Federal Circuit Hears Myriad Gene Patent Case

At 10 am this morning, the Court of Appeals for the Federal Circuit will hear oral arguments in high profile gene-patent case of Association for Molecular Pathology, et al. v. USPTO.  In a sweeping opinion, Southern District of New York Judge Robert Sweet held the Myriad Genetics gene patent claims invalid as merely claiming products of nature.  

The patents cover the BRCA1 and BRCA2 gene mutations that, when present, indicate a high likelihood of developing breast cancer.  In addition to claims to the isolated genes themselves, challenged claims are also directed toward methods of isolating  the genes in order to test for whether the mutation is present. These patents have led to more than a billion dollars in revenue for Myriad Genetics and the University of Utah.

The court rejected the patentee’s claims to have invented the isolated BRCA1/2 gene as a product of nature — holding that the “isolated” form does not alter the fundamental quality of DNA as it exists in the body nor the information that it encodes.  In addition, the court found the methods of comparison invalid under the Federal Circuit’s now defunct machine or transformation test.

In an e-mail, Hal Wegner correctly suggested that the key threshold question for this case will be whether Federal Circuit will reject the case on jurisdictional grounds.  The ragtag group of declaratory judgment plaintiffs is led by the ACLU and the Public Patent Foundation.

More than two-dozen friend-of-the-court briefs were filed.  Most notably, the U.S. Government in its brief argues that isolated but otherwise unmodified genomic DNA is not patentable.

76 thoughts on “Federal Circuit Hears Myriad Gene Patent Case

  1. the case went down precisely as anyone would predict considering the issues already presented.

    Lolz – the eskimo finally got arouns to posting his version, and – surprise, surprise – it be “precisely as anyone would predict” completely different than what 6 done seen.

    link to ipwatchdog.com

    This isn’t just research by tweezers.

    looks like substance and procedure will both knock ACLU down. Mayhaps too, the uppity DOJ kid will think twice abouts stickin his nose in and goin against what should be the official gov position – that of the patent office.

  2. Myriad is much more than this year’s hot patent litigation case (i.e., this year’s successor to Bilski). It’s critical for the courts to get this one right. I hope the Justices of the SCOTUS are already doing their research, so they’ll be proficient on the details when this case finally reaches them.

  3. ping, I know nothing at all about stem cell research, but I find it funny as well that the report advocate coerced submission of stem cell data to information sharing hubs and that such data be “collectively owned.”

    This is the way one operates in a world without property rights and without a market. The market creates incentives (greed). The Utopian shares the resources developed by the few with the many for the benefit of all mankind. But then they notice that the few object. The solution: coercion.

  4. Wow, no takers at all.

    I wonder if that should be seen as a reason to NOT post it, or a reason TO post it?

  5. “I have no idea how it would be applied to invalidate a claim to an isolated, novel and useful gene isolated from, say, the aortic tissue of a rare Amazonian catfish.”

    Ah, but the person having ordinary skill in that art is much higher. Most of the professionals have PHDs. But isolating genes is easy. I’ve isolated genes in a lab course that has the same labs in it that undergraduate students perform. I’m sure it would be no problem at all for the CAFC panel to say “isolating this gene is so easy, an undergraduate biology lab class could do it.”

  6. TINLA the prior art need not evidence all elements of the claims, so long as the entirely novel elements are “so easy to make that a high school shop class could do it.

    Assuming this is a binding holding, I have no idea how it would be applied to invalidate a claim to an isolated, novel and useful gene isolated from, say, the aortic tissue of a rare Amazonian catfish.

    These three judges can do whatever they like. There’s very little chance a sweeping holding would survive en banc, and even less chance it would survive the Supreme Court.

    And as 6 notes: doesn’t really affect me personally either way.

  7. “I don’t like the patentee’s chances here. The only valid patent is the one this pair hasn’t gotten its hands on yet. ”

    Couldn’t be better news.

    Besides MM doesn’t mind that much. His clients will be fine and so will he.

