Today's Date: October 31, 2014 Search | Home | Contact | Services | Patent Attorney | Patent Search | Provisional Patent Application | Patent Application | Software Patent | Confidentiality Agreements

Foaming at the Mouth III: And Then Came Bilski


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: July 7, 2010 @ 3:48 pm
Tell A Friend!

When I wrote my first “Foaming at the Mouth” article (see Foaming at the Mouth: The Inane Ruling in the Gene Patents Case) on Association for Molecular Pathology v. USPTO (hereinafter AMP, but also known as “the gene patent case” or “the Myriad case” or “ACLU v. Myriad”), I never expected it to become a sequel.  But Judge Sweet’s inane 152-page ruling on the ACLU challenge to the Myriad patents was soon to be followed by the new and equally inane Becerra Bill by Congressman Xavier Becerra (D-California, aka “The Gene Patent Terminator”) that would plunge us into an “anti-gene patenting hell” with the potential to destroy American biotech industry.  See Foaming at the Mouth II: My Alternative to the New But Inane Becerra Bill .  And then came the U.S. Supreme Court ruling last week in Bilski v. Kappos.  See Section 273 is NOT a Red Herring: Stevens’ Disingenuous Concurrence in Bilski where I “foamed” on and waxed lyrical about now retired Justice Stevens’ disingenuous sophistry in his concurrence.

One reason I was quite interested in Bilski was because the Supreme Court (not surprisingly) ruled that the Federal Circuit’s “machine or transformation” test was too inflexible, much like the “teaching, suggestion and motivation” (TSM) test in KSR International v. Teleflex. So why my intense interest in the Supreme Court (aka the Judicial Mount Olympus) relegating the “machine or transformation” (aka MoT) test to “second class status” in Bilski?  Besides the inanity of MoT as the sole test for patent-eligibility, I am interested because of Judge Sweet’s ill-advised reliance on MoT (now smitten by the thunderbolts from our Judicial Mount Olympus in Bilski) for invalidating Myriad’s method claims using its BRCA1 and BRCA2 gene sequence technology.

With the AMP case now on appeal to the Federal Circuit, I could just hear in my own mind the judicial mental knives being sharpened to cut up this portion of Sweet’s opinion into microscopic pieces.  In fact, I predicted that AMP might be the Federal Circuit’s first opportunity to clarify the “fuzzy” (and do mean very “fuzzy”) ruling by the Supreme Court in Bilski as to what is now the standard for patent-eligibility under 35 U.S.C. § 101.

Another issue lurking in the Supreme Court’s Bilski ruling was one left unresolved by them in the 2006 Laboratory Corp. v. Metabolite Laboratories, Inc. case on the patent-eligibility of comparative/correlative medical diagnostic method claims.  By “comparative/correlative medical diagnostic method claims,” I mean those method claims which typically involve a first step of gathering/analyzing data, and then comparing/correlating in a second step that gathered/analyzed data to a “bench mark” value to see if, for example, a certain medical condition exists or there is potentially a predisposition to such a medical condition.

In fact, I opined that the Supreme Court’s Bilski ruling might also give the Federal Circuit the opportunity (in AMP) to reconcile two other apparently inconsistent rulings by the Federal Circuit which are based on the “machine or transformation” test as applied to comparative/correlative medical diagnostic method claims.  Compare Prometheus Laboratories, Inc. v. Mayo Collaborative Services (drug dosage calibration patent claims are “transformative” and therefore patent-eligible) with Classen Immunotherapies, Inc. v. Biogen Idec (with no/minimal explanation, claimed method for essentially calibrating an immunization schedule for a treatment group, relative to a control group is patent-ineligible in view of Federal Circuit’s Bilski) which I discussed in my article CAFC: Method for Calibrating Drug Dosage Is Transformative .

But then we received another “thunderbolt” from our Judicial Mount Olympus last Tuesday when the Supreme Court summarily granted certiorari in Prometheus and Classen, and then vacated and remanded both cases to the Federal Circuit to consider (with equally “fuzzy” guidance) in light of the Supreme Court’s ruling in Bilski.  See Eric Steffe’s and Michelle Holoubek’s Diagnostic Testing in the Wake of Bilski v. Kappos .  This could mean the Prometheus and Classen cases would resolved by Federal Circuit the before AMP.  Or maybe the Federal Circuit would do an en banc trio of these cases.  Who knows now what the Federal Circuit is going to do with this trio of cases.

