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

Category Archives: 35 U.S.C. 101

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.

“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.

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

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.

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

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

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.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. 

Continue reading this entry

Patent-Eligibility Trilogy: One of Three Reaches U.S. Supreme Court

Posted by Antoinette Konski on Posted in 35 U.S.C. 101; Diagnostic Methods; Gene Patents; Genetic Testing; Petitions for Rehearing

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.

Continue reading this entry

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.

Continue reading this entry

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.

Continue reading this entry

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.

Continue reading this entry

ACLU and Myriad Both Petition for Panel Rehearing In Myriad “Gene Patenting” Case

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

On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties filed their Petitions in response to a precedential decision by the Federal Circuit a month earlier. In that decision, a three-judge panel held, among other things, that all “isolated DNA” claims at issue are patent-eligible, contrary to Plaintiffs’ position. All three judges wrote detailed opinions, with Judge Lourie writing the majority opinion, Judge Moore concurring-in-part, and Judge Bryson concurring-in-part but dissenting-in-part regarding claims encompassing isolated genomic DNA. For background details of the case, see August 9 post, July 31 post and July 29 post. (Many thanks to Kevin Noonan at Patent Docs for first providing the Petitions.)

ACLU/Plaintiffs Petition for Panel Rehearing

In their recent petition, Plaintiffs ask the same three judges rehear the case again. Notably, they do not ask for a rehearing en banc, which would entail reconsideration by all active Federal Circuit judges.

Continue reading this entry

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.

Continue reading this entry

Myriad’s Gene Patenting Debate Continues

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

Late last week the Federal Circuit issued its much anticipated opinion – Assn. Molec. Path. et al. v. USPTO et al. - which addressed, inter alia, the issue of whether and to what extent is genetic material patent-eligible. Judge Lourie, writing for the majority, held that isolated genetic material is patent-eligible. Judge Moore concurred-in-part that isolated DNA can be patent-eligible while Judge Bryson dissented and opined that cDNA, but not isolated DNA, is patent-eligible.  

Continue reading this entry

Highly Anticipated “ACLU/Myriad” Gene Patenting Case Decided by Federal Circuit

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

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.

Continue reading this entry

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:

Continue reading this entry

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.

Continue reading this entry