Federal Circuit: Patentability of Isolated Genes

Association for Molecular Pathology v. USPTO and Myriad Genetics (Fed. Cir. 2010)

In a landmark 2010 declaratory judgment decision, a Southern District of New York court invalidated claims from seven Myriad patents associated with the BRCA1/2 breast and ovarian cancer genes.  The patents include both composition claims covering isolated DNA molecules and method claims covering the processes of detecting and screening for BRCA mutations.  The lower court held that these claims all fail the patentable subject matter eligibility test of 35 U.S.C. §101.  A typical invalidated claim includes Claim 1 of Patent No. 5,747,282 which reads “1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.” (The amino acid sequence No. 2 was provided as a part of the patent filing).

Myriad has now filed its Federal Circuit appeal brief on the merits and argues two main points: (1) that the declaratory judgment plaintiffs had no standing to sue because there was no actual case or controversy between them and Myriad and (2) that Myriad's patents cover inventions that fit well within the broad scope of Section 101 subject matter eligibility. As I wrote earlier, I believe that the Federal Circuit will reverse.

Standing: A general rule of appellate advocacy is to lead with your best argument. One caveat involves standing — when standing is argued, it is invariably argued first. Although the weaker of its two primary arguments, Myriad led with its case for no standing.

It is important to remember how this case arose — with twenty plaintiffs joining together to sue Myriad and to ask the Federal Court to declare Myriad's patents invalid.

Declaratory Judgment Jurisdiction is governed by Article III of the US Constitution, the Declaratory Judgment Act of 1934, and most recently, the 2007 Supreme Court case of MedImmune v. Genentech which eliminated the reasonable-apprehension-of-suit test that had been previously followed by the Federal Circuit. 

The basic question for this case is whether sufficient controversy and adversity exists between the parties or, as Myriad argues, did the lower court improperly provide an advisory opinion.  The Supreme Court restated its standing test in MedImmune — asking “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” Myriad argues that there is no controversy between the parties because Myriad has not taken any (recent) action toward the plaintiffs and that any controversy between the parties lacks “sufficient immediacy.”

Here, neither plaintiffs’ complaint nor the district court’s opinion identifies any “affirmative act” by Myriad within the past ten years putting plaintiffs at risk of an infringement suit. There is no allegation, much less evidence, that Myriad ever identified the patents-in-suit (or any claim thereof) to any plaintiff, or identified any plaintiff’s product or conduct as infringing. In fact, there is no allegation that Myriad was even aware of any plaintiff’s “ability and desire” to infringe (A1034-64), let alone that Myriad evaluated any product or conduct to determine infringement. Accordingly, plaintiffs have no basis for declaratory judgment jurisdiction because “the totality of the circumstances analysis in the instant case is that which has not occurred.”

The district court disagreed with these arguments — holding that a controversy existed based on Myriad's activity against researchers along with an understanding “within the research community . . . [that] Myriad has taken the position that any BRCA1/2 related activity infringes its patents and that Myriad will assert its patent rights against parties engaged in such activity.” 

Discovering the Importance of a Mutation: The important scientific discovery in this case is the knowledge that BRCA mutations predict breast and ovarian cancer.  Of course, that informational discovery by-itself cannot be patented because it represents an abstract idea rather than a useful implementation.  The mutation itself occurs in nature and therefore is not sufficiently new to be patentable. The patents therefore were drafted to cover “isolated” forms of the mutated gene and methods of isolating the gene.  As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.  Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.

With this setup, the Federal Circuit will be asked to determine whether tying the informational discovery to the isolated compound or method of isolation is sufficient to move the patent outside of the scope of abstract ideas and natural phenomena.  The question may be whether the Court should follow Diehr or instead follow Flook and Benson. The Bilski decision does not help in analyzing the claim here other than by revitalizing the precedential value of Flook and Benson.

Amicus briefs supporting Myriad will be filed shortly.

86 thoughts on “Federal Circuit: Patentability of Isolated Genes

  1. Myriad’s standing issue seems like a Hail Mary. It doesn’t strike me as a terribly strong argument, in the context of the issues at play in this patent litigation. Personally, I think both of Myriad’s main arguments are weak. Moreover, what with the DOJ having just decided that isolated genes are unpatentable, Myriad’s chances of success on the merits of its case seem increasingly remote. I hope this issue still goes up to the SCOTUS and the Court grants cert, because I’m looking forward to reading that opinion.

  2. When you can reach out and touch someone…And that was “a necessity”

    And then with a 10 year vacation.. He’s still able to go from Law Firm to law Firm, but pufffffff….. gone when there is any dust kicked up oughta tell me something. I apologize believe me I do. I apologize honest and true. And I imagine it will immediately happen again. That is if they keep up.

  3. I Think I need to apologize Malcolm. Tomorrow I will show you my apology. Well not literally… figuratively speaking. Ping you earned your money.
    Sensing all the things that have been thrown at me is one thing, but putting them in the wrong Buckets is another.

  4. anon How does the Breyer dissent in LabCorp bring us back to the standing issue?

    Was that the same Breyer dissent that was summarily dismissed at the CAFC (and rightly so, but on other grounds) as not even persuasive dicta?

