By Kevin E. Noonan —

Appellant Myriad Genetics (the real "target" in interest of the ACLU/PubPat lawsuit over isolated human DNA molecules) filed its Supplemental Brief pursuant to Federal Circuit order in the remand of AMP v. USPTO.  Not surprisingly, the brief urges the Court to reaffirm its judgment that claims to isolated DNA molecules are patent-eligible.  Perhaps more surprisingly, the brief argues that Claim 20 is not before the Court on remand, but that if the Court considers it then the Court should recognize and reaffirm its prior determination that Claim 20 is patent-eligible.

Myriad argues that the Supreme Court's decision in Mayo v. Prometheus does not affect Federal Circuit's decision that Myriad's composition of matter claims are patent eligible.  The brief uses the Supreme Court's own language and considerations rather than their own, amici, or the Federal Circuit's rationales in making this argument.  This language includes the Court's express intent not to "break new ground" and merely to provide "an examination of the particular [method] claims before [it] in light of the Court's precedents."  Supreme Court precedents cited in the brief as "supporting" the Court's Mayo decision include Bilski v. Kappos, Diamond v. Diehr, Parker v. Flook, Gottschalk v. Benson, O'Reilly v. Morse, and Neilson v. Hartford (the British case); all cases involved solely method claims, according to the brief.  Myriad asserts that the Mayo decision by its own terms is limited to method claims, and consistent with this earlier precedent.  When the Court wishes to address composition of matter or manufacture claims patent-eligibility, as it did in Diamond v. Chakrabarty, the Court cites other precedent – Hartranft v. Weigmann and Funk Bros. Seed Co. v. Kalo Inoculant Co. — as precedent.  And the brief notes that "no appellate court has ruled a product patent ineligible since the 1952 Act," citing In re Kratz, In re Chakrabarty, In re Bergstrom, and Merck & Co. v. Olin Mathieson Chem. Corp. in addition to In re Bergy.

The brief asserts that the Mayo decision stands for there being a requirement for something "significantly more" than reciting a "law of nature" coupled with "well-understood, routine, conventional activity."  By satisfying the Chakrabarty standard, Myriad argues that the composition of matter claims satisfy the Mayo standard.  According to the brief, the "overarching" question posed by Mayo is whether there is "invention" and that the changes in the naturally occurring genetic materials as claimed by Myriad satisfy that requirement.  The brief expressly cites In re Bergy as the paradigm for the current situation before the Federal Circuit.  In that case, there was a decision by the appellate court (the Court of Customs and Patent Appeals, C.C.P.A.) on composition of matter claims, later vacated by the Supreme Court and remanded for reconsideration over an intervening Supreme Court decision on method claims (Parker v. Flook).  The CCPA (in an opinion by Judge G.S. Rich) found its earlier decision, that an isolated and purified culture of a naturally occurring bacterium was patent eligible, to be unaffected by the intervening Supreme Court precedent.  Myriad contends that "[t]he same result is compelled here" because "Mayo sheds no new light on the patent eligibility of the isolated DNA claims" and thus the Mayo decision "should not alter the Court's prior judgment."

The brief argues that the Supreme Court standards for patent eligibility for method claims and composition of matter claims are different, and Myriad's claims satisfy the Chakrabarty standard that the claimed compositions have "a distinctive name, character and use."  The brief characterizes the Mayo decision as requiring "the application of human ingenuity" as a requirement for patent-eligibility, and cites Mayo for the proposition that, for composition of matter claims, "a novel and useful structure is patent-eligible," based on Mackay Radio & Tel. Co. v. RCA.  This is because "[e]very product has its origins in something that exists in nature" (echoing Chief Judge Rader's comment that "all we have is nature"), according to the brief.  Thus, there is not (and indeed, cannot) be a requirement that all inventions be "wholly artificial"; "[h]uman ingenuity must simply have played a role," the brief argues.  The Court's previous, now vacated decision is consistent with these standards according to Myriad.

In deference perhaps to the extent to which the Mayo decision blended considerations other than subject matter eligibility into the criteria to be applied by courts (including, specifically, considerations that resemble obviousness), the brief explains that even the isolation of the BRCA genes involved unconventional, non-routine methods that were not well-understood and, indeed, were contrary to conventional wisdom on how to isolate a gene.  Reminding the Court that these method steps are not part of the claim, the brief argues that they were nevertheless "groundbreaking" and "a major breakthrough."  Myriad's brief takes pains to explain these steps and their unconventionality.  The brief also includes what can only be described as "secondary considerations" or "objective indicia" on nonobviousness, including that the methods used and that their successfulness were surprising and unexpected.  The brief also ties the inventors' decision to patent the genes, and disclose the information regarding them thereby, as enabling "thousands of researchers to publish thousands of papers" on the genes.

