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
Kevin,
Nice review of Lourie's opinion. This is definitely one Lourie's better opinions compared to Ariad and especially Prometheus which are very obliquely (and in my opinion, confusingly) written.
Your comments on footnote 6 in Lourie's opinion are interesting. I especially share your puzzlement as to why Lourie characterized In re Bergy as no longer binding precedent in the Federal Circuit. In fact, Sweet, the district judge in this case, treated Bergy as if it was still binding precedent. This is yet another instance where what Lourie says mystifies me.
Posted by: EG | August 02, 2011 at 07:19 AM
The court's opinion is not only fractured, it's half-witted. It's half-witted because it only gets half of the way to an intelligent IP policy for molecular diagnostics. It upheld the patentability of isolated DNA, which it clearly should have, based on well-reasoned case law and 30 years of practice. However, by attempting to jam the method claims into the Bilski framework (which has its own problems, even when limited to software), the court missed the forest for the trees.
Those who support the patentability of such claims need to put aside the tortured legal analysis – analysis equivalent to the medieval debate of how many angels can dance on the head of a pin – and emphasize the broader policy. Does it really make sense, in terms of the goals of the patent system, to hold that these kinds of diagnostic claims are not patentable? Clearly, they are based in technology. (See Article 1 Section 8 of the Constitution.) Clearly, they represent an extremely useful advance in the field of personal medicine. I realize that case law says that abstract ideas are not patentable. However, mental steps are not necessarily the same as abstract ideas. These claims represented the application of technology to a real world problem, which provided an extremely useful real-world result. That should be enough.
Posted by: Geoff Karny | August 02, 2011 at 10:13 AM
"Does it really make sense, in terms of the goals of the patent system, to hold that these kinds of diagnostic claims are not patentable?"
Yes. Issuing patents on abstractions, facts, and/or mental processes is bad policy.
"I realize that case law says that abstract ideas are not patentable. However, mental steps are not necessarily the same as abstract ideas."
They are both ineligible for patenting, and rightly so. That's what matters.
Posted by: KIR | August 02, 2011 at 11:44 AM
I have a quick question Kev, how does the mRNA know how to leave the introns out?
In other words how does the mRNA know the difference between introns and exons?
One other question if you don't mind. Could the pre-RNA fragment in the picuture be termed "an isolated gene"?
Posted by: 6 | August 02, 2011 at 02:23 PM
"the court missed the forest for the trees. "
For the record Geoff (can I call you NWPA v2.0?), I agree that the court missed the forest for the trees. Specifically, it focused on whether or not the claim was itself directed to a chemical (the tree), and forgot to analyze what the claim actually preempts in a Bilski style analysis. It is for that reason that I believe ACLU still has a wonderful opportunity higher up the chain.
"Clearly, they are based in technology."
Making a diagnosis is based in technology? L O to the L? LO^L?
"These claims represented the application of technology to a real world problem, which provided an extremely useful real-world result. "
The application of what technology? The "technology" of making a "diagnostic"? You realize that a diagnostic is not "technology" right?
Posted by: 6 | August 02, 2011 at 02:29 PM
"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.""
One of my favorite parts of the decision. According to this, apparently all one needs do is take a leaf from a tree and then chop the stem of the leaf off half-way. Wallah! Patenable! Leaves don't occur naturally with their stems chopped halfway off!
Posted by: 6 | August 02, 2011 at 02:47 PM
Let's consult the Magic Microscope(TM). It knows all, it sees all.
Posted by: General Admission | August 02, 2011 at 04:32 PM
I guarantee that if I filed a composition claim tomorrow that included within its scope a fallen leaf or even a "chopped off" leaf, it would never, ever be rejected under 101 by the USPTO.
As an argument for ineligibility of an isolated composition under 101, the leaf analogy is the least compelling argument out there.
Posted by: KIR | August 02, 2011 at 05:09 PM
"According to this, apparently all one needs do is take a leaf from a tree and then chop the stem of the leaf off half-way. Wallah!"
