Guest Commentary by Paul Cole,Professor of Intellectual Property Law, Bournemouth University, and European Patent Attorney, Lucas & Co, Warlingham, Surrey, UK.
ASSOCIATION FOR MOLECULAR PATHOLOGY v MYRIAD GENETICS – an isolated decision?
By Paul Cole[1]
How does the Supreme Court decision of 13 June 2013 match international opinion on the patentability of biological material? From a European and indeed from an Australian standpoint it can be said with some confidence: not so well.
In Europe patentability in this genus of fields of endeavour was considered in the 1990’s in a debate that resulted in the passage of the European Biotechnology Directive of 6 July 1998, [1998] OJL 175/1[2]. For the relevant philosophy underlying that Directive it is only necessary to quote the relevant recitals (with emphasis added):
(16) Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented;
(17) Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system;
(20) Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment;
(21) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself;
(22) Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this Directive, the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed…
The consequential legislative provision is to be found in Article 3 which was arrived at following a three-year debate involving the EU Commission and the European Parliament:
1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.
In Australia the patentability of such materials has recently been confirmed by the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013)[3], see Vaughn Barlow, CIPA, March 2013, 122-123. This very well-reasoned and detailed decision considers relevant US and UK opinions including the Kalo v Funk opinion, and explains:
105 In my opinion the patentability of the isolated nucleic acids referred to in the disputed claims does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated. In particular, the question of whether these substances constitute patentable subject matter does not depend upon the type of chemical bond that may have been broken in the process of isolating them. It is inevitable that some bonds will be broken in the course of isolating nucleic acids, but it is not apparent from the evidence that these will necessarily include covalent bonds. As I have already explained, the disputed claims do not require that the isolated nucleic acids they describe differ from those found in the cell in this or any other respect so far as their chemical composition is concerned.
106 Accordingly, the issue in this case turns upon whether an isolated nucleic acid, which may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings, constitutes an artificial state of affairs in the sense those words should be understood in the present context. There are three considerations which lead me to think that it does.
107 First, in explaining the concept of manner of manufacture as one involving the creation of an artificial state of affairs, it is apparent that the High Court in NRDC was deliberate in its use of very expansive language. Not only did the High Court emphasise the “broad sweep” of the concept involved, it also made clear that metaphorical analysis may not be helpful in determining whether or not something constitutes patentable subject matter.
108 Secondly, in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.
109 Thirdly, as Dann’s Patent demonstrates, the isolation of a particular micro-organism may require immense research and intellectual effort. In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.
The Court went on to explain that its findings were consistent inter alia with a report of the Australian Law Reform Commission of June 2004 entitled Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99, 2004). That report concluded that it would be difficult, on any rational basis, to confine reform to genetic materials and technologies, and that the extension of the reform to other fields – where the patenting of pure and isolated chemicals that occur in nature was uncontroversial – could have unknown consequences.
What a shame that nobody told the Supreme Court of this body of opinion and legislation in Europe and Australia, which is believed consistent with the opinions and legislation existing in most other countries of the industrialised world, or that if it was aware of this position elsewhere the Court decided to ignore it in favour of a judge-made exception to the express provisions of 35 USC 101!
European equivalents of the patents in issue have been considered by the EPO Appeal Board. For example, T 1213/05 UNIVERSITY OF UTAH/Breast and ovarian cancer[4] concerns the BRCA 1 gene. T 666/05 UNIVERSITY OF UTAH/Mutations[5] relates to the use of the same gene in diagnosis.
In case T 1213/05, opponents argued that the socio-economic consequences of patenting the claimed subject-matter should be considered under a.53(a) EPC because these consequences touched ethical issues. Patenting of the claimed subject-matter would not only result in increased costs for patients, but would also influence the way in which diagnosis and research would be organized in Europe, which would be clearly to the detriment of patients and doctors. The fact that a particular group of patients, i.e. patients suspected to carry a predisposition to breast cancer, would be faced with severe disadvantages and would become dependent on the patent proprietor was contrary to human dignity so that the claimed subject-matter constituted an exception to patentability under a.53(a) EPC. In rejecting this argument the Appeal Board held that the possible consequences of the exploitation of the patent were are the result of the exclusionary nature of the rights granted by a patent, i.e. the right to stop competitors from using the invention. Logically such an objection applied to the exploitation of any patent and was the same for all patents. A resolution of the European Parliament, P6_TA(2005)0407 of 26 October 2005 "Patents on biotechnological inventions" did not vest the EPO with the task of taking into account the socio-economic effects of the grant of patents in specific areas and of restricting the field of patentable subject-matter accordingly. Similar arguments were rejected by the Board, in a different composition, in Case T 666/05.