In a footnote, the brief makes creative use of the Court's discussion in Chakrabarty regarding the Plant Protection Act (which the Patent Office used to argue that Congress had not authorized utility patents on "living" inventions).  Here, Myriad argues that by creating the PPA, Congress determined that "the work of the plant breeder in aid of nature was a patentable invention."  This focuses the inquiry on the difference between what is naturally occurring and what is the product of human ingenuity, a standard reinforced by the Court's decision in J.E.M. Ag Supply Inc. v. Pioneer Hybrid Int'l. Inc. (which extended the scope of plant patent protection, under appropriate circumstances, to utility patenting under Section 101).

And in another footnote, the brief asserts that, under plaintiffs' reading, the Chakrabarty bacterium would have been patent-ineligible:

That bacterium was identical to the naturally occurring one, except for a few small pieces of DNA that had been transferred to it with the aid of human researchers (essentially through a process of selective breeding).  It had the same genome and same internal components.  It also retained all of its original functions and properties; it just gained a few new ones.  In fact, the invention in Chakrabarty merely added known utilities from one bacterium into another (by contrast, the molecules in the present case gave rise to entirely new utilities that were impossible before, such as sequencing a patient's BRCA1 gene).

The policy concerns raised by the Supreme Court in rendering its Mayo decision — for example, that the claims monopolize "the basic tools of scientific and technological work" — are not to the contrary.  The brief argues that the Supreme Court has cautioned against "categorical rules" for patent eligibility and requires a "fact-intensive analysis" of the particular claim(s) before it when deciding questions of patent eligibility.  And the brief cautions that, if the law should be changed or clarified to exclude patent eligibility for DNA claims nunc pro tunc, the resulting upset of settled expectations is for Congress, not the courts, to decide (characterizing the contrary as "judicial lawmaking").  The role of the PTO in granting patents to isolated DNA molecules, and Congressional disinterest and inaction in modifying the law regarding composition of matter claims are factors to be considered by the Court in reconsidering its earlier determination that the composition of matter claims are patent eligible, Myriad argues.

The brief gets to the heart of the matter with regard to the mischief that the Court could wreak on the patent system by considering the effects of ruling for plaintiffs outside the area of DNA claims:

The impact of this case is not limited to human genetics.  In 2012, the era of human gene discovery has been over for more than a decade, and human isolate DNA patents are in their twilight.  But the consequence of ruling these claims ineligible would be tragic, and would reach far beyond this field and industry.  Striking them down, despite the reliance of the inventive and investing communities on the well-established rule, would send a shiver up the spines of future investors and commercial research and development — and not just in molecular diagnostics.  Such a ruling would additionally cast a pall on other innovation industries whose existence depends on patent protection.

In a footnote, the brief enumerated such ancillary consequences to include pharmaceuticals, antibiotics, immunosuppressants, biologics drugs and viruses, vaccines, human therapeutic proteins such as erythropoietin, enzymes used for producing biofuels, nutritionally improved fruits and vegetables, biological pesticides, flavorants, dyes and enzyme used, for example, in detergents.

And the brief reminds the Court that while all claims are "pre-emptive" the standard is that they not be unduly preemptive.  Myriad's claims are not, the brief argues, because they are claiming just what the inventors invented:  isolated BRCA gene encoding DNA molecules, "not any of the other 20,000 human or other genes."  Even claims to the BRCA genes themselves are not unduly preemptive, as evidenced by the cited scientific research and other ways to test for hereditary breast cancer that are not impacted by Myriad's DNA claims.

With regard to Claim 20, the brief's argument that this claim is not properly before the Federal Circuit on remand is based, in part, on the plain language of the certiorari petition which was limited to the composition of matter claims and affirmatively stated that all of the method claims were not appealed — "None of the method claims is the subject of this [certiorari] petition" — so that there is no basis for further review.  In any event, Myriad argues that Claim 20 is patent eligible because it encompasses "significantly more than" a "law of nature" and "well-understood, routine, conventional activity."  That "more than" includes the transformed cell, which is not naturally occurring, particularly insofar as it has been genetically engineered to include an exogenous human BRCA gene, and these factors are enough to distinguish Claim 20 from the Prometheus claims in Mayo and to be patent eligible.

Oral argument is set for Friday, July 20th and will be available on the Federal Circuit website shortly thereafter.

By Andrew Williams —

On April 30th, the Federal Circuit issued an Order in the Association for Molecular Pathology v. U.S. Patent and Trademark Office case vacating its July 29, 2011 opinion and reinstating the appeal.  That Order was based on the Supreme Court's decision vacating the Federal Circuit's prior judgment and remanding the case for further proceedings.  In addition, the Federal Circuit requested that both parties file supplemental briefs to address the following issue:  "What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and the method claim 20 of the '282 patent?"  The Order also scheduled oral argument for this Friday, July 20, 2012, at 10:00 a.m.  As a preview of that hearing, we are providing a summary of the supplemental briefs from both parties.  This post will address the supplemental brief for Appellees Association for Molecular Pathology, et al. ("AMP").

