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Dolly the Cloned Sheep Not Patentable in the U.S.


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: May 8, 2014 @ 1:25 pm
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Dolly the Sheep.

Earlier today the United States Court of Appeals for the Federal Circuit ruled that Dolly the cloned sheep, and any other genetic clones, are patent ineligible in the United States because the “claimed clones are exact genetic copies of patent ineligible subject matter.” The case decided was In re Roslin Institute (Fed. Cir. May 8, 2014).

The Roslin Institute of Edinburgh, Scotland (Roslin) is the assignee of U.S. Patent Application No. 09/225,233 (the ’233 application) and had appealed from a final decision of the Patent Trial and Appeal Board, which held that all of Roslin’s pending claims were unpatentable subject matter under 35 U.S.C. § 101. The Board also rejected Roslin’s claims as anticipated and obvious under 35 U.S.C. §§ 102 and 103. Having determined that genetic clones are not patent eligible the Federal Circuit, in a decision by Judge Dyk who was joined by Judges Moore and Wallach, did not reach the 102 or 103 issues, instead simply affirming the Board’s rejection of the claims under § 101.

To tell the story involved in this case we must travel back to July 5, 1996, when Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first ever cloned mammal from an adult somatic cell: Dolly the Sheep. The cloning method Campbell and Wilmut used to create Dolly was a significant scientific breakthrough. Campbell and Wilmut obtained U.S. Patent No. 7,514,258 (the ’258 patent) on the somatic method of cloning mammals, which was been assigned to Roslin. The ’258 patent was not at issue in this case.

What was at issue in the case was the ‘233 application, which claims the products of Campbell’s and Wilmut’s cloning method: cattle, sheep, pigs, and goats. Claims 155 and 164 were deemed representative and are as follows:

155. A live-born clone of a pre-existing, non- embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

These claims were rejected by the patent examiner and an appeal was taken to the Board. On February 7, 2013, the Board affirmed the examiner’s rejection of all of Campbell’s and Wilmut’s claims. The Board acknowledged that the claimed clones “may be called a composition of matter or a manufacture” as required by § 101, but ultimately concluded that the claimed subject matter was ineligible for patent protection under § 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature.”

The Federal Circuit, per Judge Dyk, affirmed the Board after explaining the meaning of the Supreme Court’s recent patent eligibility cases. Ultimately concluding, as is required by this troubling line of Supreme Court cases, that even if something is made by man it is not patentable if what results is an exact copy of what occurs in nature.

Roslin did try and save these claims by arguing that the clone is not truly genetically identical to the original, but the Federal Circuit dismissed this line or argument saying: “There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies.” Of course, it is hardly surprising the claims and specification wouldn’t provide support for that given the entire point of the invention was to create a clone that was identical.

I hate to say I told you so, but I explained that this would ultimately be where the law had to head, particularly after the Supreme Court decision in AMP v. Myriad, although I have been criticized by many who dismissed my predictions and erroneously proclaimed that this line of Supreme Court cases wasn’t so bad. Well, I suppose this line of Supreme Court cases isn’t bad — it is horrendous! Perhaps my claims that the Supreme Court functionally overruled Chakrabarty won’t be viewed so skeptically any more.

Recall that in Myriad, Justice Thomas, writing for a unanimous Supreme Court, wrote:

Justice Thomas also explained:

[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

So, cDNA is patent eligible as long as the series is not too short, and so long as it is not “indistinguishable from natural DNA.” The importance of this, which was simply ignored by most in the field, is to say that as innovation becomes capable of replicating nature exactly then the resulting product is not patent eligible.

At the time of the Myriad decision I wrote this, which predicted the demise of personalized medicine:

Furthermore, you can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.

The holy grail of personalized medicine, at least with respect to organ transplantation, is to create an organ that is identical to what occurs in nature. Now we know that if that is accomplished the resulting organ will not be patentable. That being the case, why is anyone going to spend the billions, or possibly trillions, of dollars it will require to make this branch or personalized medicine a reality? Without possibility of exclusive rights research will dry up, and the dream will never be realized. Sure, some universities will continue to use grant money to pursue as much as they can, but without the private sector working to engage in commercialization research it simply won’t happen, and no company is ever going to spend the money required to make this a reality without an expectation of recouping their investment in R&D plus a suitable return on that investment.