In the US litigation it was argued that patents for isolated genomic DNA inhibited more innovation than they incentivised. However, even if that proposition is accepted it appears arguable that this is also the result of the exclusionary nature of the rights granted by a patent and is the same for all patents.
It is submitted that the decision is based on a narrow and short-term view of the public interest. The drug amoxicillin was invented in 1959, became available in 1972 and was the subject of much litigation in the 1960’s and 1970’s in which this author personally participated. The relevant patents have now expired and the drug which continues in widespread use is now a generic in a competitive marketplace. In addition to the US and the UK, the drug is now made in, for example, Brazil, Canada, Italy, Mexico, New Zealand Singapore, Spain, Thailand and South Africa. The well-known Indian generic company Ranbaxy was approved a supplier for the US market by the FDA in 2003. An invention can enrich the inventor or an employer for a limited period provided by the patent system: mankind is enriched forever.
@ Anon
My day job is patent practice. One of my major hobbies is teaching and writing in the field of intellectual property. I have a number of published books on the subject and teach a course at Bournemouth University.
However, an adverse reaction can be expected from me, and from a very large number of my professional colleagues, when the norms under which we do our daily work are summarily torn up.
It has been taken for granted for at least many decades that a new chemical entity is patentable subject-matter. As noted in this blog, that used not to be the case in the UK for historical reasons connected with dyestuff and drug patents before the First World War. But since the UK Patents Act, 1949 new chemical entities have been patentable subject-matter, and that is now the norm in all the countries where I file patents. However the issue is fudged, isolated DNA for a single gene is the result of chemical reactions that sever the gene from its surrounding DNA and create a new chemical entity. It is a sequence of different molecular weight from anything that exists in nature, and it has end groups that do not exist in nature. The isolated gene is a molecule that does not exist in nature and has never existed in nature. The dismissive way in which these facts have been treated in the Supreme Court decision is profoundly shocking to many chemical and biotechnological practitioners.
It has also been taken for granted for many decades that substances isolated from nature are patentable. In the US the chain of authority, as we both know, goes back to to the decision of Judge Learned Hand in the 1900’s and has been affirmed by subsequent decisions although, as we also both know, the position is not wholly free from controversy. As a practical working guide, however, an isolated substance has been presumed patentable. The abandonment of this by now settled and widely accepted principle is profoundly shocking to many practitioners.
We then have the issue of settled expectations. That subject was considered in an impressive, detailed and scholarly opinion of Judge Moore in the CAFC. Her overall conclusion was for patentability and it is worth quoting her conclusion:
“The Patent Office has, for more than a decade, affirmatively stated its belief that isolated DNA is patentable for the same reasons as isolated vitamins or hormones. There is no indication from Congress that this view is wrong; to the contrary, it appears Congress also believes DNA is patentable. This long-term policy of protecting isolated DNA molecules has resulted in an explosion of innovation in the biotechnology industry, an industry which, unlike the financial services industry or even the software industry, depends on patents to survive. Holding isolated DNA not patentable would destroy long settled industry expectations for no reason other than a gut feeling that DNA is too close to nature to be patentable, an arbitrary decision based on a judge-made exception. I believe that isolated DNA fragments, which have both chemical changes from the naturally occurring genomic DNA as well as new utility, are “the kind of ‘discoveries’ that the statute was enacted to protect.” I therefore decline to extend the “laws of nature” exception to include isolated DNA sequences.”
The penultimate sentence deserves attention: in the final analysis Judge Moore AGREES with Judge Lourie. The summary dismissal of this reasoned and detailed opinion and the rejection of settled practice which has existed over many decades is also, to many practitioners, profoundly shocking. It should not be forgotten that the USPTO has trilateral discussions with the EPO and the JPO. In these discussions some 20 years ago the USPTO was putting forward the very position that the Supreme Court now rejects. It is not clear that the Supreme Court had any knowledge of this, or if it did that it felt any embarrassment. The abandonment of a long-settled practice in granting patents to isolated sequences for no very compelling reasons, and in the absence of a substantial body of evidence that there is a public interest in doing so, is to many practitioners profoundly shocking.
It is not for me as a European practitioner to express a concluded view as to whether Myriad is inconsistent with preexisting law. However, compared to the opinions in the CAFC, I find the present opinion less scholarly, less well-considered and unwise.
“did you bother to download and read the Beauchamp article‘
Did you?
It does not support your position, by the way – at least not quite the way you have been writing here. Yes I know you are saying “background,” but the better background would have been paying attention for the last several years.
The article is seriously flawed as well. Sure it has some decent stuff, but it also has things that are flat out wrong, and some things that are unbelievably pollyanna (even more pollyanna than McCracken).
