By Kevin E. Noonan —

Judge Bryson, the third member of the panel deciding the Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad) case, wrote an opinion concurring-in-part and dissenting-in-part.  Judge Bryson concurred in the Court's judgment on all issues except the patent-eligibility of isolated DNA molecules including genomic DNA and DNA fragments; he concurred that cDNA was patent-eligible based on its non-existence in nature; indeed, Judge Bryson's opinion was the only one that noted (in a footnote) that plaintiffs' (and certain amici's) argument that the existence of pseudogenes rendered cDNA to be a "natural product" did not establish that any BRCA pseudogene had the sequence recited in any of Myriad's claims.  However, Judge Bryson's analysis of the patent-eligibility is flawed by some misunderstandings about biology and chemistry (including particularly medicinal chemistry), and some conclusions having potentially far-reaching consequences for patent-eligibility of more than DNA, consequences more far-reaching than the purported negative impact on innovation postulated by Judge Bryson in his opinion.

The dissenting opinion goes astray almost immediately, by characterizing the question before the Court "[i]n its simplest form" to be "whether an individual can obtain patent rights to a human gene."  "From a common-sense point of view, most observers would answer, 'Of course not.  Patents are for inventions.  A human gene is not an invention.'"  The Court's task, of course, is not to apply its version of "common sense."  Moreover, this "common-sensical" approach would limit patent-eligible subject matter to the electrical and mechanical arts.  An apt example is lincomycin, the antibiotic produced by the bacteria at issue in In re Bergy.  In those halcyon days, the patent-eligibility of the purified antibiotic was not at issue, rather it was whether an isolated and purified culture of the bacteria should be ineligible for patenting because they are alive.  The antibiotic, also claimed as isolated and purified, is no less a "product of nature" and, by "common sense" reasoning, not an invention.  The same will be true of everything falling within the scope of medicinal chemistry.  Later in the dissent Judge Bryson disparages the patent-eligibility of isolated DNA as being analogous to plucking a leaf from a tree (echoing Judge Dyk's assertion in his dissent in Intervet Inc. v. Merial Ltd.).  The rationale behind the dichotomy between what is an invention and what is not that results from "common sense" would deny patent-eligibility not only to the leaf but to any beneficial chemical compound contained in the leaf.

Next the opinion insinuates that the named inventors' contribution was insufficient to warrant a patent for the claimed isolated DNA molecules, by citing chromosomal mapping work by Mary-Claire King and the use by the inventors of "known sequencing techniques" to isolate the gene.  Anachronistically, the dissent treats gene isolation in 1994 as being routine; the achievement of the Human Genome Project and the sequence information resulting therefrom seems to make it easy to forget how difficult gene isolation once was.  In view of the fondness of plaintiffs and many amici (as well as members of the panel) for analogies, consider the following:  finding the BRCA gene in view of the technology and knowledge before its isolation is like finding a particular house in Chicago from space (or using Google maps) without knowing the location of the house you are looking for.  In this analogy, the U.S. is the human genome, Illinois is chromosome 17, and Chicago is the chromosomal region analogous to the location (17q21) identified by Dr. King.  This knowledge, which the dissent calls "an unpatentable fact" in no way leads directly to the isolated DNA claimed by Myriad (this DNA also characterized by the dissent as an "unpatentable fact"; in reality, it is a specific chemical compound neither identified nor isolated before Myriad's inventors cloned and sequenced the gene).

Another mischaracterization (advanced at oral argument by plaintiffs' counsel) was that Myriad's composition of matter claims "effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing."  The inaccuracy of this interpretation of the claims is that it would only be the case if the claim is interpreted to encompass total genomic DNA, an interpretation that would render the claims unpatentable for lack of novelty (inter alia by Miescher's isolation of nuclein in 1869).  But this misapprehension clearly informed Judge Bryson's decision, since he concludes that "a contrary ruling [i.e., that isolated DNA is patent-eligible] is likely to have substantial adverse effects on research and treatment in this important field."

Judge Bryson takes from relevant Supreme Court precedent (like Judge Lourie and Judge Moore, Diamond v. Chakrabarty and Funk Bros. Seed Co. v. Kalo Inoculant Co.) the principles used to reach his conclusion (contrary to his fellow judges) than the isolated DNA claims are not patent-eligible.  He draws the line at whether the "product of nature" is "structurally and functionally" the same.  This focus leads directly to his conclusion, since the dissent discounts the very same structural and functional differences utilized in the majority and concurring opinion to distinguish Myriad's claimed DNA molecules from their "structure and function" in their natural state.  (Of course, it should be recognized that these structural and functional differences are much greater than the differences between an antibiotic as it occurs in nature and in its isolated and purified state.).  Relying on one of the analogies advanced by plaintiffs (and further exemplifying the rubric that "bad analogies make bad law"), the dissent concludes that Myriad's isolated DNA molecules are "analogous to the 'new mineral discovered in the earth' or the 'new plant found in the wild'" and thus patent-ineligible, again relying on the (false) invention/non-invention dichotomy.  In making this argument, the dissent discounts the differences in chemical structure between DNA as it exists in a chromosome and as it exists isolated in a test tube, citing Linus Pauling for the proposition that "[a] chemical bond is merely a force between two atoms or groups of atoms strong enough 'to make it convenient for the chemist to consider [the aggregate] as an independent molecular species.'"  Judge Lourie refuted this proposition in the majority opinion with the reality that "a covalent bond is the defining boundary between one molecule and another" and not merely an abstract concept.  Indeed, the dissent posits that "there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken," thus refuting hundreds of years of chemical arts devoted to producing "new products" precisely by breaking and forming chemical bonds between molecules.  Harkening back to another analogy, the dissent admonishes the majority for not recognizing the patent-eligibility of elemental lithium, which may also be purified from its native salts by breaking covalent bonds.  A proper reading of the other opinions reveals the actual basis for the other judges' contrary conclusions:  elemental lithium is not DNA, and claims to elemental lithium are not before the Court.