So much for my prediction that AMP might be the first case where the Federal Circuit would shed light to us “mere mortals” as to what the Supreme Court’s opinion in Bilski means.  In any event, the Federal Circuit (unlike our Judicial Mount Olympus) can’t simply dodge the impact of the Supreme Court’s Bilski ruling, including what does it mean for the patent-eligibility of comparative/correlative medical diagnostic method claims in the Prometheus, Classen, and AMP cases.

For those wishing to prevent their IP in medical diagnostic technologies from sinking into oblivion, the hope would be that the Federal Circuit would affirm its ruling in Prometheus (as being either “transformative” or on some other basis consistent with the Supreme Court’s Bilski ruling), as well as reverse the rulings in Classen and AMP for relying upon the “smitten” MoT test to invalidate those method/process claims.  In other words, the Federal Circuit will decide to stand “tall in the saddle,” and not be “bullied” by our Judicial Mount Olympus into creating a new patent-ineligible class of subject matter (i.e., for comparative/correlative medical diagnostic method claims) to be added to the abstract idea “dead zone?”

But then again, the Federal Circuit has been thumped repeatedly, starting with KSR International and now ending with Bilski, for tests which are considered by our Judicial Mount Olympus to be too inflexible (and perhaps too pro-patent).  Will the Federal Circuit simply grow timid (and weary) from this repeated onslaught from our Judicial Mount Olympus, turn tail, and run in the direction of simply casting yet another class of subject matter into the patent-ineligible “dead zone,” with adverse consequences for American innovation and job creation in the medical diagnostic industry?  Will the Federal Circuit be pummeled (again) in to submission by the Judicial Zeus and simply make Justice Breyer’s dissenting opinion Laboratory Corp. (which opined against the patent-eligibility of such comparative/correlative medical diagnostic method claims) come true?

Rather than prognosticate further, maybe it’s time to simply consult the Oracle at Delphi as to what the Federal Circuit’s answer will be in the Prometheus, Classen, and oh yes, AMP cases.  I can’t see how we could do worse in view of our Judicial Mount Olympus who wouldn’t know patent-eligible subject matter if it hit them square in the face.

© 2010 Eric W. Guttag.


- - - - - - - - - -

For information on this and related topics please see these archives:

Tags: , , , , , , , , , , , , , , , ,
Posted in: Bilski, Biotechnology, Business Methods, Federal Circuit, Gene Patents, IP News, IPWatchdog.com Articles, Patentability, Patents, US Economy

 

 


Tags & Categories

Tags: , , , , , , , , , , , , , , , ,
Posted in: Bilski, Biotechnology, Business Methods, Federal Circuit, Gene Patents, IP News, IPWatchdog.com Articles, Patentability, Patents, US Economy

29 comments
Leave a comment »

  1. Eric, chill my friend.

    Some things are more important than the Supreme Court….go to the beach, look at the girls in their bikinis, and have a cold adult beverage.

    To be politically correct, those of the female persuasion can do the same, except look at the guys in their trunks with rippling biceps.

    To be uber-correct for the LGBT crowd: Look at the boys in their speedos.

  2. AC,

    Thanks for your concern, but I’m fine, just getting this off my chest. I also don’t care about being PC (and I’m also a die-hard Washington Redskin fan, although being 1/32 Cherokee which doesn’t count in the PC world). All I had was a “little fun” with our “friends” in SCOTUS. And get ready for the “verbal blood-bath” that will occur when the Federal Circuit gets Sweet’s opinion; I predict it won’t be pretty.

  3. Eric,

    Here’s some contrarian advise.
    Don’t chill.
    Keep foaming at the mouth.

    You are providing a valuable service even if some cowboys don’t want to hear it and would rather be gawking all the time at their objects of amorous attention.

    Here’s the deal.
    B.v.K. represents one of many examples of those who are too incompetent to know they are incompetent, nonetheless incompetently adjudicating over a matter they have no competence in.

    The District Court decision in AMP/Myriad is yet another example of the same phenomenon.