What this all boils down to is this: as innovation marches forward we are starting to bump up against the god question. We are in small ways close to creating things that are undoubtedly man-made, but which are identical to nature. It  strikes me as extraordinarily peculiar that something man-made but imperfect would be patentable, but something man-made and perfect couldn’t be patentable. It is infinitely more difficult to create something identical to the way nature created it, yet we are willing to grant a patent on something that is easier to accomplish because it doesn’t offend our limited notions of humanity. Truthfully, the law and the public are not ready for scientists that can create like god, so there is a fearful retreat from extraordinary scientific accomplishment thanks to the enlightened 17th century thinking of jurists and Members of Congress.

Simply stated, there is no intellectually honest reason why that which is undeniably man-made should be denied a patent. Chakrabarty has clearly been overruled because that decision stood for the proposition that if something were man-made it was patent eligible. That was the correct decision.

And to those who don’t believe things like this should be patent eligible because giving a patent would allow the patent owner to sue everyone who has a kidney, for example, I say this: GROW UP! Granting a patent on a MAN-MADE kidney would NOT entitle the patent owner to sue everyone who has a kidney given to them at birth. Why? Because the kidney given to each of us at birth was NOT man-made!

Another nail in the coffin of innovation and a functioning patent system all because decision makers don’t have enough guts to state the obvious. Being able to create something that is identical to what nature creates is an extraordinary achievement that should be celebrated, should be fostered and incentivized, and should be awarded with a patent.

Sadly, until further notice, personalized medicine is dead!

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Posted in: Biotechnology, Federal Circuit, Gene Quinn, Government, IP News, IPWatchdog.com Articles, Patentability, Patents, Technology & Innovation

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

31 comments
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  1. Gene,

    As I have intimated before (per Chakrabarty), you need something different. You cannot claim that which already is in nature’s warehouse – even if you created a replica (an exact replica) from scratch.

    You can claim the process of creating a replica. But the item itself? That would be like claiming H2O when you have created a new desalination process.

  2. “Campbell and Wilmut obtained a patent on the somatic method of cloning mammals, which has been assigned to Roslin. See U.S. Patent No. 7,514,258 (the ’258 patent). The ’258 patent is not before us in this appeal. Instead, the dispute here concerns the Patent and Trademark Office’s (PTO) rejection of Campbell’s and Wilmut’s claims to the clones themselves …” slip op. at 3.

    Gene, the above passage undercuts your doom and gloom interpretation of this decision. There is a huge difference between patenting a method of cloning sheep, and patenting all cloned sheep, regardless of the method used to clone them. There is plenty of incentive in obtaining a patent for a new cloning method even if a patent on clones generally cannot be obtained.

  3. Gene,

    You’re overreacting to this decision. The method of cloning was patent-eligible, not the clone itself which, by definition, is identical (i.e., not novel). Also, as Dyk’s opinion points out (and believe me, I’m no fan of Dyk), all the features that the applicant pointed to as differentiating the clone from Mother Nature WERE NOWHERE TO BE FOUND IN THE CLAIM. So what we have here is an unremarkable “failure to define in the claim what the applicant regards as his invention” issue that caused it to become a patent-ineligible issue under 35 USC 101.

  4. EG-

    I disagree that I’m over reacting. In fact, Dyk’s language makes it all the more clear that I am correct. The first person that invents an artificial organ that is identical to what occurs in nature will not be able to get a patent. Since it will be identical to a natural kidney, for example, there will be no differentiating features to include in a claim.

    And what if the method of making that artificial, identical to nature kidney is not new or it is obvious? It is nice that methods are still patent eligible, that is unless they deal with computers, but there is no intellectual honest way to support the viewpoint that a man-made anything is patent ineligible even if it is identical to nature.

    With each new case, every new decision by the Board or a patent examiner, my view continues to prevail.

    -Gene

  5. Anon-

    You say: “You cannot claim that which already is in nature’s warehouse – even if you created a replica (an exact replica) from scratch.”

    I say that there is absolutely no intellectually honest, principled way to arrive at that policy decision. Furthermore, the fact remains that if man made the animal then it isn’t a naturally occurring animal by definition. It exists because man made it, not because it occurs naturally in nature.

  6. Non Sequitur II

    So you personally guarantee me that methods will remain patentable? You personally guarantee that a method to produce a man-made version of something that occurs in nature will under all circumstances always be new, non-obvious and lead to a patent issuing?

    I’m glad you and others are happy to rely on methods, particularly at a time when the Supreme Court seems virtually guaranteed to say that computer implemented processes claimed as methods are not patent eligible simply because they are not patent eligible… just because.

