By Kevin E. Noonan --
Biotech has met its Benson in the Court's Prometheus decision. Before considering what can be done, it is prudent to consider the implications of this decision (and the previous decade of Supreme Court decisions on patent law).
It is now clear that the only patent law that matters is Supreme Court law. In decision after decision, the Court has chosen to ignore thirty years of Federal Circuit precedent in favor of its decisions from thirty, sixty, or over a hundred years ago. Despite sentiments (dicta, to be accurate) from Bilski v. Kappos regarding the dangers of imposing horse-and-buggy thinking about technology to the 21st Century, the Court seems happy to do so.
This creates problems for American innovation because of the increased complexity of modern technology compared to those halcyon days of plows and cotton gins. Those devices needed patent protection because they were easily reverse-engineered and thus could be freely copied without the ability to stop the copyist without a patent. Today's inventions, particularly in the biotechnology sphere, are often the opposite -- harder to reverse engineer, and capable, with a modicum of effort, of being made more so.
The reason that, by and large, the efforts necessary to rely less on patent protection have not been made are many-fold, but relate in large part to the fruitful cooperation between academic science and biotech startups that for a generation has transferred technology created in universities into useful (and profitable) products. These have included true "wonder drugs" such as human growth hormone, interferon, and insulin, as well as a wealth of research tools that have made it possible to perform screening of small molecule drugs much more easily, cheaply, and humanely. And in the process, the money American taxpayers have contributed to university research has been recompensed by licensing fees (and commercially available drugs), rather than providing no return on that investment following the disclosure of such research in scientific publications that academic scientists rightly still believe are their principle stock in trade.
But the current spate of Supreme Court decisions has threatened this balance, because in almost every case the Court has seen fit either to make continued viability of various categories and types of patents uncertain (reversing a generation of efforts by the Federal Circuit to increase certainty in patent law, pursuant to Congressional mandate) or to "upset the settled expectations" of patent holders. Under these circumstances, investors can be expected to be less ready to choose already risky biotechnology inventions, where return on investment of even a successful product may be vitiated by the next decision of the Court.
The current trend is also bad for the Federal Circuit, whose jurisprudence is threatened to be relevant only at the margins. The Federal Circuit did yeoman's work in harmonizing U.S. patent law from the patchwork of regional circuit differences into a (relatively) cohesive whole, with increasing business certainty the explicit goal. As a consequence, the first 15 years of the CAFC's existence saw a large increase in technology-driven companies in America, from Genentech, Amgen, Genzyme, and Biogen in biotechnology to Cisco, Intel, Microsoft, and Apple in the electronics arena. While these different industries relied to different extents on patent protection, the availability of patents to protect innovation had a beneficial effect on technological innovation in this country unmatched in the centuries before.
Another entity with diminished effects on patent policy is the Administration (or, perhaps, just this Administration), where for the second time in less than a year, the Supreme Court expressly disregarded the views of the Solicitor General in rendering its decision. While the earlier instance, in Stanford v. Roche, may have been credited to the subject matter (statutory interpretation of the Bayh-Dole Act) and the involvement of the government in being the presumptive assignee of Federally funded research (and thus less of a disinterested party), here the Court expressly rejected the considered views of the Executive, presumably informed by the experience of the U.S. Patent and Trademark Office. While it is easy to appreciate why the government would prefer to utilize other sections of the patent statute to assess claims like the ones in Prometheus, the Court's decision has made it more difficult to administer the patent laws fairly and even-handedly, in view of the "we know what's patentable when we see it" nature of this and several other of the Court's decisions.
It is also clear that the Court has little time for the specifics of patent law generally, not surprising from a Court who characterized obviousness law as "gobbledygook" not so many years ago. The problem with this approach, and the "totality of the circumstances" approach in general, is that it makes patent law even more uncertain in all respects: from the increased likelihood of the variable application of patentability standards during patent prosecution to the likelihood that a judge or jury will be able to impose their own subjective beliefs on whether something should or should not be protected by patent.
In an interesting departure from its recent denigration of the efforts of the legal academy, the Court also signaled its willingness to credit their theories of what drives and sustains innovation against the arguments, based on actual experience, from groups and individuals who have created companies and been involved in innovation in the biotechnology industry. And the Court seems equally ready to be influenced by the consumers of innovation, such as amicus the American Medical Association, who understandably wish to have the maximum freedom to have their patients benefit from new technology (and the minimum interference from patent holders who would reduce their opportunities to profit therefrom).