    I don’t recall or care what aspects of Breyer’s Metabolite dissent was summarily dismissed at the CAFC. But his analysis of the claim at issue in Lab Corp v. Metabolite Labs is logically and legally irrefutable:

    At most, respondents have simply described the natural law at issue in the abstract patent language of a “process.” But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge. Cf. id. at 192 (warning against “allow[ing] a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection”). One might, of course, reduce the “process” to a series of steps, e.g., Step 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly. But one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable “natural phenomenon,” and I can find nothing in claim 13 that adds anything more of significance.

    You may need to refresh yourself on the claim at issue in Metabolite labs. And please remember that the patentee in that case admitted that the claims cover merely thinking about a particular implication of an observed fact (i.e., a patient’s homocysteine levels).

  5. In a perverse sort of way I am sorry that the First Amendment argument was so easily avoided. It would have made for very interesting reading.

    Not nearly as interesting as a Second Amendment challenge to gun patents, which if anything is a stronger (but less practically significant) argument with essentially the same logical underpinnings.

    I’m not sure the First Amendment issue was even avoided, really. Section 101 would appear to preclude patenting pure information, under any test that has ever existed. If applying the law always moots the constitutional argument, that simply means the law is constitutional.

    It would have been an interesting read, though, if only to see how a judge rationalized invalidating an individual patent as being unconstitutional without declaring section 101 unconstitutional.

  6. IANAE,

    IIRC, the ACLU did present a claim in its complaint that the First Amendment is implicated. The judge avoided that argument (per the long established doctrine of “constitutional avoidance) by his simple declaration that the patents were invalid under Section 101, thus rendering moot any First Amendment argument.

    In a perverse sort of way I am sorry that the First Amendment argument was so easily avoided. It would have made for very interesting reading.

  7. it is amusing to imagine someone like the ACLU pressing the notion that the First Amendment controls patents,

    They don’t have a whole lot of choice in the matter, unless they want to hang their collective hat on the 13th Amendment. They begin with the premise that they’re not fans of gene patents, and they need to make a federal case of it, so to speak.

  8. “..possible (sic) a 101 issue to the extent that it removes information itself from the public domain…”

    Obviously a casual use of terms in a blog post (which is to be expected since they are not academic treatises), but it is amusing to imagine someone like the ACLU pressing the notion that the First Amendment controls patents, a position it and others seem to be inclined to advocate on a regular basis with respect to almost the entire body of copyright law. Perhaps there is needed a new doctrine entitled “Patent Fair Use”.

  9. hm: I see a misguided attempt to import the latter to the former, or, more generally, to “read-in” legal tests to the statutory patentable subject matter requirement to satisfy policy views.

    People often see what they want to see.

    Stop seeing and start looking.

  10. Printed matter. Information. Abstract ideas.

    Posted by: Ned Heller | Oct 27, 2010 at 02:36 PM

    Ned, your homework assignment exploring the boundaries of the printed matter doctrine, as explicated in case law, is overdue. Please pay attention to the actual words used in case law as to the relationship aspect required from printed matter that serves a functional aspect of that boundary. Until you hand in that assignment, you must refrain from commenting on the issue, as you will merely reinforce your currently unfounded viewpoint and solidify a position built on nothing.

  11. Malcolm,

    How does the Breyer dissent in LabCorp bring us back to the standing issue?

    Was that the same Breyer dissent that was summarily dismissed at the CAFC (and rightly so, but on other grounds) as not even persuasive dicta?

  12. For this comment, “Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.”, I hope there is a new process of identifying a genuine isolation steps that will be separate from old method.

  13. Blix Those are the method claims, and Sweet was positively on the money when he invalidated those. Those claims seek to place in private hands the mere observation of a natural phenomenon.

    A very real problem that Justice Breyer recognized in his LabCorp dissent. Which brings us back to the standing issue …

  14. Vanslice, you are correct that the case is ridiculous insofar as it concerns the composition claims, as those claims are certainly patent-eligible. The claimed compositions don’t exist in nature, end of story. Sweet was plainly wrong about this part of the case, and will be summarily reversed. Of course, those are not the claims that exclude others from generically testing for the presence/absence of BRCA1 mutations (putting an end to which monopoly is what the plaintiffs really wanted). Those are the method claims, and Sweet was positively on the money when he invalidated those. Those claims seek to place in private hands the mere observation of a natural phenomenon.

  15. I see a misguided attempt to import the latter to the former, or, more generally, to “read-in” legal tests to the statutory patentable subject matter requirement to satisfy policy views.

    OK – so what? Ya see the carpet bomb that IANAE gonna lay on ya and there be nothin ya can do. He be that good.

    Bombs away!

  16. I get you and the other three Horsemae Malcolm Mud Mooney. I get the first mess. I get they wanted it so bad, if they couldn’t get it one way they just tie me up. Why else would the Issuee Fee Match the same time I went Belly up. I get the words Vice Counsel.
    And if the Money they claimed I owed them ROFLMFAO…., it only stands to reason. No bills, no dunning letters, no companys that bought their so called debt. So there is only one Law Firm that could have done this sneaky planned attack. Otherwise I would have gotten the biil, etc. after I said SUE ME. And you know about all those other nasty things that went on and on and on.

  17. IANAE: I didn’t miss his point at all. I did something different, which I like to call “disagreeing with Bob’s point”.

    Clearly you were disagreeing, but your proffered reasons for doing so show that you missed the point.