AMP alleges that Mayo "gave new vigor to three principles for determining whether a law/product of nature has been 'transformed' into something patentable."  The first of these principles is whether the claims "preempt what is unpatentable," for example laws and products of nature.  The second principle is that what is patented must either be based on an "inventive concept," "add enough" to the natural phenomena, or have "markedly different characteristics from any found in nature."  The third principle is that the court must make this determination without regard to industry reliance.  Of course, the significant difference between now and nearly a year ago when the original opinion was released is the Supreme Court's Mayo decision.  Therefore, it is important keep in mind what Mayo said, and more importantly, what Mayo did not say (regardless of what either party would like to read into the decision).

AMP's first argument is that the claims to isolated DNA preempt the use of laws/products of nature.  It begins by quoting Mayo (and other Supreme Court cases) for the proposition that patenting laws of nature, natural phenomena, or abstract ideas is prohibited because "they are the basic tools of scientific and technological work."  Mayo, 132 S. Ct. at 1293.  However, AMP does not cite to any Supreme Court precedent for the proposition that "products of nature" are not patentable, and indeed because it is a case about a claimed method, Mayo is basically silent on the issue.  Nevertheless, there is sufficient support for the idea that machines, manufactures, and compositions of matter can also run afoul of § 101, for example such as when they are "manifestations . . . of nature," as indicated in Chakrabarty.  Apparently to cover its bases, however, AMP points out that isolated DNA is both a law and product of nature — the law is the correlation between the DNA and the BRCA protein, and the product is the DNA itself.  In other words, isolated DNA is the physical embodiment of the law of nature.  As support for this proposition, AMP alleges that isolated DNA can be reintroduced into a cell, and it will be able to "code for" and "transmit" the same protein with the same traits.  However, this is an oversimplification of the biology involved.  Clearly one cannot reinsert a naked piece of DNA, without more, into the cell and have any hope of obtaining an expressed protein.  In fact, figuring out what else would be required to get an expressed protein from an isolated DNA is not necessarily a trivial matter, and would be highly dependent on what cell you were reintroducing the DNA into.

Nevertheless, AMP highlights several "aspects" of the claims-at-issue that it alleges make "unduly preemptive of laws/products of nature" (emphasis added).  AMP's "unduly preemptive" aspects are (1) that because humans did not invent DNA, it is not possible to invent around the claims; (2) the disputed claims are broader than those in Mayo; (3) the claims "threaten to inhibit the development of more refined treatment recommendations"; (4) the claims pose a barrier to the development of targeted cancer therapies, and (5) the contested claims have already inhibited research.  In so noting these, however, AMP is implying that it is possible for something to be "less preemptive," and thereby make it patent eligible.  However, in doing so, AMP turns the Supreme Court's inquiry on its head.  In Mayo, the Court articulated (again) that laws of nature, natural phenomena, or abstract ideas are not patent eligible.  The Court went on to explain that one of the reasons for this was the "concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature."  However, the Mayo opinion made clear that Supreme Court precedent has "not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow."  Instead, as Mayo articulated, there is a bright-line prohibition against patenting laws of nature — and so the inquiry must be whether isolated DNA claims are (or improperly incorporate) laws of nature.

AMP's second argument is that isolated DNA claims are not based on an inventive concept and therefore do not add enough to the law and/or product of nature to make them patent eligible.  AMP's argument is based on the Supreme Court Mayo decision, which pointed out that the claims at issue in that case were nothing more than informing the relevant audience about the law of nature (specifically the correlation of the levels of metabolites).  The fact that the claims also had "administering" and "determining" steps was irrelevant, because they were conventional steps, and therefore could not be considered to contribute to an "inventive concept."  In an attempt to analogize, AMP alleges that the techniques for the isolation of DNA are similarly well-known, and therefore would add nothing to the law and/or product of nature.  First, this argument presumes that the DNA itself is the law (or product) of nature, and the only difference between it and the isolated DNA is the process of isolating it.  However, Mayo dealt with a process claim, in which the recited claim steps themselves were found to be conventional — because people had already been "administering" thiopurine drugs, and methods to "determine" the levels of 6-thioguanine were already known.  Therefore, all you were left with in the claim was the correlation — or the law of nature.  In the present case, the claims are to the composition of matter of isolated DNA, regardless of how it was obtained.  The Federal Circuit previously found that isolated DNA consisted of a different chemical composition than the full-length DNA.  Mayo should not change the conclusion that isolated DNA did not exist in nature, regardless of whether isolating DNA is simply the application of conventional steps.