Finally, the true villians of the decision are clearly patent drafters, whose efforts the Court expressly held out for disdain if not contempt; its precedent "warn[s] us against interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws].'" This analytical principle is in direct conflict with the patent statute, of course, which requires claims that set forth the "metes and bounds" of the invention and indeed are the legal description of the patent grant. Not to be bothered with these niceties, the Court is more than happy to impose its own (and by extension, any judge, jury or patent examiner's) subjective understanding of the underlying "principles" at stake in assessing whether a technology should be patented. But the reality is that claims will (by statute and practical necessity) define whatever scope of patent protection may remain available, and suggests that only by accepting the Court's challenge can patent claim drafters minimize the negative impact of this and other decisions of the Court. Suggestions on how that may be done will be in another post.
Well stated, Kevin. You noted in a post earlier this year that in circumstances where it's hard to reverse engineer a biotech drug, biotech companies may prefer to forego patent protection; it seems to me Prometheus has increased several-fold the incentive to retain as much information as possible about such drugs as proprietary.
Posted by: Dan Feigelson | March 23, 2012 at 02:56 AM
" And in the process, the money American taxpayers have contributed to university research has been recompensed by licensing fees (and commercially available drugs), rather than providing no return on that investment following the disclosure of such research in scientific publications that academic scientists rightly still believe are their principle stock in trade."
I'm a little bit confused, how are the dollars that the taxpayers pay for uni research being recompensed by licensing? That money hardly goes to things that the taxpayers pay for at the uni other than perhaps yet more research so far as I've heard. If you know differently please, do tell us all about how many kids are now going to school on the dime of these licenses or how the school has a new building because of these licenses.
So far as I hear, they blow that cash on sht totally unrelated to actually teaching. And frankly, if they didn't then I might be more amenable to the whole idea.
"(reversing a generation of efforts by the Federal Circuit to increase certainty in patent law, pursuant to Congressional mandate)"
Well if you consider affirming validity at pretty much any cost "increasing certainty" then I suppose...
"Under these circumstances, investors can be expected to be less ready to choose already risky biotechnology inventions, where return on investment of even a successful product may be vitiated by the next decision of the Court."
Meh, my generation needs better mechanisms to reward inventors anyway. Let's be honest, patents are so last century. They're probably the worst possible way that could possibly be imagined, by the stupi dest person in the world, to spur disclosure of inventions in our current era. Just to be honest right? The only thing that it has going for it is that it masks the costs in "the market" and so keeps that cost hidden from the general population.
"likelihood that a judge or jury will be able to impose their own subjective "
Don't forget examiners! :)
Kev, I have to say, all in all it looked like you were half repentant for your evil deeds in this here post. But then, right at the end, you seemed to fall back to your old scofflaw ways asserting that the court has in some way challenged, rather than simply chastised, the patent drafters ever trying to circumvent their caselaw designed specifically, indeed flexibly, to deal with exactly such behavior. The court made no challenge. The court simply noted with disdain that you patent attorneys deviated from the true way and noted that they had to set you back on the true path.
Also, there is a super lot of almost qq in your post but not a lot of explanation of how and why the bar became scofflaws in the first place in this arena. Perhaps you could give us all a history lesson about why the bar suddenly got selective amnesia about the caselaw that is supposedly binding upon everyone in this nation, and certainly the appeals courts.
Posted by: 6 | March 23, 2012 at 03:08 AM
the Court has seen fit either to make continued viability of various categories and types of patents uncertain (reversing a generation of efforts by the Federal Circuit to increase certainty in patent law, pursuant to Congressional mandate).
Underlying (and perhaps in need of its own focused article) is the schism that Congress engendered with the mandate to a lower court and what the third branch may view as to exactly who owns ANY final judicial view.
Posted by: Skeptical | March 23, 2012 at 07:15 AM
What empiric support do you have for your assertion about reimbursement of taxpayers?
(" And in the process, the money American taxpayers have contributed to university research has been recompensed by licensing fees (and commercially available drugs), rather than providing no return on that investment following the disclosure of such research in scientific publications that academic scientists rightly still believe are their principle stock in trade.")
Posted by: Kirk Hartley | March 23, 2012 at 07:26 AM
Welcome back, 6. I'll try to enlighten you.
Next time you want to go out of town, visit my graduate alma mater, Princeton, and have a tour around their new, state-of-the-art chemistry building, paid for by the royalties the university obtained from a successful drug developed by its researchers. That is but one example of how the public benefits from Bayh-Dole; on your trip north maybe you could visit Jon Solderstrom at Yale who is much more informed about this that I am.