The dissent also asserts that the compositions claims are "not defined by any particular chemical formula."  This statement ignores the reality that the chemical formula of the BRCA gene could be set forth as the smaller sequence that illustrated Judge Moore's concurring opinion, but that the convention is to represent the chemical formula of isolated DNA by its sequence.  This convention does not mean that the isolated DNA is its sequence, any more than any other chemical formula is the claimed chemical compound.  The dissent cites the representation of species of the human BRCA genes as being represented by "gaps denoted 'vvvvvvvvvvvvvvvv,'" and that this results in an "almost incalculably large number of new molecules that could be created by filling in those gaps."  Insofar as this argument has any relevance, it is to sufficiency of disclosure under 35 U.S.C. § 112, however; that Myriad may not have claimed its invention to satisfy the substantive provisions of the Patent Act does not address the issue of whether the subject matter is itself patent-eligible (presuming that it is properly claimed).  The dissent does recognize the unifying principle required for any isolated DNA molecule to fall within the scope of the claims:  that it "codes for the same protein as the naturally occurring BRCA1 gene," thus providing its patentable utility.

The dissent then makes yet another analogy, that "extracting a gene is akin to snapping a leaf from a tree."  As Judge Lourie noted in the majority opinion,"[w]ith respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect.  Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity."  It is only by ignoring every substantive difference between cloning a gene and "snapping a leaf from a tree" that the analogy has any merit.  And the distinction drawn by the dissent between prior precedent finding patent-ineligibility for naturally occurring products (In re Merz (ultramarine); In re King (vitamin C); In re Marden (vanadium); Gen. Elec. Co. v. De Forest Radio Co. (tungsten)) and patent-eligibility (Parke-Davis & Co. v. H.K. Mulford Co. (adrenaline); Merck & Co. v. Olin Mathieson Chem. Corp. (vitamin B12)) holds only by ignoring the distinctions between the DNA as it exists in the chromosome and the change in structure and function resulting from its isolation.  That the dissent considers these differences to be irrelevant (or at best insufficient) to patent-eligibility is evident in the conclusion of the dissent regarding the isolated DNA claims:

The structural differences between the claimed "isolated" genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form.  The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession.  In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body.  Indeed, that identity of function in the isolated gene is the key to its value.  Moreover, as Judge Moore's concurring opinion explains, Myriad has failed to credibly identify new uses for the isolated BRCA genes as probes or primers.  The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty.  For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.

Turning to the other claimed compositions of matter encompassed by Myriad's claims, the dissent agrees that cDNA is patent-eligible at least because it cannot be isolated from nature.  However, Judge Bryson again parts company with the panel over claims to oligonucleotide fragments of the BRCA genes.  Here, the objection is two-fold:  first, some of these fragments comprise a BRCA exon, which is "naturally defined by transcription" and that "small sequences of DNA are repeated throughout the three billions nucleotides of the human genome."  The latter objection again sounds in overbreadth rather than patent-eligibility, or perhaps novelty (at least with regard to 35 U.S.C. § 102(f)), on the grounds that "efforts to sequence almost any gene could infringe [Myriad's claims] even though Myriad's specification has contributed nothing to human understanding of other genes."  This aspect of the dissent's reasoning is illustrated in its discussion of claim 5 of U.S. Patent No. 5,747,282:

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

which the opinion says "is breathtakingly broad."  While acknowledging that the claim would most likely be invalidated on other grounds, its breadth gives rise to a discussion of "the effects of broad patent claims on the biotechnology industry" (although if the intent is to somehow protect biotechnological innovation, no doubt many biotechnology companies would gladly forego the proffered protection).  Here, the dissent cites the potential problem of patent thickets, and Professor Eisenberg for the possibility that patents might inhibit commercialization of biotechnology inventions.  It is well to remember that Professor Eisenberg was originally concerned with patenting inhibiting basic genetic research, and that there is no evidence of any such inhibition despite numerous attempts to detect it.  And while it is certain that patents inhibit commercial exploitation by any entity other than the patentee and its licensees, this is hardly unexpected.  As noted by Judge Moore in her concurrence:

The dissent suggests that "this may well be one of those instances in which 'too much patent protection can impede rather than 'promote the Progress of Science and useful Arts.'"  Dissent at 15-16 (quoting Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126 (2006) (Breyer, J., dissenting from dismissal of writ as improvidently granted)).  Yet the biotechnology industry is among our most innovative, and isolated gene patents, including the patents in suit, have existed for decades with no evidence of ill effects on innovation.  See David E. Adelman & Kathryn L. DeAngelis, Patent Metrics: The Mismeasure of Innovation in the Biotech Patent Debate, 85 Tex. L. Rev. 1677, 1681 (2007) ("The existing empirical studies find few clear signs that the patenting of biotechnology inventions is adversely affecting biomedical innovation."); id. at 1729 (concluding "that overall biotechnology innovation is not being impaired by the growth in patents issued").

Similarly, the dissent raises the analogy of the baseball bat made from wood from a tree, and the distinction with isolating DNA that "man has defined the parts that are to be retained and the parts that are to be discarded."  As argued by Judge Moore:

The dissent explains why the baseball bat is directed to patent eligible subject matter:  "man has defined the parts that are to be retained and the parts that are to be discarded.  The result of the process of selection is a product with a function that is entirely different from that of the raw material from which it was obtained."  Dissent at 10.  The exact same thing is true with regard to primer and probe claims.  Man has whittled the chromosomal DNA molecule down to a 15 nucleotide sequence — defining the parts to be retained and discarded.  And the result is a product with a function (primer or probe) that is entirely different from the full gene from which it was obtained.³

³ The dissent analogizes the full BRCA gene to a slab of marble found in the earth as distinct from the sculpture carved into it, which the dissent indicates would be worthy of intellectual property protection.  If the multi-thousand nucleotide BRCA gene is the slab, isn't the 15 nucleotide primer the sculpture?

Finally, the dissent rejects the stare decisis principles espoused by the majority and concurring opinions, on the grounds that the Court is not bound by Patent Office policy determinations and that the government's position "substantially undermine[s]" this position.  Judge Moore addresses this argument as well:

Changing course years after the fact will only serve to punish those companies who made the reasonable decision to invest large amounts of time and money into the identification, isolation, and characterization of genes.  Unsettling the expectations of the biotechnology industry now, based on nothing more than unsupported supposition, strikes me as far more likely to impede the progress of science and useful arts than advance it.  Given the complicated technology and conflicting incentives at issue here, any change must come from Congress.  See Gottschalk v. Benson, 409 U.S. 63, 72-73 (1972) (A section 101 analysis raises "considerable problems … which only committees of Congress can manage, for broad powers of investigation are needed, including hearings which canvass the wide variety of views which those operating in this field entertain.  The technological problems tendered [by the parties] . . . indicate to us that considered action by the Congress is needed.")