    Patentable subject matter and obviousness are separate tests. I see a misguided attempt to import the latter to the former, or, more generally, to “read-in” legal tests to the statutory patentable subject matter requirement to satisfy policy views.

  18. MM>>that pierces the veil of composition claiming to reject, e.g., Beauregard claims would be perfectly welcome and would not need to affect the patentability of other compositions.

    Uh huh. Seems like you are almost the definition of someone that wants to bend patent law to suit your policy goals.

    1) functional claims do define structure.
    2) there are functional claims in biotech.

  19. Sweet held that since the utility is in the information, the isolated DNA is not materially different. You say the isolated DNA is structurally different.

    These don’t sound factually incompatible to me, Ned. Your characterization of Sweet’s conclusion, on the other hand, seems to be a legal rule, to the effect of “two things having different structures but storing the same information are not materially different if their utilities flow from the stored information.” I don’t think he gets any deference for that.

  20. IANAE The prior art is presumably the wild human genome. What makes the novel isolated gene non-obvious?

    Indeed, it is very difficult if not impossible to obtain a valid patent on an isolated nucleic acid molecule of a sequence X, where X is identical to a sequence found in a sequenced genome, UNLESS you provide data demonstrating that the isolated sequence has a significant, unexpected property. The PTO does not hand these claims out and hasn’t been handing these claims out for some time.

  21. Malcolm, “new” is a defined term. It does not include subject matter that varies from the prior art only in information content.

    As to isolated DNA, the whole issue is whether it is materially different than that which occurs in nature. Sweet held that since the utility is in the information, the isolated DNA is not materially different. You say the isolated DNA is structurally different. I am not a chemist, so I have no way of determining which is true independently.

    If the issue on appeal is primarily one of fact, then the Feds would be somewhat bound by Sweet’s findings. Somehow, though, I think the Feds (arrogantly) will ignore this and resolve the case as one of law.

  22. An isolated DNA molecule is a chemical composition, described structurally to distinguish it from prior art compositions.

    I know that. All I said is that a claim to testing for a gene is no better than a claim to the gene itself.

    This is absolutely not the case with novel, isolated DNA sequences.

    The prior art is presumably the wild human genome. What makes the novel isolated gene non-obvious? Does the inventor have to be the first person to appreciate the significance of that particular gene? Because it would seem that any gene patent is inherently a selection patent.

  23. Ned in my view, the “isolated” DNA claims are equivalent to the results of an assay

    IANAE All you can do with the result of a BRCA assay is tell someone the result

    An isolated DNA molecule is a chemical composition, described structurally to distinguish it from prior art compositions.

    It’s not “information” and, in the case of the BRCA technology, has a substantial utility for 101 purposes (unlike, say, a randomly pulled expressed sequence tag).

    Ned Even if the programmed machine did something new, the disk with new information is NOT new.

    Can we try to be accurate and clear, Ned? The disk with new information IS new. The problem is that the Beauregard claim tries to claim a new composition without identifying a single structural feature of the composition that distinguishes it from the prior art. This is absolutely not the case with novel, isolated DNA sequences.

  24. Otherwise we have the problem of Flook, where the updated alarm limit was clearly useful, but that use was not claimed.

    We have a bigger problem. At least Flook could have claimed some use of the alarm limit, which is pretty much what Diehr did. All you can do with the result of a BRCA assay is tell someone the result, which adds nothing patent-eligible that the sequence itself doesn’t have.

  25. Malcolm, in my view, the “isolated” DNA claims are equivalent to the results of an assay.

    Now the assay results (or the method of producing the results) might be useful, but I think the use must be claimed. Otherwise we have the problem of Flook, where the updated alarm limit was clearly useful, but that use was not claimed. The problem then becomes essentially an 102 problem of newness. The result of the Flook calculation was useful information, but even useful information alone is not patentable subject matter, regardless of how useful the information.

    As with Beauregard claims, there is an essential step missing in the claims. Even if the programmed machine did something new, the disk with new information is NOT new.

    Printed matter. Information. Abstract ideas.

  26. Ned I think this is the problem. The patents were not on any practical use

    I believe there were method claims in addition to composition claims, Ned. To the extent they didn’t suffer from a Prometheus problem (i.e., lacking a reporting step and/or lacking a step of administering a personalized therapy following the reporting step) they were certainly of practical use.

  27. It hasn’t really “worked”, has it, other than to create some press?

    The patentee lost at the District Court level, which is a victory of sorts. And the press would be a veritable triumph if there were any evidence at all that Congress could get its act together and legislate about patents.

    More importantly, a “sane” defendant sued for infringing one of these isolate nucleic acid claims may very well have similar patents of its own that it is not interested in invalidating.

    I’ll give you that point, though I wonder if a really creative do-gooder might try to assert some kind of public interest standing on the basis that no infringer would plausibly challenge the 101 eligibility of a gene claim, and as a result we have to pay more for our BRCA tests.

    After all, cancer is far too important to be subjected to a system that is designed to promote innovation.

  28. Bob First, a composition of matter is a composition of matter (and thus is an explicitly statutory class of patent-eligible invention) regardless of whether it embodies an “idea,” abstract or otherwise. I agree with numerous posters above and other commentators that sorting compositions of matter based on whether they embody information or not would be bad policy and blow up patent law. Whether such a composition is new and nonobvious is a completely different and important question.

