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Foaming at the Mouth: The Inane Ruling in the Gene Patents Case


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: March 30, 2010 @ 3:51 pm
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There are certain areas of patent law that will immediately cause me to “foam at the mouth.”  One is the doctrine of “inequitable conduct” which has rightly been called a “plague” in patent litigation.  Another is what is “patent-eligible” subject matter under 35 U.S.C. § 101.  For a taste of my “foam” on that subject, see The Bilski Oral Argument Speaks Volume: Start with 35 U.S.C. § 112 where I express my displeasure with the illogical and unworkable “machine or transformation” test currently being reviewed by SCOTUS in Bilski v. Kappos.

A case which has recently drawn my ire is Association for Molecular Pathology v. USPTO which involves various patents obtained by Myriad Genetics (NASDAQ:MYGN) relating the BRCA1 and BRCA2 gene sequences which have been found to be potentially useful in identifying the presence of mutations correlating with a predisposition to breast or ovarian cancer.  The plaintiffs in AMP who want Myriad’s patents invalidated are represented by the ACLU.  The ACLU has put forth (in my opinion) the preposterous and deliberately distorted view that Myriad’s patents cover the BRCA1 and BRCA2 gene themselves.  That is simply not true, as Dale Halling pointed out in his article ACLU Should Be Hit With Rule 11 Sanctions posted on IPWatchdog.  I also agree with Dale (as do others), that the ACLU should be sanctioned under FRCP Rule 11 for this gross and deliberate misrepresentation of what Myriad’s patents cover.

Unfortunately, the ACLU appears to have found an “ally” in Judge Sweet, who is the district court judge handling the AMP case.  In my view, Judge Sweet has either been duped by the ACLU, or is more likely complicit in accepting the ACLU’s warped view of what these patents cover.  That became evident when Judge Sweet denied the motions by Myriad and the USPTO to dismiss this case for lack of subject matter jurisdiction, lack of personal jurisdiction, and failure to state a claim upon which relief can be granted.

In a 152 page opinion (which even includes a lengthy and overdone history on genetics going back to Watson and Crick), Judge Sweet has now added “insult to injury” by declaring all of Myriad’s patents invalid under 35 U.S.C. § 101 as not being patent-eligible subject matter.  At least Judge Sweet had the sense to dismiss ACLU’s even more strained and absurd “constitutional claims” against the USPTO by employing “the constitutional avoidance” doctrine.  Nonetheless, Judge Sweet’s ruling that all of Myriad’s patents are invalid under 35 U.S.C. § 101 is inane (and unsupportable) in the extreme.

Why do I say that?  Well, for one, I could be considered more knowledgeable than Judge Sweet on the subject of why purified (or isolated) “products of nature” can be patent-eligible subject matter under 35 U.S.C. § 101, having written on this subject over 30 years ago (just after graduating from law school) when it was a very “hot topic.”  See Guttag, “The Patentability of Microorganisms:  Statutory Subject Matter and Other Living Things,” University of Richmond Law Review, Vol. 13, page 247 (1979).  In other words, I’m very familiar with the SCOTUS (and other court) precedent on the patent-eligibility of “products of nature” cited by Sweet in his opinion (and why this SCOTUS precedent doesn’t support Sweet’s ruling), as well as the CCPA case of In re Bergy which Sweet cites, and more significantly, misrepresents, because the holding in Bergy actually supports the patent-eligibility of Myriad’s BRCA1 and BRCA2 gene sequence technology.  In fact, Judge Sweet would have done himself a favor by reading my article of 30 years past which discusses the holding in Bergy extensively, as well as the CCPA precursor to SCOTUS’ ruling in Diamond v. Chakrabarty (which also, in my opinion, is contrary to Judge Sweet’s position), In re Chakrabarty, instead of opining on an area of patent law he obviously (to me) doesn’t understand.

