Myriad Seeks to Enforce its BRCA1/BRCA2 Gene Patents

By Dennis Crouch

Myriad Genetics v. Ambry Genetics (D. Utah 2013)

In AMP v. Myriad, the Supreme Court ruled that the process of isolating naturally occurring DNA is insufficient to transform the natural phenomenon into a patentable invention. At the same time, the court ruled that a manmade cDNA version of naturally occurring human DNA is patent eligible.

Within hours of that Supreme Court ruling, Ambry Genetics issued a press release indicating that the company would begin offering genetic testing for the BRCA1/BRCA2 mutations at a significantly reduced rate.

Now, Myriad Genetics has filed suit against Ambry alleging infringement of ten different patents including the patents challenged in the original lawsuit. These include U.S. Patent Nos. 5,709,999; 5,747,282; 5,753,441; 5,837,492; 6,033,857; 5,654,155; 5,750,400; 6,051,379; 6,951,721; and 7,250,497. In the complaint, Myriad was careful to only assert claims that were left valid by the Supreme Court decision. Myriad writes:

As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.

The lawsuit requests injunctive relief, damages for willful infringement and lost profits. In addition, Myriad filed a motion for preliminary injunction arguing that Ambry’s low prices create irreparable harm:

Ambry is able to offer testing at [a] discounted price by unfairly and improperly “free-riding” off of the hundreds of millions of dollars invested by Myriad Genetics in developing the science and market for clinical diagnostic testing for hereditary cancers. …

At a minimum, [the harm caused by ongoing infringement] consists of: (1) price erosion and the loss of the benefit of Myriad’s established pricing strategy; (2) the loss of market share; (3) reputational injury; and (4) loss of the benefit of the remaining limited term of patent exclusivity and Myriad’s business plans for that period, as well as the inability to fully obtain its reliance interest obtained by disclosing its discovery and investing hundreds of millions of dollars to commercialize that discovery in exchange for a limited exclusive right. The Federal Circuit has recognized each of these forms of damage as irreparable harm that warrant the imposition of injunctive relief.

It appears that Myriad has a very strong case here. One question will be whether the district court will entertain arguments that the public’s need for access to multiple sources of cancer diagnostic tools weigh heavily against injunctive relief.

The case has been assigned to one of the newest district court judges – Judge Robert Shelby. Judge Shelby is an Obama nominee who received his commission on September 25, 2012. Shelby’s court has become something of a dumping ground for IP cases. About half of the 83 open intellectual property cases in Utah in his docket.

File Attachment: myriadcomplaint.pdf (70 KB)

File Attachment: myriadmotionforpreliminaryrelief.pdf (608 KB)

94 thoughts on “Myriad Seeks to Enforce its BRCA1/BRCA2 Gene Patents

  1. Leopold,

    I will tell you what Hal Wegner thinks:

      If a group purporting to support the patent system takes a position that eviscerates exclusive rights in health care patents, the future for patent-based approval of pharmaceuticals may be darker than previously thought.

    I find it ‘curious’ that you venture no opinion on this. Or do you need to wait to see where I stand so that you know where to charge?

  2. Nothing like waiting a few days to make an absolutely mindless and vacuous comment, Malcolm.

    Attaboy.

  3. the archives have you dancing wildly

    Are these dreams of yours in color. Or black and white?

    All of this is in black and white

    Oops. I asked too early.

    it is so yummy

    Weirdest. Blogtroll. Ever.

  4. Surely he can’t be thinking of taking away their cDNA claims?!?!? That stuff is, like, so totally eligible subject matter. Because it’s, like, three cuts and then you paste two pieces together unlike merely isolated DNA where you just cut it twice.

  5. I just read a note by Senator Patrick Leahy to NIH (through Hal Wagner) advocating the government use its “march in” rights and trample any patent rights that Myriad may (have left) to pursue.

    Myriad is certainly an excellent poster child for such a beating.

  6. What does this say about the 10,000 foot picture?

    I don’t know. What do you think it says about the 10,000 foot picture?

  7. On a related note (to the general topic of the thread), I just read a note by Senator Patrick Leahy to NIH (through Hal Wagner) advocating the government use its “march in” rights and trample any patent rights that Myriad may (have left) to pursue.

    What does this say about the 10,000 foot picture?

  8. What’s the point of your post Ned? Congress writes patent law. Whether or not a Surpeme court case exists on any particular pinpoint area of legislative law is completely irrelevant.

    Point in fact: you are trying to write your own law and ignore the actual statutory law that Congress has written.

    Sorry – no one died and made you the despotic king of the US and you simply don’t have that authority. It remains your ETHICAL duty to acknowledge controlling law.

  9. anon, name me one process the Supreme Court has ever held eligible that does not involve making or using a machine, an article or a composition?  Just one.
     
     

     
    Sent from Windows Mail
     

  10. or a process that makes or uses any of these,

    We have been on this merry-go-round ride before Ned.

    You are attempting to redefine ‘process’ from what is in the Statute (and no doubt showing your ‘vintage’ and the Justice Story-bias).