It's a baseball bat for a fetus.
Posted by: KIR | August 02, 2011 at 05:11 PM
Dear 6:
To answer your question (to the best of my understanding of how this has been worked out):
Certain protein factors interact with the portion of the chromosome (generally) adjacent to the "gene," meaning the expanse of chromosomal DNA defining the exons that encode a protein and any introns that may be positioned in between separated exons. This configuration permits an enzyme, RNA polymerase II, to transcribe the gene into a single-stranded RNA molecule, having a "cap" at the 5' end; the opposite end has a string of A residues that are added enzymatically after the RNA is produced (i.e., they are not in the chromosomal DNA).
This RNA is then processed by enzymes in the cell nucleus that recognize subsequences at the margins of the introns and "splice" the exons together in the proper frame for translation by ribosomes (which are in the cytoplasm; the rest of this happens in the cell nucleus). While not everything is understood, there are mutations in these subsequences in the beta-globin genes that cause diseases called thallosemias (sp?) due to mistakes in this splicing process. Once the RNA has been properly and completely spliced, it is called an mRNA, is transported to the cytoplasm and proteins made using it. Discussion of this process is beyond the scope of the question.
Since all this happens in the cell, in no way could it be considered "isolated," and in any event it is RNA not DNA - single-stranded vs. double-stranded, ribose sugar vs. deoxyrobose sugar, uridine vs. thymidine bases, capped vs. uncapped, etc.
Posted by: Kevin E. Noonan | August 02, 2011 at 05:22 PM
"I guarantee that if I filed a composition claim tomorrow that included within its scope a fallen leaf or even a "chopped off" leaf, it would never, ever be rejected under 101 by the USPTO."
Really? Because I may or may not be a person who rejects and I may or may not be able to assure you that I would reject such under 101.
"It's a baseball bat for a fetus."
Lulz.
Posted by: 6 | August 02, 2011 at 05:24 PM
I am not sure I get what was transformative about the Prometheus claims. The problematic machine-or-transformation test aside, these tests, namely, the ones in Prometheus v Mayo, AMT v USPTO and Classen v Biogen, all rely on one essential stage, that of comparing one set of values to another. In Prometheus, it was achieved by first administering a drug (in order to get the second set of values to be compared) followed by the determining step; In AMT, one was by a straightforward comparing (determining step); and the other was by “growing”; “determining” and then “comparing”. Interestingly, the Federal Court in AMT glossed over the fact that in Prometheus, the “determining” step also involved comparing, and was not considered as a separate step. In Classen, the steps were similar to those in Prometheus.
If the Federal Court is to be believed, the essential difference between Prometheus and AMT was that the steps of “administering” and “determining” result in transformations, thereby satisfying the machine-or-transformation test. The Federal Circuit’s analysis in respect of ‘Methods of “Comparing” or “Analysing” Sequences’ reflect my approach to this issue. The methods claim a “phenomena of nature’ and are mental processes, both of which are unpatentable. The confusion, it seems to me, lies in a misunderstanding of what the invention is. The inventive concept in a majority of these types of claims is that a correlation between two values provides information. In Prometheus, the information was necessary to determine an optimized dosage regime for that patient; in Classen, the information was necessary to determine which regime was less likely to cause a disorder. Neither of these claims are diagnostic methods; they merely enable the physician to determine an optimum course of treatment. In AMT, the information gathered determined whether the patient had cancer or was predisposed to it. This was a classic diagnostic method, as was the claims in Lab Corp v Metabolite (a method detecting vitamin deficiency). I doubt very much that it makes a material difference for the purposes of the analysis whether the claims are diagnostic methods or merely part of the treatment regime for the patient.