    It’s not a “completely different” question if the obviousness theory rests on expunging the unpatentable information (e.g., recitation of “instructions” or a “capability”) from the claim. I don’t think it is important to hold that all compositions are patent-eligible subject matter per se. A legal theory that pierces the veil of composition claiming to reject, e.g., Beauregard claims would be perfectly welcome and would not need to affect the patentability of other compositions.

  29. Dennis said: As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.

    I think this is the problem. The patents were not on any practical use, but on the genes themselves and on the correlation of their presence with brest cancer, as opposed to the use of the information to do anything.

    I briefly discussed this point in the AIPLA thread, but it struck me that claims having two elements: assaying and correllating; are not “new.” The assaying is old. The correlating is not physical, but is simply information. Thus, the only thing new in the claim is information, and this is not NEW under the printed matter doctrine.

    102 is the issue.

  30. Repost because it’s an important point:

    Also, for the record, I agree with the proposition that a claim that literally covers all methods — existing and yet to be conceived — of detecting the presence of a particular genetic sequence should not be patentable. It’s an enablement issue and also possible a 101 issue to the extent that it removes information itself from the public domain (as many methods for sequencing genomes are in the public domain and people should be free to use those methods to sequence any part of a person’s genome that they wish, just as people should be free to study the sky or the earth, to the extent they have permission from the person or property owner).

    And claims that tack on only additional mental steps (or steps carried out by a POWERFUL COMPUTER BRAIN) that are limited only to “inferring” or “correlating” some probability based on the information should also be invalid for adding only another level of abstraction to the claim. There has to be more.

  31. IANAE If you were a sane defendant, why wouldn’t you try what has worked once already?

    It hasn’t really “worked”, has it, other than to create some press?

    More importantly, a “sane” defendant sued for infringing one of these isolate nucleic acid claims may very well have similar patents of its own that it is not interested in invalidating.

    See, e.g., previous discussion on the lack of court cases dealing with the invalidity of Beauregard claims.

  32. If a signal isn’t patentable subject matter should applying the signal, applying variations of the signal, measuring the response of what you applied the signal to, and plotting the response be patentable subject matter?

    It depends. But the fact that a signal by itself is not patentable subject matter has nothing to do with the answer.

    How’s that LSAT prep going? Somehow I’m not surprised that you’re having difficulty with the logic puzzles.

  33. “Chuckles, 6 – on what conceivable legal theory are you using to get to that answer.”

    The legal theory of lulzors. Or “chuckles” as you have termed it. According to this theory, a given court will overwhelmingly rule in such a fashion as to cause maximum lulz for all involved nearly without fail.

    It has a proven track record as is readily apparent from the state of legal affairs in this country today.

  34. NWPA,

    Donk ey hasn’t (yet) been banned – (just a matter of time before the crybaby goes running to the big D, though).

  35. I think you missed Bob’s point.

    I didn’t miss his point at all. I did something different, which I like to call “disagreeing with Bob’s point”.

    And I wasn’t disagreeing by much, either.

  36. “Third, there is no concept in patent law of preemption of all uses of a composition of matter. Let’s be clear about this, if there was such a concept, no claims to compositions of matter, manufactures, or machines per se would be patent-eligible because the per se claim would preempt all uses of the composition of matter, manufacture, or machine.

    That’s a good point, and a good answer to 6.”

    Lulz, u wish I (or anyone else) said that there was bucko. And you also wish that your composition of matter claim at issue didn’t also preempt a natural phenomena, mathematical formula or an abstract idea.

    “If solving Schrodinger’s equation isn’t patentable subject matter, using an unspecified computer to solve Schrodinger’s equation shouldn’t be patentable subject matter either, even if you phrase it as an apparatus claim.”

    If a signal isn’t patentable subject matter should applying the signal, applying variations of the signal, measuring the response of what you applied the signal to, and plotting the response be patentable subject matter?

  37. IANAE: Suppose you were the guy who discovered that radon causes cancer. You could definitely get a patent on a particular type of radon detector, but could you get a patent on “detecting whether there’s radon in someone’s house, and telling them about it”? And that’s without even getting into the issue that there’s really only one kind of gene detector, and it’s obvious once you know the gene sequence.

    I think you missed the part where Bob Hodges stated: “Again, whether such a method is new and nonobvious is a separate question.”

    IANAE: What we’re concerned with, I think, is adding an otherwise-unpatentable trivial or overly general composition of matter to an abstract principle to make it look like an invention. If solving Schrodinger’s equation isn’t patentable subject matter, using an unspecified computer to solve Schrodinger’s equation shouldn’t be patentable subject matter either, even if you phrase it as an apparatus claim.

    Again, your example should fail not on patentable subject matter but on obviousness/novelty. I think you missed Bob’s point.

  38. “Third, there is no concept in patent law of preemption of all uses of a composition of matter. Let’s be clear about this, if there was such a concept, no claims to compositions of matter, manufactures, or machines per se would be patent-eligible because the per se claim would preempt all uses of the composition of matter, manufacture, or machine.

    That’s a good point, and a good answer to 6.”

    Lulz, u wish I (or anyone else) said that there was bucko. And you also wish that your composition of matter claim at issue didn’t also preempt a natural phenomena, mathematical formula or an abstract idea.