    It is ridiculous to think that a robotic arm could be patented and someone who creates a man-made arm that is identical to nature couldn’t get a patent on the man-made arm. It is infinitely more difficult to create something identical to what occurs in nature, yet we award a patent on that which is easier. Where are the patent laws going?

    In time I know I will be proven correct. Every new case, every new rejection, every new PTAB pronouncement further demonstrates that Chakrabarty is overruled. Once the Supreme Court starts doing away with method claims relating to computers I hope you all remain as optimistic.

    -Gene

  7. Gene,

    You seem to place too much emphasis on who makes something as opposed to what is made.

    If the what is something in the warehouse of nature, it is off-limits. While you may cry out that this is ‘intellectually dishonest,’ this has been a central theme in 101 doctrine for basically forever.

    Take my example of water. Please. Do you really think a novel method of desalination should earn a patent for the product of that process?

    Let’s take another example (with a hat tip to lower case anon): http://news.yahoo.com/unique-crystals-newfound-purple-pink-mineral-no-other-150542725.html

    Putnisite.

    Let’s say that you had (prior to the discovery) developed a process for making Putnisite, and that Putnisite had this incredible specific utility. Now let’s say after you have been granted your patent this same exact mineral is discovered in the wild. Let’s say the day after, it is discovered in my backyard.

    Exactly like water, this mineral is from the warehouse of nature and is just not patent eligible. Your patent – duly earned on the same exact product is void under 101. To quote Chakrabarty, “Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.

  8. Anon-

    You say: “If the what is something in the warehouse of nature, it is off-limits. While you may cry out that this is ‘intellectually dishonest,’ this has been a central theme in 101 doctrine for basically forever.”

    I respectfully disagree. How can you say that? We are talking about issues that have never come up. There is no way that this has been a central theme under 101 forever. We are now, for the very first time, discussing the very real prospect that man will be able to make something as complicated as a living being where that living being is identical to a nature made being. Granted, that is not the case with Dolly, nor are we at the point where we can grow identical organs, but we are approaching that point quickly.

    What has been a central principle of 101 forever is the desire not to kill entire avenues of technology at the very beginning with the harsh clever that is 101. Since no one can say with exacting certainty that methods are enough to adequately protect an man-made kidney that is indistinguishable from nature, 101 principle and logic (as well as Chakrabarty) demands that it be patent eligible. All that should be required is a statement in the claim that the kidney, or mammal, is “man-made,” which would prevent those who run around like chicken little from saying the patent office is giving away patents on people born alive.

    As for the water scenario, I really don’t know what the answer is. My guess, however, is that relatively basic scientific knowledge would render the man-made water molecule obvious, if not simply incapable under 102. But the fact that we know today how to create a water molecule doesn’t strike me as a true equivalent. Do we know how to make a kidney? No. So I think the water scenario you pose isn’t an accurate comparison. Having said that, as everyone here knows my knowledge of chemistry is extraordinarily limited.

    With respect to Putnisite, the logic you use means that little in the field of genetics should be patent eligible because it is always possible that nature will select a particular mutation.

    Invention is about human intervention, and that was what we all said, to a person, was the teaching in Chakrabarty. That fundamental teaching in Chakrabarty is no longer true, at least under the law. I say, however, from a logical standpoint it remains as correct as ever. Innovation is about the human activity. Focusing on the result in determining patent eligibility is a mistake. Isn’t that what the Supreme Court said in Bilski when they threw out the State Street concrete, useful or tangible result? It has to be. They couldn’t eliminate the “useful” requirement, which is found elsewhere in 101. Nor could they throw out the requirement that inventions be described in a concrete and tangible way, as is required under 112. So what they did, perhaps without understanding the consequences, is throw out the result oriented focus. Which seems to be a perfect explanation of what is happening with computers. The fact that the software provides a certain result is meaningless, the question is whether the processes employed to get to that result are defined adequately, new and unique enough to be non-obvious.

    -Gene

  9. Everyone—

    Another thought… what exactly is the problem with granting a patent on the kidney that is identical to what appears in nature if we are going to protect the method? At the end of the day the same thing winds up being protected, right? That is true if and only if the method is patentable. So it seems extremely clear to me that those advocating reliance on the method are swinging a shinny object before your eyes. If the method isn’t protected, or if another method could be used to come up with the natural kidney, then that first of its kind natural kidney gets no protection.