    Plus, as 101 Integration RIGHTLY slams you, you are (again) insisting on puttin in your strawman of MoT and (again) ignoring what I have told you nigh countless times now regarding what the Supremes have done with MoT:

      Bilski: MoT NOT REQUIRED
      Prometheus: MoT not sufficient

    Why do you insist on trying to maintain arguments that have been destroyed? Do you realize how negatively this affects your credibility? Do your third party benefactors realize this?

  11. anon, if in fact you agree with this proposition, for one would be surprised.

    I think we can generalize the proposition into a statement that if a claim is directed to a machine, article manufacture, composition of matter, or a process that makes or uses any of these, and a claim varies from the prior art only in subject matter that is otherwise ineligible for patenting, and that subject matter is not integrated into the old elements so that the claim, “when considered as a whole is [not] performing a function which the patent laws were designed to protect (e.g., transforming reducing article to a different state thing), then the claim does [not] satisfy the requirements of §101.” (Quoting Diamond v. Diehr, 450 US 175 (1981) at 192.)

  12. LOL – the archives have you dancing wildly after the oral arguments of Myriad. In a discussion with another Ph.D, you danced so wildly, that you ended up saying the very position that I have put forth from day one.

    I made specific note in the archives of not only that you were dancing wildly, but that you were edging ever closer to my position. I made specific note of when you reached my position.

    All of this is in black and white in the archives, Malcolm.

    And it is so yummy precisely because you were such a pr1ck about it – in fact – you are STILL a pr1ck about it and cannot even admit the most obvious FACT that I was right in the Myriad case and that you were wrong. You would rather spew TENS of thousands of words of vacuous mewling QQ than to admit the simple and plain truth: anon was right.

    LOL – the more you struggle, the greater my enjoyment. Please, let’s have another 20,000 words on Myriad.

  13. Ned states

      But if the process is in fact old, and the claim varies only by the product of nature, then I would agree that the claim fails under 101 per Myriad regardless that it might be “unobvious” per 103.

    and I reply: Ned – isn’t that what I taught you when we were discussing the fact that 101 overrides 102/103/112/271?

    If you fail at 101, you cannot be ‘saved’ by any of the other sections of patent law. The other doctrines are simply inapposite. I explained this several times now. I explained this in connection to your desired (and inappropriate) attempts to use music (a non-useful art item – thus falling out at 101) in some of your strawman arguments.

    Please pay attention to what I have taught you.

  14. MM, we don’t have any cases on this, but I think under claim as a whole, if the product of the process claimed is novel, it is irrelevant that the process is old.  See the now repealed 103(b).
     
    What you are saying, in essence, that DNA sequences are known and are prior art if they are in nature.  I don’t think that is right. 
     
    But if the process is in fact old, and the claim varies only by the product of nature, then I would agree that the claim fails under 101 per Myriad regardless that it might be “unobvious” per 103.
     
     

     
     
     

  15. Same result.

    LOL – more of that ‘great legal reasoning of WHATEVER.’

    Except for the fact that the reasoning of 101 is critically different than the reasoning of 102/103, your ‘sharp’ legal mind resembles a perfectly smooth plane.

    Say Malcolm, not only who was right in the Myriad case, but why (here you should try to use actual legal reasoning) was that person right?

    What? Speak up, I can’t hear you.

  16. you came to the exact position of mine that you said you could not understand

    Dude. Whatever you are holding onto … let it go.

  17. if this process just happens to be the process used by almost everyone, the claim effectively covers the DNA sequence.

    Yes, well this is why I asked for a hypothetical. 271(g) is really beside the point, I think. If the prior art teaches a method for isolating DNA from animals, then adding a limitation about “wherein the animal is [new animal]” isn’t inventive. It’s just a field of use limitation, a post-amble that doesn’t breathe any life into the claim (as a patent-eligible invention). The invention is inherently anticipated or you can look at it from the subject matter perspective (which the Supreme Court seems inclined to do) and recognize that the “invention” — i.e., applying the old method to a naturally-occuring species (e.g., a newly discovered organism) of the genus (e.g., any organism) that is the stated object of the old method — is not one that is eligible for patenting.

    Same result.

  18. Ned,

    Riding the merry-go-round again are we?

    We covered this exact same thing previously with patents on the process of making water.

    More of the same from you – ignore my posts and then later repeate the same sad CRP.

  19. I assume there is more than one way to isolate DNA from nature.  Let is call one of those ways, process X.
     
    Now let’s apply it to a particular DNA sequence in a particular gene of a particular animal.
     
    Process comprising:using process X to isolate a DNA sequence located in gene Y of animal Z, beginning at location P and ending at location Q.
     
    I will assume this claim is eligible.  Yet it covers a sequence of DNA isolated by a specific process, process X.
     
    Now, if this process just happens to be the process used by almost everyone, the claim effectively covers the DNA sequence.
     