In any event, the central point made in Prometheus (2008) and (2010) remain. It boils down to this: the insertion in a claim of a step which provides one set of values to be compared (by, for example, administering a drug), makes that step transformative. As the Court in Bilski v Kappos noted, the Information age may very well require different, and perhaps a more sophisticated, approach to patent eligibility. In relation to process claims, where a thing is being created, then, surely, the machine-or-transformation test is appropriate. However, where the process claim relates to information that it generates, as the examples above show (rather than a “thing” being created), then there is nothing to be transformed. It is this failure to appreciate that the “inventive concept” in such claims is really to the method of getting the “information”; whereas the machine-or-transformation test is appropriate where a “thing” is being created using a process. The analogy is not the same. The end product from the claimed process, the “thing”, must be transformed under the test; but, in medical patent claims, there is nothing to transform as the “thing”, the object of the claimed method, does not come till the end. This possible distinction has been troubling me for some time now, so any comments are welcomed.
Posted by: EDV | August 03, 2011 at 12:44 AM
Kevin,
As I read the majority and concurrence, it's not the "being in the cell" that suffices for isolation, but rather the separation of the gene sequence from adjacent nucleotides. Can you show me where the court's idea of isolation is linked to "being in a cell"
best,
David
Posted by: David Koepsell | August 03, 2011 at 07:07 AM
Dear David:
Sorry for the confusion; I was responding to 6, insofar as he was asking whether production of mRNA is "isolation." It seems to me that both the majority and the concurrence start from the premise that we are talking about the patent-eligibility of something in a test tube; no one believes that any of Myriad's claims (or anyone else's) cover the DNA in the cell (indeed, an isolated DNA claim is not infringed if the DNA is transferred into another cell unless the patentee has a separate claim for the recombinant cell).
Thanks for the comment.
Posted by: Kevin E. Noonan | August 03, 2011 at 10:45 AM
Kev thanks for the breakdown. I had drafted a response but idk where it went. In any event, the summary over at PO by D on the matter was very easily read and understood (although this could be because I took the time to look up everything before he laid it out and then he just laid it out again in very simple terms).
Bottom line after I understand the whole issue is that I still find fault with the practical effect that such claims have in so far as they effectively preempt practically all practical applications of the genetic information. I know there are folks that say that there are other uses that are not covered, but I just don't know if having limited the claims to not cover those will rise above adding insignificant post solution activity or limiting yourself to the specific field of use. But idk, we'll see what the USSC has to say shortly I imagine.
"I am not sure I get what was transformative about the Prometheus claims."
That's because there was nothing transformative about them. You didn't miss anything, the Fed's made something up, and they're likely to get reversed. Just another year at the patent protectionist federal circuit.
Posted by: 6 | August 03, 2011 at 01:36 PM
"no one believes that any of Myriad's claims (or anyone else's) cover the DNA in the cell"
Not if you read the popular press, who STILL claim that someone else is owning your DNA.
Posted by: Skeptical | August 03, 2011 at 01:51 PM
"Not if you read the popular press, who STILL claim that someone else is owning your DNA."
Is owning the sequence of your DNA that much different? Mmmmm, idk.
Posted by: 6 | August 03, 2011 at 04:34 PM
Kevin,
Case in point: 6's response.
Posted by: Skeptical | August 04, 2011 at 09:19 AM
Skeptical,
I totally concur with your last point. Mind you, you'll be labeled as an "elitist" but who cares?
Posted by: EG | August 05, 2011 at 07:14 AM
Although a bit of trepidation is likely in order (no matter on what end of the spectrum you tend to fall), I look forward to reading what the SCOTUS has to say when the esteemed Justices opine on gene patents. Particularly since Myriad presents a bit of a chicken-and-egg question -- that is thus perhaps not scientifically, definitively solvable -- policy considerations will probably weigh heavily in their ultimate determination. Which also makes one wonder to what extent the Court's new political makeup will affect the case's outcome.
http://www.GeneralPatent.com/blog/
Posted by: patent litigation | August 09, 2011 at 12:20 PM