Judge Sweets ruling that the Myriad’s patents covering the “isolated” (and I do want to emphasize “isolated”) BRCA1 and BRCA2 gene sequences rests primarily on a line of SCOTUS cases often cited (and sometimes even miscited) for the proposition that “products of nature” are patent-ineligible:  the 1874 case of American Wood-Paper Co. v. Fibre Disintegrating Co.; the 1931 case of American Fruit Growers, Inc. v. Brodgex Co.; the 1928 case of General Electric Co. v. De Forest Radio Co.; and the 1948 case of Funk Bros. Seed Co. v. Kalo Innoculant Co. The very age of these cases is troubling for determining the patent-eligibility of Myriad’s BRCA1 and BRCA2 gene sequence technology which occurred long afterward.  Even more troubling is that all of these cases are discussed in my article, and Judge Sweets take on what these cases mean doesn’t convey the whole picture.

First, Judge Sweet’s opinion suggests that these cases have consistently applied the “products of nature” doctrine in determining whether subject matter patent-ineligible.  But as my article points out, that is far from the truth:  “A major difficulty for the courts has not been in stating the [“product of nature”] doctrine, but rather in determining whether there is such a doctrine and how to apply it.”  In this regard, I contrasted the General Electric case (where SCOTUS held a patent on substantially pure tungsten to be invalid for covering a “product of nature”) with Judge Learned Hand’s opinion in the 1912 case of Parke-Davis & Co. v. H.K. Wolford Co. (which upheld the patent on adrenalin extracted from glands of animals and which essentially deemed the “product of nature” doctrine irrelevant to patent-eligibility).  In fact, Judge Sweet’s dismissal of Judge Hand’s ruling in Parke-Davis as being based strictly on “novelty grounds” is astonishing given that Myriad’s “isolated” BRCA1 and BRCA2 gene sequences are also “novel” as they don’t exist in nature.  That Judge Sweet’s suggests that Parke-Davis is “contradicted by subsequent case law” (i.e., Bergy and the 2009 Federal Circuit case of Prometheus Labs. V. Mayo Collaborative Services) also doesn’t “hold soap” in my view.

Second, several of these SCOTUS cases don’t rest primarily on “products of nature” being patent-ineligible.  For example, in the American Wood-Paper case, SCOTUS ruled a patent covering a purer form of cellulose pulp suitable for manufacturing paper invalid in view of cellulose pulp suitable for manufacturing paper already being in existence (i.e., was an attempt to patent an “old compound” and thus not novel).  The holding in Funk Bros. Seed Co. is more properly viewed as an attempt to patent a mixture of non-inhibiting strains of bacteria which was deemed to be unpatentable as being obvious (i.e., under 35 U.S.C. § 103), which Judge Sweet also incorrectly suggests as being based strictly on “patent-eligibility” grounds.

Third, it is questionable whether the “product of nature” cases such as American Fruit Growers are still good law, especially in view of SCOTUS’s ruling in Diamond v. Chakrabarty.  In American Fruit Growers, SCOTUS ruled that fruit impregnated with borax was not a “manufacture.”  As my article pointed out, that ruling appears to be bizarre based even on the definition of “manufacture” used in American Fruit Growers.  In fact, later cases (including Diamond v. Chakrabarty) have cast the decision in American Fruit Growers (rightly so in my opinion) into oblivion.  Accordingly, Judge Sweet’s statement that the “clear line of [SCOTUS] precedent and accompanying lower court authorities, stretching from American Wood-Paper through to [Chakrabarty v. Diamond], establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter” simply won’t stand up under critical scrutiny.

What is most alarming about Judge Sweet’s opinion is his characterization (or more appropriately mischaracterization) of the CCPA’s Bergy case.  Judge Sweet makes numerous quotes from Judge Rich’s opinion in Bergy on how 35 U.S.C. § 101 should be interpreted.  But what Judge Sweet neglects to point out is that Judge Rich ruled in Bergy that a biologically pure culture was deemed to be patent-eligible under 35 U.S.C. § 101.  Why did Judge Sweet neglect to point out this highly relevant fact?  Instead, if the holding in Bergy is considered in appropriate context, it supports Myriad’s “isolated” BRCA1 and BRCA2 gene sequences as being at least patent-eligible under 35 U.S.C. § 101 because they don’t exist in nature and cannot exist without significant human intervention.