Association for Molecular Pathology v. U.S. Patent and Trademark Office (Fed. Cir. 2011)
Panel:  Circuit Judges Lourie, Bryson, and Moore
Opinion for the court by Circuit Judge Lourie; opinion concurring in part by Circuit Judge Moore; opinion concurring in part and dissenting in part by Circuit Judge Bryson

By Kevin E. Noonan —

In the Federal Circuit's decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case), Judge Kimberly Moore wrote a separate opinion in which she concurred with the opinion of the panel affirming the District Court's judgment on the standing issues and the method claims, and concurred with the judgment reversing the District Court's judgment that the composition of matter claims were not patent-eligible under 35 U.S.C. § 101 as  being "products of nature."  Judge Moore joined Judge Lourie's majority opinion fully with regard to some of the composition of matter claims at issue (specifically, claims to cDNA embodiments of the BRCA genes and claims to subsequences such as primers) and concurred in the result regarding claims that encompassed isolated genomic DNA.  This post will discuss her reasoning.

Like Judge Lourie, Judge Moore begins her opinion with her view on the subject matter at issue, stating that "DNA is a chemical polymer.  In principle, a polymeric DNA sequence is no different than any other well known polymer, for example, nylon."  Illustrating this concept, her opinion contains a drawing, showing that "polymerization changes the monomers and results in a molecule with a different ionic charge, different chemical bonds, and a different chemical composition, as compared to the monomers in aggregate."

The opposite of polymerization, "deconstructing" in her parlance, "leads to similar results: a fragment of a DNA sequence has different properties than the parent molecule from which it is derived."  Judge Moore uses the example that:

[A] two nucleotide sequence (T-C), has a different chemical structure, and different chemical connections than the same subunit found within the larger A-T-C-G-T structure.  Despite many similarities, it is impossible to find the isolated T-C structure in the A-T-C-G-T molecule.  This is because, instead of being connected to a phosphate, the C subunit terminates in a different functional group, a hydroxyl.  Likewise, instead of being connected to another sugar via a phosphodiester bond, the T subunit instead terminates in a phosphate.  The isolated T-C sequence is a different molecule than the "T-C" sequence appearing as part of the larger A-T-C-G-T polymer.

The relevance of these chemical facts is that, for Judge Moore, "[t]he isolated DNA sequences at issue in this case have the same type of chemical changes, but on a much bigger scale":

[L]ike the simple sequences discussed above, just because the same series of letters appears in both the chromosome and an isolated DNA sequence does not mean they are the same molecule.  While the isolated DNA molecules claimed in this case are undoubtedly inspired by the corresponding naturally occurring sequence present on the chromosome, man must create these isolated DNA molecules.  This can be accomplished by building them de novo using chemical or biological means, or by chemically altering the larger polymer to cleave off adjacent portions.

Judge Moore makes a distinction similar to Judge Lourie's between "isolating" and "purifying" DNA molecules:  "Isolation of a DNA sequence is more than separating out impurities: the isolated DNA is a distinct molecule with different physical characteristics than the naturally occurring polymer containing the corresponding sequence in nature.  These differences, of course, are directly related to the change in chemical bonds in the isolated DNA."

She also cites the distinction that the isolated DNA molecule claimed by Myriad is no longer contained in the chromosome, and that for some of the claims at issue these DNA molecules are "as short as fifteen nucleotides, and the isolated BRCA1 cDNA sequence has approximately six thousand nucleotides (see, e.g., '282 col.67-80 (SEQ ID NO:1))," noting the further distinction between he structure of cDNA (i.e., lacking introns) and genomic DNA.  "Even the isolated BRCA1 gene, however, is substantially smaller than chromosome 17, which includes the unisolated BRCA1 gene as well as many other genes.  Isolation of a DNA sequence thus results in a substantially smaller molecule compared to the naturally occurring sequence as part of the chromosome" (citations omitted).

Next Judge Moore discusses the distinctions between cDNA, which "unlike isolated or unisolated DNA, has a unique sequence of DNA bases (A, C, G, T) which is not actually present in nature."  These include "form[ing] DNA sequence that is completely different than the corresponding RNA" as well as the fact that "[t]here is no contiguous sequence on the chromosome that duplicates the cDNA sequence" due to the lack of introns (as shown in the figure below from Judge Moore's opinion).

For both genomic DNA and cDNA, Judge Moore recognizes that "[c]reating isolated DNA allows a scientist, among other things, to remove potentially confounding sequences that are naturally present in the larger chromosomal polymer, and instead focus on just the sequence of interest.  This aspect of isolated DNA has important practical consequences and leads to additional utility, particularly for the smaller isolated fragments" (citing, inter alia, the use of primer sequences to detect mutations in the BRCA1 genes in a patient sample).  Having set forth her understanding of the relevant scientific principles ("[a]rmed with this scientific background"), Judge Moore's concurrence sets the legal basis for her conclusions regarding "the isolated DNA claims at issue."

Like Judge Lourie, Judge Moore considers Funk Bros. Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty as controlling precedent.  "[T]erms as 'the work of nature' and the 'laws of nature' . . . are vague and malleable terms . . .  .  Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost every patent," she writes, citing Funk Bros. Seed Co., 333 U.S. at 134-45 (Frankfurter, J., concurring).  Like the majority opinion, Judge Moore contrasts the patent-ineligible mixture of bacteria claimed in Funk Brothers with the patent-eligible recombinant bacterium claimed by Chakrabarty.  However, she states that "Funk Brothers and Chakrabarty do not stake out the exact bounds of patentable subject matter.  Instead, each applies a flexible test to the specific question presented in order to determine whether the claimed invention falls within one of the judicial exceptions to patentability."  Funk Brothers sets forth one end of this spectrum, where an invention that "serve[s] the ends nature originally provided" is likely unpatentable subject matter, but an invention that is an "enlargement of the range of . . . utility" as compared to nature may be patentable.  333 U.S. at 131.  Chakrabarty, on the other hand, is an example of an invention having "a distinctive name, character, and use, e.g., markedly different characteristics with the potential for significant utility, is patentable subject matter.  447 U.S. at 309-310."  While she admits that these cases come to different conclusions, "the inquiry itself is similar."

