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Tag Archives: Prometheus

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Posted by Antoinette Konski on Posted in Biomarkers; Companion Diagnostics; Personalized Medicine

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to satisfy 35 U.S.C. Section 101. (See PerkinElmer, Inc. v. Intema Ltd., 496 F. App’x 65, 105, U.S.P.Q.2d 1960 (Fed. Cir. 2012)). Late last month, Intema petitioned the U.S. Supreme Court to reverse the Federal Circuit’s holding that the claims of U.S. Patent No. 6,573,103 are invalid as patent-ineligible under Section 101. Intema contends that the Federal Circuit erred by misapplying Mayo in a manner that creates erroneous, rigid rules for determining patent-ineligibility in cases involving laws of nature. Failure to reverse the Federal Circuit’s decision, Intema argues, will have the practical effect of rendering most diagnostic, screening and personal medicine tests unpatentable.

The ’103 Patent

U.S. Patent No. 6,573,103 (the ’103 Patent) entitled “Antenatal Screening For Down’s Syndrome” issued on June 3, 2003. All twenty-four claims relate to methods for determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome. Claim 1 is representative:

1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one screening marker from a first trimester of pregnancy by:

 (i) assaying a sample obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or

 (ii) measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy;

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

 (i) assaying a sample obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or

 (ii) measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; and

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one screening marker from the second trimester of pregnancy with observed relative frequency distribution of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

The Federal Circuit’s Asserted Errors

Intema argues that the Federal Circuit erred when it ignored material differences between the claims of the ’103 Patent and the claims held invalid by the Supreme Court’s Mayo decision. Such errors include, for example:

  • the failure of the Federal Circuit to recognize the claims of the ’103 Patent are more than the use of a law of nature – the claims embody the use of data gathered was completely non-standard when developed, and improved screening efficacy;
  • the failure of the Federal Circuit to acknowledge that the measuring step, achieves a simple and useful test result using statistical analysis when it wrongly characterized the measuring steps as conventional and obvious presolution activity;
  • the failure of the Federal Circuit to give proper weight to the steps of selecting the measured marker levels during two separate trimesters of pregnancy and the integration of that in a carefully specified manner;
  • the Federal Circuit’s finding that the determining step is insufficient as being a “known and conventional” algorithm;
  • the Federal Circuit’s interpretation of the “assaying” portion of the measuring steps to be insufficient to impart patent-eligibility to the claims because it could be performed without transforming the sample should science develop a totally different system for assaying for a biochemical marker that did not involve such a transformation; and
  • the Federal Circuit’s error in concluding that a transformation, if it existed, would be insufficient relying on another rigid rule excluding all transformations from consideration under Section 101.

Personalized Medicine and Diagnostic Patents

The Supreme Court’s Mayo ruling has created uncertainty for diagnostic technologies that support and promote personalized medicine. Inventions simply defined by correlating a natural biomarker with a clinical outcome or therapeutic treatment are now ineligible for patent protection as a result of the Mayo decision. For inventions that offer more than a simple correlation, patent protection may still be available. However, how much “more” is necessary to move an invention involving a biomarker and correlation to patent-eligibility is still an open question. With that in mind, more clarity and direction would be welcome, provided the Supreme Court does not take the opportunity to further restrict patent protection for these important technologies.

A copy of Intema’s petition is attached.  PerkinElmer’s reply is due June 19, 2013.

Personalized Medicine Patenting Update

Posted by Antoinette Konski on Posted in Personalized Medicine; Prometheus

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

Video Interview: Discussing Myriad & the Supreme Court with LXBN TV

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

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.

 

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.