What takes Judge Sweet’s opinion from the sublime to the surreal is his ill-advised reliance upon the “machine or transformation” test from Bilski to invalidate Myriad’s method claims using this BRCA1 and BRCA2 gene sequence technology.  In fact, Judge Sweet’s reasoning for distinguishing the Prometheus case makes even more glaring the problems in trying to apply the “machine or transformation” test from Bilski to medical diagnostic technologies such as those encompassed by Myriad’s method claims.  See CAFC: Method for Calibrating Drug Dosage Is Transformative where I point out how “Judge Lourie’s opinion in Prometheus is clear evidence of how tortuous it is to apply the Bilski machine or transformation’ test objectively to drug dosage calibration methods like those in Prometheus.”  That Judge Sweet would even rely so heavily on the Bilski test which is likely to be overturned by SCOTUS (and replaced with who knows what “test”) to invalidate Myriad’s method claims doesn’t seem very wise (or prudent) to me.

In the end, it is my considered opinion that Judge Sweet knew the result he wanted to reach (i.e., invalidate Myriad’s patents), and simply cobbled together a justification for it.  (Treating the claims in Myriad’s patents are a “lawyer’s trick” also doesn’t suggest impartiality.)  If nothing else, there is enough of a dispute about the essential facts needed to reach Judge Sweet’s conclusion to deny the plaintiff’s motion for summary judgment of invalidity based on 35 U.S.C. § 101.  That Judge Sweet needed to spend 152 pages trying to justify his grant of plaintiff’s motion for summary judgment speaks volumes about why this grant was inappropriate.

But then, that’s my opinion.  Even so, I do hope the Federal Circuit thoroughly trounces Judge Sweet’s opinion.  It’s “bad law” based on “badly distorted facts,” as my article of 30 years past shows.  Just the holdings in Bergy and Diamond v. Chakrabarty alone should be enough to overturn this misguided ruling in AMP.

*© 2010 Eric W. Guttag


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17 comments
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  1. Ho-hum

    Federal Circuit decision? No
    Supreme Court decision? No
    Do I care? Not really

    When a court that (somewhat) knows what they are doing (I don’t want to give too much credit to the Federal Circuit or SCOTUS) affirms this decision, then I’ll sit up and take notice.

    I take this same stance when it comes to anything out of the BPAI — glorified examiners who got night-time law degrees while examining don’t strike me as the end-all and be-all of patent law.

    This will play well with the media who will jump all over this, but I wouldn’t be selling my stock in genetic companies over it (or at least not for that reason).

  2. JV,

    I hope you’re right. My fear is that the Federal Circuit is so “gun shy” of SCOTUS that when someone (like Sweet) cites (or more correctly miscites) SCOTUS precedent, the Federal Circuit will get timid. This case requires boldness on the Federal Cricuit’s part, not timidity, to put a “senrior” district court judge permanently into retriement.

    Sweet reminds me of former district court judge Miles Lord, a notorious “judicial activist” who almost put one of my dad’s partner’s in the “disbarment zone” based on unfounded findings of fraud on the patent office and fraud on the court. Fortunately, the 8th Circuit pounded Lord’s grant of summary judgement into the turf. We don’t need “cowboys” like Sweet or Lord on the bench.

  3. One imminent issue is the effect this will have on investment in biotech. The dicta in this case stretches far and wide. I wonder weather or not dna patents might be reduced to “mere indicia” and impact 102 as well? Will investment in biotech and diagnostics be impacted immediatly or will they dismiss this under the “district court” nonsense viewpoint. No matter what, the decision creates uncertainty at a time when credit is tight, the Fed’s interest balancing act might sway, and the healthcare bill is being dissected for unanticipated consequences. Put this all together and do we have some perfect storm or omen? If so, what do they say?

  4. “…glorified examiners who got night-time law degrees while examining…”

    Speaking as one who got a “night-time” law degree while examining, I’m offended by your comment.

    But as I’m not all that impressed with those who got “day-time” law degrees while kicking a hacky sack around the quad 5-6 hours a day, I guess the feeling may be mutual.