    “If solving Schrodinger’s equation isn’t patentable subject matter, using an unspecified computer to solve Schrodinger’s equation shouldn’t be patentable subject matter either, even if you phrase it as an apparatus claim.”

    If a signal isn’t patentable subject matter should applying the signal, applying variations of the signal, measuring the response of what you applied the signal to, and plotting the response be patentable subject matter?

  39. >There may or may not be good policy reasons to >exclude some (more) types of inventions from >patent-eligibility, but twisting the statute >and blowing up basic patent law is not the best >way to address these concerns.

    Exactly. And, they are intellectually dishonest for intentionally misrepresenting patent law or in some cases willful ignorance. Lemley is a good example of such a person. Richard Stern is another. To my mind, these people are the lowest possible form of participant.

    I thought MM was a one trick b@boon–at best.

  40. the question still obtains whether preemption applies if your claim only preempts the only presently known useful application of the abstract idea,

    If you’re the first person to discover a practical use for an abstract idea, why shouldn’t you be able to claim it?

    Preemption should really be based on no less than a colorable attempt to disguise the abstract concept itself as a statutory invention.

  41. 6, I don’t think the preemption principal applies with claims to the isolated gene becaseu the gene is not an abstract idea or law of nature. So preempting all uses of the isolated gene by claiming the isolated gene itself is not an issue. A method claim to making a diagnosis based on detection of the gene might be a different story, but the question still obtains whether preemption applies if your claim only preempts the only presently known useful application of the abstract idea, but there may very well be others that are discovered later.

  42. Malcolm: I’m not aware of any other defendant in patent case involving isolated nucleic acid composition claims raising the 101 defense in the ten years before Myriad or afterward. Are you?

    No, but I also don’t know how much litigation there is in that area. If you were a sane defendant, why wouldn’t you try what has worked once already? Especially when you can cite that case as “reversed on other grounds by the Federal Circuit”, and doubly-especially if you happen to be sued on the very same patent. I hope the Federal Circuit at least has the good sense to say that they don’t endorse the reasoning at trial that invalidated the patent.

    Bob Hodges: Second, use of even an unaltered product of nature in a useful method is a method involving a particular “machine” (that is, the product of nature) and thus is patent-eligible at least for this reason. Such a method makes use of a physical composition of matter. Whether the product of nature embodies an “idea” does not change this. Again, whether such a method is new and nonobvious is a separate question.

    Suppose you were the guy who discovered that radon causes cancer. You could definitely get a patent on a particular type of radon detector, but could you get a patent on “detecting whether there’s radon in someone’s house, and telling them about it”? And that’s without even getting into the issue that there’s really only one kind of gene detector, and it’s obvious once you know the gene sequence.

    Bob Hodges: Third, there is no concept in patent law of preemption of all uses of a composition of matter. Let’s be clear about this, if there was such a concept, no claims to compositions of matter, manufactures, or machines per se would be patent-eligible because the per se claim would preempt all uses of the composition of matter, manufacture, or machine.

    That’s a good point, and a good answer to 6. What we’re concerned with, I think, is adding an otherwise-unpatentable trivial or overly general composition of matter to an abstract principle to make it look like an invention. If solving Schrodinger’s equation isn’t patentable subject matter, using an unspecified computer to solve Schrodinger’s equation shouldn’t be patentable subject matter either, even if you phrase it as an apparatus claim.

  43. Friend – good point – too bad the district court bought the kool-aid and fanned the flames of misconception and rhetoric. The court shouldn’t have to be bogged down with such claptrap and obvious political manuevering.

  44. The case or controversy in fact is between the “twenty plaintiffs joining together to sue Myriad” and the king (the Federal Government). Generally, you can’t sue the king. A solution to addressing a law you politically disagree with is to elect different representatives who will alter the existing law. For some, that is too much trouble! So, you find a court to generate a “landmark” decision.

    The district court holding seems to be that anyone engaged in research of subject matter covered by a patent has a standing to seek a declaratory judgment of noninfingement (?)/restraining order/unconstitutional law holding, even if the patent holder has taken no action against those suing, no basis to take action, and/or the research is permitted experimental research. If upheld, then all patent holders can be sued merely by holding a right to exclude others. In reality, it will be the individual electrical/mechanical inventor being sued by big business looking to capture an electrical/mechanical invention for themselves.

    The only thing landmark about this decision seems to be that it is another example of powerful individuals finding a friendly court to use the legal process by pass the political process to achieve their political desire. I believe that the Federal Circuit will reverse and hope they do so on a lack of standing to discourage these types of actions that bypass the political process.

  45. Bob,

    Where would the fun be in such clarity? Whole bunches of pet theories would have to be consigned to the windmill farm at the edge of the rye fields.

  46. Re Dennis: “As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.” and Courtenay Brinckerhiff:

    First, a composition of matter is a composition of matter (and thus is an explicitly statutory class of patent-eligible invention) regardless of whether it embodies an “idea,” abstract or otherwise. I agree with numerous posters above and other commentators that sorting compositions of matter based on whether they embody information or not would be bad policy and blow up patent law. Whether such a composition is new and nonobvious is a completely different and important question.