In discussing Learned Hand's decision in Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911), that adrenaline was patent-eligible, and the same result in Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958), for vitamin B12, Judge Moore's analysis reveals an important consideration for her reasoning:  "mere purification of a naturally occurring element is typically insufficient to make it patentable subject matter," which explains the decisions in the In re Marden and DeForest Radio cases (which the majority recognize to be novelty rather than patent-eligibility cases).  Unfortunately, this doctrinal admixture confuses the analytics, and while the relevance of its casting aside of the neat analytical boundaries set forth by Judge Rich in In re Bergy raises jurisprudential questions, perhaps its greater significance is that it undercuts the reasoned basis for determining patent-eligibility by conflating it with the different question of patentability.

Regardless, Judge Moore concludes that there is "no reason to deviate from this longstanding flexible approach in this case.  Keeping these principles in mind, I analyze the isolated DNA claims below, to determine whether they have markedly different characteristics with the potential for significant utility, e.g., an "enlargement of the range of . . . utility" as compared to nature.  Chakrabarty, 447 U.S. at 309-310; Funk Bros., 333 U.S. at 131."

The cDNA embodiments of the claimed invention "present the easiest analysis."  She rejects the District Court's determination that these molecules are "products of nature" for the simple reason that they "do not exist in nature."  In addition, these molecules have different "uses" (an "enlargement of the range of  . . . utility") because "it can be used to express a protein in a cell which does not normally produce it."  She also cites the various chemical distinctions (different constituent sugars and bases) and consequent differences in chemical stability as reasons to conclude that cDNAs are not "products of nature."  In the language of the Supreme Court precedent relevant to her decision:

cDNA sequences thus have a distinctive name, character, and use, with markedly different chemical characteristics from either the naturally occurring RNA or any continuous DNA sequence found on the chromosome.  The claimed isolated cDNA sequences are the creation of man, made using biological tools and the naturally occurring mRNA as a template.  cDNA is therefore not one of the "'manifestations of . . . nature, free to all men and re-served exclusively to none'" that falls outside of the patent system.  Chakrabarty, 447 U.S. at 309 (quoting Funk Bros., 333 U.S. at 130).

The "more difficult issue" are "DNA sequences that have the same pattern of DNA bases as a natural gene, in whole or in part."  These sequences are present in the human body, "albeit as part of a much larger molecule, the chromosome."  For Judge Moore, the "markedly different chemical structure" of such DNAs when isolated, relied upon in Judge Lourie's opinion, are not a sufficient basis for determining that such isolated DNA molecules are patent-eligible because they are not "markedly different" enough, citing by analogy Funk Bros., 333 U.S. at 130-31 (Creation of "a new and different composition" of bacterial strains was nevertheless not patentable subject matter).

However, "the mere fact that the larger chromosomal polymer includes the same sequence of nucleotides as the smaller isolated DNA is not enough to make it per se a law of nature and remove it from the scope of patentable subject matter."  The chemical distinctions noted earlier in the opinion distinguish these isolated DNA molecules from minerals, for example, because minerals are "created by nature without the assistance of man.  Instead, the claimed isolated DNA molecules  . . . are not naturally produced without the intervention of man.  Cf. Chakrabarty, 447 U.S. at 312-13.  For Judge Moore, the question then resolves into a determination of "whether these differences impart a new utility which makes the molecules markedly different from nature."  The "short" DNA molecules (as claimed for example in claim 5 of U.S. Patent No. 5,747,282):

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

pass muster under this analysis:

The shorter isolated DNA sequences have a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature.  These smaller isolated DNA sequences — including isolated radiolabeled sequences mirroring those on the chromosome — can also be used as the basis for probes.  Naturally occurring DNA cannot be used to accomplish these same goals.  Unlike the isolated DNA, naturally occurring DNA simply does not have the requisite chemical and physical properties needed to perform these functions.

This new utility ("use [of the] isolated DNA molecules as the basis for diagnostic genetic testing"]) satisfies the Funk Brothers requirement for "an 'enlargement of the range of . . . utility,'" at least because "[d]iagnostic testing . . . is not a natural utility" and "the claimed DNA does not 'serve the ends nature originally provided.'"  These isolated DNA molecules have "markedly different properties which are directly responsible for their new and significant utility," she writes, noting that "[t]he same sequence, as it appears in nature as part of the chromosome, simply cannot be used in the same way."  Accordingly, "small, isolated DNA fragments are patentable subject matter" in her opinion.

The "[l]onger strands of isolated DNA" are what apparently provided most of the impetus for Judge Moore's concurring opinion, since for her (as opposed to Judge Lourie), the patent-eligibility of these molecules present "a much closer case."  And while Judge Moore "ultimately conclude[s] that these longer isolated sequences, including the isolated gene sequence as a whole, are also patentable subject matter," her reasoning is different than for the shorter sequences.  She concedes that "[a]ll of the same structural arguments apply to any length of isolated DNA so, like the shorter strands, an isolated DNA coding for a gene does have a literal chemical difference from the gene as it appears on the chromosome."  However, "[u]nlike the shorter strands of isolated DNA, the chemical and structural differences in the isolated gene do not clearly lead to an "enlargement of the range of . . . utility" as compared to nature she says, citing Funk Bros., 333 U.S. at 131, and this difference raises her concerns for whether isolated genomic DNA molecule should be included within the scope of patent-eligible subject matter.

In view of these concerns, it may seem curious that Judge Moore decides that such molecules are patent-eligible.  She explains that "[i]f I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter."  This is due to the fact that "[d]espite the literal chemical difference, the isolated full length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence."  This statement ignores the real-world uses to which isolated DNA molecules can be put (uses Judge Moore appreciates, citing Amgen's EPO product later in her opinion) specifically the basis for the biotechnology industry:  providing useful quantities of proteins (erythropoietin, human growth hormone, interferon, blood clotting factors, and a host of other products) that would otherwise be in insufficient quantities from biological sources or have deleterious side-effects (such as adverse immunological reactions to animal insulins despite their ready availability).  However, Judge Moore recognizes that the Court does not write with a blank slate:

This case, however, comes to us with a substantial historical background.  Congress has, for centuries, authorized an expansive scope of patentable subject matter.  Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries.  There are now thousands of patents with claims to isolated DNA, and some unknown (but certainly large) number of patents to purified natural products or fragments thereof.  As I explain below, I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved.  Combined with my belief that we should defer to Congress, these settled expectations tip the scale in favor of patentability.