    We know that innovators are highly sensitive, indeed over sensitive, to the incentive structure and attempts to take incentives away. To think that we will get the same level of investment in breakthrough medical research with this patent climate strikes me as foolish.

    -Gene

  10. I’m pretty much with Gene on this one. This case establishes a rule, hinted at in Myriad, that an artificial copy of a naturally-occurring thing is not patentable (i) even if there is no prior art-based reason to deny a patent and (ii) even if the public remains free to use the naturally-occurring original. I see no reason why this is the right outcome, since the patent would protect only the inventor’s creation and the public would have continued access to “nature’s warehouse.” After all, the claim to the cloned sheep doesn’t cover sheep generally – it doesn’t even cover the original donor sheep (or the natural offspring of the cloned sheep). Roslin’s claim didn’t take anything from the public domain, so I’m really at a loss what policy purpose, underlying Section 101, we’re trying to advance here.

    And as far as Judge Dyk’s alternative reason goes – “the public is entitled to copy unpatented things” – what is that even supposed to mean? The public is entitled to clone unpatented animals? By that logic we would be free to use even the patented method of cloning, because without the act of cloning we wouldn’t be able to enjoy the clones we’re apparently entitled to.

  11. Gene,

    Respectfully suggest you reconsider your declaration that Dolly was “identical” to the original.

    IIRC, cloned sheep do not live as long as naturally reproduced sheep. There is something different. We’re just not smart enough yet to know what the difference is.

  12. Gene,

    We’ll have to “agree to disagree.” As step back suggests, you need to point out what is “different” about the cloned animal, other than it was done by the “hand of man.” If the cloned animal is identical to that in nature, you don’t even get past the “new” language of 35 USC 101. Again, as the opinion In re Roslin Institute clearly says, point out what’s “different” and put that into the claims. Unfortunately for the applicant inIn re Roslin Institute, they didn’t do that.

  13. I am on Gene’s side fo the fence but not all the way to where he is at.

    I have no problem with the idea of product by process patent protection for this sort of innovation. I do not like the idea of saying that because an inventor developed ONE way of making a man made organ, then all man made organs are subject to their patent. If we are going to permit patenting of items which are either obvious or already in nature, then we should be a bit more judicious in handing out protection.

    The water example gives a glimpse of a path. I cannot patent water generally, but I should be able to patent the process of purifying water, the machine that embodies this process and the product resulting from this process. But I should NOT be able to patent all water purified by man just because I came up with one way to purify water.

    If the disclosure includes more than one way to create the man made organ, then the protection should extend to that method as well. In good scope of equivalents fashion, as more teaching is within the disclosure, then more scope is given. If you disclose a single very specific method and do not generalize this or postulate other viable alternatives, then you should not get the coverage for all possible methods of production.

    There is no new ground that needs to be broken with patent law here, only a logical progression of what we already know. But we also do not need to go to the extreme. We don’t do this for mechanical devices or electronics, so let’s not go down that path for life sciences. Yes, you can copy unpatentable things and if you do it in a new and unique way, you should be able to patent the process and the product of that process. But you should be able to prevent me from creating a new process to copy an unpatentable process just because you have a patent on one workable approach to copying that same unpatentable item.

  14. Gene,

    To your question of “ At the end of the day the same thing winds up being protected, right?” – the answer is no.

    When the item is not constrained, reaching that item through alternative means is a driver for additional invention. If the item itself were constrained – aside from the fact that you invite problems of enforcement (how does one distinguish picking up the natural mineral of Putinsite – which nature provides freely to all – from your claimed version), the fact that Putinsite itself is off-limits means that attempts in the alternative to create Putinsite would be fruitless (why bother?).

  15. I do not wish to sound as if I am splitting hairs, but strictly looking at the decision, we are talking about farm animals here. There is already a proprietary interest in these animals under common law and statute. Is it really necessary to superimpose another form of ownership on these animals?

  16. Alan Stewart,

    Your logic falters at “and the product resulting from this process.” That product is H2O – indistinguishable from any other H2O. It simply makes no sense to allow a patent on the product, since to show infringement, you would necessarily have to show the specific product being accused was obtained by the patented process (and not collected from the sky, for example).

  17. I would add the notion that the 101 argument differs from a 102/103 argument in a fundamental manner.

    This difference is often difficult to see, given that most examples for clarity’s sake use products that are easily recognized (and naturally ‘old’). But the words in the Chakrabarty decision itself – as I noted above in comment 7 indicate a timeless dimension, indicating that even a new discovery, that is, a discovery after a man-made item is created, does in fact remove the item (but not necessarily the man-made process) from the realm of patent eligibility.