Patenting Business Methods After Mayo

Posted by Antoinette Konski on Posted in Business Method Patents; Health Care IT; Personalized Medicine

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

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

Lilly Urges “Poison Species” Test for Process Patents

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

June 15th, 2012 was the deadline for the parties and interested parties to file briefs in the controversial ACLU gene patenting case (see our post of March 26th, 2012), remanded to the Federal Circuit after the U.S. Supreme Court’s recent Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (“Prometheus”) decision which held that certain claims to medical methods are not patent-eligible for failing to satisfy 35 U.S.C. § 101. On June 12th, Eli Lilly and Company (“Lilly”) filed an amicus brief that urged the Federal Circuit to review the U.S. Supreme Court’s holding in Prometheus as it applies to multi-step process claims. Lilly’s amicus brief, filed in support of neither party, argued that new test is required to simplify the line between patent-eligible and ineligible subject matter, as [i]t is as best intellectually challenging to meaningfully apply the tripartite exclusions from patenting for laws of nature, natural phenomena and abstract ideas.”[1] The issue of whether or not the DNA claims are patent-eligible, the most contentious issue in this proceeding, was not briefed by Lilly. Rather, in footnote 1 of the brief, Lilly stated that only the appealed process claim is addressed because Prometheus “appears to be irrelevant to the manifest patent-eligibility of man-made materials that are nowhere to be found as such in nature.”[2]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.

Mayo Reported To Start Pilot Study To Provide Whole Genome Sequencing

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

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). 

Continue reading this entry

Winning Strategies for Personalized Medicine

Posted by Antoinette Konski on Posted in Diagnostic Methods; Health Care IT; Reimbursement

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.

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Subject Matter Jurisdiction Challenged in Supreme Court’s Review of Mayo v. Prometheus

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

An international intellectual property association filed an amicus curie brief urging the U.S Supreme Court to dismiss the dispute and issue presented in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (2011), arguing that the district court and Federal Circuit lacked subject matter jurisdiction. The amici argued that for reasons that are not clear, the district court and the Federal Circuit unapplied, misapplied, or simply overlooked Congress’ legislative efforts to achieve a globally-desired limitation of exclusive patent rights.

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In Classen, the Federal Circuit Determines That Certain Method Claims Satisfy 35 USC § 101

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Diagnostic Methods; Infringement

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.

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Top Twelve Practice Tips Following Myriad and Prometheus

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

*  Written by Kristel Schorr and Jackie Wright Bonilla, both partners in the Washington, DC office of Foley & Lardner LLP

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.

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Diagnostic Method Claims and Patent Eligibility – Supreme Court Has Something to Say In Prometheus v. Mayo

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Diagnostic Methods

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:

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Patent Eligibility of Diagnostic Method Claims – What Have Courts Considered So Far?

Posted by Jackie Wright Bonilla on Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Gene Patents

Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101.  While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of how to proceed when drafting relevant claims, and which existing diagnostic method claims are viable, remain unclear to many.

It is possible that the Federal Circuit and/or Supreme Court may provide additional direction in cases yet to be decided.  Such cases include the AMP et al. v. USPTO et al. (Myriad) “gene patenting” case (pending at Federal Circuit after oral argument on April 4, 2011), Classen Immunotherapies v. Biogen IDEC (pending at the Federal Circuit after remand by the Supreme Court in 2010) and Prometheus Labs., Inc. v. Mayo Collaborative Servs. (awaiting decision by Supreme Court on certiorari petition-again).

In the meantime, patent attorneys glean what they can from cases decided before and after Bilski v. Kappos (2010), such as In re Grams (Fed. Cir. 1989), Justice Breyer’s dissent from dismissal of the grant of certiorari in Lab. Corp of America Holdings v. Metabolite Labs., Inc. (2006), as well as the most recent Federal Circuit decision in Prometheus Labs., Inc. v. Mayo Collaborative Servs. (Fed. Cir. 2010) (albeit cert. pending at Supreme Court).

While such pending and decided cases are not an exhaustive list of ones that may impact patent eligibility of diagnostic method claims, it is informative to look at claims at issue in these cases.  Below provides a brief summary of representative claims, and what the courts have said about them so far.

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