AMP also cites to Mayo as allegedly changing the "transformation" test, almost to the point of doing away with it in the case of chemical changes.  In Mayo, the Supreme Court rejected Prometheus' argument that both the body and the blood were transformed, which could have made the claims patent eligible.  First, the body was not transformed because the "administering" step merely selected the individuals for whom the law of nature was to be applied.  Second, the "determining" step was not transformative because the method could theoretically be done without transforming the blood.  In this case, isolated DNA was found to be transformative because there were at least covalent bonds broken.  AMP alleges that this is not enough, because such steps are routine.  However, just because the step itself might be routine doesn't mean that the selection of that step, or the decision of which starting chemical entity to use is also routine.  In fact, for chemical entities, such a line of reasoning is a slippery slope.  A lot of new small-molecule chemical entities can be obtained by routine steps, but this does not (and should not) preclude their patent eligibility.  To say that a composition of matter cannot be patent eligible simply because the methods used to obtain it were "routine" would have serious implications on the pharmaceutical and biotechnology industry.

AMP further cites to the fact that the use of small fragments of DNA in diagnostics is well known and conventional.  However, this is relevant to determining whether isolated DNA has utility, not whether it is a law/product of nature.  Therefore, such an argument is not well suited to the present case.

AMP's final argument against the patent eligibility of isolated DNA claims was that Mayo rejected the idea that you could rely on industry reliance as a factor in applying the law/product of nature doctrine.  In making this argument, however, AMP cited to its previous briefs, and those of their amici, that allegedly identified the harms of gene patents.  If Mayo teaches that you cannot consider the reliance on the industry in upholding the patents, it also has to stand that you cannot look to alleged harms that result from such patents.  Instead, the analysis should be whether the claims attempt to patent a law of nature, a natural phenomenon, or an abstract idea.

As almost an afterthought, AMP briefly addresses method claim 20 of the '282 patent, but only to allege that it is indistinguishable from the method claims in Mayo.  However, other than pointing out that the claims are both method claims, AMP does not spend much time explaining why they were otherwise the same.  Instead, AMP analogizes the "growing" and "determining" steps of claim 20 to the "administering" and "determining" steps in Mayo, and concludes that the steps in claim 20 could not be transformative.  However, with all of the detail found in claim 20, it is difficult to see how it is simply a law of nature, and without more explanation, the Federal Circuit's decision regarding this claim should be the same.

For additional information regarding this topic, please see:

• "Biopharmaceutical Companies Weigh-In on Myriad Case," July 17, 2012
• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012

By Andrew Williams —

In addition to the various associations, academics, and interest groups that filed "supplemental" amici curiae briefs in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("the Myriad case"), two briefs were filed by companies that would be directly negatively impacted if either "the isolated DNA claims [or the] method claim 20 of the '282 patent" were found to be patent ineligible.  This is because, as one of the briefs put it, a broad application of patent ineligibility "could disrupt the expectations of large numbers of chemical and biotechnology patent holders and researchers who have depended on the patent system to secure rights to valuable intellectual property and to attract necessary capital and investment."  Therefore, these organizations have "a strong interest in ensuring the stability of the patent system as it relates to chemical and biotechnology inventions."

The above language comes from an amici brief filed by research-based biopharmaceutical companies Gilead Sciences, Inc., Confluence Life Sciences, Inc. and Euclises Pharmaceuticals, Inc. (collectively "Gilead").  Gilead's brief is directed solely to the issue of "whether a synthetic, man-made sequence of nucleotides forming a 'composition of matter,' which is both 'new and useful," is § 101-includable," and therefore it focuses exclusively on the cDNA sequence defined in claim 2 and recited as SEQ ID NO:1 of U.S. Patent No. 5,747,282 ("the '282 patent").  However, Gilead is quick to point out that this is not a "gene patenting" case — most likely because the synthetic sequence of nucleotides invented by Myriad Genetics, Inc. ("Myriad") never existed in nature prior to its invention.  Gilead alleges that the lower court (the District Court of the Southern District of New York) erred as a matter of law for failing to recognize the "made-by-man" standard for determining whether a new chemical substance satisfies 35 U.S.C. § 101, and erred as a matter of fact by misapplying the "markedly different" test.  Gilead concludes by arguing that nothing in the Supreme Court's Prometheus decision changes the Federal Circuit's July 2011 decision that claim 2 of the '282 patent is § 101-eligible.

Gilead begins by pointing out all of the transformative steps that Myriad had to undergo in order to make SEQ ID NO:1.  First, Myriad researchers identified that genetic defects in the BRCA1 gene were the likely source of a pre-disposition to breast and ovarian cancer.  Further, before any chemical transformative step was undertaken, the researchers used natural product genomic screening to narrow Chromosome 17 (with about 81 million base pairs) to a 100,000 base pair isolated BRCA1 gene.  This gene, of course, includes both introns and exons (with 23 coding exon segments).  Therefore, Myriad had to chemically manipulate, or transform, the isolated gene to derive its cDNA construct (as shown in the below figure from Gilead's brief).