    Yes Gene, you are correct in one outcome of this doctrine. Any one particular item crafted by man (but not only in the bio world, as the Putinsite example shows) does have a weakness in the fact that any later discovery of that item existing through natural means will remove that item from the sphere of patent eligibility,

    As it should (using the example of Putinsite, can you really continue to lay claim to the item that I can pick up in a natural state right off of the ground? – or in the example of H2O, can you really lay claim to H2O as an item, H2O that is completely indistinguishable from what falls freely from the sky?)

  18. Frankly, I think your are being a bit pessimistic on the issue of commercialization. As in the Dolly the sheep case, even if the final product (a sheep, a cow, a kidney, a lung,…) is not patentable, the method and processes and other technologies used to create that product may be. Just because a kidney can not be patented, does not imply that researchers and commercial entities will not strive to find novel and patentable ways to create that kidney. If I have a lock on creating body parts, I really don’t care if the body part ultimately created is patentable or not, no one else can create them in the manner that I do, so if you want one you have to come to me anyway. If someone else comes up with an alternative method and technology that is also patentable, fine, that is what innovation and commercialization are all about, let the market decide which method produces a better, cheaper, more natural body part and let the competition begin. As a counter example, I point you to the Monsanto “Patent on the Pig” hype that came out some years ago. Monsanto patented a genetic test for certain attributes of pigs that made them grow faster and put on more weight than other pigs, along with a method of using that test in herd management. Although they could not patent the pigs that resulted, as those genes are present in pigs naturally, that certainly did not dissuade Monsanto from researching the field, patenting a test and a method, and commercializing that test and method.

  19. EG-

    You say: “you need to point out what is ‘different’ about the cloned animal, other than it was done by the ‘hand of man.'”

    I disagree. I understand why you say that is the case, but I still disagree.

    The prohibition against finding something patent eligible is this: you cannot patent something that is naturally occurring. A man-made kidney, for example, is not naturally occurring even if it is identical to the kidney given to us at birth. By definition a man-made object, even if identical, is not naturally occurring.

    I get what you and everyone else is saying, but these are really questions of first impression because we have never been able to exactly replicate nature. We still aren’t there yet I suppose, but the genetic revolution is making it closer and closer.

    Take for example Dean Kamen’s artificial arm, Luke. See:

    https://www.youtube.com/watch?v=R0_mLumx-6Y

    A prosthetic arm is clearly patent eligible. But what you all are saying (and the Supreme Court and now CAFC have said) is that a man-made arm that is identical to a nature/god created arm is patent ineligible. How does it make any logical sense that something that is imperfect and easier to create (i.e., a robot arm) is patentable but something that is perfect and infinitely more difficult to create is not patentable?

    It seems in the new genetic era the goal is to achieve imperfection because if you realize the goal completely you wind up with something that cannot be protected even though it is clearly and undeniably man-made.

    -Gene

  20. Jamie-

    You say: “If I have a lock on creating body parts, I really don’t care if the body part ultimately created is patentable or not, no one else can create them in the manner that I do, so if you want one you have to come to me anyway.”

    Of course, if someone can create the body part by a different method then you have no protection. That would be odd given that if you created a robotic prosthetic arm you could protect both the method and the arm, which would give you protection even if others could create the prosthetic arm using a different method.

    What bothers me is that more patent protection is afforded to what is imperfect that to what is perfect. The incentive structure is not to achieve the best, which means the best won’t be achieved.

    -Gene

  21. “What bothers me is that more patent protection is afforded to what is imperfect that to what is perfect. The incentive structure is not to achieve the best, which means the best won’t be achieved.”

    Then change the law of subject matter eligibility under 35. U.S.C. 101.

    Don’t resort to corrupting what the statute says and how it has been historically. Your arguments ultimately justify the point of view of the Supreme Court in their horrible Prometheus decision, i.e., that a statute can be interpreted to produce the result that a majority of the Supreme Court justices want no matter what the statute actually states and what the statute has historically been interpreted to state.

    What the Supreme Court did in Prometheus was wrong and how you are suggesting 35 U.S.C. 101 should be interpreted, no matter how desirable the result may be for protecting technology, is equally wrong.