  5. This ruling is based on emotion not in law. The Myriad patents are almost expired, so this is just the ACLU grandstanding. Unfortunately, this Judge bought into the emotional arguments.

    An Isolated DNA sequence is a unique chemical entity. This type of patent will no longer issue now that the human genome is prior art. You are looking at this through today’s technology when the patent issued, there was no genome available, no ORF map, and it required a lot of work to identify and isolate the correct gene from the genome.

    Everyone acts like Myriad did no work and got a free patent. Myriad actually had to statistically tie mutations in the BRCA1 and BRCA2 gene to a statistically significant probability of cancer. They paid a lot of money to conduct clinical studies and achieve FDA approval for this test – de novo – without any guarantee of success. They also had many failures, the scattered remnants of their patent applications are testimony to that. They filed many patent applications and had a few issue to some specific genes. Their original applications were way too broad, although they appear to have done a lot of research and studied a lot of genes BEFORE the human genome was publically available.

    They have a very strong IP portfolio and paid a lot to get some very good patents (although some claims may be overly broad). They are running their company like a branded drug – we own the patent keep everyone else out. This is a diagnostic method and not a drug, a second opinion would be nice, but I am not in charge of their business model. Should Pfizer be forced to license or drop patent protection because their drug is essential or saves lives? Should all AIDS drugs be mandatorily licensed or taken off patent protection? IF you remove incentives for all life saving technologies, you will be left with all VC investment in only cosmetic surgeries. I guess that is where society is headed anyway – orange glow tans, artificial body parts, and skin tightening technologies should take off!

    I guess I’m preaching to the choir though?

  6. JV – I couldn’t agree more. This was a decision of stating that black was white to support his decisions. Some district court judges have a handle on patent issues, but even fewer have any handle at all on biotech and genomics patents, which is why the CAFC exists. Judge Sweet’s reliance on SCOTUS “precidence” was so off-base, I seriously doubt the CAFC will be swayed by them, and with the CAFC’s habit of reviewing everything de novo, I suspect that this decision will be thoroughly analysed by the Court. This decision will make some headline news and hopefully, be put to bed quickly; I hope.

    Ho-Hum – BPAI judges have far more practical experience than a lawyer fresh out of law school (evening or day), who helps in a few patent litigations and call themselves patent experts. Don’t think so lowly of them – you’ve got to get past them (and their interpretation of law and PTO practice) to even get to the courts…

  7. Eric,

    I want to compliment you for this blog post. It’s the best and most succinct take on the issue I have seen yet. Cheers!

  8. -Eric

    “because they don’t exist in nature and cannot exist without significant human intervention.”

    I have to disagree with you here. If you look at things from an evolutionary perspective, then all things are possible given time. The range of possibilities is infinite, and we happen to live in a very small slice of time where things are just the way they are. It may be that specific combination wouldn’t exist right now without human intervention, and if all life, as we know it is destroyed, it may never exist., but life is constantly changing and it has an infinite amount of space to do so, which makes all life inevitable given time and without human intervention.

    I have no doubt that your legal position is accurate, but this is more of a moral issue to me than a legal one. We need ways to encourage spending on research, but patents seem to me to be the wrong way to go when it comes to genetics and other biological methods.

    A patent isn’t worth fighting for if it isn’t going to make you money, and that means it has to be useful, so perhaps we could set up a system where useful research is directly compensated by the government, or we could increase government grants for research, or both, but letting the public sector do research and then giving them patents on it is just wrong.

    This is a similar issue to health care and we shouldn’t let the monetary interests of corporations direct the research and usage of anything that directly involves life forms. The scientists aren’t the ones laughing all the way to the bank, the shareholders are, so why can’t we cut out the middle man, save some money, keep the scientists who are doing the real work active and let this kind of progress be made available to everybody?

  9. Brian – it is good to meet up with you again from our PTO days! (hint to JV – we’re not happy with your examiner comment!)