    Second, use of even an unaltered product of nature in a useful method is a method involving a particular “machine” (that is, the product of nature) and thus is patent-eligible at least for this reason. Such a method makes use of a physical composition of matter. Whether the product of nature embodies an “idea” does not change this. Again, whether such a method is new and nonobvious is a separate question.

    Third, there is no concept in patent law of preemption of all uses of a composition of matter. Let’s be clear about this, if there was such a concept, no claims to compositions of matter, manufactures, or machines per se would be patent-eligible because the per se claim would preempt all uses of the composition of matter, manufacture, or machine. And again, this is true regardless of whether the composition of matter, manufacture, or machine embodies an “idea,” abstract or otherwise.

    It is clear to me that a main motivation behind the arguments to narrow patent-eligibility is based on the belief that some patent-eligible subject matter should not be given patent protection (with business methods being the main focus prior to this case). There may or may not be good policy reasons to exclude some (more) types of inventions from patent-eligibility, but twisting the statute and blowing up basic patent law is not the best way to address these concerns. Many countries have statutorily-based exclusions form patent-eligible subject matter. While I do not favor adopting such exclusions in the U.S. (for policy reasons), that is where the effort should be made by those wanting to limit patent-eligibility, not by reading limitations into what is a very clear statutory provision.

  47. What is the naturally occurring composition of whom all uses are covered? A body? a tissue sample? a tissue homogenate? a cell? the fully isolated genome? a partially isolated genome? isolation of the chromosome that contains the mutation? The full length natural gene with introns? The cDNA sequence? The preprocessed protein? the post-processed fully functional protein in the cell? etc? etc? Has anyone seen my naturally occurring isolated fully processed BRCA mutated protein lying around? This whole case is ridiculous.

  48. “Did someone take a survey”

    Yes, I took a survey; well more of a show of hands. It’s pretty much unanimous.

    Everyone is pretty much, per se, of the opinion that Mooney is a one trick pony.

  49. “Beauregard claims are per se obvious or otherwise unpatentable”

    Mooney, that statement is per seridiculous AND annoying at the same time

  50. >>And claims that tack on only additional mental >>steps (or steps carried out by a POWERFUL >>COMPUTER BRAIN)

    You mean machines performing a method to do things that people do. Sure wouldn’t want to call that an invention.

    Besides we have your aunt who needs work.

    Rustboy.

  51. I see MM is up to his ole nonsense.

    Funny, though, rust brain, that you said yet to be conceived. That should be a clue stronger than anything Benson can invoke that it is an invention.

    Rustboy.

  52. Ping,

    You are 100% correct – The Answer is indeed found in Bilski, and indeed that answer is:

    BILSKI 14 !

    The only possible way of meshing Benson and Flook is by realizing that Diehr cabins the earlier decisions. Either Benson or Flook on their own is simply not good law, and cannot be used on their own. Diehr must always be invoked, because that is what the majority in Bilski has said in plain black and white.

    BILSKI 14 !

    Nonbelievers need to go back and read once again. Read and understand. The tide has turned. Inventors win.

  53. “Of course, what’s really important is that even if you can’t patent isolated genes for saving human lives you can still, in theory, patent methods of screwing over an entire nation of consumers with your new business method. Isn’t that awesome?”

    I can continue to dream of a better world, your irrational biases aside.

  54. But they may very well invalidate them all even if to different people/companies.

    Chuckles, 6 – on what conceivable legal theory are you using to get to that answer.

    Oh wait, you don’t know what legal theory is.

  55. “I don’t know why we want to go there when better examination by the PTO in the first place would take care of the perceived problems. Oops, I just answered my own question, didn’t I?”

    How is “better examination” going to “take care of the perceived problem” that genes are being patented when they ought not be?

  56. “is it a problem to cover “all conceivable uses” of a composition using a spectrum of distinct method claims?”

    That is quite a question and one which I believe would be awesome for a court to hear. IMO, I believe that if all the uses went to one company/person then there’d be a problem. If it went to distinct companies/people then I believe the court would look the other way on that issue you bring up. But they may very well invalidate them all even if to different people/companies.

  57. Iza think that Big D be taking a page out of the Gene the eskimo Quinn’s book O blog inflation methods.

    As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.

    Seriously – every invention can be traced to such underlying principles of the underlying physics – that’s how nature works. Geesh – that’s about as lame as 6′s abstract-in-to-get-abstract-out test. Buildin blocks and levels of abstraction. It be universal.

    those several hundred carpet-bomb postins get kinda addictive.

  58. Cy,

    It be the windmills near the rye fields.

    Malcolm, he just can’t help hisself. Odd thing though – he keeps on trying to find a professor to take him and tuck him in bed, murmuring something about holden this or that…

  59. Did someone take a survey?

    Seriously, we’re aware of one District Court case and zero Federal Circuit cases that even involve a Beauregard claim. You’ve got a different definition of “landmark” than I do if you think Beauregard claims are interesting to anyone other than a few anti-patent “software wants to be free” types and a couple of I-really-don’t-have-any-technical-skills-so-I’ll-hold-myself-out-as-a-business-method-patent-specialist agents. And you. I’m not really sure why you’re so interested.

  60. As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.

    Dennis, it sounds like you drank Judge Sweet’s Kool-Aid. The isolated DNA claims are directed to compositions of matter. If they are not patentable it is as a “product of nature” not as “information” or an “algorithm.”

