konski on Posted in Bioethics; Genetic Testing; Genomics; Privacy

On November 24, 2009, President Obama established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him on bioethical issues generated by novel and emerging research in biomedical and related areas of science and technology. As part of this initiative, the Commission issued a Notice on March 27, 2012 (Federal Register) seeking comments on the ethical issues raised by the ready availability of large-scale human genome sequencing data.

Privacy And Access

Tremendous technological advances have reduced the cost of sequencing to the point where relatively inexpensive, rapid sequencing of whole genomes is not only likely but imminent. The emergence of this new technology raises, for the Commission, issues how this information can and ought to be collected, used, and governed. Of particular initial interest are issues relating to the privacy of and access to this information by patients, researchers, and medical professionals.

The Commission is particularly interested in comments informing policies, practices, research, and perspective on issues of privacy and data access as they relate to the integration of large scale human genome sequencing into research and clinical care. Of additional interest are models and mechanisms for protecting privacy in both genetic/genomic databases of sensitive information and the sharing and management of information and access to large-scale human genomic data. 

To Submit Comments

Individuals, groups, and organizations interested in commenting may submit comments by email to info@bioethics.gov or by mail to the following address:

Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005.

To assure consideration, comments must be received by May 25, 2012.

For additional insight into the Commission’s thinking on the issues concerning genetic testing, see the Commission’s blog. 

 

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.”

 

Dissecting Prometheus – My Wish List

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic Testing

In his March 23rd Patently-O blog, Dennis Crouch posted a U.S. Patent and Trademark Office memorandum to examiners setting forth the Office’s current thinking on application of the U.S. Supreme Court’s recent Mayo v. Prometheus holding to patent examination. The memorandum preliminarily advises examiners to reject a patent claim under 35 U.S.C. § 101 if the claim Continue reading this entry

U.S. Supreme Court: Prometheus’ Patents Set Forth Laws of Nature

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

The U.S. Supreme Court reversed the Federal Circuit and held that Prometheus’ patents claiming a method to optimize therapeutic efficacy for the treatment of immune-mediated gastrointestinal disorders were invalid. Mayo Collaborative Services v. Prometheus Laboratories, Inc., __ U.S. __ (2012). [Prometheus] Justice Breyer, writing for a unanimous Supreme Court, held that Prometheus’ patent claims set forth laws of nature, namely the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.  Laws of nature, the Justice noted, are excluded from patentable subject matter.

Continue reading this entry