    Pop – in a perfect world – we can all do altruisitic endeavors and all will be happy. The scientists do good work – I should know – I was a scientist in a former life – but scientists cannot bring a product to market. The cash that is needed to get the drug developed and into the hands of Physicians, will not be invested with out some assurances that the product is protected. Without patent protection, the BRCA1 gene would make some good scientific publications, but that is about it. No patient could afford any therapies based upon the scientific work because the therapies would not be available. Public funding – out of your pocket – cannot possibly provide the resources that would be needed. Public policy would dictate that the pipeline stay open. Judge Sweet’s decision would effectively cut off the pipeline to a slow trickle.

  10. POP –
    “The range of possibilities is infinite…”

    Not true, a gene sequence could not exist on it’s own because A) it would not have the proteins to maintain structure, B) it would not replicate, and C) it requires an entire organism for the DNA to exist within an entire genome. Even viruses have a series of proteins, coat proteins, equipment to initiate replication, and equipment to invade a host. Their is no evolutionary selection to generate a stand alone gene (a unique chemical entity, more unique than penecillin, aspirin, or taxol on an atom per atom basis).

    Secondly, a million monkeys with a million typewriters will eventually produce all of shakespeare’s works given enough time, therefore copyright shouldn’t exist either. It has been demonstrated over time that there are two ways to generate new products – government funded research and free market. Government funded research did not generate as many novel drugs/medical devices as the free market -hence Hatch-Waxman. Although universities and research institutes are great at very early technologies, academic research, and other more theoretical investigations, they have shown an inability to generate marketable products without patent protection and start-up companies to carry the torch between for the period between the initial discovery and a marketable product. Start-up companies typically do the majority of clinical trials to identify legitimate leads, test efficacy, determine dosage, track side effects, and complete FDA approval. This takes specialized training in the FDA process and an ability to hurdle through government red tape. Then, if promising, the drugs are typically snatched up by a major pharmaceutical with a marketing team, mass production and distribution experience. After that, generics jump on board to join in the mass production and distribution without needing additional efficacy, dosage, or side effects studies to get FDA approval. This is a complex process, not something that universities have any training, experience or funding for. Because of the current patent system, the universities are able to license their inventions and get more research dollars in the process.

    Just ask the Cancer Institute , the initial developer of BRCA1 and BRCA2 research, if they would like to take on development, FDA approval, marketing and distribution. I think they’d prefer just to receive royalties and continue their research. They don’t seem to be volunteering to license their technology or offer alternatives for the BRAC analysis, interesting, maybe they’re not interested in cancer patients health.

  11. Curious how polarizing the issue is. More curious how much self-aggrandizement it evokes!

    Joking aside, clearly intellectual property rights are crucial to maintaining discoveries in a marketable fashion. However, there is definitely a moral component here that so many patent lawyers seem apt to dismiss, attempting to justify the “no-second-opinion” quandary as mere business practice. There is obvious human suffering attached to Myriad’s business practice. The fact that there’s so much controversy attached seems an indicator that something is wrong with the way the current system is working.

    Why haven’t we seen a newly synthesized solution equitably considering both sides of this issue rather than 30-year-old regurgitated analyses or festering opinions from either side?

  12. There is something wrong with every system. there are no perfect systems. I do not dismiss the no second opinion outright, I just don’t control their business model. There are other business models that hurt people, there are other business models that help people. Who’s hurt and helped also affects the decision. The Supreme Court has said it’s OK to take homes, owned outright by the elderly, if it improves the community. In (Ohio?) homes were taken by the government and sold to an apartment development to improve the community. Fair, NO. Do I agree, NO. Can I change it, I aint no senator’s son.

    BRAC analysis is probably the most widely publicized genetic test simply because of Myriad’s advertisements. It is relevant to a select portion of the population, women who have a family history of breast cancer. Will everyone who needs a BRAC analysis get one? NO. Will everyone who learns of a propensity for cancer via BRAC analysis get a masectomy? NO. Are there other options out there? YES. No one is upset at the insurance companies, but shouldn’t they make sure their clients have access to the care they need?