    Some of the diagnostic method claims may be vulnerable under a “machine or transformation” analysis, but we all know that that’s not the only test for patent-eligibility, don’t we? ;-)

    The important scientific discovery in this case is the knowledge that BRCA mutations predict breast and ovarian cancer.

    If you accept the Constitutional principle that patents promote “the useful arts,” isn’t this the type of discovery that we want to encourage and incentivize with patent protection?

    Would we rather companies keep their genetic discoveries as trade secrets (they could still market and sell their tests, but the rest of the world would not be able to build on or improve thier work)?

    Would we rather not have this “information” –these diagnostic tools at all?

    Depending on what issues the court addresses, this could be a very important decision with far-reaching impact.

  61. Did someone take a survey?

    Someone considered it, but decided against it. It just wasn’t that interesting a question.

  62. 6 “Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.”

    So what you’re saying is that in the instant case the entire claim is to insignificant post-solution activity? And that we’ve granted a patent covering practically all uses of the information regarding BRAC mutations?

    As I alluded to above, 6, the problem with this argument is that, taken to its logical conclusion, it negates patentability of a huge chunk of all composition and apparatus claims, many of which are based on the conception of some bit of “information” followed by a reduction to practice (actual or otherwise) of all the obvious readily-engineerable useful methods and compositions exploiting that conception.

    I don’t know why we want to go there when better examination by the PTO in the first place would take care of the perceived problems. Oops, I just answered my own question, didn’t I?

  63. 6 If you are covering every single concievable use (or thereabouts) of the naturally occuring composition then we may as well just give you a claim to the naturally occuring composition right?

    This is an issue that I recall discussing here years ago which is: is it a problem to cover “all conceivable uses” of a composition using a spectrum of distinct method claims? What if the method claims are in separate applications? That is the set-up in Myriad (although I haven’t done an “all conceivable uses” analysis, nor am I aware that anyone has).

    Also, for the record, I agree with the proposition that a claim that literally covers all methods — existing and yet to be conceived — of detecting the presence of a particular genetic sequence should not be patentable. It’s an enablement issue and also possible a 101 issue to the extent that it removes information itself from the public domain (as many methods for sequencing genomes are in the public domain and people should be free to use those methods to sequence any part of a person’s genome that they wish, just as people should be free to study the sky or the earth, to the extent they have permission from the person or property owner).

    And claims that tack on only additional mental steps (or steps carried out by a POWERFUL COMPUTER BRAIN) that are limited only to “inferring” or “correlating” some probability based on the information should also be invalid for adding only another level of abstraction to the claim. There has to be more.

  64. “No, it is not mere cynicism in the Federal Circuit. Even after writing and teaching about these cases for several years, I still lack a full understanding of how Benson and Flook mesh with Diehr.”

    And that’s sad because it took me all of what? 2 years to understand it pretty much crystal clear?

  65. “I do have a problem with invalidating claims based on a theory that is incomprehensible to the extent it doesn’t invalidate every patent on a composition that is derived from a different, “naturally occurring” composition.”

    I don’t think that is the current theory. The current theory is that if there are other things which can be derived from that naturally occuring composition then you’re probably in the clear. If you are covering every single concievable use (or thereabouts) of the naturally occuring composition then we may as well just give you a claim to the naturally occuring composition right? Well, the USSC says that is impermissible, and I would tend to agree with their reasoning.

  66. “Of course, that informational discovery by-itself cannot be patented because it represents an abstract idea rather than a useful implementation.”

    U guys keep on cracking me up. Acting like preempting the abstract idea is all fine and peachy so long as you do it with a claim to a useful implementation. Lulzers, that is what courts have been smashing faces for in the past few decades and you still refuse to acknowledge it.

    Get it through your skulls guys. Your claiming a useful implementation of the abstract idea will not save you from 101 if YOU ALSO GET THE WHOLE ABSTRACT IDEA. See Benson. See Flook. See Bilski.

    “As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered. ”

    As with many “invalid” software algorithm patents I think you mean.

    “Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.”

    So what you’re saying is that in the instant case the entire claim is to insignificant post-solution activity? And that we’ve granted a patent covering practically all uses of the information regarding BRAC mutations?

    Funny, that last is what the District Court said iirc. And the claim went down because of it.

  67. As a biotech practitioner, does this case put Malcolm’s livlihood at risk?

    Hardly. In fact, I’d have no problem with Congress deciding that claims such as Myriads are unpatentable (and that’s not including the claims that are already obvious and/or non-enabled and should never have been granted in the first place).

    I do have a problem with invalidating claims based on a theory that is incomprehensible to the extent it doesn’t invalidate every patent on a composition that is derived from a different, “naturally occurring” composition.

    Of course, what’s really important is that even if you can’t patent isolated genes for saving human lives you can still, in theory, patent methods of screwing over an entire nation of consumers with your new business method. Isn’t that awesome?

  68. As a biotech practitioner, does this case put Malcolm’s livlihood at risk?

    Seems not long ago that Malcolm was crowing wuith glee over Bilski and telling us software and biz met practitioners that we could just do something else for a career.

    Karma is swift in some cases.

    It’s OK Malcolm, you can always do something else for a paycheck. Maybe you can even examine Design patents at the PTO.

  69. The fact is, nobody who knows anything really cares that much about Beauregard claims.

    Did someone take a survey?