Not sure what brave new world your generation is thinking of - perhaps you should give yourselves some time to achieve something before you start patting yourself on the back. Not a criticism - just not enough time to know if you will be able to change the world. It's tougher to do than it looks.
Trust me, I didn't forget examiners. But I do think the Court underestimates the ability to craft legal documents to achieve legitimate ends no matter what obstacles may arise. It may not be as efficient, but it will get done.
Finally, no qq here - this is just part of the patent-lawyers-full-employment act. Bad for the country, though.
I do agree with one thing you said - we got a little complacent about the Court leaving the Federal Circuit alone for more than a decade. I have no gripe with oversight - I just wish it was better informed oversight.
Thanks for the comment.
Posted by: Kevin E. Noonan | March 23, 2012 at 07:39 AM
Kevin, 6 makes a very good point. We did this to ourselves. I have asked you before about when the biomarker correlation patent rush started. I contend that this is a pretty modern phenomenon. You can always go back and find an old patent here or there seeking to claim the correlation, but by and large, this started less than 20 years ago. Now we're all up in arms, saying that SCOTUS is completely out of touch. Really? The decision provides perfect guidance going forward: don't try to prevent others from all uses of a fact by dressing your claim up as a process with steps that are incidental. Does the existence in a human body of thiopurine metabolites occur without first administering thiopurine? Of course not. But it's incidental to what you're really trying to prevent. In order to figure out whether to adjust dosage, you have to determine the metabolite levels. Again, so what? Using thiopurines to treat immune-mediated GI disorders was known, as was the fact that thiopurines have side effects, as was the fact that people metabolize drugs differently, as was at least one way of determining metabolite levels. This decision was perfect.
Posted by: Gary Johnston | March 23, 2012 at 08:11 AM
Well said, Kevin. I would also point out the inexplicable comment that the Court "decline[s] the Government's invitation to substitute 102 , 103 and 112 inquiries for the better established inquiry of 101." !!!!! And, yes, no matter what they say, it does all come down to claim drafting.
Posted by: Courtenay Brinckerhoff | March 23, 2012 at 08:11 AM
Kevin,
Very astute analysis. The only qualification I would make to your statement “that the only patent law that matters is Supreme Court law” is that it’s the only legal precedent that matters in our nook of the law to SCOTUS. Unfortunately, as the “court of last” resort, these 9 technologically-challenged and patent law-ignorant Justices are literally exerting “veto power” over 30 years of Federal Circuit precedent which, as you correctly point, was intended by Congress to be the arbiter of patent law jurisprudence.
As you also astutely point out, SCOTUS is even ignoring a very cogent suggestion from the U.S. Solicitor General (one I, Michael Risch, Chief Judge Rader, and many others agree with is the better approach) that it might be a better approach to look at the other patent statutes (i.e., 35 U.S.C. §§ 102, 103, and especially § 112) before jumping into the patent-eligibility “quagmire” of 35 U.S.C. § 101. So much for listening to the thoughtful advice of others. Instead, SCOTUS deliberately chooses to be “deaf, dumb, and blind” to those who know much more about patent law then they do.
What is really sad is that SCOTUS let the Federal Circuit do the role it was mandated by Congress to do up until around 2006 or 2007 (startign with the eBay and KSR International cases). Instead, what we have now with this almost endless “vetoing” of Federal Circuit patent law decision is, in effect, “patent law despotism” being exerted by SCOTUS. If you won’t accept the jurisprudence of the court designated by Congress to be the prime arbiter of patent law, if you won’t listen to the Executive Branch (i.e., the U.S. Solicitor General) about what might be better approach to resolving patent claim validity, if you simply render decisions as if the patent statutes enacted by Congress don’t exist, then what else, pray tell, do we have? That’s why I’ve got very little respect for the current SCOTUS, and why their credibility with me on patent law doctrine is almost nonexistent, other than I’ve got to deal with it somehow so patent protection for my client’s innovation doesn’t simply get “flushed down” SCOTUS’ patent law “toilet.”
In fact, the current SCOTUS brings back some very unpleasant memories from the 1970’s (i.e., the era of Gottschalk v. Benson and Parker v. Flook). Frankly, I haven’t seen a SCOTUS as “patent hostile” as this one is (and Justice Breyer is now the “new” Justice Douglas in terms of “patent hostility”) since that time. (I also know those who are “cheering” Breyer’s opinion will suggest I’m going “overboard” but I’m not.) Fortunately, back in the 1970’s, Congress realized that this “hostile” patent law jurisprudence was having a damaging impact on promoting and encouraging American innovation, thus the creation of the Federal Circuit in 1982. Unfortunately for us now, Congress, as expressed in the AIA (the Abominable Inane Act) is starting to become as “patent hostile” as the current SCOTUS.