     
     
     
     

  20. I am minded to inquire, on the subject of Myriad’s “hundreds of millions”, what part, if any, came indirectly from U. S. taxpayers by way of federal government research grants, or from Utah taxpayers as state research support.

  21. consider a claim to the process but with the only thing new in the claim that it be applied to a specific, but newly discovered, product of nature.

    Old process, new product of nature.

    Maybe you can come up with a simple hypothetical (or two) that gets at the issue you are driving at. I can see a number of issues here but I don’t want to guess at which one concerns you. Interesting subject, though.

    And if you bring Univis Lens up I really will “self-immolate.” ;)

  22. I agree — in part.

    Now consider a claim to the process but with the only thing new in the claim that it be applied to a specific, but newly discovered, product of nature.

    Old process, new product of nature.

    To infringe, one must still perform the process steps.

    What now?

  23. But now consider that the patent laws say that the product of the process is an infringement under §271(g). How does one reconcile this statute with the holding of the Myriad case?

    The statute only applies to products made by the patented process, correct? Infringement requires carrying out the steps of the method. 271(g) requires a product be produced, but it’s essentially limited to method claims.

    Reconciled.

  24. Well, JBS, I fully agree with you that Parke-Davis and the other decisions that have been relied upon by the patent office and others for such a long time to support claims to purified or isolated products of nature are now, all of them, suspect.

    But think about this: I invent a process for isolating “name that product of nature” from its natural form to place it into a useful form. That process patent certainly is eligible for patenting even under the Myriad case. I hope you would agree with this proposition.

    But now consider that the patent laws say that the product of the process is an infringement under §271(g). How does one reconcile this statute with the holding of the Myriad case?

  25. They didn’t discuss them because they are wrongly decided IMO. They absolutely do not mesh with the product of nature doctrine as it currently stands and the Court should have acknowledged as much. In my view, these cases have been effectively overruled for some time now. Parke-Davis is especially troubling to me and Hand all but admits he has no idea what he is talking about.

  26. “Two ineligible compositions of matter, wherein the two ineligible compositions of matter could be used (but don’t need to be used) in an old sequencing method.”

    Now that’s funny!

  27. To make it clear, those cases do not involve:

    methods of extraction/purification

    but:

    molecules identical to molecules existing in nature

  28. Reputation with research community, which is nill, since Myriad already blocked research related to those patents.

    Reputation with competitiors or “medical” industry at large. That is same.

    Reputation with clients. Dunno. 3000$ price tag for those tests was plainly there due to their monopoly. And tests are faulty in some cases (false positives). But competitors selling same (to the client) service for ~30% of what Myriad charged? That can ruine reputation. But then “infrigers” could probably make some pools to check if Myriad reputation in the eyes of client wasn’t shattered already by SC rulling.

    Reputation on wall streat. SC was disaster. Offers from competitors more so.

    So on the last account Myriad do loose on those announcments. (And data is easy to obtain and correlate)

    Lets how court will see it.
    (Anyone have any case where injunction was based on stock shares dropping after **just** the anouncment from competitor?)

  29. Not as off the wall as you think Ned.

    Read the Annotated Code book, note the other sections that apply when you apply the 288 section, and read just a few of the dozens of cases listed therein.

  30. (Did you know that USPTO employees are measured at how MUCH patents they grant where more is just better?)

    Do you know that you are just making things up now?

    przemoli, I’ve commented before: you are so ill-informed as to make any conversation with you impossible. You need to ground yourself in a little bit or real world (this world) knowledge, and then come back.

    Thanks

  31. “Furthermore, unless there are some unusual circumstances, the patentee
    can normally collect damages only with respect to actual notices of
    infringement and they have to be specific as to claims and products. This would typically simplify the matter
    quite a bit.”

    Unless they avoid litigation completly, and relay on quick cash in from settlements. Here every bit of disambiguity, and uncertaintity helps. (As it rise litigation cost, which is main leverage for settlement)

  32. Just remove validity presumption.

    Patent == monopoly.

    Monopoly is bad to economy (or very bad is monopolyst use that possition to execute some nasty and illegal actions against it competitors).

    That is why we have PTO. To make sure that we do not grant Monopoly rights left and right.

    But if you remove validity, patent will be tested by someone who have very strong will to prove its invalidity. Not by someone who have strong pressure to grant it.

    (Did you know that USPTO employees are measured at how MUCH patents they grant where more is just better?)

    Now add to it “validity” for each invalidation theory it stood against in court.

    Its no longer “pass by USPTO and we are golden*!” (*when targeting end users who usually settle, or at “worst” just ignore you).

    Or alternatively one could lower costs of litigation, so that patent holders have stronger incentive to fille for and obtain perfectly valid patents, that wont be invalidated in likely litigation.

  33. Are you suggesting that USPTO never issued 2 different patents to one entity which covered same invention?

    And not a single entity ever applied for 2 different patents, which covered same invention?

    We all know that law make second one invalid. But do you suggest that nobody ever wanted to slip past USPTO grant process?