    I agree, a doctor’s second opinion, especially about such a big decision is important. I agree that it is not available here, in this instance. Other genes have been under patent protection and come into the public domain without issue – insulin, etc. Why should the entire biotechnology industry be thrown around at the whim of an emotional NY judge? This case LEGALLY should have been tossed as frivolous – regardless of the MORAL issue. If you are offended by the morals of it you should push that one up to congress in a bill to modify the realm of patentable subject matter. Meanwhile, DNA patents are naturally getting narrower as the field matures. In this instance, if allowed to stand, one judge and one group of people have decided the morals for a nation based on the flawed business practices of 1 business. Leaving the rest of us with a shattered biotech industry in a time of economic turmoil.

    How many biotechs lost value today? How many are going to survive? Are the best, latest, greatest innovations going to be the ones knocked off by this soapbox grandstanding? I’m Judge Sweet, look at me, the CAFC is going to review my case and remand it telling me I don’t understand patent law, but my daughter will be so proud of me because I gave those Myriad bullies a black eye.

  13. Secondly, a million monkeys with a million typewriters will eventually produce all of Shakespeare’s works given enough time, …

    MM,

    Interesting that you should assert the above.
    Did you come up with that line as an original work of creativity on your own or are you merely mimicking the behavior of others around you?

    Why did you not vary it a little bit by saying for example:

    Secondly, a million PARROTS with a million typewriters will eventually produce all of Shakespeare’s works given enough time, …

    But of course, as we know, parrots parrot each other. Or so we are told and believe. So once a first parrot pecks out some nonsense on his typewriter all the other parrots will plagiarize and peck out essentially the same thing. It might not be 10^6 years till they reproduce the works of Shakespeare. It may be never. Because they are all just plagiarizing each other’s nonsense.

    We have all of course heard the saying:

    Monkey see, monkey do.

    Shakespeare would recognize this latter saying as merely a rose by another name but smelling out the same idea of parrots parroting each other. Mimicry is a basic hard-wiring in mammalian and other brains. Even small brained fish mimic one another. They call it being in school (swimming as a school).

    Human beings are not far removed from monkeys and parrots and schools of fish. Humans mimic each other all the time. (Some even make a good living impersonating others.)

    All this brings us full circle to the notion that originality and clear vision are not all that common in human beings and many of us merely parrot the words of others without questioning them or truly understanding all their implications.

    You said, in parroting mode: “a million monkeys with a million typewriters will eventually produce”. I said , No. It will never happen because none of the monkeys is Shakespeare and all of the monkeys are copy parrots (what? did you expect me to say copy cats? how about copy cougars? a cougar is a form of cat. )

    Judge Sweet appears to be yet another parrot cat. He pays great homage for appeal to authority in the first 100 pages of his lengthy dissertation and then parrots the position of one side in the dispute while giving no weight or understanding to the opposed view. In this, I don’t mean to say that Judge Sweet is evil or ignorant or something else along that line. It appears that he has done a commendable job as a lay person trying to come to grasp with some complicated scientific ideas. In the end he gets it all wrong. But hey, don’t blame him, blame all the monkeys he is copying from.

    At the same time, why is everyone here blaming the patent system? Are you just copying each other?

    The patent system didn’t make Myriad opt for the business model they chose.
    Blaming the patent system is like blaming firearm technology for the fact that someone acquired a firearm and then chose to use it in a manner that others might consider immoral. If you want to say that Myriad “abused” its patent rights, then say that and prove it. But saying that all gene patents are invalid because we don’t understand basic chemistry is indeed inane.

    (An BTW, relax. No one said all of Gene’s patents are invalid. That’s a toucan of a different color.)

  14. “However, there is definitely a moral component here that so many patent lawyers seem apt to dismiss”

    Rich,

    I’m a patent attorney and I’m definitely not dismissing the moral component here. I’m certainly not going to say that Myriad hasn’t created a PR issue with their approach to marketing the BRCA1 and BRCA2 gene sequence technology. In fact, many drug companies are quite sensitive to the PR impact of the affordability of the drugs they market, and even note prominently in their ads how those who are struggling to pay for those drugs can get help.