Gilead alleges legal error on the part of the lower court because, as the Supreme Court reiterated in Diamond v. Chakrabarty, "Congress intended statutory subject matter to 'include anything under the sun that is made by man.'"  In fact, Gilead provides a reminder of the broad statutory goal of the patent system, pointing out that it was Jefferson's philosophy that "ingenuity should receive a liberal encouragement."  Therefore, even though patent eligibility has clear limits, the fundamental question "should be whether the invention is truly 'made by man," i.e., whether the invention is 'the result of human ingenuity and research.'"  Gilead supports this proposition by citing to eleven Federal Circuit, CCPA, and District Court cases that found synthetic compounds and materials patent eligible, and six Federal Appellate and District Court cases that found purified compounds to be patent eligible.

In contrast, the Gilead brief does not spend much effort explaining why the lower court erred as a matter of fact by misapplying the "markedly different" test.  Instead, it simply points out that, to the extent the Chakrabarty decision imposed a "markedly different characteristics" requirement into § 101, the Federal Circuit had already found that this requirement was satisfied in its July 2011 decision.  The brief also reiterates the practical utility of new DNA molecules at least as a diagnostic tool, which is evidenced by Myriad's medical and economic success using the synthetic cDNA compound as a predictor of genetic pre-disposition to cancer.

Gilead's conclusion, however, focuses exclusively on explaining why the Prometheus decision does not apply to Myriad's synthetic cDNA.  First, unlike Prometheus's method claims, there were at least 20 transformative steps that resulted in a sequence of nucleotides that had not, and could not, exist in nature.  Second, these transformative steps fully meet the Diehr standard of not being mere applications of "mathematical formula" or "laws of nature."

Protein Sciences Corporation ("PSC), another biopharmaceutical company, filed a separate amicus brief.  However, instead of limiting its analysis to the DNA claims, PSC addresses all of the claims that were originally at issue.  Importantly, PSC explains how the "Growth Rate Claim" continues to be patent eligible, even after the Prometheus decision.

According to PSC, Prometheus reduced the patent-eligibility question to the following test:

(1)  Is the claim a method or process claim?  If yes, then:
(2)  Does the method or process call for applying a law of nature?  If yes, then:
(3)  Do the steps of the method or process:

a.   Merely call for a particular audience to apply the law of nature or for applying the law of nature in a particular technological environment, or
b.  Call for "[p]urely 'conventional or obvious' '[pre]-solution activity'"?

If the answer to either (3)(a) or (3)(b) is "yes," then the method or process fails to be patent eligible, and also fails to meet § 112, ¶ 1.  If either question cannot be answered because of an insufficient record as to whether the steps are "conventional or obvious," the case should be remanded to develop the record.  This is, of course, a very narrow reading of Prometheus (suggesting that any composition of matter would be patent eligible), but PSC's application of Prometheus to the present claims is rooted in this understanding.  PSC also finds it necessary to define "law of nature," which according to the 1993 New Shorter Oxford English Dictionary is a "scientific generalization based on empirical observation" (as paraphrased by PSC).

Therefore, the analysis as to whether isolated DNA or cDNA are patent eligible according to Prometheus is simple — they are compositions of matter, and therefore Prometheus does not apply.  However, apparently to be safe, PSC also explains that "isolated DNA molecules are chemical compositions that possess physical, chemical and structural properties that differ from their naturally-occurring counterparts, and are molecules that man must create."  In addition, PSC points out that isolated DNA has new properties not shared by its native counterpart, including uses as a probe, a diagnostic tool, a primer, and in sequencing.  Thus, as to part 2 of the alleged Prometheus test, they are not products of nature.  To further bolster its conclusion, PSC points out that this conclusion comports with the longstanding practice of the PTO and the Federal Circuit.  PSC's analysis of cDNA is similar to that of isolated DNA, and the same conclusion is reached — cDNA is patent eligible.

As for the method claims, PSC first notes that Myriad's "analyzing" and "comparing" claims, which the Federal Circuit previous held to be not patent eligible, would also fail the Prometheus test.  However, the Growth Rate Claim, claim 20 of the '282 patent, would be patent eligible under this test.  The claim at issue reads:

20.  A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Because this claim is a method claim, question (1) of the test is answered in the affirmative.  However, according to PSC, the method uses transformed cells that contain an altered BRCA1 gene, which are not naturally occurring (after all, even the claim language itself indicates a "transformation" has occurred).  Moreover, because these cells do not occur naturally, they cannot be calling for the application of a law of nature.  Therefore, PSC concludes that this claim is more akin to the claim in Diehr (applying the Arrhenius equation) than the claims in Prometheus.

It is unclear if either of these briefs adds anything new to the discussion.  However, it is clear that each of these four companies, and many others like them, have invested substantial research and development (and therefore money and time) with the understanding that the patent system will protect their investments.  If the Federal Circuit were to take a narrow view of patent eligibility after the Prometheus case, it could seriously negatively impact the development and investment of future biopharmaceuticals and vaccines.  As such, hopefully the Federal Circuit will at least consider the perspective of these companies.