  34. You got it right, anon, but you have to admit that the Supreme Court did not discuss cases such as Parke-Davis, the B12 case, the aspirin case, all of which seem to hold that if the product being claimed was purified or isolated from the surrounding tissues so as to make it useful, then what was being claimed was not the naturally occurring product, but a product of man. The way the Supreme Court decided the case throws all those prior cases into question.

    I don’t think they really thought they were doing that, do you? But they did.

  35. Myriad has since sued another company, Gene by Gene, asserting more or less the same claims.

    Still curious as to why Dennis believes Myriad has a “strong case.” Is it because Myriad filed a lot of claims?

  36. As always, your contribution here is really informative.

    LOL – just not in the way you think.

    It appears that other pupppies can be potty-trained by watching Malcolm’s nose be rubbed in his own CRP repeatedly.

    (after all Ned – you DID find the nuts right away to say that I got the Myriad case right)

  37. LOL

    Do we need to revisit my posts explaining to you what the word ‘effectively’ means?

    Even your cheerleader Leopold piped in and provided you a definition.

    Funny you seem to have forgotten that (again).

    Or do we need to revisit my reminding you of hte Prometheus case and how ‘not enough’ would factor in to the product of nature exception as used by the Supreme Court (funny how the Court had no problem with my Engllish as a second language on that thought).

    Or should we visit the archives again and visit the post YOU MADE while dancing madly around after the oral arguments and you came to the exact position of mine that you said you could not understand?

    LOL – which way do you want to self-immolate Malcolm? You have soooo many choices.

  38. Tired: “My entire point is that enabling multiple bites
    at the apple unnecessarily and expensively shift costs to society.

    Analyzing a multiplicity of claims across a multiplicity of patents over the
    "same" disclosure is a hugely expensive endeavor. It's much cheaper
    for the patentee to add obvious variants to an independent claim than it is for
    an accused to conduct a post-hoc invalidity analysis on all of them (especially
    once a presumption of validity attaches) — invalidating the broad independent
    claim isn't enough
    .

     

    Tired, I’m not sure I quite understand your position.  Are you talking about invalidating all the claims
    of the patent in court?  Or, are you
    talking about providing an invalidity opinion with respect to patent at the
    request of a client who has been notified of the patent but not much more.

    In my experience, patentees don’t unnecessarily multiply the number of
    claims in court because they don’t get additional royalties or damages for proving
    infringement of a dependent claim.

    With respect to an invalidity opinion, admittedly it gets tough when the
    patent contains a lot of claims; but the focus in most opinions should not be
    directed to validity, but to noninfringement. 
    Furthermore, unless there are some unusual circumstances, the patentee
    can normally collect damages only with respect to actual notices of
    infringement and they have to be specific as to claims and products.  This would typically simplify the matter
    quite a bit.

     
     

  39. You cannot obtain a patent on a product of nature.

    As noted by the Supreme Court, Myriad’s claimed isolated DNA compositions were man-made non-natural chemicals. Whatever “test” you believe the Supreme Court applied in Myriad, there is certainly more to it than you seem capable of understanding or willing to admit.

  40. Myriad is claiming infringement when one uses an ineligible composition, ineligible because it is identical to sequences found in nature, in a conventional process to identify whether the patient has the mutated gene. If this is in fact the case, then the work of the Supreme Court will have been rendered all but inconsequential.

    Yes. It’s pretty remarkable, in fact, that the composition claims Myriad is asserting are, in certain respects, even worse than the composition claims that were tanked by the Supreme Court.

    The Supreme Court tanked Myriad’s DNA compositions (except for the relatively worthless “cDNA claims”) because, it reasoned, the compositions were an attempt to claim control over the information content of “newly discovered” regions of the human genome.

    The claims that Myriad is presently asserting generically cover (1) any and all useful mixtures of those same ineligible molecules; (2) any and all useful old, conventional modifications of those ineligible molecules; and all conventional methods of using (1) and (2) to determine the sequence at a person’s BRCA1 or BRCA2 locus.

  41. Malcolm, thanks for your discussion of Myriad’s claims. As always, your contribution here is really informative.

    As I understand it, Myriad is claiming infringement when one uses an ineligible composition, ineligible because it is identical to sequences found in nature, in a conventional process to identify whether the patient has the mutated gene. If this is in fact the case, then the work of the Supreme Court will have been rendered all but inconsequential.

    In our recent discussions involving 101, we know the Supreme Court looks to whether enough has been added to the unpatentable subject matter in order to not preempt its use. I would think that adding a conventional process would not be sufficient just as it was not sufficient in Funk Brothers.

  42. Now, you say “I espoused (and continue to espouse) is that so-called “cDNA” is “not per se eligible subject matter”.

    I disagree with this to the extent that the SC at Page 17 of the Myriad decision states: “As a result, cDNA is not a “product of nature” and is patent eligible under section 101.”

    Right, but you also agree that there is a rather important caveat associated with that quote, which appears in the footnote we discussed. We’re just quibbling over semantics now, because we’re lawyers. ;) And we both agree, I think, that it would have been nice for the Supreme Court to have spent just a teensy bit more time discussing what these words mean to all of the people affected by their holding (which includes just about everyone in the industry). After all, that’s what we pay them to do.