As far as “nothing thoughtful or useful to contribute” – again, you would do well to pay attention to what I have to say. There is a reason while I NAILED both the decision and the reason in the Myriad case: I know this stuff. As to a period of silence? Yes, given the position you are advocating here, I can easily see why you would want my silence: your position is quite simply WRONG for US jurisprudence. If you haven’t figured out why yet, perhaps a different day job for you would be in order. One that would allow you to understand the background of what you advocate.
And you should also YOURSELF have remembered that saying on the drink tray – because the thing that I am NOT being silent about is explicitly YOU failing to engage your brain before operating your ‘mouth.’
“favour me with a listing of each and every important question you have in mind”
Gee – You are SO busy, let’s just start simple – like with the questions that I have already asked you here. Deal? And I will even leave out most of the sarcasm if you can try to do the same, deal?
Paul,
Shhhhhh.
As to a link, sorry, but this has been an ongoing discussion with hundreds of posts over dozens of links going back at least to Bilski. Notwithstanding that, one link I was looking at over the weekend that has some good conversation is link to patentlyo.com
While you consider my posts ‘obscure,’ I consider yours immature. And that’s not good for your ‘day job.’ Isn’t your day job teaching this stuff?
WHERE?????
IF YOU DID, WHY NOT SUPPLY A LINK???
THEN YOUR COMMENTS MIGHT BE UNDERSTANDABLE AND HELPFUL. OTHERWISE THEY ARE MERELY OBSCURE.
@Anon
Before you made your last posting did you bother to download and read the Beauchamp article?
And as my time is limited by my day job and other responsibilities, could you favour me with a listing of each and every important question you have in mind? It would be helpful if they could be presented as a numbered or bulleted list.
And what makes you think that I agree with the Beauchamp article or am relying on the Learned Hand decision merely because I happen to cite them as useful background reading? Please do not put words in my mouth or attribute to me opinions that I have not expressed.
If you have alternative or better references or judicial opinions, please cite them. Otherwise, and if you have nothing thoughtful or useful to contribute, a period of silence from you would be welcome. As was said on a drinks tray in a friend’s house that I used to visit as a child: “Please engage brain before operating mouth”.
Paul,
I find it curious that you “have time” to reinforce the belief structure you already have and yet don’t want to address the more important questions.
Learned Hand’s decision was early in his career, and to lean on the ‘history’ of the great judge (who, by the way, missed on the precedent of the Latimer decision) is to simply – and willfully – continue down the wrong path.
I would dare say that what you are doing is ‘thoroughly lousy.’
It all depends on the “from” aspect, arbitrage789.
I explained all of this prior to the decision.
That, I fear, is a major point.
And in the US the basis for such compound claims is more open to question than might be supposed because authority for them although 100 years old is at the level of the lower courts, not the Supreme Court. Revival of the decision in Kalo v Funk which was really an obviousness case and was intended to have been over-ruled by the 1952 legislation does not help. That decision is correct in its outcome but in the way in which it was expressed is thoroughly lousy authority for anything.
An article by Christopher Beauchamp : The pure thoughts of Judge Hand is very helpful and informative. It can be accessed here
link to law.nyu.edu
Seems like it won’t be long before someone challenges the validity of a patent in which the claims are drawn to naturally-occurring proteins. Given the Myriad/SCOTUS decision, why wouldn’t the CAFC be obligated to invalidate all such patents?
Ditto for all claims drawn to naturally occurring compounds from plants, fungi or insects.
Or you can be like the flaming @$$ Malcolm…
(but, really, would anyone want that?)
That’s not my chin, son.
“. I just want the reasoning behind those decisions to be forthright”
LOL – you mean the reasoning that I explained to you and that you wouldn’t listen to? The very same reason that AFTER the oral arguments you in a panic took the very same position I advocated when you were talking with another PhD on these boards? That reasoning?
LOL – it’s archived you duplicitous pr1ck.
And yes the bonfire is clearly understood – I pointed out that I was going to use that archive liberally and invited you to use your ‘stellar legal logic’ and your ‘absolute mastery of English as a first language’ to undo your self-immolation when you FINALLY took your first substantive attempt at squaring the Prometheus decision with the precedent case most on point.
That too is forever archived.
And you still don’t have the nuts to simply admit that I was right and that you were wrong.
Nearly 21,000 words of mewling QQ. LOL, what a meltdown, and I have enjoyed every last word of your tortious and futile twisting.
Best.
Week.
Ever.
And please, add another 21,000 words. Squirm away son. Who knows, you may burn more than your hands if you attempt again to delve into substantive law.