Frankly, the only hope we likely have to overcome this “patent law despotism” by SCOTUS is how resistant the current Federal Circuit is to being “vetoed” on patent law jurisprudence. Given what I’ve seen the Chief Judge say recently, I’m hopeful that Rader will lead to the charge to try to “cabin” decisions like Mayo Collaborative Services to lessen their illogical impact and avoid significant “collateral damage” to patent law jurisprudence. In other words, the Federal Circuit needs to engage in a “battle of attrition” to wear down this “patent law despotism” by SCOTUS, and thus render some “balance” and “logical sense” in patent law jurisprudence authored by a court (the Federal Circuit) that was mandated by Congress to do so and which knows (exponentially) more about patent law then does 9 technologically-challenged and patent law-ignorant Justices.
The Federal Circuit can also win such a “battle of attrition.” The late Chief Judge Markey did so back in the 1980’s when he first led the Federal Circuit to “cabin” some of the more atrocious and illogical SCOTUS patent law decisions authored at least as far back as the 1950s. The fact is, SCOTUS can’t take every single patent law decision by the Federal Circuit that they might disagree with. I also know this sounds “Machiavellian” to suggest the Federal Circuit could (and should do) this. But with SCOTUS exerting such unprincipled “patent law despotism,” we’re also now in a “battle for survival” to make sure our patent law jurisprudence is based on a logical, rational, and balanced, and especially an informed (not deliberately ignorant) interpretation of our patent statutes and case law precedent.
Posted by: EG | March 23, 2012 at 09:15 AM
Well, Gary, perfect appears to be in the eye of the beholder, too.
I have less difficulty with the outcome than with the uncertain scope of this decision, and the potential for mischief it may occasion.
It will depend on the extent to which "laws of nature/ natural phenomena" rationale for patent ineligibility is stretched.
Thanks for the comment
Posted by: Kevin E. Noonan | March 23, 2012 at 09:25 AM
Surely it's a message when the vote is 9-0 and yet the commentary in patent law circles is that SCOTUS simply does not understand. My guess is the justices understand all too well, but are stepping back and looking at IP as a means to an end rather than the end itself, and that's the difference between their views and the consensus among the patent bar.
I find the series of cases that have gone to the Supreme Court illuminating in a way you allude to, but don't fully engage in your blog.
The unification and consistency you allude to was mainly strengthening exclusive rights and expanding their scope. CAFC reversed the odds of losing patent rights on appeal; CAFC was more patent-friendly.
One way to view the half decade of Supreme Court re-entry into patent law is as a reaction to that process, particlarly when, as in Prometheus, it begins to intrude on other domains like medical care.
There is a mischaracterization of motivation of AMA and other health organizations in your post as being against profiting from IP. That's simply wrong.
This is much more about control of care than caviling against capitalism. The objections to exclusivity come from how it is used: over-reach using patents as the forcing tools. If McGill had nonexclusively licensed this Dx patent, or if Myriad had allowed out-licensing of its patents, neither Prometheus nor AMP v USPTO would have been litigated. It is the underlying business models that elicit the backlash, when they unsettled practices by enforcing IP. There are many uncontroversial cases where patents do not cause backlash, when the business models comport better with settled *medical* practice. But the strengthening and expansion of IP you note, increasingly settled law developed in the 80s and 90s, then unsettled medical practices; no surprise there is push-back.
McGill exclusively licensed to a company that then sublicensed to nonprofit Mayo. When the nonprofit then changed technology, Prometheus (and McGill) wanted to continue to extract rents based on very broad method claims. Mayo has a very systematic vetting process for IP--the most systematic we have come across in studying this area--and they respect patents. But these particular claims seemed too broad and were getting in the way of optimal medical practice. Mayo made a decision to fight back. And they won.
But the fight was not about patents in general, but these particular claims, and the business model that was enforcing them.
This *is* obviously partly about patent law, but it's also about how patents are used in pratice. There really is a lesson here for claims drafters that very broad claims won't survive. That's almost surely good for diagnostic practice, where it would not necessarily be so good for therapeutics. My guess is court systems can figure out that difference.
And there's a lesson for patent-holders, esp. universities--that exclusive licensing of diagnostics elicits push-back. Under point 2 of the AUTM-endorsed "Nine Points," why exclusively license it? Exclusivity would make sense if needed to get a test on the market or to make the initial discovery. The fact that Mayo developed and used an alternative test argues against needing exclusivity for development; the fact the metabolite-Rx associatoin was initially discovered at a university suggests exclusivity is not what drove discovery. The arguments for the social value of exclusivity *in this particular case* are weak.