  43. It all makes sense if you apply the rule of law to
    the facts at hand.

    You cannot obtain a patent on a product of nature.

    The examples of certain cDNA discussed by the Court (yes, examples) are meant for illustrative purposes. Short cDNA which “may be indistinguishable from DNA” WOULD suffer the same fate.

    You are trying way too hard to NOT understand something that is rather easy.

  44. Renee stated that the SC did not hold that cDNA is patenable.

    This statement is partially true in that the SC did not rule on the question of whether Myriad claims to cDNA survive a 102, 103 or 112 challenge. (We will find out in this case.)

    Now, you say “I espoused (and continue to espouse) is that so-called “cDNA” is “not per se eligible subject matter”.

    I disagree with this to the extent that the SC at Page 17 of the Myriad decision states: “As a result, cDNA is not a “product of nature” and is patent eligible under section 101.”

    The problem we both struggle with is whether the SC intended (or even comprehended) that their rationale for finding cDNA eligible doesn’t make sense in when considering other organism’s DNA.

    What I don’t think the SC appreciates is the inconsistency they create with respect to pending applications in front of USPTO examiner’s trying to apply Myriad.

  45. I don’t think the SC blindly made the broad holding that you espouse

    The holding I espoused (and continue to espouse) is that so-called “cDNA” is “not per se eligible subject matter”. First, that’s not a “broad holding.” A broad holding is the holding that you espoused in response to Renee: “cDNA is eligible subject matter”.

    Second, the footnote you cited undercuts your own statement of the holding.

    There is nothing magical about cDNA. The “blindness” of the Supreme Court is evident in their complete lack of discussion of the fact that their holding, to the extent anyone can make sense of it, rendered ineligible DNA (including all “cDNA”) that is complementary to prokaryotic mRNA. And prokaryotic mRNA, as you surely are aware, comprises the vast majority of distinct mRNA sequence space on the planet.

    denigrating comments

    They weren’t meant to denigrate you. My denigrating comments were directed at the Supreme Court.

    Nothing in your response directly or indirectly addresses my quoted section of the SC’s decision

    Pretty sure that’s not true.

    Let me know if you have any other questions.

  46. MM – Nothing in your response directly or indirectly addresses my quoted section of the SC’s decision in response to Renee’s blanket statement that the SC “did not rule that cDNA was patentable.”

    I do agree that the simplicity of the SC’s holding becomes complicated when trying to apply it to claims to a prokaryotic organism DNA or to intron markers of eukaryotic organism DNA. But, I don’t think the SC blindly made the broad holding that you espouse because, in my opinion, the SC left this door open and unanswered when they stated: “except insofar as very short sequences of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short stand of cDNA may be indistinguishable from DNA.” again page 17.

    [note the "may." Also, on what factors they "may" or "may not" survive 101 eligibility is a fight for another day]

    BTW – I have always found that adding denigrating comments to an argument does make one more convincing and superior (at least in one’s own mind).

  47. Let me know if you have any more questions.

    LOL – an easy one that you have avoided even in your 21,000 mewling QQ words:

      Was anon right in the Myriad decision and Malcolm wrong?

    LOL

  48. LOL – you and Prometheus.

    Your record of what that case means is quite funny.

    You were the first to post to the Official USPTO guidelines that (gasp) ignored completely your pet theory and instead extolled 101 Integration Expert’s views.

    Then I schooled you on what exactly the Court was not going to let become dead leters (hint: it was THEIR exceptions).

    Then, when you FINALLY took a substantive attempt at squaring Prometheus with the precedent most on point, you tossed your lovely pet theory into a bonfire of your own making.

    Dance that 9-0 Jig while I hand you a marshmallow to toast upon your flaming pet theory.

  49. Inventors do not have “rights” to patents.

    35 USC 102: A person shall be entitled to a patent unless…

    RMJ, your ‘patently‘ anti-patent views have gotten you kicked off of one blog already.

    Try to actually post with some knowledge of the law, OK?

  50. No Tired, the fact is that they are duly earned at issuance. That is exactly WHY we have the examination process at all.

    Let’s not mistake that with the notion that at a later time a mistake in issuance may be uncovered.

    If you want to go that route in which you indicate, remove ALL examination (Saving Billions of agency dollars – yes with a B), remove the LEGAL presumption of validity and let people fight about it for the first time in court.

    (something tells me that you won’t go for that idea)

  51. While we’re clarifying, the “c” in “cDNA” stands for
    “DNA that is complementary to an mRNA.” There is no chemical distinction between “cDNA” and DNA”. That means that cDNA is not per se eligible subject matter. Some cDNAs are eligible (those with sequences derived from mRNAs which have been spliced to remove introns) and some are not.

    An isolated cDNA whose sequence is derived from an unspliced mRNA (e.g., an mRNA lacking introns) is ineligible for patenting. It doesn’t matter what you call it or how it was synthesized. This is why the Supreme Court appears to have blindly (?) rendered ineligible nearly all DNA molecules isolated from prokaryotes, in spite of never using the word “prokyarotes.”