    We need to ask ourselves how the judicial system evolved into this foaming at the mouth state and what can be done to soak up and plug up the still out-spilling foam?

  4. Speaking of foaming at the mouth,
    the USPTO BOPAI has started releasing post-Bilski 101 rejections:

    http://des.uspto.gov/Foia/ReterivePdf?system=BPAI&flNm=fd2009006599-07-08-2010-1

  5. Step back –

    I wish they would appeal that decision to the Federal Circuit. The real party in interest is Hewlett-Packard, so there is some chance that they will.

    First, not only do they reject method claims, which would likely meet the MOT test (at least 1 of the dependent claims certainly does), they reject a computer apparatus claim and a computer program product claim. For all of the software-hating folks, this is the BPAI’s broadside against software claims (or at least a rogue APJ’s broadside).

    Second, I detest their bullsh1t we aren’t even going to rule on the art rejection because all claims are barred “at the threshold by 101.” Appellant filed his appeal brief 2 years ago, and now he gets no resolution on the prior art rejections. Wasn’t there a Federal Circuit case that stated the BPAI cannot ignore rejections (or something to that effect).

    Also, when will the BPAI (or Examiners) realize that there is a difference between software per se and software. Not every discussion in a specification regarding software refers to “software per se.”

    Finally, on a side note, the claim language definitely could be cleaned up. Still the BPAI got it entire wrong. For example, the claimed step wthin claim 1 of “instantiating the set of data items” necessarily requires a computer. To instantiate is a term of art that clearly takes the invention out of the realm of abstract ideas.

    This is classic BPAI BS. However, it would be a good test case to take the Federal Circuit.

  6. BTW —

    That decision issued today.

  7. SB and JV,

    Thanks for the encouraging words. Nothing I like better than pouring more gasoline on this Bilski fire. Our Judicial Mount Olympus doesn’t get it at all when it comes to patent-eligibility or why you need to start with 35 USC 112 to screen out badly defined inventions. Instead, they resort to their version of the “federal common law of patents” which sounds good to them, but to us “mere mortals” is simply rhetorical “gobblydegook” that we can’t apply with any degree of certainty to any situation beyond the one they ruled on (if that). Bilski has done nothing to change my very low opinion of the ability of SCOTUS to rule competently (or objectively) on matters of patent law. And I’ll continue to “foam on”!

  8. “I wish they would appeal that decision to the Federal Circuit. “

    33. A method of controlling processing of data, wherein the
    data comprises a plurality of rules associated with a plurality of
    data items comprising a set of logically related data items, each
    data item in the set having a rule associated therewith, said rules
    acting to individually define usage and/or security to be
    observed when processing each of the data items in the set of
    data items, and in which forwarding of the set of data items is
    performed in accordance with mask means provided in
    association with the rules
    .

    If it is appealed, perhaps the CAFC will place the emphasis on 35 USC 112 and whether the claims actually particularly point out and distinctly claim the subject matter which the applicant regards as his invention. (The Board also did away with the 103 rejection and put the emphASIS on 101.)

    This could be a very good case all around for guidance.

  9. “federal common law of patents” ???

    Didn’t the Supreme Court rule in 1939 in Erie RR v Tompkins that there is NO federal common law?

  10. cmeans @8

    I agree with you that the new BOPAI case is not one with immaculate claims.
    For example, the claim 33 listed as representative in the BOPAI decision asserts itself to be a method claim. But were are the steps performed within the method? Is “forwarding” the data the only step, and if so how does that control processing?

    That said, claims have to be read in light of the specification, and I for one have not read the specification. So criticizing the claim at this stage may be premature.

    What troubled me is what the BOPAI panel said about hardware and “software” nodes.

    Common sense would (should?) indicate that all “software” nodes MUST be contained in implementing hardware. They cannot exist on their own as floating out there in space and no reasonable practitioner would interpret a software node as being mere abstraction. It is something that is implicitly implemented on a hardware platform of some sort.

  11. SB — common sense at the BPAI (and in the USPTO as a whole) is in short supply.

    You are right — common sense (and one skilled in the art’s knowledge) would lead to the conclusion that software nodes must necessarily be part of hardware. They cannot exist separately from hardware despite the wishful thinking of many examiners/APJs.