Hmmm, maybe you want to put some salve on those mits of yours before you venture into the Ultramercial case. I am guessing that 101 Integration Expert will want to hear from you. Maybe you can invite Keeping It Real, Robert, Francis, Shrivan and Vivika M – don’t worry, you won’t need more than two chairs for all of you and 101 Integration Expert.
LOL.
the Prometheus claim would have been both patent-eligible and inventive.
Huh. I talked to several partners at some of the best EP patent law firms and they all agreed that the claims would have been found obvious.
I wonder what facts you are confused about.
Unfortunately that is indeed what it may have done.
Aw shucks – it is easy to fend off the arrows you shoot as they are all around your own feet.
Now if you actually had a legal point to make…
Once again, and quite fittingly, “D’Oh!” (said in the best Homer Simpson tones)
If you agree with me (as you say you do), then why shoot arrows at me? … Instead, we are treated to you running around in your cheerleader outfit, eyes full of petroleum, begging for another spear to the shoulder.
Honest Abe, fending off arrows and spearing blind cheerleaders in the shoulder, all in the defense of our constitutionally derived patent regime. What can’t this man do?
Creating a dust cloud by throwing yourself into the dust seems like a really poor way of trying to make a point.
The only point being made is that you are obsessed with self-destruction.
As with Malcolm, I have no problem handing you your head when you ask me to do so.
Open your eyes Leopold.
If you agree with me (as you say you do), then why shoot arrows at me? If you do not agree with me, then why not express the legal point you disagree with and explain the way the legal point should be understood?
Instead, we are treated to you running around in your cheerleader outfit, eyes full of petroleum, begging for another spear to the shoulder.
Why is it that you feel that urgent need to charge at “anon said,” when you have nothing intelligent to say?
Honest Abe is a matador, too! Truly, a legend in his own time.
link to lcanimal.org
LOL – like the calls to go easy on Malcolm, (and the crybaby veto when I ‘attack’ those who only want to soapbox), once Leopold steps into the ring with me, his fate is preordained.
Unlike the bulls, though, he does have the choice of whether to engage me or not.
As I have oft posted, there is a simple way to avoid the gore: don’t post the CRP in the first place.
LOL – still clenching your eyes tight and proclaiming “I cannot see”…
Some friendly advice (unless you really like to collecting puyas:
Put. The. Shovel. Down.
You first could not figure out which case (after I used the name of the case). You then tried to twist it that I wanted to talk about race.
I think I understand now. First you invoked the three-fifths clause of the Constitution to calculate the number of “robes” on the Court, somehow concluding (apparently without reference to race) that one of those robes should only count as 3/5. Then you tell us that you were actually drawing an analogy between the Dred Scott case and the Supreme Court’s recent jurisprudence. Then you complain to NWPA that some kind of “liberal trap” prevented upstanding people like yourself from even discussing racism, and that refusing to acknowledge race was disrespectful. Then, when I expressly invited a discussion about racism, you tell us that you were not talking about race at all. Now we find out that you were merely parroting Abraham Lincoln when you referred to the Court as having eight-and-three-fifths robes.
It’s all perfectly clear. I think I’ll call you “Honest Abe” from here on out.
Cheers, Honest Abe!
Because a Supreme Court writing law beyond their authority has nothing to do with the Supreme Court acting beyond their authority…
D’oh! (said in the best Homer Simpson tones)
And it’s amazing how hard you try to not understand.
You first could not figure out which case (after I used the name of the case). You then tried to twist it that I wanted to talk about race.
Funny that you NEVER shoot your arrows at Malcolm (and believe me, there are oh so many targets provided), and yet, the little red cape of “anon said” send you into a frenzy…
Perhaps if you actually think – and actually open your eyes, you will see the commonality that this “amazingly flexible ‘point’” has. Maybe you will try to understand, instead of trying so very hard NOT to understand.
I doubt it, since all you see is the moving red and blindly want to charge.
Olé!
EXACTLY my point with the 8 and 3/5 robes comment.
That’s an amazingly flexible “point” you made with that comment, anon. Just yesterday you said that your comment was intended to draw an analogy between the Dred Scott decision and the Supreme Court’s recent decisions in patent law, because of the powerful emotions that they invoke. Now it turns out that you were actually invoking the spirit of Abraham Lincoln! Congratulations – you’ve outdone yourself (again).
“ and that is what has been done here.‘
Most decidedly not Paul. You have backtracked and now attempt to deny the obvious.
You not only showed a difference, you advocated a position on that difference.
I merely called you out for this and suggested that if you are going to advocate a position, you would be better off by providing meaningful support for that position. Such support would necessarily involve recognizing the sovereign jurisprudence.
Had you done that, then you would have quickly realized that your call for our US Court to give comity to other nation’s laws would result in that Court actually WRITING law (and not just interpreting law).