For additional information regarding this topic, please see:

• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012

By Donald Zuhn —

Seven organizations of health care professionals argue in an amici brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") that Myriad's isolated DNA and cDNA claims, as well as claim 20 of U.S. Patent No. 5,747,282, are all invalid under 35 U.S.C. § 101.  The organizations, which include the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, American College of Embryology, and Medical Society of the State of New York, open their brief by expressing their "concern[] about the effect of gene sequence patents on the practice of medicine," stating that "[s]uch patents interfere with diagnosis, treatment, and research and contravene the United States Supreme Court's long-standing precedents about the scope of patentable subject matter, which was reiterated in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)."

In arguing against the patent eiligibility of isolated DNA and cDNA, the amici brief, which was authored by Professor Lori Andrews of Chicago-Kent College of Law, states that:

Nature's handiwork is excluded from patentability.  Prometheus, 132 S.Ct. at 1293; Bilski v. Kappos, 130 S.Ct. 3218, 3225 (2010).  Just as a patent involving a law of nature must have an "inventive concept" that does "significantly more than simply describe these natural relations" (Prometheus, 132 S.Ct. at 1294, 1297), a patent involving a product of nature must have an inventive concept that involves significantly more than describing the product of nature.  Indeed, the claimed invention must be "markedly differently" from what occurs in nature.  Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The brief notes that:

For over 150 years, the U.S. Supreme Court has held that products of nature are not patentable (Chakrabarty, 447 U.S. at 309), nor are isolated or purified products of nature (American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. (23 Wall.) 566, 594 (1874)), nor are synthetic products that are not markedly different from what is found in nature (Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884)).  The Supreme Court has repeatedly held that compositions of matter involving products of nature or isolated products of nature must be "markedly different" from what occurs in nature to be patentable.  See, e.g., Chakrabarty, 447 U.S. at 309-10; Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948); American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11-12 (1931); Cochrane, 111 U.S. at 311; American Wood-Paper Co., 90 U.S. (23 Wall.) at 594.

The brief contends that because claims covering isolated DNA and cDNA constitute claims "on products of nature without an inventive concept" that are "not markedly different from what occurs in nature," these claims are invalid under § 101.

With respect to isolated DNA, the brief contends that "Myriad's composition of matter claims involving gene sequences are not unconventional or novel creations and do not involve an 'inventive concept,"" adding that "[t]he term 'isolated' adds nothing of significance to the claims."  In responding to the panel's earlier decision regarding these claims, the brief argues that:

[T]he breaking of covalent bonds [does not] make isolated DNA patentable.  The breaking of covalent bonds (itself a natural process that occurs in the body) is not an "inventive concept" and does not make the gene sequence "markedly different" and therefore patentable subject matter.  The change in chemical bonds is insignificant because the isolated gene sequence is the same string of nucleotides that exists in the cell.  Additionally, because the claims are written in terms of the genetic sequence, patentability should be determined by an analysis of the genetic sequence, not by the chemical structure.

Going further than other amici, the brief contends that cDNA is also patent ineligible under § 101.  Noting that "cDNA is useful in the laboratory because it has the same nucleotide sequence and contains the same information as found in the exons of naturally occurring DNA and can perform the same functions as a full nucleotide sequence or DNA molecule," the brief argues that "Myriad's use of routine chemical tools to synthesize cDNA lacks the inventive concept for patentable subject matter," and further, that "cDNA is not 'markedly different' from the sequence as it occurs within the chromosome."  According to the brief, "[o]nce the gene's naturally occurring DNA sequence — an unpatentable product of nature — is known, synthesis of cDNA is a routine mainstay of the art of biologists and chemists," and therefore, "[a]llowing a patent on cDNA would be a disproportionate reward in relation to what the alleged inventor contributed."

As for Myriad's method claim 20 of the '282 patent, the brief contends that the claim is analogous to the claim at issue in Mayo, arguing that claim 20 contains an "administering" step that "serves to identify who would be interested in the law of nature — physicians or researchers using or studying cancer therapeutics," a "determining" that "tells the physician or researcher to measure the growth of the cells — a routine activity for physicians and scientists in the field," and a "wherein" step that "tells the physician or researcher about the relevant natural law."

The brief also chastises the U.S. Patent and Trademark Office for granting gene sequence patents, stating that the Office "ignored the U.S. Supreme Court's precedents and applied invalid reasoning to grant patents on genetic sequences and, consequently, its decision should not be accorded deference."  The brief indicates that in granting such patents, "[t]he USPTO relied on the 1873 grant of a patent to Louis Pasteur for a purified yeast and on a lower court decision upholding a patent for isolated and purified adrenaline," but suggests that "Pasteur never enforced his patent, so there was no judicial assessment of whether the patent was valid."

The brief further contends that upholding Myriad's claims would be a detriment to further innovation, stating that:

Th[e] inhibition on future innovation is particularly true with patents on isolated DNA and cDNA.  There is no way to "invent around" gene patents.  Because an isolated gene sequence is identical to the sequence of the gene in the body, a patent holder can prevent scientists and clinicians from undertaking any genetic research related to a disease arising from a mutation in that gene.