    Let me know if you have any more questions. This is basic high school level stuff but understandably difficult for a Court that asked a m0r0nic question and was schooled by lawyers deeply invested in obscuring the facts.

  52. Just for clarification: Page 17 “As a result, cDNA is not a “product of nature” and is patent eligible under section 101…”

    footnote 9 “We express no opinion whether cDNA satisfies the other statutory requirements for patentability. See e.g., 102, 103 and 112″

    So yes, the court did not rule cDNA was patentable. It did hold, however, that cDNA is eligible subject matter and not precluded from patentability by reasons of section 101.

  53. Actually, the whole point is that they’re NOT duly earned in this case. The proof that the independent claim was invalid means that the inventor themselves was not an inventor for which he was given a patent right for. So we’re already tying up society and accused infringers over that claim. Now, you’re imposing additional costs by requiring further investigation into mostly obvious variants on the same thing.

    If the independent claim was valid and infringed, you have your protection of the inventor and your reward.

    Why is that so difficult to understand?

    If they didn’t deserve that which they claimed the first time round, why should we impose great costs and expense on society to undertake needless additional investigation? Especially vis-a-vis a party that had no say in the original award of the patent right in the first place.

    On the cascading coverage point: if you get your infringement of a valid independent claim, then cascading coverage is needless. If you didn’t deserve a patent for your independent claim, what is the value to society for an invalid claim + 100 obvious variants? To society and the accused infringer, each of those 100 variants can’t simply be dismissed in the same way they can be written.

  54. Inventors do not have “rights” to patents. Patents are a privelege we can choose to give or not to give. The Constitution specifically leaves this as an option for Congress to decide. Since our experiment with patents has proven such a dismal failure, it is time to quit and eliminate all patents. Penecillin was never patented. The Salk vaccine was not patented. We do not need patents. Research can be funded by other, much more efficient mechanisms.

  55. The court did not rule that cDNA was patentable. It soecifically said that it had NOT made that determination.

  56. I love how ‘convenience’ for you is enough to override the duly earned rights of others.

    The whole point of dependent claims and cascading coverage is just ‘so unfortunate.’

    /off sarcasm

  57. I understand the “why” — though, I don’t know if your “damages” or invalidity analysis is correct. My entire point is that enabling multiple bites at the apple unnecessarily and expensively shift costs to society.

    Analyzing a multiplicity of claims across a multiplicity of patents over the “same” disclosure is a hugely expensive endeavor. It’s much cheaper for the patentee to add obvious variants to an independent claim than it is for an accused to conduct a post-hoc invalidity analysis on all of them (especially once a presumption of validity attaches) — invalidating the broad independent claim isn’t enough.

    I think it would do society a huge favor if “obviousness” rejections during prosecution could be used to reject (and require cancellation of) claims that dependent from allowed independent claims in the current application and/or divisional or continuation applications.

    In other words, the only dependent claims would be permissible are those that themselves add something non-obvious to an allowed independent claim. This, at some level, would provide additional protection to the patentee against invalidity.

  58. Are they kidding us? Myriad’s reputation

    Who is this “us?”

    You, Keeping it Real, Robert, Francis, Shrivan, Vivika M?

    Do you know what your reputation is like Malcolm? Do you even care?

  59. An injunction in this case would be absurd given Myriad’s history of aggressively asserting invalid j-nk.

    LOL – they were not ‘j-nl’ when asserted. UNless you just want to dispense with the presumption of validity in your world…

  60. an action may be maintained

    Was the action to disclaim necessary to maintain a suit?

    No. These are NEW suits Ned.

  61. I do, by the way, urge anyone and everyone with thoughts about how to tank Myriad’s claims to publish and disseminate those thoughts. Myriad is counting on its giant swarm of j-nk claims to intimidate its victims into settling.

  62. 16. A pair of single stranded DNA primers …

    the sequence of said primers being derived from human chromosome 17q …

    wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

    Also, even if we give the j-nky functional limitation in the last clause seriously narrowing weight, we’re still talking about an arguably indefinite (or non-enabled) gigantic class of primer pairs. The number of possibilities in turn opens the door to novelty and obvious arguments.

    Remember: it doesn’t have to be the case that one would use the two short nucleotides for PCR, much less for PCR of the recited gene, and that goes for the prior art as well. Any motivation in the prior art to make any two of the massive number of possibilities covered by the claim should do the trick.

    What Myriad is doing with these claims is trying to prevent anyone from using conventional methods to look at their own DNA sequence. In that respect, the claims are no better than the method cr-p that the Federal Circuit shot down and the Supreme Court approved of. Allowing Myriad to retain control over who gets to use old, conventional methods to determine their own DNA sequence would make a mockery of both the Prometheus and Myriad decisions.

    Will it fly? Well, consider how well Myriad’s apologists did the first time around trying to cover this sick company’s greedy butt.