However, Paul, you do edge closer when you state “But there may be less room for such a task where what is involved is interpretation of a statute” but you need to go that one rather small further step for US jurisprudence and look at explicitly which branch of the US government (and only one such branch has been designated) has been provided that power to write law under our constitution in this EXPLICIT domain of intellectual property. That one branch is not the judiciary. That one branch is not the executive. That one branch is not the federal agency (our ‘fourth branch’ in the modern world).
Your hesitancy is confusing:
“However, I cannot undertake to do so and publish it because that detailed study could lead to the opposite conclusion.“
LOL,… could? Far greater standard of care? You need a lower standard to blurt out orthodoxy?
And you better take more care in understanding what happened in 1952. The common law authority that had been given to the judiciary was revoked at that point (your comment about “1836 substantially unchanged” is substantially wrong).
“His warnings about the limitations of the Court are becoming more pertinent.”
EXACTLY my point with the 8 and 3/5 robes comment. And yet, those of the little circle club jump at the chance of closing their eyes and running full speed into the nearest wall.
I see no meaningful excuse why this topic has not been addressed by academia. Not in your posts here, nor anywhere.
One additional comment may be helpful.
At first sight both Prometheus and Myriad have the appearance of judicial legislation. The US Supreme Court routinely embarks on that task and many of its decisions are far-reaching and enduring in their consequences. But there may be less room for such a task where what is involved is interpretation of a statute, and that is an aspect which in my opinion needs consideration. In the UK the UK Supreme Court (formerly the House of Lords) considered its role more limited than its US counterpart.
@ Anon
It is straightforward to say that the Myriad decision puts US law out of line with the rest of the world. On the whole when you write a posting, you should confine yourself to a single topic, and that is what has been done here.
It is far less straightforward to say whether or not the decision is objectively wrong having regard to the evidence and previous case law (including Supreme Court case law). I plan to study that issue and write a piece. However, I cannot undertake to do so and publish it because that detailed study could lead to the opposite conclusion. And in view of the importance of the case, it is unlikely that I will be the only person embarking on that task, so that other papers and postings may appear which make anything from me unnecessary and inappropriate. It is one thing to say that a decision is unwise; it is quite another to say that the decision is wrong, and a far greater standard of care and thought is needed for the latter.
Whether or not the Supreme Court is acting ultra vires is not a question I have the knowledge to consider. The correct interpretation of the claims objected to, the plain literal meaning of the statute and the impact of the Court’s judicially created exceptions are matters that are more straightforward. The question that I will be looking at is whether the decision was reached per incuriam, e.g. creating a conflict with older established case law or with the plain meaning of the statute (the wording goes back to 1836 substantially unchanged). In that regard, attention needs to be paid both to the questions actually addressed in the opinion, and also to other questions that ought to have been addressed and in fact were overlooked.
So far as the last question is concerned, lawyers in the UK have ways of dealing with situations where a decision was handed down per incuriam. They usually say that even though the decision may have been correct as between the parties there is no binding rule or principle that should survive to other cases. What US lawyers may wish to do given the extreme respect for the Supreme Court within the US is difficult for a non-US person to judge. But if you look at Lincoln’s first inaugural address you will find an alternative view of the Supreme Court that came from a distinguished lawyer who had only just given up his legal practice to embark on the Presidency. His warnings about the limitations of the Court are becoming more pertinent.
Yes Paul – even though you said your purpose was something else, it was clear that your view was that the decision was objectively wrong. I hope you picked up that not-so-subtle hint.
But you kind of left out any type of support for that position.
And that is no doubt far more important than the simple notice that this decision is different than ROW (don’t get me wrong – I do appreciate your fine work in showing how ROW went about this – thank you!)
However, for you to simply state “unsupportable under US domestic law” and not address this – nor any of the points I made showing why the reverese is true, well, that is a glaring lapse.
I do enjoy your last question. That is the major gist of my long running commentary on the Supreme Court itself acting ultra vires. Would love to see some academics try to answer that.
Let the record show that Malcolm has failed.
Failed to find the nuts to admit he was wrong and I was right.
Failed to defend his pet theory that he tossed on a bonfire of his own making in his first substantive attempt to square Prometheus with the precedent case most on point.
Failed to deny his own 1ying svckpuppetry (that he had previously sworn he did not do when he was QQng up a storm).
And my intern just came in with this: Malcolm has posted nearly 21,000 words in one week on something ‘that he doesn’t care about.’
LOL – nearly 21,000 words of mewling QQ and not word to show he has the nuts to admit the plain FACT that I got the decision and reasoning right and that he was wrong.