  8. Ned Malcolm: from the NYTimes: The PTO does not agree, it appears

    Thanks. I knew you had it wrong.

    Fyi, the Government has it wrong, too. They will lose this case and the PTO’s position will not change.

  9. Uh Oh. Lourie and Bryson are the duo that recently ruled in Tokai that the prior art need not evidence all elements of the claims, so long as the entirely novel elements are “so easy to make that a high school shop class could do it.”

    I don’t like the patentee’s chances here. The only valid patent is the one this pair hasn’t gotten its hands on yet.

    And Moore is the other Judge I would not want decidign the fate of my patent. If this were a siftware case, I think this panel would be Malcolm’s dream team.

    Sorry Malcolm. I think your dream team is about to smash your world into tiny bits.

  10. Malcolm: from the NYTimes: The PTO does not agree, it appears, but they have no choice at this point. They are not in charge of this decision. The government position is as stated in court.

    However, for the time being, the PTO policy will not change for the reasons stated beflow.

    “The reversal appears to be a result of discussions among agencies within the Obama administration, including the National Institutes of Health and the Patent and Trademark Office. In the short run, however, it appears the new policy will have little practical impact. The patent office said in a statement that it would not immediately put the policy into effect and would not start denying patents on genes because of pending litigation.

    The office will “maintain the status quo while this matter is pending resolution by the Federal Circuit Court of Appeals,” a spokesman said, referring to the case on the cancer risk genes. A lower court had ruled against Myriad, deciding that human genes could not be patented.

    An administration official said it would be too disruptive to change the longstanding patent policy now, since the court might end up ruling the other way on the case involving the cancer risk genes. Over two decades, the agency has issued thousands of patents on genes.

    The patent office appears to have opposed the position taken in the Justice Department’s brief. None of its lawyers were listed as authors.

    Mr. Wegner, who is at the firm Foley & Lardner, said he had talked recently with David J. Kappos, the director of the patent office. He said Mr. Kappos “seemed chagrined that the Department of Justice was taking a viewpoint very different from the patent office.””
    link to nytimes.com

  11. So, is there anybody who would like me to post my formulation of utility tests and 112p1 criteria for machine, manufacture, and composition of matter claims?

    Because, you know, I have one…

  12. What next, the EPA talking bouts patents too?

    Maybe. But if they want to do it via an amicus brief, guess how they would do it? (Hint: it involves the Justice Department, which be TASKED with representin the Federal goverment in litigation.)

    DAAFR.

  13. The type O lawsuit matters – dont it late?

    It aint a matter of the Gov being involved – it be a matter of which hand of the gov be TASKED with patent policy bein involved.

    What next, the EPA talking bouts patents too?

    Get a clue, my little man.

  14. It actually be kinda of [sic] a joke that the JD is even involved here.

    It’s kind of a joke that the Solicitor General is involved in representing the Government’s position in a lawsuit? You really are as DAAFR.

  15. Now how did this does this work…
    Can the PTO in face of the Justice Department’s opinion to the contrary continue to issue patents on genes?

    Um, just an observation, but there is no control over the PTO by the Justice Department.

    It actually be kinda of a joke that the JD is even involved here.

  16. Now how did this does this work. The government attorney clearly said that the PTO was part of the group that made the decision that the patenting of genes was not in accordance with Supreme Court precedents.

    Can the PTO in face of the Justice Department’s opinion to the contrary continue to issue patents on genes?

  17. and nobody will know the difference for, oh, ten minutes

    Prime time chuckles there Sunshine, as your attention span be thirteen minutes as evidenced by a post on another thread wherein thirteen minutes elapsed between your asking a question and your swearing that you never asked the question.

    Either Ned was wrong, or the attorney was wrong (or both)

    Or Ned was correct (which does happen on some rare occasions – this time bein easy ta observe since teh tape was fresh. Svcks ta be you.