    When faced with a situation such as in the In re Roslin Institute case, I think about A Man from All Seasons (description below and quotes are from the Wikipedia article):

    At one point More’s future son-in-law, Roper, urges him to arrest Richard Rich, whose perjury will eventually lead to More’s execution. More answers that Rich has broken no law, “And go he should if he were the Devil himself until he broke the law!” Roper is appalled at the idea of granting the Devil the benefit of law, but More is adamant.

    “What would you do? Cut a great road through the law to get after the Devil? … And when the last law was down, and the Devil turned round on you – where would you hide, Roper, the laws all being flat? This country is planted thick with laws from coast to coast, Man’s laws, not God’s, and if you cut them down – and you’re just the man to do it – do you really think you could stand upright in the winds that would blow then? Yes, I give the Devil benefit of law, for my own safety’s sake!”

  22. Step Back,

    Dolly died of an illness common in sheep. Her telomeres were not determined to be longer either.

    http://www.roslin.ed.ac.uk/public-interest/dolly-the-sheep/a-life-of-dolly/

  23. “Simply stated, there is no intellectually honest reason why that which is undeniably man-made should be denied a patent.”

    By this logic, copyrighted and trademarked materials should be patentable. So if you want to survive reducio ad absurdem, you’ll need to come up with a better principled argument then what you just gave.

    Protecting sec. 101 has nothing to do with fear of God-like scientists, but reserving the patent system for applied technology. The Roberts court would love to find a way to patent things such as business method patents (also undeniably man-made), or personalized medicine. If you or anyone can come up with a principled argument on separating mental conceptions or ideas and the application of those ideas, then these sort of things will be patentable.

  24. James-

    Why did you feel the need to take the conversation into the ridiculous? Seriously? This is a patent conversation. Did you really think that what I was saying in a patent article, about patents, talking about patentable subject matter, that the comment related to copyrights and trademarks?

    I see you have a .edu e-mail address, so I’m willing to cut you a break. Perhaps that type of asinine, smarmy commentary is what passes for thoughtful discussion in academia, but if you want to participate with the big boys here please refrain from that type of self righteous, ridiculous commentary in the future.

    You also ask: “If you or anyone can come up with a principled argument on separating mental conceptions or ideas and the application of those ideas, then these sort of things will be patentable.”

    Perhaps you just need to catch up on your reading. I’ve written about this numerous times. The reality is that Judge Rich was correct in State Street, at least to a point. The test should focus on whether the invention is described in concrete and tangible terms without focusing on the result. Furthermore, the Supreme Court had a perfectly fine 101 test that dealt with preemption that they are now turning their back on since in recent cases they admit that the claims do not preempt an entire field but are still patent ineligible for reasons they have chosen not to articulate. Well, they did articulate to some extent if you can call it that. In Myriad they said the claim does not cover something that occurs in nature but the claim is still patent ineligible because it is a law of nature. Of course, none of them know enough about patent law to realize what they had said.

    -Gene

  25. I understand the need for a blog to weed out trolls, so I’ll chalk up the personal response to that. Let me be more straightforward with my responses.

    The intellectual honest reason why State Street is no long applicable is because the test articulated is too broad and would allow patent protection for things that do not need patent protection. Not everything needs patent protection. The Court doesn’t want to see something that occurs in nature patented simply because it was copied by man, such as someone’s genetic code or a sheep. Of course, a poem shouldn’t receive patent protection. And eventually, maybe in CLS v. Alice, the Court will conclude that business methods shouldn’t receive patent protection, either. Mental conceptions are not patent eligible because they will or have occurred without the help of the patent system.

  26. James-

    So now you are in the business of deciding what deserves patent protection? So what invention exactly doesn’t need patent protection despite being entitled to patent protection under the explicit terms of 101?

    As for State Street, the reason that State Street is no longer applicable is because it wasn’t applied properly pretty much ever. If you pay attention you will notice that thoughtful commentators are increasingly acknowledging that Judge Rich was correct and on the right path.

    You say: “The Court doesn’t want to see something that occurs in nature patented simply because it was copied by man, such as someone’s genetic code or a sheep.”

    But what about when it isn’t copied? What about the kidney that is created by man?

    You say: “maybe in CLS v. Alice, the Court will conclude that business methods shouldn’t receive patent protection…”

    So you actually think they will directly overrule their decision in Bilski?

    You say: “Mental conceptions are not patent eligible…”

    No one here has said that they should be patent eligible.

    I don’t know whether you are a troll, but your understanding of the topics seems exceptionally rudimentary.