Judge Moore cites as one example U.S. Patent No. 3,067,099 (claiming vancomycin, an antibiotic produced by bacteria found in soil) and U.S. Patent No. 4,552,701 (claiming a vancomycin fragment produced by removing a sugar unit), and then (curiously) focuses on the second and ignores the first in discussing patent-eligibility of biologically derived molecules.  She further cites U.S. Patent No. 141,072, claiming "[y]east, free from organic germs of disease," issued to Louis Pasteur in 1873 (ironically, in view of how the opinion has been treated, one of the patents cited by Judge Rich in In re Bergy a generation ago), as well as the Patent Office justification that "isolated DNA is no different from the isolated natural products of Parke-Davis.  See 66 Fed. Reg. at 1093 (quoting Parke-Davis)."  She also notes that such claims have not been strangers to the Federal Circuit, citing (again, ironically in view of its author) the Court's opinion in Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991), which "involved a claim to "'[a] purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin.'"  Id. at 1203-04 (quoting U.S. Patent No. 4,703,008, claim 2).  "We affirmed that this claim was valid and infringed.  Id. at 1219."

In addition, she notes that:

The settled expectations of the biotechnology industry — not to mention the thousands of issued patents — cannot be taken lightly and deserve deference.  This outpouring of scientific creativity, spurred by the patent system, reflects a substantial investment of time and money by the biotechnology industry to obtain property rights related to DNA sequences.  The type of fundamental alteration in the scope of patentable subject matter argued in this case "risk[s] destroying the legitimate expectations of inventors in their property."  Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002).

In this regard, she notes that Isolated DNA claims, at least in the case of Amgen, represent crucial and exceedingly valuable property rights, citing Amgen's EPO product and the basis this product (protected inter alia by patents to isolated DNA molecules) has had for the company's success.  Accordingly, Judge Moore asserts that "leaving intact the settled expectaions of property owners is particularly important in light of the large number of property rights involved, both to isolated DNA and to purified natural products generally."  Specifically, "[t]o change so substantially the rules of the game now," after more than a century of practice, "'could very well subvert the various balances the PTO sought to strike when issuing the numerous patents which have not yet expired and which would be affected by our decision.'"  Festo, 535 U.S. at 739 (quoting Warner-Jenkinson v. Hilton Davis Chem. Co., 520 U.S. 17, 32 n.6 (1997)).

Judge Moore also visits the opinion of the Solicitor General (who had a lively twenty minutes under Judge Moore's questioning (and open skepticism) regarding whether the Justice Department's position was a change in policy that had split the government).  Kindly, she notes that:

Certainly the magic microscope has curb appeal — its child-like simplicity an apparent virtue.  The magic microscope, however, would not see the claimed DNA molecules at issue in this case.  An isolated DNA molecule has different chemical bonds as compared to the "unisolated" sequence in the chromosome (the ends are different).  In short, the claimed molecules cannot be seen in nature through the magic microscope.  While you may be able to see the order of DNA nucleotides in the chromosome, the isolated fragment of DNA is a different molecule.  It may be that the microscope can also break and form chemical bonds to yield the claimed isolated DNA.  Even so, the microscope must make some decisions:  should the isolated DNA begin and end in a phosphate? a hydrogen? a hydroxyl? a methyl group? an acyl group?  These decisions might be obvious to a person of ordinary skill in the art, but they are not inherent to the unisolated sequence as part of the chromosome.  Creating the claimed isolated DNA sequences therefore results in a distinctly unnatural molecule.

Her conclusion is simply that "[t]he magic microscope test simply does not work the way the government claims," and moreover, is itself contrary to Supreme Court precedent:

While the magic microscope creates a bright line rule, it presents a poorly defined question:  can we "see" the claimed molecule, or something fairly similar, in nature?  Even if the scientific imprecision of the test were excusable, the government also asks us to do away with Chakrabarty's flexible inquiry as to whether the invention, as claimed, has "markedly different characteristics from any found in nature" which result in "the potential for significant utility."  Id. at 310.  Indeed, the bright line magic microscope test actually appears to be contrary to Funk Brothers, since the combination of bacteria in that case was a "new and different composition of non-inhibitive strains," 333 U.S. at 130-31, and therefore not actually present in nature.  There may be additional nuance in the government's argument that accounts for this inconsistency, but under my understanding of the magic microscope test, the combination in Funk Brothers would be patentable subject matter.

Judge Moore also sees inconsistencies in the government's profferred test, noting that according to the government's brief "[a] chemical alteration of a bioactive molecule to improve absorption by the body . . . would likely satisfy section 101."  United States Amicus Br. 31 n.8.  But she sees the isolated DNA molecules here being "the result of a 'chemical alteration of a bioactive molecule' that leads to different properties, including a dramatic reduction in size."  In the same way, the hypothetical "chemical alteration" posited by the government produces a (patent-eligible) molecule because it has "improved absorption properties," the isolated DNA claimed by Myriad changes the properties of the gene in the chromosomal DNA.  "This is not '[m]erely sorting the proverbial wheat from the chaff,' as the government contends, id., but the creation of new DNA molecules with distinct properties and additional utility, including the ability to be used as a primer in genetic testing."

Judge Moore, in her concurring opinion (as she was at oral argument), is concerned by the "apparent lack of awareness about the impact of the proposed test."  Although the Solicitor General claims that the magic microscope represents "a very limited position," Judge Moore disagrees.  She recognizes that there is neither a legal nor a scientific basis to limit the application of the government's "magic microscope" to isolated DNA molecules; she posits that "Louis Pasteur's 1873 claim to 'Yeast, free from organic germs of disease, as an article of manufacture' runs afoul of the magic microscope since the microscope could zoom in to see that yeast free from contaminants,'" and that other "isolated naturally occurring molecules" (including adrenaline, vitamin B-12, and prostaglandins," as well as "smaller fragments of naturally occurring molecules, for example claims to truncated proteins (see, e.g., U.S. Patent No. 4,762,914, entitled "Truncated Protein of Interleukin-1") that have been "long considered patentable subject matter" would fail the government's test.