All that said, while I like the outcome, I'm not sure I completely understand Justice Breyer's logic. He very clearly sees value in using 101 "patentable subject matter" and does not buy the argument that 102, 103, 101-utility, and 112 could reach the same ends with greater clarity and precision. But I don't quite understand why, even after reading those sections a couple times.
We do, however, at least now have a solution to the riddle "what did Justice Breyer mean when he said 'You're getting warm' in oral arguments."
Posted by: Robert Cook-Deegan | March 23, 2012 at 12:50 PM
Kevin, excellent analysis, and as well a number of the comments here.
This debate brings back fond memories of Prof. Irving Kayton at GW Law School back in 1970 getting all red in the face ranting about the state of patents in the Federal Judiciary, particularly SCOTUS and his bete noire Justice William O Douglas. Indeed, Kayton was right. Douglas was an ideologue from the trenches of antitrust who just didn't get it. I smile now whenever I use a pencil with an eraser on the end, thinking of Douglas' denigration of this wonderful invention as merely a trivial combination of old elements.
Is there a patent Kondratiev Wave, where judicial acceptance of patent law is now ebbing back into the Douglas swamp from which the Fed. Cir. and Congress rescued it 40 years ago?
Maybe we have our own talents to blame. We've just been damn good at getting every possible thing patented, and the more success we had the more oxes we gored (business methods, surgical techniques, etc.). The inevitable push-back is occurring, and now bears fruit at SCOTUS.
The really interesting question is what exactly provoked all this around 2007? A SCOTUS clerk, someone at a cocktail party, someone in Congress? Somehow SCOTUS got all stirred up, and I'd be curious to know what provoked this deflection in the patent wave.
Posted by: max hensley | March 23, 2012 at 03:41 PM
Dear Bob:
I don't think the Supreme Court doesn't understand; I don't think they care. I think attitude is the law is what they say it is, and that's pretty much that.
We can argue about Prometheus and Myriad being poster children for bad patent behavior, but your comment illustrates the problem: white coats shouldn't equal a free pass for patent infringement. These claims may be bad and they may need to be invalidated. But the worry is that the Court has constructed a bright line test and then provided nothing other than a subjective assessment of whether a claim preempts a law of nature. Not very helpful.
As for the 9-0, Justuice Breyer is passionate about this issue and none of the other Justices have any skin in this game. I am disappointed that Justice Kagen did not dissent along the lines of "The Court should give more weight to the views of the government, charged with administering patent law." Wouldn't have changed the outcome, but would have provided some perspective.
Thanks for the comment.
Posted by: Kevin E. Noonan | March 23, 2012 at 04:15 PM
"I'm not sure I completely understand Justice Breyer's logic. He very clearly sees value in using 101 "patentable subject matter" and does not buy the argument that 102, 103, 101-utility, and 112 could reach the same ends with greater clarity and precision."
That's a major problem with Breyer's opinion What Breyer’s opinion does is try to determine the “patent-eligibility” question under 35 U.S.C. § 101 in a vacuum, divorced from any consideration of the other relevant patent statutes such as 35 U.S.C. § 102, and especially 35 U.S.C. §§ 112 and 103. That’s what Breyer’s opinion essentially does when he dismisses the approach suggested by the U.S. Solicitor General which I, Michael Risch, Chief Judge Rader, and many others believe is the only way you can make rational, logical, and objective determinations what is or is not “patent-eligible” under 35 U.S.C. § 101. That’s also why the Flook case that Breyer’s opinion so heavily relies upon for precedential support is so logically flawed: (1) it forces you to treat previously unknown “laws” (or relationships) as if they’re part of the prior art; (2) it dissects the claim language to try to separate out the supposed “law of nature” from the rest of the claim context. When you do either of these techniques with the claim, you do so in contravention of what 35 U.S.C. § 103 explicitly says (especially that the claimed invention should be considered “as a whole”), as well as what is implicit in 35 U.S.C. § 112, second paragraph (that claim defines what the invention is). Unless you’re willingly to address the claimed invention in the context of all of the relevant patent statutes (which Breyer and his 8 cohorts appear to be unwilling to do), determinations of patent-eligibility under 35 U.S.C. § 101 are no more objectively based than using a Ouji board.