  63. It’s also, um, “interesting” that Myriad forgot to mention the Supreme Court’s (admittedly bizarre) discussion of Funk Brothers, which seemed to be a very important case for the Justices. In that discussion, the Court characterized Funk’s claims to a novel mixture of bacteria as covering a “law of nature” because “the patent holder did not alter the bacteria in any way.”

    The mixture of two primers claimed here would fail for the same reason: the ineligible nucleic acids are “not altered in any way”.

    We can look forward to watching Myriad pretend that their claim is narrower than they wrote it. And should they succeed in doing that, we can look forward to learning whether an ineligible nucleotide becomes eligible merely by reciting in very general terms some old, conventional “modification”.

    This could all have been easily addressed in the Myriad Supreme Court decision, of course, had someone on the Court taken the time to frame the question properly for cert. Or the claims could have been dealt with using the other sections of the patent statute, which would have been perfectly adequate to tank Myriad’s absurdly broad j-nk.

  64. 16. A pair of single stranded DNA primers …

    the sequence of said primers being derived from human chromosome 17q …

    wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

    If it helps to make it more clear to people who lack the technical background, this claim can be re-written in the following way:

    16. Two ineligible compositions of matter, wherein the two ineligible compositions of matter could be used (but don’t need to be used) in an old sequencing method.

    That’s all that’s in the claim. You’d think this company would have learned something by now. How st00pit are their lawyers? Will Noonan cheerlead Myriad pressing forward with these cr-p claims, too, so we can have more incompetent lawyers trying to teach Justice Thomas what a chemical is?

  65. It’s amazing how quickly the unsettled (and unaddressed) issues many of us were discussing before and after the Myriad case are going to be immediately addressed here (assuming Ambry doesn’t fold — they would be wise to press forward).

    Let’s just jump to the conclusion: it’s impossible to believe that after Prometheus and Myriad that anyone could have patent rights that could prevent someone from using old, conventional techniques (e.g., PCR, Sanger sequencing, probe hybridization) to (1) determine a person’s genetic information and then (2) infer from that genetic information that a person is more or less likely to be disposed to a disease.

    But that’s all that Ambry is doing.

    Here’s Myriad in their brief:

    All of Myriad’s patent claims asserted in this case either require the use of inventive DNA synthesized in a laboratory based upon knowledge about the BRCA1 and BRCA2 genes
    (e.g., gene specific probes, primers and arrays) and thus are patentable under § 101 based on the Supreme Court’s and Federal Circuit’s analysis, or pertain to such synthetic DNA compositions themselves, which are patentable under the same analysis

    Uh … what analysis is that? I don’t recall the Supreme Court saying anything that would suggest that it matters whether a probe that is identical to a sequence in a human genome is “created in a lab.” What are they talking about? They bury a more detailed argument in a footnote addressing Prometheus but it’s nothing more than the same self-serving statements.

    According to the Supreme Court in Myriad, an isolated DNA molecule (e.g., a probe) that is identical to a sequence found in a chromosome in nature is ineligible subject matter. That applies to every probe that is complementary to any human DNA sequence, until the end of time or until the Myriad decision is reversed. Myriad’s position appears to be that they can stop people from using ineligible, unprotectable probes to perform a standard technique! To top it off, Myraid’s claims (e.g., claim 16 of the ‘282 patent) don’t even recite any specific DNA sequences. If anything, they are worse than the claims that were before the Supreme Court.

    Here’s claim 16:

    16. A pair of single stranded DNA primers …

    the sequence of said primers being derived from human chromosome 17q …

    wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

    Between Prometheus and Myriad, there is simply no way this functionally claimed j-nk is eligible for patenting.

    If all this isn’t enough to make you pull your hair out, let’s also not forget Myriad (and their apologists, e.g., Kevin Noonan) endless hand-waving about how Myriad’s claims didn’t prevent anyone from sequencing the BRCA1 gene blah blah blah. What was the point of that smokescreen and dust-kicking? Now we know.

  66. Dennis: It appears that Myriad has a very strong case here.

    Doesn’t look that way to me. An injunction in this case would be absurd given Myriad’s history of aggressively asserting invalid j-nk. Given that, it’s actually quite amusing to read Myriad asserting in its brief that failure to enjoin will lead to “significant harm to Myriad’s (and the other patent owners)
    reputation in the industry”. Are they kidding us? Myriad’s reputation is right there with the reputation of a typical patent troll.

    And it seems they still haven’t learned much. Check this out:

    As the discoverer of the sequences of the
    BRCA1 and BRCA2 genes and the knowledge of their disease association, Myriad has significantly advanced the knowledge in the field of hereditary cancer and improved patient health care.

    Right, except the Supreme Court in both the Prometheus decision and in Myriad’s own case just told everybody that the “discovery” Myriad tried to claim was ineligible information that they dedicated to the public. And it’s also well-known that whether or not Myriad was first to publish their information, others were making the same discovery nearly simultaneously. So Myriad’s assertions here are just puffery. Nobody could have predicted. Myriad is one of the greediest, self-absorbed and narcissistic corporations on the face of the earth. It’s a loathsome company run by clueless people.