    The whole notion of “software per se” is a USPTO creation that has nothing to do with how one skilled in the art recognizes software. Nobody outside of the USPTO uses the phrase software to mean “software per se” (i.e., unconnected from anything, including hardware).

  12. American Cowboy at 7/9/10. 9:54 AM:

    Erie v. Tompkins pertains to matters of state law being heard in federal court under diversity jurisdiction. It does not pertain to matters of federal law such as patents. Thus (and…yes), federal common law has evolved regarding patents under the guidance of the SCOTUS that steers this ship of state we know as “patent law” with its hands firmly placed off the wheel.

  13. I am personally against all gene patents, whether or not they meet all the requirements or not, and whether or not they are beneficial to the economy or not. For me, it is a moral issue, and not matter arguments a person can put forward, they wont change my opinion about the corruption that is occurring by corporations by Monsanto because of the hole that is opened up by gene patents. The harm is far, far, greater than the benefit and we should end them as soon as possible forever, and make it part of the law so that it never happens again.

  14. I am personally against all gene patents

    @Andrew (re comment 13):

    “Gene” Quinn is going to be unhappy that you are against ALL “gene” patents including those written or prosecuted by him.

    Humor aside, the word “gene” (in the biochemical sense) is a nebulous and indefinite term (just as are words like “computer”, “software” and “truly innovative”). Who is going to decide and exactly how are they going to decide whether a given “patent” (having many different claims) is a “gene” patent or not a “gene” patent?

    What is your definition of this thing you refer to as “gene”?

    __________________
    (p.s. If you do not have a clear definition of “gene”, then by definition, you are talking about something you know nothing or very little “about” –because you cannot circumscribe the territory.)

  15. For me, it is a moral issue,

    Moral issues are important, to be sure, but they generally don’t mix well with patent law. If Monsanto is doing bad things with its gene patents, there should be a separate law against doing those bad things, like the laws we have against selling untested pharmaceuticals.

    My personal feelings about Monsanto aside, it’s pretty darn clever to have a food crop designed to be herbicide-resistant. That’s got to be worth some patent protection. Definitely more useful and less abstract than Myriad’s BRCA1/2 patents, which I initially thought you were talking about when you said “gene patents” and “moral issue”.

  16. -IANAE

    In terms of their invention, I would agree that on the surface it seems to be perfect for patenting. The problem comes from the fact that their process is not the only way to create that gene. If it were, then I wouldn’t have any problems. If it were only the process for creating those specific crops that were patented, then I would also have no problem, but it isn’t. In order to provide financial protection, they have to be able to sue anybody who possesses it without their permission. However, plants have a funny little habit of reproducing themselves and scattering themselves as far as possible to ensure their survival.

    If some seeds with their gene in it blow into a farmers fields, then Monsanto can sue. Not only can they sue, but they have been, like crazy. Farmers who never even wanted the stuff mixed into their crops are forced to destroy all their saved seeds and crops or pay Monsanto a fine. They want to force all farmers to use only their seeds, and they are getting away with it by imposing those seeds on the farmers fields. It is impossible to keep seeds out. You can’t build a wall high enough because birds will come in. Even if you could, it would be impractical. In essence, they are systematically killing off all seed diversity in the patented world as fast as possible to turn a buck.

    Like I said, I don’t care if they patent the gene, or the process for creating the gene, but they shouldn’t be allowed to prosecute against people in possession of it because it reproduced itself onto their property, with or without consent. If they want to prohibit people from using or manufacturing the gene in a lab, then that is ok with me, but keep it away from living organisms. A gene by itself can’t self-replicate. I would propose that all rights to exclusion pertaining to genes and other compositions of matter be denied if the gene or composition of matter is found inside an organism that is capable of self-replication.

  17. -Step Back

    I have clarified my position somewhat in my response to INANE (I think he misspelled his handle?) that I am not against the patenting of genes, just the exclusive rights they grant over organisms that can self-replicate. I use the term gene to mean what it does in science, which is basically a string of DNA. In the case of Monsanto, they take sections of DNA from other organisms like e. coli and insert them into the crop DNA so that it will have properties that they desire when it grows, like being resistant to their chemical herbicides.