I frankly find the whole “law of nature” reference in Breyer’s opinion to be completely inappropriate for evaluating Prometheus’ claimed method. We’re not talking about Einstein’s “theory of relativity” or Newton’s discovery of the “law of gravity.” Instead, we’re talking about administering a specific man-made (thiopurine) drug, measuring the levels of measured metabolites (which only humans can do, even if they use instruments), and evaluating the measured level metabolites to decide whether the drug dosage needs to be adjusted because it’s too high or too low. You may fault how Prometheus’ drug dosage calibration method was claimed (the “draftsman’s art” as Breyer calls it). But doing so on the basis of this claimed method being essentially nothing more than a “law nature” in the guise of “routine, conventional activity” is totally unpersuasive and illogical reasoning to me.
In fact, and without getting into whether Prometheus’ claimed method is patentable under 35 U.S.C. §§ 102/103 of which the U.S. Solicitor General raises some reasonable “doubts,” this claimed method is highly vunerable under 35 USC 112, 2nd paragraph, as not “particularly pointing and distinctly claiming” what the invention is. Prometheus’ mehod, as claimed, is analogous to what we used to call improperly describing a machine as “so many elements in box,” but not saying how those elements are connected and/or function together. Admittedly, the crux of what is unique (if anything) in Prometheus’ claimed method is the specifically identified ranges in the “wherein clauses” telling you whether the drug dosage is too high or too low, but those specific ranges are simply a “theoretical” exercise unless you do something with those ranges based on measuring the actual level of metabolites. I would be perfectly fine with describing Prometheus’ method, as claimed, as being too “abstract” under 35 USC 101 in view of Bilski, or incorrectly described in view of 35 U.S.C. § 112, 2nd paragraph.
Instead, Breyer's opinion drops the equivalent of an atomic bomb on Prometheus's method because he and his 8 cohorts are too patent law ignorant (and frankly too arrogant) to use the "smart" bomb that U.S. Solicitor General and others suggested (i.e.,consider 35 U.S.C. §§ 102, 103, and especially 112 first before diving into the 35 35 U.S.C. § 101 "quagmire"). Not only does Breyer's opinion use the wrong weapon to invalidate Prometheus' claimed method, but it also causes, as Kevin has correctly pointed out, severe and unnecessary "collateral damage" to IP protection for other analytical and diagnostic methods. Even worse, Breyer's opinion is so full of logical inconsistencies and conflicting statements that all we know is that Prometheus' claimed method didn't make the grade; we "mere mortals" are left absolutely clueless by Breyer's opinion as to how to determine what analytical and diagnostic methods will reach the patent-eligbility zone. SCOTUS has done this over and over again, starting with KSR International, then Bilski, and now Mayo Collaborative Services. That's why I currently have no respect for the current SCOTUS in our nook of the law, and what the say has no credibility with me beyond needing to figure out how to advise my clients what they need to do to avoid the next "thunderbolt' to be hurled from our Judicial Mount Olympus. And I'm not alone in that view.
Posted by: EG | March 23, 2012 at 04:39 PM
EG,
Have you ever seen the movie, "Idiocracy"?
Well, on March 20, 2012 when I popped open the Mayo v. Prometheus decision I realized we were already there.
The Justices of the US Supreme Court are supposed to be some of the brightest minds our country can produce. And this is their Magnum opus (*)
** See http://en.wikipedia.org/wiki/Magnum_opus
Posted by: step back | March 24, 2012 at 05:05 AM
Hi Kevin,
Great analysis. Despite angry protestation by some, maybe the effects of Prometheus on the biotech industry may not be that fatal or even profound. This reminds of KSR, when there was such big uproar. Yet the industry adjusted. Surely, Prometheus creates some uncertainty for diagnostic method claims, but at least it is certain that merely correlating or relating does not make patentable subject matter. I believe Prometheus claims were bad claims to begin with, and its application as precedent likely will involve consideration of the facts as a whole.
Posted by: Baltazar | March 24, 2012 at 07:22 AM
Max,
You're correct about Justice Douglas being the bete noire when I first entered patent practice back in the 1970's. The new one is Justice Breyer. You could see this coming with his LabCorp dissent and with this case, Breyer has now gotten his wish and has gotten his 8 cohorts to buy into his nonsenscial bilge. That's why I've got no respect for this current SCOTUS.
How this nonsense will play out in the USPTO and whether you'll see some "blowback" from the Federal Circuit will be interesting watch. Fortunately for me, I'm 60, so if this situation goes completely south, I can hang up my IP spikes and not need to continually bang my head against this SCOTUS "patent law despotism" wall.
Posted by: EG | March 24, 2012 at 10:10 AM
"and its application as precedent likely will involve consideration of the facts as a whole."