So ends this chapter on Myriad, with a wonderful bookmark to the torching admission by Malcolm and a whole lot said that amounts to nothing.
Life is good.
@Anon
Since I have a day job I cannot answer everything. Besides the point of this posting was simply to point out how far the US has deviated from the law of other countries.
It may be no great secret, but my preliminary view is that the decision is objectively wrong and unsupportable under US domestic law. The errors, I suspect, are at the undergraduate level. That, however, will have to be the subject of considerable further investigation and if supported with be the subject of another posting.
And what should be done with a decision of a high authority such as the Supreme Court which is simply and plainly wrong?
Ned, your stonewalling and refusal to cooperate in discussions is legendary. This simply is one more example.
Ned, your stonewalling and refusal to cooperate in discussions is legendary. This simply is one more example.
Ned, your stonewalling and refusal to cooperate in discussions is legendary. This simply is one more example.
Ned, your stonewalling and refusal to cooperate in discussions is legendary. This simply is one more example.
Ned, your stonewalling and refusal to cooperate in discussions is legendary. This simply is one more example.
You are welcome Paul.
I take it then that you are passing on the other questions I asked…
The process patent is fine.
There does appear to be an IMPLICIT problem with 271. You might want to check with the Black Robes.
“ on the contrary, congress can and has authorized patents on processes that product products regardless that those products are in nature or even old”
Nice strawman. No one is arguing about the patent for the process.
“The products produced by the process are covered by statute.”
There you go again, assuming the conclusion of the matter, and ignoring all the points I have raised that say you simply cannot make such a presumptuous statement.
“not a product of man”
There you go again, repeating a blatant error that I have corrected you on man times now. PAY ATTENTION NED.
271? Ned, you cannot do an end around against 101.
No matter how many times you repeat your errors, you are still wrong.
And you haven’t even bothered to try to address my points. Who is the one not being cooperative Ned?
That would be you.
Dialogue takes two. Won’t you join me?
anon, on the contrary, congress can and has authorized patents on processes that product products regardless that those products are in nature or even old. The Supreme Court agreed, even in Myriad, that such processes are eligible, see the beginning of Section II. The products produced by the process are covered by statute.
The first isolation of DNA was done in 1869 by Friedrich Miescher. link to en.wikipedia.org The fact that the isolation process is now more than a century old does not make isolated DNA not a product of man. It remains a product of man because isolation is a man made process invented by man.
I think they really need to reconsider this case in view of 271(g). It cannot be that when a patentable process produces a product that is chemically identical to an old product or a product found in nature that that process is not eligible for patenting. This would imply that Rader's decision in the en banc case concerning products by process claims is flat out wrong.
Rader is never wrong.
Right?
You are not listening Ned.
271 – your tie-in cannot trump 101, just as 102 or 103 cannot trump 101.
This is at least the third time I have explained this to you.
L I S T E N
Anon, but this is nonsense.
You agree that one can patent a process. By statute that process covers the product it produces. Then you say that one cannot patent the product of the process because it is a product of nature even though it is a product of a patented process and not a product of nature.
Let's stop using the ultimate legal conclusion in our statements for a moment. The patented process produces chemical X, call it processed X. The claim covers, under 271(g), the products produced by the process, processed X.
Now, a I read Myriad, the process claim cannot cover processed X because it has the same chemical structure as chemical X in nature. But that implies that 271(g) is unconstitutional.
What the Supreme Court needs to do is reconsider its holding in light of 271(g).
Now, remove the stipulation that the product is NOT a product of nature.
As it turns out, examplelitus grows like a berry on shrubery in Boxtawani, and is merely plucked like a life from the shrubery for export.
Clearly, this then is product of nature and should be free to all men, and unencombered by patent law.
Dicusss.
Many thanks to all contributors for their comments on this posting
Same reply as below: 101 trumps (102/103/112/271)
No Ned, you miss the point – and the law – and that is exactly why I was right in Myriad and you were wrong.
One simply cannot do as you indicate the attempt to do to get around the 101 issue.
The 101 issue (product of nature) simply trumps (102/103/112/271).
Exactly as I have explained to you. Continue in your ignorance at your own peril .
No, anon, you miss the point. If one limits the claim to the product of the process, it is not a product of nature. It is a product of the process.
That is what Myriad claims do.
Anon, you seem to miss the point. If “isolation” is a process, and I think it is, then Myriad claimed the product of a process, that is clearly not a product of nature.
Sent from Windows Mail
Another (non-101) wrinkle to throw at the 271(g) problem – and another reason 271(g) won’t save you.
Take a product that is admitted to NOT be a product of nature. Let’s call it ‘examplelitus.’
Examplelitus is invented in 1971, and has passed into the public domain.