In addition to these practical concerns, Judge Moore contends that "[t]he government's new test fundamentally changes more than a century of precedent and Patent Office practice in the pharmaceutical and biotechnology arena" being "a purely mechanical inquiry that fails to account for the possibility that chemical changes to the isolated DNA sequences at issue, as compared to their natural state, could result in markedly different uses."  As a result, adopting the government's position would "call[] into question the validity of an unknown number of patents and claims and upsets the settled expectations of some of our most innovative industries," which she refuses to considern a "very limited position."  She also recognizes that the administration could change U.S. patent policy and not affect any existing patent rights, but that the government is asking the court to retroactively invalidate ("destroy existing property rights") thousands of granted patents containing claims to isolated DNA molecules.

Judge Moore believes that the proper place to debate such a drastic change in the law is Congress, and she refuses to "ignore the years of Patent Office practice and the accompanying expectations that practice created within the industry."  She refuses to do so, despite the "temptation" to rule on matters that "raise substantial moral and ethical issues related to awarding a property right to isolated portions of human DNA — the very thing that makes us humans, and not chimpanzees" because to do so would "usurp Congress's constitutionally mandated authority to promote science and useful arts."  Such "[j]udicial restraint is particularly important here because an entire industry developed in the decades since the Patent Office first granted patents to isolated DNA.  Disturbing the biotechnology industry's settled expectations now risks impeding, not promoting, innovation."  Continuing in this vein, Judge Moore finishes her concurrence by remarking that "[u]nsettling the expectations of the biotechnology industry now, based on nothing more than unsupported supposition, strikes me as far more likely to impede the progress of science and useful arts than advance it.  Given the complicated technology and conflicting incentives at issue here, any change must come from Congress" (noting the several times legislation has been introduced limiting the scope of 101 to exclude patenting genetic material, and that Congress has passed none of them).  And she closes her opinion by citing to one of the lions of patent law in the 20th Century, saying that "[t]his case typifies an observation by the late Chief Judge Markey, our first Chief Judge, that "[o]nly God works from nothing.  Men must work with old elements."  Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549, 1556 n.3 (Fed. Cir. 1985) (quotation, citations omitted).  Judge Moore concludes:

Human DNA is, for better or worse, one of the old elements bequeathed to men to use in their work.  The patents in this case revealed a new molecular understanding about ourselves; "the inventions most benefiting mankind are those that 'push back the frontiers of chemistry, physics, and the like.'"  Chakrabarty, 447 U.S. at 316 (quoting Great A. & P. Tea Co. v. Supermarket Corp., 340 U.S. 147, 154 (1950)).  We cannot, after decades of patents and judicial precedent, now call human DNA fruit from the poisonous tree, and punish those inquisitive enough to investigate, isolate, and patent it.  "Our task . . . is the narrow one of determining what Congress meant by the words it used in the statute; once that is done our powers are exhausted."  Id. at 318.  This inquiry does not have moral, ethical, or theological components.  Cf. id. at 316-17 ("[W]e are without competence to entertain" arguments about "the grave risks" generated by genetic research.).  The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve.  I therefore decline to extend the "laws of nature" exception to include isolated DNA sequences.

Association for Molecular Pathology v. U.S. Patent and Trademark Office (Fed. Cir. 2011)
Panel:  Circuit Judges Lourie, Bryson, and Moore
Opinion for the court by Circuit Judge Lourie; opinion concurring in part by Circuit Judge Moore; opinion concurring in part and dissenting in part by Circuit Judge Bryson

By Kevin E. Noonan —

The Federal Circuit rendered a fractured decision on Friday in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case), with a majority opinion by Judge Lourie, a concurring opinion by Judge Moore joining in certain parts of the "majority" opinion and in other parts concurring with the result, and a concurring-in-part and dissenting-in-part opinion by Judge Bryson (both judges writing separately to share their views of only a portion of the case, the question of subject matter eligibility under 35 U.S.C. § 101 for isolated DNA molecules) (see "Federal Circuit Issues Decision in AMP v. USPTO").  This post will discuss the majority opinion on the substantive issues:  the patent-eligibility of the composition of matter claims (where the Court reversed the District Court's finding that "isolated DNA" was not patent-eligible under the "products of nature" "exception") and the method claims (where the Court affirmed the District Court on the diagnostic method claims under the Bilski "machine or transformation test") and reversed on the sole screening method claims (claim 20 of U.S. Patent No. 5,747,282).  Future posts will discuss Judge Moore's and Judge Bryson's views on the composition of matter claims, as well as address the standing issue (where the Court affirmed the District Court's finding that the plaintiff's, albeit not all the plaintiffs, had standing under Supreme Court precedent, inter alia, MedImmune, Inc. v. Genentech, Inc.).

The opinion sets forth "representative claims" for the composition of matter, diagnostic method, and screening method claims; for the composition of matter claims, these were claims 1, 2, and 5 of U.S. Patent No. 5,747,282:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2.  The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

Claim 1 of U.S. Patent No. 5,710,001 and claim 1 of U.S. Patent No. 5,709,999 were cited in the opinion as representative of the "analyzing" or "comparing" claims:

1.  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Ta-bles 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a se-quence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleo-tides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

'999 patent claim 1 (emphases added).

1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises [] comparing a first sequence selected from the group consisting of a BRCA1 gene from said tu-mor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic altera-tion in the BRCA1 gene in said tumor sample.

'001 patent claim 1 (emphasis added).

Finally, the opinion cited claim 20 of U.S. Patent No. 5,747,282 as the sole screening method claim:

20.  A method for screening potential cancer therapeutics which comprises: growing a trans-formed 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.

After a brief recap of the factual background of the case, illustrated by a number of drawings representing the chemical structure of DNA:

the processes of transcription and translation:

how DNA encodes individual amino acids in a protein:

and the structure of "naturally occurring" DNA in the human chromosome:

the Court addressed the District Court's decision on each of the different types of claimed subject matter in turn.