    Like I said before, the problem comes from the fact that these plants then reproduce and in the process recreate that engineered section of DNA which Monsanto has exclusive rights over. Not only that, but that DNA can then make its way into other species and variations that didn’t have it before, effectively spreading itself outside the original plant DNA. This is unknown in any other field where patents exist. Even in computers where code you don’t want can copy itself and get on your computer through viruses can’t force its way into the source code of your other programs.

    Actually that would interesting. What is happening right now is the equivalent of a software company getting a patent on a process, putting it into a virus, and then suing people who get the virus for having it on their computer without permission. Just replace virus with seed, process with gene, and computer with field, and it is identical. Some people buy the seed, and know what they are getting into, but others don’t, and it isn’t fair to them.

  18. If some seeds with their gene in it blow into a farmers fields, then Monsanto can sue.

    Well, really, if Monsanto has your name then Monsanto can sue.

    What we’re really concerned about, I think, is which suits Monsanto can win. You’ve definitely identified a real problem, and the law of infringement will have to evolve to deal with self-replicating inventions that can also transport themselves onto your property. Personally, I don’t see how incidental cross-pollination of your field of canola from your neighbor’s field of canola falls under “make, use, or sell”, but the courts will need to find some conclusive way of dealing with that, even to the point of sanctioning frivolous litigation when it’s clear the accused infringer didn’t actually do anything with the invention. I propose the same way they deal with voluntariness as an element of actus reus.

    But none of that should be any reason to deny Monsanto their patents.

  19. I’m not sure about here in the states, but in Canada, the Supreme Court ruled that growing the crop was considered “use”. The farmers aren’t growing it intentionally, and once it is grown, there is no way to tell the difference without testing each one. They go in, and take a small sample, select some that are contaminated, and then use that as a basis that all the seeds are contaminated. They put the onus on the farmer to prove they rest aren’t, but how can you do that?

    Its funny you mentioned the fact that they can sue but might not win. The cost of defending yourself against them, especially for farmers who may not have even heard of patents, is usually much greater than the “fine” Monsanto wants to impose. Most farmers settle out of court and pay up. It’s similar to the disabilities act scams. Lawyers go around and find a place that looks like it might not be meeting some of the guidelines of the disabilities act and threaten to sue. They offer to settle out of court for an amount that is small enough to make it worth not going to court.

    Like you said, infringement policy will have to evolve to combat this, but until they do, I don’t support gene patents in their current form. If reform comes, then I’ll change my mind.

  20. in Canada, the Supreme Court ruled that growing the crop was considered “use”. The farmers aren’t growing it intentionally,

    If we’re thinking of the same case, that farmer actually was growing the crop intentionally. And you can apparently tell the difference (as that farmer did) by spraying everything with roundup and seeing what dies.

    Its funny you mentioned the fact that they can sue but might not win. The cost of defending yourself against them, especially for farmers who may not have even heard of patents, is usually much greater than the “fine” Monsanto wants to impose. Most farmers settle out of court and pay up.

    All that is true, of course, but if Monsanto wants to be a jerk they can do that to anyone regardless of whether they even own a farm. This is purely a litigation issue. The US court system is designed to encourage frivolous litigation of all kinds. Being against the kinds of patents that one aggressively litigious company happens to own is not going to make the problem go away, it’s just going to lead to bad and inconsistent patent law.

  21. -IANAE

    You say that you can tell, but really you can’t. It becomes a game of his word against theirs. Of course the round-up ready crop is going to survive the round-up and other isn’t, but you can’t know whether he intentionally planted round-up ready seeds or not. If they blew in years before and cross pollinated with this other seed that he collects every year for the next years planting, and they look exactly the same, then how can know?

    Besides, the issue here is about the ability of the plant to self-replicate and physically move itself into people’s private property without their permission or knowledge. Again, I wonder what the outcome would be for a person sued because they accidentally got a virus on their computer that contained a patented process? I would hope it would get thrown out, but now I wonder.

  22. but you can’t know whether he intentionally planted round-up ready seeds or not.

    Of course not. That’s part of the patentee’s burden – proving the act of infringement.

    Chances are, if spraying roundup would kill most of the defendant’s crop, he wasn’t planting the infringing seeds on purpose. That would be pretty silly of him, wouldn’t it?

    Besides, the issue here is about the ability of the plant to self-replicate and physically move itself into people’s private property without their permission or knowledge.