  70. And another very very important bit of info. When I was being charged for a third verbatim App., and also charged for Marketing, and also for preparing a Tether application I never really asked to be done. I told the Law firm to just SUE ME. but of course they never did.
    Then when I was listing my Debtors. I never listed them as one? So how did I never got put into a dunning situation or that someone bought the debt because they didn’t? Then how did the Lawyer come up with that information that was handling my Forced Bankruptcy? HMMMM
    This sounds like a set up? Like this was a planned attack with information that was never divulged because I never heard another word from the Law firm or the Lawyer about the so called money I surely did not owe them.
    Wow this was a Conspiracy clear and simple!

  71. Dennis: As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.

    More importantly, at least some of the composition claims are drafted to include actual structural limitations that distinguish the compositions from those in the prior art.

    This isn’t true of so-called “software algorithm patents” which distinguish themselves from the prior art compositions only by their alleged functions.

    That could be the best thing to come out of this kerfuffle: a Federal Circuit decision that affirms the patentability of isolated DNA but sets the stage for the tanking of Beauregard claims. That would be sweet.

  72. The landmark case will be the district court case that holds that Beauregard claims are per se obvious or otherwise unpatentable.

    Yes, that will be a truly momentous non-event. The fact is, nobody who knows anything really cares that much about Beauregard claims.

  73. Ping I wish I had the answers. I only know what I do have I can’t find.I didn’t send it out of the Country. So where is this secret Patent? And what I don’t have has my name on it. And the second one justs sits there? I remember copying the first one many times in the Transaction pages and the Issue fee was never matched. For years and years. It only said Issue fee payment. So I know that was the problem. And if things were copied off another and the OED decision says that. Then why is it still on the WEB? You can’t make the folded one without making mine first. It’s the MATH. you would have to have the math. And the flat one. well I have a photo of it done in Vinyl months before sent it in. And if all this time it was already someone else’s. Then why am I assigned? It makes no sense. And if that is true then how can I be Imprisoned by something that is Fraudulent? How can a Lawyer or Lawyers bend rules to apply to them and not the Rule of Law?

    Ah, I get it now. She’s ping’s only friend in the world. Sorry, ping. Didn’t mean to interfere with your relationship, although I didn’t think it was possible to interfere with self-loving.

  74. IANAE the next time the BRCA claims go to court they’ll have to endure the same song and dance at trial again before the Federal Circuit sets the record straight

    Highly doubt it. I’m not aware of any other defendant in patent case involving isolated nucleic acid composition claims raising the 101 defense in the ten years before Myriad or afterward. Are you?

  75. There is a word for this….

    Yes: a prediction.

    Care to place a bet? I’m thinking within the next three years.

  76. Ping I wish I had the answers. I only know what I do have I can’t find.I didn’t send it out of the Country. So where is this secret Patent? And what I don’t have has my name on it. And the second one justs sits there? I remember copying the first one many times in the Transaction pages and the Issue fee was never matched. For years and years. It only said Issue fee payment. So I know that was the problem. And if things were copied off another and the OED decision says that. Then why is it still on the WEB? You can’t make the folded one without making mine first. It’s the MATH. you would have to have the math. And the flat one. well I have a photo of it done in Vinyl months before sent it in. And if all this time it was already someone else’s. Then why am I assigned? It makes no sense. And if that is true then how can I be Imprisoned by something that is Fraudulent? How can a Lawyer or Lawyers bend rules to apply to them and not the Rule of Law?

  77. The Bilski decision does not help in analyzing the claim here other than by revitalizing the precedential value of Flook and Benson.

    Egads, here comes a helping of Bilksi 14….

  78. district court case that holds that Beauregard claims…

    Not content with the ordinary bland windmill excursions, Malcolm reaches for the hijacked windmill excursions.

    There is a word for this….

    hmmm…

    I guess “pollution” would do.

    Dennis, please ban Malcolm.

  79. No, it is not mere cynicism in the Federal Circuit. Even after writing and teaching about these cases for several years, I still lack a full understanding of how Benson and Flook mesh with Diehr.

  80. Dennis, I don’t believe the three are inconsistent, so I will interpret your cynicism as a lack of confidence that the panel will correctly apply them all. Which I share, by the way.

  81. The district court disagreed with these arguments — holding that a controversy existed based on Myriad’s activity against researchers along with an understanding “within the research community . . . [that] Myriad has taken the position that any BRCA1/2 related activity infringes its patents and that Myriad will assert its patent rights against parties engaged in such activity.”

    We have a controversy because other people do. Kind of a reach. If Myriad was really that aggressive, they should have simply sent Myriad a friendly letter saying that they do something Myriad considers infringing. Or at least get one of those poor, oppressed researchers on board for the suit.

    The real problem here is that if Myriad wins on standing, that moots their substantive case, and the next time the BRCA claims go to court they’ll have to endure the same song and dance at trial again before the Federal Circuit sets the record straight.

    The question may be whether the Court should follow Diehr or instead follow Flook and Benson.

    Seems to me they should be following all three.

  82. In a landmark 2010 declaratory judgment decision,

    Landmark?

    More like “bizarre” or “controversial.”

    Or “short-lived.”

    The landmark case will be the district court case that holds that Beauregard claims are per se obvious or otherwise unpatentable.

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