    And late riser – you obviously either havent been payin attention or are suffering from some type of dementia yourself, cause my names for good Ol Sunshine have never included “a monkey” or any of those derivatives. Perhaps you be ASSuming that I am someone else…

    Perhaps we need ta get Cy involved on a sockpuppet conspiracy mystery thrilla here (specially given the lame first grade attempts at rippin on my style – although they do say that copying is the sincerest form O flattery, so I guess a Thank You is in order for the compliments). Just try a little ta be original, m’k?

    Chuckles at how easy ta poke others be with me sharp stick and how predictable the response.

  18. You really are DAAFR, pingaling. And apparently getting dxmber every day. Maybe time to quit for a while. You can come back in a couple months with another name and nobody will know the difference for, oh, ten minutes. That’s when I’ll remind everyone what a complete and worthless tool you are.

    Me quoting me quoting Malcolm! It doesn’t get any more chucklezy than that.

  19. Oh, and ping, you might note that part of that last comment was actually addressed to you, despite the fact that the post was labeled “in reply to Malcolm Mooney.” You (or at least most people) could tell from the context…

    More chucklez!

  20. You really are DAAFR, pingaling. And apparently getting dxmber every day. Maybe time to quit for a while. You can come back in a couple months with another name and nobody will know the difference for, oh, ten minutes. That’s when I’ll remind everyone what a complete and worthless tool you are.

    Some serious chuckles today! Thanks, Malcolm. Ping, I think this is where you make one of your “gold” observations, like “No, you are!” Or maybe “Malcolm’s a monkey!”

    Chuckles indeed!

  21. pingaling you did indeed jump before looking

    I didn’t need to “look” pingaling because I knew Ned’s comment could not be correct. Either Ned was wrong, or the attorney was wrong (or both) or the USPTO was issuing sweeping, baseless proclamations about the patent eligibility of certain structurally claimed and novel compositions and nobody anywhere was discussing it.

    You really are DAAFR, pingaling. And apparently getting dxmber every day. Maybe time to quit for a while. You can come back in a couple months with another name and nobody will know the difference for, oh, ten minutes. That’s when I’ll remind everyone what a complete and worthless tool you are.

  22. Malcolm: “He just made himself, Ned, and pingaling look like idjits”

    pingaling “Because some Gov Official attmepts to mislead the court…?

    No, that’s not why you and Ned look like idjits, pingaling. LOL!

  23. “,I.He just made himself, Ned, and pingaling look like idjits”

    Um, No.

    Because some Gov Official attmepts to mislead the court…?

    This doesnt even pass the smell test for your unwarranted labeling (not to mention the fact that you jumped before looking – which was the point being made – that point still holds true – you did indeed jump before looking).

    Geesh, talk about moving goalposts…

  24. Thanks, crelboyne. That’s pretty pathetic of Katyal. He just made himself, Ned, and pingaling look like idjits. Of course, that’s not saying much.

  25. It is a bold-faced lie. Katyal gave a clever, careful answer that may suggest the PTO’s agreement to those who don’t listen carefully, but he ultimately says “we” came to the decision that isolated DNA is not patent-eligible. In context and knowing more of the background of the case (including Kappos’ recent comments defending patenting of isolated DNA), it’s clear “we” means the Obama administration and excludes the PTO.

  26. The government lawyer assured the court that the PTO had been consulted and now agreed with the government position that such patents on isolated genes did not comport with controlling Supreme Court precedent.

    Sounds like a bald-faced lie to me, particularly since the government’s brief on this point makes no sense.

  27. C’mon Ned-O, do ya really think that Sunshine actually looks inta facts before he makes his O-Solomon-Like judgments on the rest O the patent world?

    Where would the chuckle factor be in that?

  28. Good point here Malcolm. The court raise the same issue of the government lawyer. He asked whether government lawyer actually represented the government considering that the PTO had been granting “isolated gene” patents for 35 years.

    The government lawyer assured the court that the PTO had been consulted and now agreed with the government position that such patents on isolated genes did not comport with controlling Supreme Court precedent.