    -Gene

  27. I’ll just say a couple things and save any future comments that I may or may not have when you post about CLS, whenever that decision is released.

    What is patent eligible and what is not patent eligible is exactly what the sec. 101 debate is about, so I am a member of the patent community just like you giving an opinion on where to draw the line on these hybrid claims (containing statutory and non-statutory material). I see the “inventions” in Mayo, Myriad, and the cloned sheep… to me, and the Court, these “inventions” are mere discoveries. My opinion is, “congratulations, go get your Nobel Prize, but come get a patent when it becomes an applied science rather than pure science.” So Craig Ventor, who wants to make an artificial bacteria, will not be able to patent it because it is just a neat cool discovery, but not really an applied technology. In this respect, I agree that it is easier to do what the Solicitor General suggested in Mayo (the part of the opinion I disagree with, page 12-13), but overall the decision in Mayo was correct, and the facts show the importance in separating statutory subject matter.

    Prometheus’ patent had basically two things, at least in view of the Court: a diagnostic recognition, and a test to enable the recognition (the test being part of the prior art, the diagnostic recognition was the true novelty). Indisputably, Mayo used a different test, but the tests were so similar that there was still infringement– but these tests were part of the prior art! So what was Prometheus really preventing Mayo from doing? In my opinion, it is preventing Mayo from the diagnostic recognition, which is a mental conception, which is non-statutory material.

    I know you disagree, Gene, but I posted on this thread to provide you the intellectually honest reason why something that is undeniably man-made doesn’t work as a test under sec. 101. Read back to my first post- the reason has nothing to do about anti-science or fear of God, but the recognition that patents are a double-edged sword- patenting the artificial kidney itself might dissuade others in developing better, inexpensive ways in making that artificial kidney.

    Finally, please don’t confuse my choice in only discussing the very basics of the patent system (something that is subject to disagreement) with only having a very basic understanding of the patent system. I try to be concise, and that may sometimes be at the expense of fully explaining my position. If I ask too much of a reader to connect certain dots, I’ll try to explain myself better.

  28. James-

    You are entitled to your opinion, but you are not entitled to your own facts. You say that patent eligibility should only be recognized with applied science rather than pure science. That, however, has never been the law at any time in the United States.

    Your comment about artificial bacteria speaks volumes. The only way you could say such a thing is if you ignore Chakrabarty, which states that genetically engineered bacteria are, in fact, patent eligible.

    You also say: “I know you disagree, Gene, but I posted on this thread to provide you the intellectually honest reason why something that is undeniably man-made doesn’t work as a test under sec. 101.”

    That is simply not true. Your comments have been riddled with incorrect statements of patent law, and your first comment was utterly absurd. What you offer here is intellectually bankrupt, not intellectual honesty. You say you are offering reasons under 35 USC 101 to support your opinions, but you show absolutely no familiarity with 101 or the cases. You simply cannot offer a coherent rationale for your position that ignores Chakrabarty and ignores the reality that SCOTUS has already said that business methods are patent eligible.

    -Gene

  29. I know exactly what Chakrabarty says, a genetically modified bacteria is patent eligible. That is, living things can be patent eligible. But you seem not think that it necessarily follows that Ventor’s bacteria would be patent eligible. It remains to be seen if it has “distinctive name, character, and use” (Hartranft v. Weigman, language cited by Chakrabarty). Here is some key language…

    “Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under 101.”

    Just to emphasize, “markedly different characteristics from any found in nature.”

    So you cite a case that seems to support your position that everything man-made is patent eligible. Only if they are “markedly different characteristics from any found in nature.” Dolly was not, a clone of a kidney is not, Ventor’s bacteria probably won’t be either. So what is your support for your position that something simply man-made is patent eligible. Citations would be helpful.

    Read really carefully the case comparison in Chakrabarty, comparing the facts to Funk, in (III).

    While you are at it, read (III) from Chakrabarty and avoiding the necessary inferential step that “pure science”, which in my context clearly means natural discoveries, are not patent eligible.

    You keep saying that Bilski v. Kappos supports the proposition that business method patents are patent eligible. Read II-C-1, and the court says that some are patent eligible, and some are not. Depends on how you define business methods. So you are right they are not categorically ineligible, but subsequent decisions clearly show a pattern that some business methods are not patent eligible. What will CLS bring? I predict a more clear instruction to the Fed. Cir. what is needed for a business method to be patent eligible, or reversing and going with what Stevens wrote in page 2 in his dissent in Bilski.