Baltazar, I am not certain why you feel this particular piece of jurisprudence will survive the trampling as opposed to any other piece of jurisprudence that was trampled in the Prometheus "Magnum opus."
Posted by: Skeptical | March 24, 2012 at 12:14 PM
Kevin Noonan: "These claims may be bad and they may need to be invalidated."
The claims are ineligible under 101, Kevin, because they effectively prevent otherwise non-infringing actors from thinking about (patent-ineligible) facts. I can think of only one reason why a person with your alleged credentials would have difficulty understanding and admitting this.
Posted by: Keeping it Real | March 24, 2012 at 12:44 PM
Real, you got it. Having to go back to clients and tell them that the piles of money they spent on pursuing patents like this will not be pleasant. Few, if any, clients would have ever dreamed of pursuing this stuff on their own. They were told to do it by their patent attorneys, who cared only about getting paid. Now the same patent attorneys are going to have to explain how the highest court in the land slapped them down 9-0. How, by saying that the Court was out of touch? That it used flawed reasoning? That it doesn't understand patent law? That should go over REALLY well. This wasn't Citizens United, or Bush v. Gore, or Bakke, or Lawrence, or Roe v. Wade. This was 9 to freaking 0! These patent attorneys will not face any professional negligence actions, since that requires deviation from the accepted standard of care, and everybody was doing this. But their wallets are going to get smaller, and I am most definitely pleased by that. The suggestion by EG that the CAFC will simply ignore the Supremes is quite amusing. As rogue as it had become over the years, the CAFC will not ignore 9-0. Second, the issue won't make it to the CAFC anymore because nobody will bother to try to get these kinds of patents anymore, and those that do hold issued patents like these will not assert them. This is why it is probably the best decision in the history of patent law.
Posted by: Gary Johnston | March 24, 2012 at 03:08 PM
Kevin,
You are wrong to suggest that the Myriad case would not have happened if Myriad had only been willing to outlicense its patents. Myriad WAS willing to grant licenses, as is clear from the litigation record. Its just that no one wanted the license...they wanted to practice the invention for free.
Posted by: Gronk | March 24, 2012 at 07:32 PM
GJ,
I sure do hope you're not an attorney (you sure don't sound like one) because, if you are, I'm very offended by your unnecessary and uncalled for ad hominem attack on us patent attorneys. I could ascribe equally impure "motives" to those supporting to your position, but I won't. You're free to debate the issue and disagree with my views, but please don't ascribe improper motives to what we patent attorneys do to represent our clients.
I also didn't say that the Federal Circuit should "ignore" Breyer's opinion in Mayo Collaborative Services; they can't and they won't. But if you think Chief Judge Rader and the rest of his Federal Circuit colleagues are simply going to "capitulate" to such logically and legally flawed reasoning, you frankly don't understand what the Federal Circuit has alreadly been doing with KSR International, as well as Bilski. The Federal Circuit will continue to retard, minimize and control the impact of such nonsensical decisions from SCOTUS. In fact, they did it before under the late Chief Judge Markey who cabined in the 1980's some of the more attrocious and nonsensical SCOTUS precedent.
If the Federal Circuit doesn't resist, then, as Kevin suggests, the Federal Circuit's role as the arbiter of patent law jurisprudence will be marginalized. Rader isn't going to stand for that, given the mandate that was handed to the Federal Circuit by Congress back in 1982 when it wa created. And as I point out, the Federal Circuit can win any such "battle of attrition" with SCOTUS (and did under Markey's watch). I repeat: SCOTUS simply hasn't got the time (or energy) to take on every single patent decision from the Federal Circuit they disagree.
You continue to "crow" about this being a 9-0 decision, but you should have listened to what Kevin said. Breyer is the only one who really has any "skin" in this decision, given he's the only remaining dissenter from LabCorp v. Metabolite. The other Justices simply don't have that big a stake in what Breyer's opinion says. Also, that 9 technologically-challenged Justices reached a unanimous decision based on nonsensical, as well as logically and legally-flawed reasoning, does not impress me, or persuade me. Just accept that and move on.
As far your comment that "nobody will bother to try to get these kinds of patents anymore," if you think us patent attorneys won't test the limits of Mayo Collaborative Services, I've got news for you: not only will we test those limits, but we've got a professional obligation to do so to protect the IP rights of our clients. We've done it in the past and we'll continue to do so in the future. Like the Federal Circuit, we're not going to "capitulate" to such logically and legally flawed reasoning as expressed in Breyer's opinion. We also survived such "patent law despotism" in the 1970's (I was there when it happened), and we'll survive it again now.
