In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the American Society of Clinical Oncology. Historically, FDA has exercised enforcement discretion when regulating LDTs and generally exempted them from regulatory requirements because LDTs have often consisted of low-risk diagnostics or tests for rare diseases with a physician evaluating the test results in the laboratory. Consequently, LDTs oftentimes have been marketed without premarket review by FDA.
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
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
If two or more actors jointly perform a patented method, is the claim infringed ? Late last week, in Akamai Technologies, Inc. v. Limelight Networks, Inc., and McKesson Technologies, Inc. v. Epic Systems Corp., __ F.3d __ (Fed. Cir. 2012)(“Akamai”) the Federal Circuit said yes, infringement can be found under 35 U.S.C. § 271(b) if a party induced others to act with him or induced others to perform all elements of the claim. In an en banc opinion, the court overruled its prior precedent which held that in order for a single party to be liable for induced infringement, a single entity must perform all elements of the claim. See BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007). The court in Akamai reasoned that a party who knowingly induces others to engage in acts that jointly practice the steps of a patented method – and those others perform those steps – has had precisely the same impact on the patentee as the party who induces the same infringement by a single infringer.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
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
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
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).
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.
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.
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
The Guardian reports that Mayo Clinic (“Mayo”) has announced that it is starting a pilot study to provide whole genome sequencing to patients. As reported, Mayo will launch the pilot study in early 2012 as part of an ambitious move towards an era of proactive genomics. Recall, Mayo Clinic is a named party in the legal challenge to Prometheus Laboratories’ patents on medical diagnostic methods. This challenge is currently awaiting resolution by the U.S. Supreme Court (see our December 7th post).
This post is co-authored by Antoinette F. Konski and Jacqueline D. Wright Bonilla
The U.S. Supreme Court entertained oral argument today in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The case is being closely monitored by the pharmaceutical and biotechnology industry, and in particular those in the industry that patent diagnostic methods and companion diagnostics. At its core, the case addresses whether certain patent claims directed to diagnostic methods or methods of optimizing therapeutic efficacy for treatment recite patent eligible subject matter under 35 U.S.C. § 101.
The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s full potential and benefits. This post summarizes the Coalition’s view of the state of the industry and the issues identified as critical to the ongoing development and adoption of personalized medicine.
On October 14, 2011 during Foley & Lardner’s life sciences conference “Winning Strategies: How to Create, Grow and Sustain a Successful Life Sciences Company”, I hosted a panel of industry experts speaking to the challenges and opportunities in realizing the promise of personalized medicine. While much progress has been made in removing legal, technical and regulatory barriers to making personalized medicine widely available to American citizens, much work needs to be done. Our panel comprised of Ken Goldman, Suneel Ratan and Anita Chawla, Ph.D., looked at those challenges and commented on the promise of personalized medicine. Copies of their presentations are provided here.
As the U.S. Supreme Court starts its next term on Oct. 3, 2011, the biotechnology industry is awaiting resolution of at least one of three pending disputes addressing the extent to which diagnostic medical methods are patent-eligible. Per colleague Hal Wegner, respondent’s U.S. Supreme Court brief in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is due Oct. 31, 2011 and oral argument is scheduled for Dec. 7, 2011. (See Hal’s List, TopTen2011Sept25 (2).pdf). U.S. Supreme Court certiorari petitions also are expected soon in two other recent Federal Circuit decisions raising similar issues: Classen Immunotherapies, Inc. v. Biogen Idec. and Assn. Molec. Path. et al. v. USPTO et al., (“ACLU/Myriad“, a/k/a “the gene patenting case”). Whether certiorari is granted in Classen and/or the ACLU/Myriad gene patenting case may provide some insight into whether the U.S. Supreme Court will tweak or revamp the Federal Circuit’s application of the Bilski “machine or transformation” patent-eligibility test to patents covering medical methods.
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.
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.
On August 31, 2011, the Federal Circuit issued a precedential decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), a patent case of significant interest to the personalized medicine industry. As with the Prometheus case, this case addresses patent-eligibility of certain types of method claims. The Federal Circuit decided Classen on remand from the Supreme Court after Bilski v. Kappos (U.S. 2010). The Federal Circuit previously issued a first decision in Classen in 2008. The original panel, comprising Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation), held in a one paragraph, non-precedential decision authored by Judge Moore that Classen’s claims failed to satisfy 35 USC § 101.
This time around, the Federal Circuit takes a closer look at Classen’s claims, and determines that two of the three Classen patents at issue are directed to patent-eligible subject matter under 35 USC § 101.
As most in the biotech industry know by now, the Federal Circuit recently issued its decision in Assn. Molec. Path. et al. v. USPTO et al., a case otherwise known as Myriad or the “gene patenting” case. For more discussion, see July 29 post and July 31 post. The majority (Judge Lourie, joined by Judge Moore) held all “isolated DNA” claims at issue patent-eligible under 35 U.S.C. §101. The majority (joined by both Judges Moore and Bryson) also held as patent-ineligible certain diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. Notably, each of the three judges on the panel wrote a separate opinion. In doing so, each expressed a different view, even if two of the three judges agreed on the ultimate holding regarding “isolated DNA,” and all judges agreed regarding the method claims at issue.
Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-on
On Friday, July 29, 2011, in one of the most controversial and publicized biotech patent cases in recent years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al. In a majority opinion by Judge Lourie, the court addressed the case on the merits, after finding that at least one plaintiff had standing to sue. The court held all “isolated DNA” claims at issue patent-eligible, but held as patent-ineligible diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. While this ruling could ultimately be subject to en banc review before all judges at the Federal Circuit and/or find its way to the Supreme Court, this decision now and its impact will undoubtedly be of great interest to everyone working in the biotechnology and diagnostic medicine fields.
On July 14, 2011, the FDA issued “Draft Guidance” relating to regulatory approval of in vitro companion diagnostic devices/tests, also called “IVD companion diagnostic devices.” The FDA intends the Guidance to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) who develop a companion diagnostic device intended for use with a corresponding therapeutic product. The FDA invites comments and suggestions regarding the Draft Guidance within 60 days.
On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform. Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value of genetic testing patents. Under Section 27 of H.R. 1249 the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed.
Today, in a short but sweet statement, the Supreme Court granted the petition for certiorari in Prometheus v. Mayo, 628 F.3d 1347 (Fed. Cir. 2010) (finding method claims relevant to personalized medicine patent eligible) (petition for cert. filed March 2011).
As discussed in our previous Personalized Medicine Bulletin post, parties once again petitioned for certiorari in the Prometheus case, after the Federal Circuit addressed this case (for the second time) in light of the Supreme Court’s decision in Bilski v. Kappos (2010). Because of the importance of this case to the personalized medicine industry, claims at issue in Prometheus bear repeating here. Representative claims include:
A patent’s value is determined by the economic monopoly provided to the patent holder. The claims of the patent define the monopoly and therefore are the core of its value. Infringement of a patent claim is the legal cause of action asserted by a patent holder, and one does not infringe a claim unless all elements of that claim are practiced. Nevertheless, under section 271(b) of the patent statute, one can still be held to infringe a claim if one actively encourages or urges another to infringe.