For the composition of matter claims, Judge Lourie's opinion (not surprisingly) focused on the chemical nature the isolated DNA molecule.  The opinion sets out the competing positions of the parties, and mentions the government's "magic microscope" in determining that all the parties seem to agree that "isolated DNA" is a composition of matter (and, although unspoken, thus literally falls within one of the statutory definitions of patent-eligible subject matter).  The issue for the Court therefore becomes whether isolated DNA falls within the scope of one of the exceptions to the "broadly construed" categories defined by § 101.  The Court starts sets out Diamond v. Chakrabarty and Funk Bros. Seed Co. v. Kalo Inoculant Co. as controlling Supreme Court precedent, citing Chakrabarty for the dicta that "the relevant distinction for purposes of § 101 is . . . between products of nature . . . and human-made inventions."  Chakrabarty, 447 U.S. at 313.  The opinion recognizes the contrast presented between the genetically engineered bacteria in Chakrabarty and the naturally occurring bacteria in Funk Bros., a contrast the Federal Circuit sees the Supreme Court making in Chakrabarty.  Notably, however, the opinion acknowledges that Funk Bros. was decided on the question of "obviousness" (or "invention" as formulated prior to codification of obviousness in the 1952 Patent Act under § 103) rather than subject matter eligibility under § 101.  Curiously, the Court in footnote 6 declares that:

We note that [In re] Bergy is no longer binding law.  Bergy was the companion case to Charkarbarty, and was vacated by the Supreme Court and remanded for dismissal as moot.  Diamond v. Chakrabarty, 444 U.S. 1028 (1980).

While this is certainly one reading of the procedural outcome of the Bergy case, it runs contrary to the generally accepted idea that the Supreme Court in Chakrabarty affirmed (or at least did not disturb) the decision in Bergy that isolated bacteria producing lincomycin were patent-eligible.  (Possibly the panel was attempting to distinguish its decision from any suggestion that this three-judge panel was overruling a CCPA decision, something only the en banc Federal Circuit can do.)  In this same footnote the opinion distinguished other CCPA cases "cited by the parties and amici" because they "were not decided based on patent eligibility," including In re Bergstrom, 427 F.2d 1394, 1394 (CCPA 1970) ("the court held that pure prostaglandin compounds, PGE(2) and PGE(3), were improperly rejected as lacking novelty"); In re Kratz, 592 F.2d 1169, 1170 (CCPA 1979) ("the court held non-obviousness claims to synthetically produced, substantially pure 2-methyl-2-pentenoic acid ('2M2PA'), a chemical that gives strawberries their flavor");  In re King, 107 F.2d 618, 619 (CCPA 1939) ("holding claims to vitamin C invalid for lack of novelty, as '[a]ppellants were not the first to discover or produce [vitamin C] in its pure form'"); and In re Merz, 97 F.2d 599, 601 (CCPA 1938) ("holding claims to artificial ultramarine that contains non-floatable impurities invalid as not 'inventive,' and thus as obvious").  Elsewhere in the opinion, the majority also distinguishes some old "war horses" of "product of nature" jurisprudence:

Other Supreme Court decisions cited by the parties and amici were decided based on lack of novelty, not patentable subject matter.  In American Wood-Paper Co. v. Fibre Disintegrating Co., the Court held the challenged patent "void for want of novelty in the manufacture patented," because the "[p]aper-pulp obtained from various vegetable substances was in common use before the original patent was granted . . . , and whatever may be said of their process for obtaining it, the product was in no sense new."  90 U.S. 566, 596 (1874).  Similarly, in Cochrane v. Badische Anilin & Soda Fabrik, the Court held that a claim to artificial alizarine covered an old and well-known substance, the alizarine of madder, which could not be patented although made artificially for the first time.  111 U.S. 293, 311 (1884); see also id. at 308-09 ("It is very plain that the specification of the original patent, No. 95,465, states the invention to be a process for preparing alizarine, not as a new substance prepared for the first time, but as the substance already known as alizarine, to be prepared, however, by the new process, which process is to be the subject of the patent, and is the process of preparing the known product alizarine from anthracine." (emphases added).

The opinion sets forth what the majority sees as the Supreme Court test:

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition's identity compared with what exists in nature.  Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given "markedly different," or "distinctive," characteristics.  Id. Hartranft, 121 U.S. at 615; see also Am. Fruit Growers v. Brogdex Co., 283 U.S. 1, 11 (1931).

The opinion concludes that the claimed DNA molecules meet this test.  This conclusion is based on the chemistry of isolated DNA:

It is undisputed that Myriad's claimed isolated DNAs exist in a distinctive chemical form — as distinctive chemical molecules — from DNAs in the human body, i.e., native DNA.  Native DNA exists in the body as one of forty-six large, contiguous DNA molecules.  Each DNA molecule is itself an integral part of a larger structural complex, a chromosome.  In each chromosome, the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure.  See supra, Figure 3.

Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene.  Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.  For example, the BRCA1 gene in its native state resides on chromosome 17, a DNA molecule of around eighty million nucleotides.  Similarly, BRCA2 in its native state is located on chromosome 13, a DNA of approximately 114 million nucleotides.  In contrast, isolated BRCA1 and BRCA2, with introns, each consists of just 80,000 or so nucleotides.  And without introns, BRCA2 shrinks to just 10,200 or so nucleotides and BRCA1 to just around 5,500 nucleotides.  Furthermore, claims 5 and 6 of the '282 patent cover isolated DNAs having as few as fifteen nucleotides of a BRCA sequence.  Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.

These are structural arguments, focused on the differences in the chemical structure between the isolated DNA molecules recited in the claims of the patents-in-suit; while this focus is not surprising coming in a Federal Circuit opinion, one of the principle flaws in the District Court's opinion is to decide the case on a philosophical basis, rather than determining what was recited in the claims.  In this regard, the Federal Circuit distinguished "isolated" from "purified," and in doing so distinguished these claims from the claims in In re Marden regarding ductile uranium and vanadium, and also from Parke-Davis & Co. v. H.K. Mulford Co., which found purified adrenaline to be patent-eligible because while the molecule was identical to the naturally occurring molecule its purification had converted it into "a new thing commercially and therapeutically."  This chemical/structural distinction that forms the (legal) basis of the Court's opinion is that the claimed DNA is not, as it is "in nature, . . . covalently bonded to such other materials."  "[A]n isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity.  In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules," according to the majority opinion.

The Court also rejects plaintiffs' argument, that isolated DNA is merely a "product of nature" because the isolated DNA shares its sequence with DNA in its native state in the chromosome, saying that this argument "looks not at whether isolated DNAs are markedly different — have a distinctive characteristic — from naturally occurring DNAs, as the Supreme Court has directed, but at one similarity:  the information content contained in isolated and native DNAs' nucleotide sequence."  This is the error that the District Court made, because "it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit."  The focus of this argument on uses is appropriate for deciding obviousness, not patent-eligibility, according to the opinion.  "The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact."