    You say my first post is ridiculous. I tested your statement that “that which is undeniably man-made should be denied a patent” with reductio ad absurdum. I don’t know why you think that reductio ad absurdum is unfair or ridiculous in attacking legal principles. Did I use straw-man your argument? Did I slippery slope your argument? I only meant to say that the principle you propose cannot be enough. I know you got the quote from Chakrabarty, but the full quote comes from PJ Federico, and he said any manufacture or machine, therefore anything under the sun that is man-made. Keep in mind he said that in 1952 before DNA was fully understood.

    But I should have just stuck to this: “Chakrabarty has clearly been overruled because that decision stood for the proposition that if something were man-made it was patent eligible” because your understanding of Chakrabarty, of which is your entire basis for this post, is “exceptionally rudimentary.”

  30. James-

    You are all over the place. You claim you understand Chakrabary, and then you say: “I know exactly what Chakrabarty says, a genetically modified bacteria is patent eligible. That is, living things can be patent eligible. But you seem not think that it necessarily follows that Ventor’s bacteria would be patent eligible.”

    I never said that an artificial bacteria wouldn’t be patent eligible. YOU were the one who said that!

    You ask: “So what is your support for your position that something simply man-made is patent eligible.”

    Chakrabarty, and every other Supreme Court decision on patent eligibility cites with approval the 1952 Patent Act. “The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to “include anything under the sun that is made by man.” S Rep. No 1979, 82d Cong., 2d Sess., 5 (1952); H.R.Rep. No. 1979, 82d Cong., 2d Sess., 6 (1952).” See Chakrabarty.

    Chakrabarty also says: “[Chakrabarty's] discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.”

    So there is the support that you apparently didn’t know about.

    You also say: “You keep saying that Bilski v. Kappos supports the proposition that business method patents are patent eligible. Read II-C-1, and the court says that some are patent eligible, and some are not. Depends on how you define business methods.”

    Once again this is an asinine comment. Bilski clearly stands for the proposition that business methods are patent eligible. The distinction you are trying to make is bizarre to say the least. If you define a compound improperly it too could be patent ineligible. We also know with great authority (see Mayo v. Prometheus) that methods can be patent ineligible despite being specifically recited as patentable in the text of 101. So would you also say that methods are not patent eligible because not all methods are patent eligible?

    You say: “I don’t know why you think that reductio ad absurdum is unfair or ridiculous in attacking legal principles.”

    And that is the problem. You don’t get it. You brought trademarks and copyrights into a patent discussion as if what I said about patentable subject matter related to trademarks and copyrights.

    I’m done with you. You can find plenty of other places on the Internet that embrace your brand of idiocy. You are just getting in the way of a thoughtful discussion and that is not tolerated.

    -Gene

  31. I do believe that James has much more convincing, sound arguments without resorting to personal remarks.

    Gene, you did not comment on James’ citation from Chakrabarty, namely, the court said the NEW bacterium has markedly different characteristics from any found in nature, and one having the potential for significant utility. The conclusion by the court was that due to these different characteristics, the discovery was obviously not one of nature’s handiwork.

    My interpretation of Chakrabarty is that living beings, in this case artificial bacteria, are indeed eligible for patent protection. However, they still have to be “markedly different from any found in nature and have significant utility”. Thus, I agree with James, that Chakrabarty never claimed that all living beings, which are man-made, are ipso facto eligible for patent protection. There needs to be some difference in the final composition of matter from that found in nature …

    I also don’t think that Roslin, Myriad or Prometheus are nails “in the coffin of innovation” or that “personalized medicine is dead….”. As many posts have previously stated, we can still bank on method patents. Since, as you correctly state, it is immensely difficult to replicate a naturally-occurring body part like a human arm, all the more reason that such a method patent will be held novel and non-obvious. It will be the job of patent attorneys like you and me to draft such method claims as broadly as possible for the client. It is true that third parties may try to find ways around such a pioneering method patent if possible, but this will only help spur on innovation and not kill it.

    And finally as the court in Chakrabarty rightly pointed out:

    “The grant or denial of patents on micro-organisms is not likely to put an end to genetic research or to its attendant risks. The large amount of research that has already occurred when no researcher had sure knowledge that patent protection would be available suggests that legislative or judicial fiat as to patentability will not deter the scientific mind from probing into the unknown any more than Canute could command the tides. Whether respondent’s claims are patentable may determine whether research efforts are accelerated by the hope of reward or slowed by want of incentives, but that is all.”