    Malcolm, you may want to actually listen to the argument on this point.

  29. Ned even the PTO itself now considers patents on isolated genes to be inconsistent with Supreme Court case law

    Please show me where the USPTO or MPEP states that the USPTO will no longer issue patents on isolated genes.

  30. Noonan that some of them are accompanied by admonitions that they should be adopted through coercion merely reflects the tendency for intelligent and well-minded people not to understand and to be offended by anyone who disagrees with them.

    LOL, coming from Noonan. Check out some of the threads re Prometheus over at Patent Docs if you want to see Noonan doing his best “not to understand”.

  31. The only thing more yawnful than a “Sheer genius” post is a post discussing the yawnfulness of the “Sheer genius” post.

    Chuckle factor on the second poster in such a chain.

    Shot ta the Head – try to be just a little bit less petty, m’k?

  32. And how unprepared we all would have been to receive the Fisher decision, were it not for this critical heads-up from Harold C. Wegner:

    “the potential of being either the single most important pharmaceutical patent case in recent years – or a yawn.”

    Sheer genius.

  33. Having Moore on any panel is bad news, but even worse on a 101 panel. Can’t that thing just cash out like all her republican buddies and get of the court.

  34. Over at the Patent Docs, the Noonster revs up his own brand of chuckles with:

    that some of them are accompanied by admonitions that they should be adopted through coercion merely reflects the tendency for intelligent and well-minded people not to understand and to be offended by anyone who disagrees with them. More troubling than the recommendations are the justifications for them contained in the preamble of the Report, about which it can only kindly be said suffers the rhetorical error of assuming the conclusion of the argument it tries to raise.

    link to patentdocs.org

    Kind reminds me a lot of the posters who ride horses here.

  35. Come to think of it I must have unless he was not on the en banc panels which I’ve been to see. I just didn’t recognize him right off hand and couldn’t find a pic of him online when I got home. Also, I forgot to read the little plaque in front of him before I left.

    And idk about him being the smartest.

    I did see a lot of old faces there though, that guy that used to be with the PTO, I think at the office of enrolement and discipline, but who is now down at GW (or was last I checked) was there. I think his name is Wayland? I also saw another guy there I recognized from other cases but I couldn’t remember where I saw him or what his name was. Seems like he might have argued at Ariad or at least been of counsel. There were some hot chics there also. And one chic literally smushed herself into my privates backing up in the elevator. Like, for more than a second. I felt kind of violated, but let it go as it was at least a little bit crowded. And she was a little hot.

  36. Malcolm, you should consider that even the PTO itself now considers patents on isolated genes to be inconsistent with Supreme Court case law.

    They and the Justice Dept. are not brainless idiots.

  37. True.

    But, you neglect to mention that the whole government and the PTO itself supports that position. They argue that to award patent protection to isolated genes would allow patents on isolated anything appearing in nature, including new metals that do not appear as metals in nature, just for example.

  38. An attorney for the U.S. government has asked a trio of appellate judges to imagine a magic microscope that would allow them to gaze into and through everything in nature, arguing that no company can legally claim ownership over anything seen though such a lens.

    If the U.S. Circuit Court of Appeals adopted this novel “magic microscope test,” it would eliminate the patents Salt Lake-based Myriad Genetics holds on two genes related to breast and ovarian cancer and overturn 35 years of established patent law. That left one of the judges to admit to being a bit “skittish” about the case.

  39. end of cut-off sentence re standing = “that allowing standing here would open the floodgates to bystander litigation against patentees.”

  40. It’s not Funk Brothers; it’s mostly Chakrabarty and also J.E.M..

    The oral argument is lengthy, but worth a listen. Katyal starts at 46:00 and goes to 1:01:30. Exchange with Judge Moore is from 53:40 – 59:15.

  41. This is hilarious. You’ve never seen Judge Bryson, literally the smartest judge on the Federal Circuit?

  42. Except that the PTO’s practice is not contrary to the Supreme Court’s 101 case law. Funk Brothers is a crxp decision that isn’t worth the paper it’s printed on and, more importantly, has nothing to do with the patent eligibility of new compositions of matter.