In support of the detrimental effect of gene patents on innovation, the brief cites a study of laboratory directors (Mildred K. Cho et al., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services, 5 Journal of Molecular Diagnostics 3 (2003)), a study of American Society of Human Genetics members (Issac Rabino, How Human Geneticists in U.S. View Commercialization of the Human Genome Project, 29 Nature Genetics 15 (2001)), and the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.

Lastly, the brief argues that Myriad's contributions do not justify the threat to innovation presented by Myriad's claims.  Citing Mayo, the brief states that "[i]n a Section 101 analysis, courts need to weigh 'how much future innovation is foreclosed relative to the contribution of the inventor.'"  With respect to Myriad's claims, the brief argues that:

Myriad's contribution to the sequencing and identification of the BRCA1 and BRCA2 genes was minor in comparison to what their patents foreclose.  Myriad used common techniques to isolate, sequence, and clone the BRCA1 and BRCA2 genes.  Further, Myriad did not identify the sequence on its own.  Myriad had significant scientific aid and financial support, including from the U.S. government.  Controversy surrounds the question of whether Myriad even sequenced the BRCA2 gene first.

The brief therefore concludes that isolated DNA, cDNA, and method claim 20 are patent ineligible under § 101, arguing that "[i]t is crucial to patient care and to medical research that the products of nature and the basic laws of nature that Myriad has sought to propertize be freely shared, used, and analyzed."

For additional information regarding this topic, please see:

• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012

By Kevin E. Noonan —

The Biotechnology Industry Organization (BIO), joined by the Association of University Technology Managers (AUTM) and the Coalition for 21st Century Medicine filed an amicus brief in support of Myriad (unlike many other amici on both sides of the issue, who wrote ostensibly "in support of neither party").  Authored by a group including Seth Waxman, former U.S. Solicitor General, and Hans Sauer of BIO, the brief argues that the patent-eligibility of isolated DNA claims is unchanged by the Supreme Court's decision in Mayo v. Prometheus.  First, the brief argues that the Mayo decision simply does not apply to composition of matter claims.  Second, that the procedural posture of the case, where the Court granted certiorari, vacated the former panel opinion, and remanded does not in any way imply that the Supreme Court thinks that its Mayo decision applies to composition of matter claims.  Finally, the brief argues that it would be error having "far-reaching negative consequences" for the Federal Circuit to apply Mayo to defeat the patent-eligibility of Myriad's composition of matter claims.  The brief also contains a short section regarding the continued patent eligibility of claim 20 of U.S. Patent No. 5,747,282 (the screening method claim that was the subject of an alternative view in an amicus brief filed by Eli Lilly & Co.; see "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad").

The first argument set forth in the brief is that the Court's Mayo decision is limited to "policing" the line between laws of nature and their applications in methods of applying such laws.  This decision did not "alter the proper framework for analyzing manufacture or composition of matter claims," according to the brief, and that precedent is governed by Diamond v. Chakrabarty.  The brief then assesses the Court's Mayo decision (which was on its own terms limited to "an examination of the particular claims before [it]").  The Court's decision was ultimately based on its conclusion that the claims at issue in Mayo "simply tell a doctor about the relevant natural laws" and do not "require any change in treatment or other action" on a doctor's part.  The claims in Mayo were not patent-eligible, according to the brief, because "this bare recitation of an idea combined with what the Court deemed to be insignificant steps placed the claim squarely within the contours of prior decisions prohibiting the preemption of abstract ideas or principles."  This "framework" for performing the Court's analysis in Mayo was not new, according to amici, being "already in place when [the Federal Circuit] issued its [now-vacated] panel decision" and this precedent "did not affect [the Federal Circuit's] analysis of the Myriad composition claims" ("and rightly so" says the brief).  This is because "it makes no sense" to apply the Court's analytic methods for assessing the patent-eligibility of a method claim to a manufacture or composition of matter claim.  The very language of the Court's Mayo decision, requiring an assessment of whether a claim "merely 'append[s] conventional steps' to a law of nature" does not apply because "[c]omposition of matter claims do not have 'steps.'"  This is not mere semantics, because as the brief points out compositions of matter have "physical form and can be claimed without regard to the manner in which they are made or used."  (This latter point is an important one, because it illustrates why a broad, undifferentiated "product of nature" ban would also preclude patenting of a synthetic form of a natural product that did not differ in physical structure from the product as it is found in nature.)  The brief cites Chakrabarty as well as Funk Bros. Seed Co. v. Kalo Inoculant Co. for the proposition that the Supreme Court has already set forth the proper measure for the patent-eligibility of a manufacture or composition of matter, i.e. "whether the claimed invention has different characteristics and uses from the naturally occurring analogue."  This standard, of course, was applied by the panel majority in deciding that Myriad's isolated DNA claims were patent-eligible when the case was last before the Federal Circuit, as amici remind the remand panel.