Posted by: EG | March 26, 2012 at 09:44 AM
Dear Gronk:
I'm sorry if I implied Myriad was at fault; I intended to say that their (justifiable) stance in defending their IP made it easy for them to be the target of the ACLU.
And there are a few things (like second opinion testing) where they could have responded differently that would have taken some of the wind out of their opponents' sails.
But no criticism - I don't know enough to criticize (and my wife's OB/GYN says they are a great company).
Thanks for the comment.
Posted by: Kevin E. Noonan | March 26, 2012 at 05:26 PM
Dear Real:
You may be right, but the Court did not strike down the claims because they prevented thinking (that would be a different argument). The Court said they preempted a natural law that should be freely available to all. If the Court had supplied some better rubrics about how they came to their decision (instead of ex post facto reasoning that the outcome of having these claims was "bad" and thus there must be a reason they are invalid), the discussion here and elsewhere might have been different.
Thanks for the comment.
Posted by: Kevin E. Noonan | March 26, 2012 at 05:29 PM
EG, you caught me, I'm not a patent attorney. I'm not even an attorney. I am what is known in my industry as a "fluffer" but I do try to stay on top of the legal and regulatory developments in the fields of biotechnology, molecular diagnostics, and personalized medicine.
Go ahead and keep making this about Breyer's "skin" and technologically-challenged justices and "patent law despotism" and blah blah blah. Any decision to invalidate the claims at issue, whether via 101, 102, 103, 112, or even 867-5309, was going to be unsatisfactory to you. You say here and on other boards that all you really want is a principled and logical approach, result be damned. Yeah, sure. The only reason you take this approach is because you think it gives you some air of credibility. Um, no it doesn't. You can't be credible when you say incredible things, such as asserting that every single justice of the United States Supreme Court is so deficient in his/her understanding of patent law that we should all just rise up and ignore the whole thing.
Oh, because I'm only a fluffer I may be wrong about this, but do not attorneys have an ethical duty to not advance legal positions that are contrary to settled law?
Posted by: Gary Johnston | March 26, 2012 at 06:18 PM
Btw Kev, challenge accepted. I'm changing the world around me as I am typing this. No, really I am.
Posted by: 6 | March 26, 2012 at 07:46 PM
Excuse my ignorance, but in the context stated, what is a "fluffer?"
Further, do you really think for a second that this area of 101 is settled law?
In part it is because of decisions like Prometheus and Bilski that this area is decidely UNsettled law.
Posted by: Skeptical | March 26, 2012 at 09:52 PM
Gary:
Your remarks here strike a cord with me. As someone interested in patenting work, I've noticed much the same thing as you. Patent lawyers remind me a lot of middle-aged scientists, approaching every problem as a nail to be bashed by their favorite hammer while reacting with hostility to anyone who suggests that their pet toy might not be universally applicable.
I look forward to seeing where this digression takes the court. Hopefully it will realign IP law more firmly with the public interest.
Posted by: Mike | March 26, 2012 at 11:00 PM
"Excuse my ignorance, but in the context stated, what is a "fluffer?"
Further, do you really think for a second that this area of 101 is settled law?
In part it is because of decisions like Prometheus and Bilski that this area is decidely UNsettled law.
"
Hmmm, two decisions made right in a row? Yeah, I'd say it is pretty settled. Nothing changed in this branch of lawl since like Flook, possibly Benson if you really want to get down to it.
Posted by: 6 | March 27, 2012 at 04:50 AM
"Oh, because I'm only a fluffer I may be wrong about this, but do not attorneys have an ethical duty to not advance legal positions that are contrary to settled law?
GJ,
They do, as do Justices of the Supreme Court. Supreme Court Justices are also bound by their own precedent unless explicitly overruled. Please consider the following direct quote from 1981 case of Diamond v. Diehr which was binding precedent prior to Mayo Collaborative Services and explain to me how Breyer's reasoning is consistent with it:
In determining the eligibility of respondents’ claimed process for patent protection under 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The 'novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the 101 categories of possibly patentable subject matter."
I can also tell you right now: for 9 Justices of the Supreme Court to basically ignore such binding and relevant precedent (and frankly not to even to address it when it's on point) is a huge problem. Sorry, I remain unpersuaded by reasoning in Breyer's opinion.
Posted by: EG | March 27, 2012 at 05:29 PM
6,
Kindly refrain from commenting on my posts. If I want idiotic banter, I know where Patently-O is.
Posted by: Skeptical | March 28, 2012 at 06:55 AM