    Huh. How come Katyal didn’t use that argument?

  43. Katyal conceded the conflict with PTO guidelines and explained that the PTO’s practice is in some respects contrary to the Supreme Court’s 101 caselaw.

    Except that the PTO’s practice is not contrary to the Supreme Court’s 101 case law. Funk Brothers is a crxp decision that isn’t worth the paper it’s printed on and, more importantly, has nothing to do with the patent eligibility of new compositions of matter.

  44. Seriously… I may have to start taking comments seriously from now on.

    Here are a few more highlights.

    Standing. Both sides seemed to run into trouble with the standing arguments, and I’m not sure where the court will come out there. Myriad’s “but we haven’t threatened them recently” argument met with a lot of skepticism. The plaintiffs ran into problems with some weaknesses in the substance of their declarations. Judge Moore expressed concern that

    Merits — DOJ Katyal was very good at answering questions and didn’t seem to get much pushback from the panel, except from Judge Moore. Judge Bryson questioned him about the details of his position. Judge Moore pointed out, interestingly, that the DOJ brief is contrary to 35 years of practice at the PTO allowing DNA patents (a specific subset of DNA patents that I don’t want to mangle by trying to recall precisely). Judge Moore said something like “you say you’re here representing the government, but I’m not sure what that means.” Katyal conceded the conflict with PTO guidelines and explained that the PTO’s practice is in some respects contrary to the Supreme Court’s 101 caselaw. As 6 points out, Judge Lourie expressed some skepticism about the government seeming to lump together physical extractions and chemical extraction.

    Merits — Other No idea how this will turn out. I doubt that the court will find that the Supreme Court’s 101 caselaw turns on whether covalent bonds are left intact. The questions covered a lot of territory and a lot of hypotheticals, and I didn’t see anyone other than maybe Katyal gaining any traction with the panel, but as noted above, even he got skeptical questioning from 2 members of the panel.

    This was a much more entertaining show than the usual CAFC argument, and I hope there were law students in the audience.

  45. Hey 6, maybe you should see if Patently-O has enough funding to hire a “man on the street”!

    Thanks, your play-by-plays are entertaining and informative.

  46. np, I was going to do a better job and maybe have taken some notes and all, but I was kind of rushed this morning so nothing went according to plan.

  47. You may find the United States Supreme Court decision in Brenner v. Manson, 383 U.S. 519 (1966) interesting reading as to that assumption, even if not followed by the USPTO?

  48. Thanks, 6.

    The judge who I don’t know kept on about discussing how separating covalent bonds is soooo different than using the scalpel.

    Sounds like this cat was breathing oxygen, at least.

  49. What makes you think that someone was there to report to you MM?

    Alright, all disbelief aside, the case went down precisely as anyone would predict considering the issues already presented.

    On the court was Moore, Lourie and some dude with all white hair that I didn’t recall ever having seen before.

    The appellant got to go first as normal and started off with the jurisdiction argument where they practically handed them one half of the argument, but then proceeded to say that the other half wasn’t met. Specifically, they didn’t feel like the appellees had standing because they hadn’t specifically threatened to sue any of them in like the last 10 years. That was the main issue, but also, they argued that even if the court didn’t find that argument sufficient then they should consider that even if the specific claims at issue are invalidated they will be able to sue the appellees who do testing anyway under other claims that they have, which, in their view, are necessary to do the testing anyway. Therefore, they believe the court would not be able to give the patentees any remedy, aka the ability to do this testing without the fear of a law suit.