There happens to be 10,000 known ways of making examplelitus (hey, it was a great material and lot’s of people wanted to make it – the patent system worked and progress was really really promoted).
Inventor Moe invents a new method of making examplelitus, Process Whoopdi. A proper and valid patent (over and above the 10,000 known ways) is obtained for Process Whoopdi in 2010.
Inventor Larry invents a new method of making examplelitus, Process Doo. A proper and valid patent (over and above the 10,001 known ways) is obtained for Process Doo in 2012.
Importer Curly has been importing examplelitus from country Boxtawani since 1995.
Both Larry and Moe file suit against Curly in 2013 under 271(g).
Discuss.
correction: the new way of processing (a method) is perfectly eligible – now, and just like before Myriad.
It is the coverage of the product (of nature) that Ned goes off the deep end and gets all wet.
“into water. This claim is 101 eligible in my view.”
Your view is wrong.
As wrong as song.
To Patent Law, it just does not belong.
Ned – WRONG WRONG WRONG.
Process elligible – yes (rather mundane) the product? no: sing the song, sing the just plain wrong song.
You reach too far with 271 to try to take something from the warehouse. It is as bad (and as wrong) as you attempting to patent music. The method is not the item.
Nothing is wrong with Myriad. It is AS logical AND consistent with the statutes AS – EXACTLY AS – any other case that deals with the judicial exceptions. As I pointed out to Paul: those judicial exceptions rise and fall together.
And just as I pointed out to you: (and yet another point you have not addressed: hanging your hat on the ‘rendered useful’ hook would mean that Benson, Flook and even Prometheus would need to be – MUST BE – overturned.
And by the way, Paul does indicate that this might be so with his comment regarding Prometheus.
“means that the product is made by man”
Ned – you are being pedantic again.
It is a term of art: product of nature. I have told you before it does NOT mean the literal ‘item producED by nature.’ You are seemingly purposefully trying to play word games (reminiscent of your obfuscation of ‘as a category’ versus ‘categorically.’)
Likewise, just because man can make something, does NOT mean that the item is not ALSO something that can be ‘producED by nature’ (to use your backlsiding.
The term of art simply means that that item cannot be patented, even if ‘made by man’ IF it is a product of nature – as the legal term of art stands.
Again, a point I raised and one you have chosen to ignore (or simply get wrong) is H20. Did you look at the patents I provided? Did your review the patent landscape report? All of these concern patents for making water. Yet NEVER did anyone even think of patenting that water, or trying to enforce 271(g) over the water made by those patented processes.
Quite simply, THAT particular product H2O falls outside of the bounds of patent law (and that includes 102/103/271) EXACTLY like the result of music falling outside the bounds of patent law. It is barred at the gate. Period. Again – this is why I “attack” you when you attempt fallacious arguments ignoring the bounds of law and the useful arts. And AGAIN, this is a point I have raised which you have chosen to ignore.
You are trying very very very hard to stay very confused.
Stop backsliding.
The “idea why anyone would say otherwise” is found in the Supreme Court case law I have long asked you to consider: Chakrabarty. There is a reason why I asked you to support your counter-position with a legal authority, and there is a reason why YOU NEVER DID SO. You continue to ignore the explanation that such items are not meant to be included in patent law as the warehouse of nature belongs to all men.
It’s like the Calvinball face sp1ke lover jumps right past the gate and wants to be mired in doctrines that need not be applied.
You are engaging in the very same type of self-deception (giving you the benefit of the doubt – others like Malcolm are engaged in the deception of others)
“means that the product is made by man”
Ned – you are being pedantic again.
It is a term of art: product of nature. I have told you before it does NOT mean the literal ‘item producED by nature.’ You are seemingly purposefully trying to play word games (reminiscent of your obfuscation of ‘as a category’ versus ‘categorically.’)
Likewise, just because man can make something, does NOT mean that the item is not ALSO something that can be ‘producED by nature’ (to use your backlsiding.
The term of art simply means that that item cannot be patented, even if ‘made by man’ IF it is a product of nature – as the legal term of art stands.
Again, a point I raised and one you have chosen to ignore (or simply get wrong) is H20. Did you look at the patents I provided? Did your review the patent landscape report? All of these concern patents for making water. Yet NEVER did anyone even think of patenting that water, or trying to enforce 271(g) over the water made by those patented processes.
Quite simply, THAT particular product H2O falls outside of the bounds of patent law (and that includes 102/103/271) EXACTLY like the result of music falling outside the bounds of patent law. It is barred at the gate. Period. Again – this is why I “attack” you when you attempt fallacious arguments ignoring the bounds of law and the useful arts. And AGAIN, this is a point I have raised which you have chosen to ignore.