    Right. But that’s not Monsanto’s fault either. Plants have been doing that forever, and they don’t have the courtesy to check with the owner before crossing property lines. Again, a valid concern, but not a patentability issue.

  23. So if a plant seed with a patented gene in it blew into your yard, or was carried in by an bird or cross-polinated by an insect, and you were sued, even though you didn’t know about, and would have had no way of knowing without getting DNA tests on your grass or plants because they look exactly the same as what you had already, and you got sued, you would be ok with losing that case?

  24. “you would be ok with losing that case?”

    Haven’t I been saying the exact opposite of that this whole time?

  25. You tell me. The way things are currently, you would lose that case, so explain to me what you would like to see changed that is different than my suggestion? I also never said they should be denied a patent, only that their exclusive rights should be restricted.

  26. Andrew, see post 18.

    Also, you write in post 25 that “I also never said they should be denied a patent, only that their exclusive rights should be restricted.”, but also in post 13 that “I am personally against all gene patents, whether or not they meet all the requirements or not,” and “we should end them as soon as possible forever, and make it part of the law so that it never happens again.”

    Also, your proposal in post 16 that “all rights to exclusion pertaining to genes and other compositions of matter be denied if the gene or composition of matter is found inside an organism that is capable of self-replication” is in direct contradiction with important principles of patent law, for example that self-replicating life forms are patentable subject matter and adding features to an infringing article does not escape infringement. And also that genes are generally only ever useful when they’re inside a living organism. I predict much farther-reaching consequences than simply preventing Monsanto from taking advantage of farmers.

  27. I don’t think self-replicating life forms should be patentable subject matter, which is what I meant in post 13, but I later had to clarify exactly what I meant in other posts. I think patents on engineered genes are ok, but genes by themselves cannot self-replicate as I have pointed out. Once those genes become part of a self-replicating life form, I think the power to exclude should end. You may be asking yourself what good a gene patent is if it can’t cover any use of the gene inside a self-reproducing organism, and I would say that I don’t know, but I don’t care either.

  28. Andrew-

    I am coming in late to the party, but allow me to point out that the problem you raise about seeds blowing or being carried is a real problem. The case cited by many in the anti-patent community is largely falsified. Yes, seeds blew over and the farmer knew it. He knew the genetically modified seeds were resistant, so he contaminated his entire crop so all but the genetically modified plants would die. He then collected seeds from the remaining genetically modified plants. Then he planted only genetically modified seeds.

    He lost because he poisoned his own crops and knew he was infringing. He was a bad actor. I think the case would come out different if it were an innocent situation without knowledge.

    There is really no basis in patent law for saying it would come out different. There is not innocent infringer defense, but there are a host of equitable theories that apply across the board in all disputes and would almost certainly allow a judge to exercise inherent power as a decicionmaker to reach a just resolution. None of these theories would help the bad acting farmer because the require “clean hands”. You don’t have to be Snow White, but pretty close.

    Sent from iPhone

  29. There is not innocent infringer defense,

    That’s why I suggest something like the criminal concept of involuntariness. There is no mens rea-based defense for parking tickets or speeding tickets, but if someone towed your car to an illegal parking space without your knowledge, or the two hours of money you put in the meter ran down in 15 minutes, or you were speeding while sleepwalking, you can still get off. Your defense is not that you lacked the requisite intent, but that you did not do the act. Seems to be a cleaner fix than getting equity involved.

    If a genetically modified seed blows into your yard and sprouts in your soil, what infringing act did you commit? Even if you harvest the plant and sell it along with the rest of your crop, what infringing act did you commit? What if a Monsanto employee trespasses on your farm at night and plants a few rows of genetically modified seed? Should you need to show clean hands to escape liability?

    What I would like to see in practice is some kind of sliding scale presumption based on the proportion of a particular crop that is genetically modified, depending on the nature of the modification and what’s in your neighbor’s fields. If the crop is supposed to survive a herbicide, chances are if you planted it on purpose it will be nearly 100% of any field where it is found. In the Canadian case, that’s pretty much what happened – seven whole fields of roundup-ready canola, I think. Sure, you could say he had unclean hands, but more importantly he deliberately planted acre after acre of seed he knew for sure was roundup-ready.