    Then on to the merits, basically they basically just ran through all the arguments posted over at the patent docs at lightning speed. They feel like the isolated DNA does not occur in nature and is the work of man, blah blah blah. Judge Moore was very interested in the difference in this case and in the case that talked about minerals in the earth though just discovered not being patentable (funk bros iirc). Appellant conceded that a new mineral is not patentable, but noted that they felt that if the mineral was separated from the rock around by way of acid etching then it would then magically become patentable. Judge Lourie chimed in at some point that there are two main different ways of getting a product like this, through isolation (where you have just the thing you want left over) and through purification (where you have the thing you want and some other leftovers leftover). The judge that I don’t know seemed pretty interested in drawing the line of patentability precisely at where covalent bonds were separated in order to obtain the new product as opposed to, oh, say, jackhammering or cutting with a knife.

    In any event, same ol arguments you’ve seen at patent docs.

    Then they moved on to the method claims, and appellant insisted they were all good to go though I don’t remember his specific arguments. Moore chimed in and Lourie did too. They basically were concerned about the nature of the steps being claimed where there was a bunch of “identifying”, and other “bs” type “steps” like that. They got sidetracked quickly and ran out of time.

    Then the appellee went.

    Judge Moore brought up that she was concerned about the fact that the primary appellee that had been threatened a decade ago with a lawsuit was not so specific in their evidence to say that they would specifically start doing the tests. Instead, that party only said they would CONSIDER doing the tests if the patents were not being threatened against them. Whereas, others of the appellees stated in their evidence that they’d like to get started doing the tests immediately, but they had never been threatened by Myriad.

    The appellee attorney brought up several things but conceded the court’s point about the one party that was threatened not having made up their minds as to whether to do the testing, but even so he felt like they had standing anyway. He also insisted that the people that weren’t specifically threatened had standing anyway under Medimmune. Bottom line, he felt like they had pretty much all of Myriads competitors in the suit so it would be inconceivable that they wouldn’t be ready to make the drug tomorrow and that at least some of them would be sued by Myriad. The attorney also brought up the fact that Myriad essentially just argued that they would sue in order to argue about the court not being able to give them a remedy. Although, he felt like his clients could do the tests without using any of Myriad’s other patented “inventionlols”, primers etc. And he also felt like many of Myriad’s other claims were wide open for invalidity, perhaps on other grounds other than 101, as well.

    Then on to the merits. As one would guess, appellee basically brought up the same arguments as we see everywhere else, the USSC having stated what it did and blah blah blah, see patent docs. They discussed the isolation of the genes and how it is done and what goes on and the nature of the boundary between unpatentable and patentable subject matter. Essentially the appellee argued that if whatever results from whatever method is being used is the same as something in nature then it is not patentable. They also discussed the mineral scenario and appellee’s attorney noted that if the doctor cuts out his kidney it has a new function and is no longer attached but it is still his kidney and it still is not patentable. They then discussed the difference between separating covalent bonds and in using a scalpel to remove a kidney, where the appellee’s attorney felt like there was no relevant difference since what you look at is the end result of the process and determine if it is found in nature regardless of whether or not it is connected to other things. The judge who I don’t know kept on about discussing how separating covalent bonds is soooo different than using the scalpel.

    Then the appellee attorney ganked a minute of time from the gov to discuss the methods. He basically set them an example of infringement out. He told them that if they went in their chambers and compared a portion of their gene’s sequence, that that they had sequenced, to this sequence that is available on the web from some doctor then they infringe the claim. They said something else I don’t remember.

    Then the gov. got to go. Basically they argued exactly what you see over at patent docs as their position. They also brought up the lithium patentability scenario where they did not feel like the element lithium, though isolated, would be patentable even if it did not exist in nature in its elemental form (which btw, it does, as do almost all elements, if not all, though these idiots didn’t seem to know it. It just might not occur on earth in very large quantities in its elemental form). They discussed this back and forth a bit but by the end the court seemed rather satisfied that lithium in its elemental form would likely not be patentable. Bottom line, the government felt like if it exists in nature then it isn’t patentable no matter what, if it does not, then it is fair game.