  67. Mr. Tired, Damages.

    No matter how many claims of a patent are infringed, one can obtain only one royalty, one damage per patent. Thus, preferentially, one should sue on the broadest “valid” claim only. But even saying this tells us why we multiply the dependent claims: validity.

    But, if we place the claims in different patents, we can get more than one damage award — for the essentially same invention. The defense can stop this only by showing that the same invention is being claimed in both patents.

    Considering this, it seems obvious why people at times like to multiply the patents as opposed to multiplying the claims.

  68. 35 USC 288
    “Whenever a claim of a patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid. The patentee shall recover no costs unless a disclaimer of the invalid claim has been entered at the Patent and Trademark Office before the commencement of the suit.”

    I wonder if they filed disclaimers on the invalid claims?

  69. Lot of potential invalidity issues here even disregarding the recent Supreme Court decision and its effect. Some novelty, probably some obviousness, and certainly some 101 under Prometheus/Bilski.

    There’s also some co-owners of a few patents who weren’t joined (government entities) which is an obstacle.

  70. As all patent cases do.

    And it have to sound serious. Myriad is publically traded company. After SC rulling there where analysys which warned about big loss of value of Myriad stock, unless Myriad can sustain its prices, and market share.

    From that perspective Myriad HAD TO sue anyone who first offered to make those tests.

    Myriad image of monopyst (patents are basically right to exclude others from market, and Myriad used it well), drived its shares up. So to bring them back (after other companies declarded that they will now make BRCA1/BRCA2 tests too), Myriad must look though again.

  71. Indeed. And, as I mentioned, I have been on both sides of this issue. My take away is that, as a business matter, any profit/protection I might extract from the behavior is far outweighed by the sheer numbers of others also playing the game. Yet, because that is the pool I swim in, I’m encouraged to do that which I dislike — better to have 10 mediocre patents claiming variations of the same thing than just 1 mediocre patent.

    You can tell the patent attorneys who don’t work in-house from those that do. I tend to be much more pragmatic and minimalistic in my patent advocacy.

  72. But that wasn’t my point.

    Ah, but you’re missing anon’s equally compelling point of “how can it be abusive to you when it’s highly profitable to me?”

  73. “You do understand that in business, there is competition and that you do not want it easy for your competition to work around your patent, right?”

    But that wasn’t my point. My point is why, as a society, do we want to foster a patent system that encourages wasteful analysis and complexity? I’d still propose that the inventor gets his or her patent, what it would take away is the ability for the patent applicant to have a huge number of bites at the apple, the real cost of which is shifted to society without a commensurate increase in the disclosure.

    Working for a company, I’ve been on both sides of this analysis. If you don’t think time and energy is wasted needlessly, you sir need to a new perspective.

  74. At the same time you say “abusive,” you seem to recognize that that actions create a barrier to invalidity challenges and increases the complaexity of the non-infringement and invlaidity analysis/case.

    You do understand that in business, there is competition and that you do not want it easy for your competition to work around your patent, right?

    Where do all these pollyanna people come from?

  75. Do you understand the words that you use?

    Do you understand the law?

    Do you know what the presumption of validity even means?

    Go, przemoli, learn the basics, so that you can at least have a chance at a meaningful comment.

  76. If we were to take patent reform seriously, we would carefully look at curbing patent strategies like this one. What benefit does society gain from issue 10 patents covering substantially the same disclosure to the same company? The same thing for issuing patents with huge numbers of dependent claims that merely add “obvious” bits to the independent claim.

    I get why the patent owner wants it: the patent owner only needs to be “right” once, but it creates a barrier to invalidity challenges and increases the complexity of the non-infringement and invalidity analysis/case.

    I’m not advocating we deprive inventors of their patent rights. I’d like to see a reform that views this mulitiplicity of filimgs as abusive rather than one that should be encouraged.

  77. Yup.

    But its for courts, layers, and jury.

    Journalist should know better than to assume perfectnes on behalf of USPTO.

    Or do you suggest that law FORCE everybody to write about patents as if they where valid for shure?

  78. Validity” [presumption is] for courts, not for journalists who report about such cases.< ?i>”

    Actually, przemoli, if you bothered to understand the subject that you wish to post upon, validity presumption is by law.

  79. “It appears that Myriad has a very strong case here”

    The what?

    Where is court rulling stating that Myriad claims are valid?

    Come one. SC rulling invalidated some claims, but not all claims in this lawsuit where contested..

    So more of Myriad claims could be invalid..
    Or Myriad could fail to show that Ambry infrige..

    “Validity” pressumption if for courts, not for journalists who report about such cases.

  80. Anyone notice the tribute that Pat Leahy pays to Judge Linn in the video? I cannot think of a greater insult to a member of the patent bar or the CAFC than to have Leahy sing his praises. (Yeah, it’s not germane to this thread but DC isn’t allowing comments on the vid itself.)

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