The brief further argues that it could not have been the Supreme Court's intention to require the rubrics enunciated in Mayo to apply to manufacture and composition of matter claims, because if it did the Court would have included Chakrabarty and Funk Bros. in its "consideration of the controlling precedents."  On the contrary, the brief reminds the Federal Circuit that those precedents were completely omitted from the Supreme Court's opinion, which "strongly implies that the Court did not consider" these cases, and thus Mayo does not control the Court's assessment of patent-eligibility for Myriad's DNA claims.  Calling the Court's delineation of patent-eligibility of manufacture and composition of matter claims in Chakrabarty a "careful textual analysis" of Section 101, the brief argues that the Court did not discard it "in favor of a free-floating 'products of nature' exception," reminding the Federal Circuit that "the Supreme Court specifically 'cautioned that courts 'should not read into the patent laws limitations and conditions which the legislature has not expressed.''"  Applied to "products of  nature," the brief asserts that its patent-eligibility might be compromised only if there was "a complete absence of human involvement," a standard consistent with the earlier panel decision and not changed, amici argue, by the Court's Mayo decision.

Turning to the procedural posture of the case, the brief notes that "grant [certiorari], vacate and remand" decisions are "a regular consequence of an intervening Supreme Court decision" and does not imply that a Court of Appeals' earlier decision was incorrect, citing Hughes Aircraft Co. v. U.S., 140 F.3d 1470, 1473 (Fed. Cir.1998).  The brief then revisits a pair of cases directly on point, Chakrabarty and it companion case, In re Bergy.  In those cases (which were heard by the Federal Circuit's predecessor court, the Court of Customs and Patent Appeals), on remand the Court, and specifically Judge G.S. Rich, decided that the intervening Supreme Court decision there, Parker v Flook, was "'inapplicable' because 'Flook was concerned only with the question of what is a "process" under 101,'" in contrast to the issue in Chakrabarty and Bergy, which "involve[d] only the construction of the terms 'manufacture, or composition of matter.'"  Ultimately, in Chakrabarty, the Supreme Court agreed (and, the brief notes that the Court in Chakrabarty did not "dissect the claimed microorganism into its individual components" but rather considered the claims "as a whole").  The CCPA avoided error in determining that Flook was not relevant to its assessment of the manufacture and composition of matter claims before it, and the brief argues that coming to the opposite conclusion here, by changing the Federal Circuit's opinion in the face of Mayo, would be error.

Finally, the brief turns on the negative consequences of a patent-eligibility ban on Myriad's DNA claims (as it must, because this is ultimately more a policy question than a legal one).  Here amici argue that the policy balance "overwhelmingly favors [the Federal Circuit's] earlier determination that isolated genomic DNA and cDNA are patentable subject matter," based on "[n]umerous studies [that] have refuted the claim that patents on isolated genomic DNA or cDNA molecules 'inhibit future innovation' or 'impede the flow of information.'"  In addition to several cited studies supporting this argument, the brief also notes that the question of whether the scope of Myriad's DNA claims "are unduly 'preemptive' cannot be substantiated or resolved without examining what activities actually infringe such claims, something that is strikingly absent from plaintiffs' case" (as is any attempt to construe the claims by either the parties or the courts).  The brief notes that "it is highly questionable" whether the isolated DNA claims would be infringed by sequencing the BRCA genes, either using existing technologies or as part of "whole genome sequencing," "because such techniques do not require isolation of the gene being sequenced."  The brief also uses rapamycin and modified analogues thereof to illustrate the unnecessary complications and uncertainties that would arise should Mayo's analytical framework for assessing the patent-eligibility of method claim be unwisely extended to manufacture and composition of matter claims.  And the brief includes several examples of how "[r]eliable patent protection is critical to the discovery, disclosure and commercialization of new and useful compositions of matter that are isolated or derived from natural sources," including erythropoietin, rapamycin, muromonab-CD3 (a mouse monoclonal antibody used to prevent transplant rejection), phytase (an enzyme used as a cattle feed component to reduce environmental phosphate pollution), and isolated enzymes used in the biofuels industry.  The brief also is careful to remind the Court that in all these instance and others, patenting "can speed the pace of innovation by encouraging the inventor to disclose the invention and make it available to other researchers," and that the fact that patents expire must be contrasted with the eternal availability of the patent disclosure.

The final section of the brief, comprising a single paragraph, relates to claim 20 of Myriad's '282 patent:

20.  A method for screening potential cancer therapeutics which comprises:  growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

The patent-eligibility analysis for this claim "need not detain [the Court] long," according to the brief, because the claim includes the step of "growing a transformed eukaryotic cell containing an altered BRCA 1 gene."  The transformed cell itself being novel, the brief argues that its use "cannot be the type of 'well-understood, routine, conventional activity already engaged in by the scientific community' required by the Mayo decision to render a claim patent-ineligible."

For additional information regarding this topic, please see:

• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012