    Appellant came back and noted that appellees shouldn’t be able to force them into deciding whether to sue or not in the future or made to sign a covenant not to sue or anything like that in order for appellees to not have jurisdiction. They then rehashed their position and got into some details and all but sorry I’m burned out from writing this. Bottom line, they feel like isolation is sufficient. They made a pretty dam ming concession though iirc, but I can’t remember what it was atm. I just remember thinking o snap, why not just hand them the case on a silver platter? I think it was that they admitted that they didn’t feel lithium would be patentable in elemental form. Or maybe it was that they did feel like it would be patentable in elemental form so long as the hand of man was required to get it there. Either way, it was pretty dam ming, and I forgot what it was. My bad.

    Overall, I feel like the appellant got grilled more about the standing thing, and I’m pretty sure the court will not bounce the case even though this would seem like it might have a big impact on who can sue patentees in a DJ action.

    I also feel like the Fed should have granted like 2-5 hours to discuss this case. They were going lightning speed and didn’t even hardly touch many issues.

    In any event, it was a decent oral argument and you should listen when it comes out, there are lots of little stuff I couldn’t put in here.

  50. Since when is the requirement for practical utility limited to the very next step performed? Nothing “useful” is accomplished by “a filament of carbon” unless it is then put into a glass receiver exhausted of air, carbonized, and subjected to an electric current. Then you have a lightbulb. If the filament of carbon in the glass is novel and unobvious, it is patentable, even if you need to perform more steps. Similarly, why would a primer that could be used in a diagnosis method to identify cancer prone patients lack “practical utility”. To me, such a primer is the essence of a practical utility, since it would inform the patient on lifestyle and treatment choices which would very significantly impact that patient’s life.

  51. Malcolm, you are correct that it all depends on the claim. I guess I was thinking of tests performed like the BRACAnalysis test. The only way composition claims would pose a problem is if the PCR primers that are required to be utilized, or actually are utilized, were claimed. But claims to PCR primers are tenuous themselves regardless of the “product of nature” analysis. An individual primer (or primer pair) has no practical utility. Nothing is accomplished just by amplifying.

  52. Hans Claims directed to isolated genes are not infringed by a test (in the real world, that is) for determining whether a person carries a disease-causing mutation.

    I agree with the gist of your comment, Hans, but I have to quibble here. Whether a particular diagnostic test infringes a claim to an “isolated gene” surely depends on the scope of the claim.

  53. IBP When will people wake up and realize that a lot of what issues from his pulpit is sandbox and press release?

    A few years ago, in the case of yours truly.

  54. “Hal Wegner correctly suggested that the key threshold question for this case will be whether Federal Circuit will reject the case on jurisdictional grounds.”

    Without the genius of Harold C. Wegner, who would have guessed that jurisdiction is a key threshold question at the CAFC?

    The cult of personality that has arisen, with Mr. Wegner as its focus, is troubling.

    It is yet another symptom of the structural problems in the decision-making structures and processes involving patents.

    He’s making a good living in his role as the Oracle at Foley. When will people wake up and realize that a lot of what issues from his pulpit is sandbox and press release? He’s considered a soothsayer, and everybody seems to feel more comfortable during his periodic release of pronouncements, or better yet, when they have his hearty endorsement.

    “Jurisdiction is a critical threshold issue.”

    More sandbox from the genius of Harold C. Wegner, and more hero worship from the usual supporting cast of acolytes.

  55. Slight correction. Diagnostic methods do not involve “isolation” of “genes.” That’s what’s so funny about this debate. Claims directed to isolated genes are not infringed by a test (in the real world, that is) for determining whether a person carries a disease-causing mutation. And it’s the patent-eligibility of the test that is the key issue (Myriad doesn’t sell a drug produced by the BRCA1 gene). As one who thinks that “determine and infer” methods are not patent-eligible, Sweet did me no favors in his sweeping ruling on the composition claims. It undercut his ruling on the diagnostic method claims, which was spot-on. But none of this will matter, as the CAFC will kick the case out on standing. That leaves Prometheus v. Mayo as the only case left to address the patent-eligibility of “determine and infer” methods.

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