In addition, the majority states that the District Court's opinion creates a new categorical rule of patent-ineligibility, something contrary to Supreme Court mandates, saying the high court "more than once cautioned that courts 'should not read into the patent laws limitations and conditions which the legislature has not expressed,'" citing Bilski, 130 S. Ct. at 3226 (quoting Diamond v. Diehr, 450 U.S. 175, 182 (1981)).

The opinion also (thankfully) rejects the "magic microscope" analysis by the government "as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities."  Moreover:

The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable.  It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect.

Such an approach would "discourage innovation," because "[v]isualization does not cleave and isolate the particular DNA; that is the act of human invention."

The Court wisely rejects the "many thought-provoking hypotheticals" which "each  . . . raise[] a complicated issue of patent eligibility" because these questions are "not before the court," taking to heart the maxim that "bad analogies make bad law."  Put simply, "courts decide cases, they do not draft legal treatises."  In this regard, the opinion mentions the litany of hypotheticals, including patenting "isolated chemical elements," "minerals found in the earth," "atomic particles," "organs," and "a leaf from a tree."  "None of these examples, however, as far as we can discern, presents the case of a claim to a composition having a distinctive chemical identity from that of the native element, molecule, or structure," according to the Court, citing the lack of distinctiveness for each example.  "Some may have a changed form, quality, or use when prepared in isolated or purified form, but we cannot tell on this record whether the changes are sufficiently distinctive to make the composition markedly different from the one that exists in nature.  In contrast, a portion of a native DNA molecule — an isolated DNA — has a markedly different chemical nature from the native DNA.  It is, therefore, patentable subject matter."

Finally, the opinion cites J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. for the principle enunciated by the Supreme Court that Congress needs to make these decisions, not the courts.  In view of the reality that the PTO has been granting patents on isolated DNA molecules for 30 years, the opinion reminds us that "courts must be cautious before adopting changes that disrupt the settled expectations of the inventing community," Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002) (citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 28 (1997); it is a principle administrations would be wide to adopt (or at least consider).

Turning to the method claims, the Court readily affirmed the District Court's finding that the "comparing" and "analyzing" claims (claim 1 of the '001 patent and claim 1 of the '999 patent) failed the machine-or-transformation test.  Although the District Court decided this case before the Supreme Court's Bilski v. Kappos decision, the majority reached a decision on the merits because it reasoned that the parties had had sufficient opportunity to address the issues.  The Court's decision was based on the language of the claims at issue, which do not recite affirmative steps for obtaining the sequence (and thus could be infringed "merely" by comparing or analyzing sequences).  "This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences:  look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position."

Myriad argued (in order to "escape this result), that the claims should be read to contain "additional, transformative steps," including "the steps of (1) extracting DNA from a human sample, and (2) sequencing the BRCA DNA molecule, arguing that both steps necessarily precede the step of comparing nucleotide sequences."  Not only were these steps not recited in the claims as affirmative limitations, the Court found that the specification required the term "sequence" to refer "more broadly to the linear sequence of nucleotide bases of a DNA molecule."  In arriving at this conclusion, the Court distinguished these claims from the claims in Prometheus Labs., which the opinion states recite affirmative steps that are transformative.  In contrast, Myriad's claims can be satisfied (i.e., infringed) by "mere inspection" alone, and thus encompass merely an abstract idea.  Claim 20 of the '282 patent (the chemotherapeutic agent screening claim) was transformative, according to the Court, because it recited transformative steps ("growing said transformed eukaryotic host cell in the absence of said compound" and "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") in addition to the comparative step.  As in Prometheus, the Court determined that the recitation of the transformative steps were sufficient to satisfy the machine-or-transformation test, and accordingly reversed the District Court's determination that claim 20 was patent-ineligible.

Association for Molecular Pathology v. U.S. Patent and Trademark Office (Fed. Cir. 2011)
Panel:  Circuit Judges Lourie, Bryson, and Moore
Opinion for the court by Circuit Judge Lourie; opinion concurring in part by Circuit Judge Moore; opinion concurring in part and dissenting in part by Circuit Judge Bryson

By Kevin E. Noonan —

On the very day that the Federal Circuit rendered its decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case), Plaintiffs sent a letter to the Court responding to an allegation regarding the standing issue in the case.  As discussed yesterday, Defendants' (Myriad's) counsel sent a letter to the Court contending that Dr. Harry Ostrer, a named plaintiff, had recently left his position at NYU Legano Medical Center for a post at the Department of Genetics at Albert Einstein Medical Center.  This event was significant, according to Defendants' letter, because Dr. Ostrer purportedly would not be able to perform clinical genetic testing in his new position, and thus his willingness to perform BRCA testing would no longer support plaintiffs' standing for its declaratory judgment action.

Plaintiffs' letter contends that Defendants are in error and that Dr. Ostrer retains his capacity and willingness to perform BRCA genetic testing in his new position.

The significance of Dr. Ostrer's status is heightened by the Court's decision today, which affirmed the District Court's decision that plaintiffs have standing based solely on Dr. Ostrer's capacity and willingness to perform BRCA genetic testing.  While the issue would appear to be mooted by the Court's decision, insofar as a factual dispute exists, it may be addressed if either party petitions for rehearing en banc.

By Kevin E. Noonan —

The Federal Circuit handed down its long-anticipated decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case).  In an extensive and thorough opinion by Judge Lourie (only appropriate in a case where the District Court's opinion reached 156 pages), the Court affirmed the District Court's decision on standing, reversed the decision regarding isolated DNA claims, and affirmed the decision of unpatentability for method claims reciting merely "comparison" steps, on the grounds that these claims failed the machine or transformation test from Bilski.

Judge Moore wrote a separate concurring opinion, explaining her decision to join Judge Lourie (with regard to the isolated genomic DNA claims) on the grounds that, at this late date it is up to Congress, not the courts, to extend the "laws of nature" exception to isolated DNA.

Judge Bryson dissented from the majority's decision to reverse the District Court on the genomic DNA claims, based (in part) on his understanding that such claims would inhibit whole genome sequencing, and that these claims were analogous to earlier (albeit non-binding) precedent and (in his view) consistent with Supreme Court decisions.

Patent Docs will provide further analysis in upcoming posts.