    But what the ACLU and Judge Sweet have done here amounts to negating somebody’s property rights (which is what patents are) by “judicial fiat.” That’s especially true as the Becerra bill, which would have achieved the result that the ACLU and Judge Sweet desired was never enacted. Instead, the ACLU, as well as Judge Sweet, have grossly distorted and misrepresented the applicable patent law precedent, as well as what the Myriad’s patents actually cover. Doing that because they consider those property rights to be “immoral” is a very slippery slope, and not one I’m going to stand by and let pass.

    Mike’s reference to the Kelo v City of New London case is a horrible example of SCOTUS exerting such an improper “judicial fiat” mentality. And what’s trully ironic is that the City of New London who pushed for this “emminent domain” nonsense (that has now turned our 5th Amendment on it’s head) is out of pocket $78 million. Why? Because Pfizer (for whom this “emminent domain” nonsense was pushed) decided not to move some of its operation to New London. Yes, there are consequences to relying upon “judicial fiat.”

    One thing I can tell is that it is almost guaranteed that the Federal Circuit will trounce Sweet’s decision. If they don’t, the impact of Sweet’s decision will be grave indeed on the development of future biologic drugs, mediical diagnostics, etc., and eveny more serioulsy, American business growth and job creation. Companies, especially American small businesses, are not going to invest in high cost, uncertain technology (which biotech is) which is unprotectable to the extent that the ROI is unsustainable. In fact, it would be ironic if future development of medical diagnostics like those developed completely dried up because no one is willing to invest the money because it’s too much for too great a risk for the ROI.

    Again, I’m not saying that we shouldn’t address the moral impact of these property rights. But letting that be done by the “judicial fiat” of one judge is the worst way to do it. Instead, this is and should be a public policy decision that is best left to the legislative branch.

  15. “However, there is definitely a moral component here that so many patent lawyers seem apt to dismiss”

    Rich, I would beg to differ – I think most patent lawyers will point out that since patents promote the inventions and discoveries in the first place, that it is those who are anti-patent that dismiss the moral component. The fact of the matter is that without the patent system, especially in the bio and pharma arenas, mankind would be far, far worse off.

  16. “hint to JV – we’re not happy with your examiner comment!”

    What do you call someone who relies upon made up evidence, findings of fact made for the first time, findings not based upon substantial evidence, twisted distortion of the law? The answer is “an Examiner.” When it happens at the BPAI, you get glorified examiners.

    I’ve personally known a few former BPAI APJs in my time. Some extremely talented people. However, the new hires they put in place since around 2005 have … what I could call … Dudasitis. It is an affliction whereby all patents are considered evil and if you can twist the law and/or fact to reject an application, then it is your duty to do so. This affliction of Dudasitis has reached epidemic portion in the 3600 group where attempting to allow more than 3 patents in a 24 month period can be considered grounds for dismissal.

    It is bad enough that the BPAI mangles the law and/or the facts. What is even worse is that certain APJs just want to re-examine the application — like back when they were an Examiner. They make findings of fact that are not on the record and proceed to reject the claims on these new findings of fact. Also, heaven-forbid that actually label any of these new findings as new grounds of rejection. I had one case in which the BPAI agreed with me that the Examiner screwed up on both the facts and the obviousness analysis. However, examiner error was not establish and the application was affirmed. WTF is that?

    I have one case where the BPAI screwed up on one of the most basic concepts of patent law. After the BPAI’s Decision, we ultimately filed a RCE and presented evidence that the Examiner’s and BPAI’s inferences were royally in error. Anyway, it looks like we’ll have that rejection withdrawn. Several years later and the claims have yet to be amended, and I’m getting a new office action — priceless. After I retire, this particular case will be the first one I will point to as example of the BPAI’s incompetence — or at least the incompetence of the BPAI to thoroughly screen new APJs for knowledge of patent law.

  17. To all:

    One thing I should clarify in the piece I wrote is that the Myriad patents weren’t invalidated in their entirety, only the 15 claims that the plaintiffs put in issue in the suit. Stil enough to make Sweet’s ruling ghastly.