You are trying very very very hard to stay very confused.
Stop backsliding.
The “idea why anyone would say otherwise” is found in the Supreme Court case law I have long asked you to consider: Chakrabarty. There is a reason why I asked you to support your counter-position with a legal authority, and there is a reason why YOU NEVER DID SO. You continue to ignore the explanation that such items are not meant to be included in patent law as the warehouse of nature belongs to all men.
It’s like the Calvinball face sp1ke lover jumps right past the gate and wants to be mired in doctrines that need not be applied.
You are engaging in the very same type of self-deception (giving you the benefit of the doubt – others like Malcolm are engaged in the deception of others)
I meant 271(g).
A man invents a new way of processing car exhaust into water. This claim is 101 eligible in my view. But under 271(g), the water produced is covered by the patent so that anyone using or selling that water in the US is now an infringer.
A man invents a new way of refining gasoline from crude. That process should be 101 eligible. Under the law, the gasoline produced by that process is covered by 271(g). But under Myriad, the claim covers a product of nature, gasoline, and therefor must be ineligible.
Something is wrong with Myriad. It is not logical or consistent with the statutes.
Someone needs to file a motion for reconsideration.
anon, I read the case. It appeared that it was hard to prove some claim elements. Did you have anything specific in mind?
Btw, the case is Dynacore, not Dynacare. I couldn’t find it for awhile.
More on o4:21. There are cases, IIRC, on the “substantially changed” issue. But I do not recall any cases where liability or potential liability was found based on 271(g) other than Zoltek.
Regarding policy: a claim to the product of a process necessary means that the product is made by man. I have no idea why anyone would say otherwise.
“That claim covers isolated DNA per 102(g).”
I will assume that you mean 271(g).
Have you read the case I provided before you responded with a question that case may have already answered?
Have you find a case (any case) that may have actually addressed the question you are seeking an answer to? (and No, Zollteck does not count, as Rantanen has suggested).
Have you even contemplated ANY of my questions at 4:21 before you typed your questions at 4:57 ?
You are thinking (and placing your desired end result) before you have informed yourself (again). Such thoughts (not to be mean), have very little value.
“That claim covers isolated DNA per 102(g).”
I will assume that you mean 271(g).
Have you read the case I provided before you responded with a question that case may have already answered?
Have you find a case (any case) that may have actually addressed the question you are seeking an answer to? (and No, Zollteck does not count, as Rantanen has suggested).
Have you even contemplated ANY of my questions at 4:21 before you typed your questions at 4:57 ?
You are thinking (and placing your desired end result) before you have informed yourself (again). Such thoughts (not to be mean), have very little value.
“On the whole, the Biotech industry will, I hope, take a longer and more pragmatic view of where to locate its research.”
Pragmatic is not the right word for you Paul.
Pragmatic is the word that fits how I have described the reality that Big Corp has NO allegience or sense of corporate citizenship to any one sovereign.
Pragmatic is mercenary in the ultimate sense of the word.
And here, I thought your purpose had a bit more than merely point out the difference. Funny how “quite a shame” is not indicative of an objective “point out the difference” and the tone of isolation – while perhaps true, carried with it more than just a casual observation of how things are.
Let’s be honest, Paul: you were advocating for a certain desired result. Yes, you were ‘pointing out the difference,’ but please, don’t be offensive in pretending that was your overall purpose. There is too much other stuff and not enough objective baseline for that to be your overall purpose.
You write better than that. At least I hope so.
Ned – more moving of goalposts from you (with questions and not answers).
We have also been on this merry-go-round before.
Or don’t you remember the rejoinder that I have provided (many, many, many times): encryption.
Stop the stalling and goalpost moving.
“a stream of American political thought”
That’s one stream that seems to have that global-big firm ‘taint.’
And pardon me for being ‘an ugly american,’ but I don’t take kindly to the ignoring of sovereignty when the desired end result happens to coincide with ROW – especially when the path there is decidedly against the way US law is designed to work.
I get (and respect) that ROW has decided differently. In that sense, I am showing more respect for law than what I am seeing ‘in the stream.’
I get the international comparision on the result – but your piece is more than just a little one sided and missing those elements of US jurisprudence that actually dictated the result here. It surely does not help matters that there are those perfectly willing to kick up dust and TRY not to understand what has happened. There is no shortage (of words) from those who would rather QQ, or have this be some sort of Apocalypse.
That is not to say that it is impossible to explore some intersting wrinkles. We KNOW the consitutional authority for writing patent law in the US lies with Congress (and only Congress). We KNOW the Court has been ultra-careful in its wording and deliberate tracing to that authority. But how many things lurk implicitly? And (as I asked above), if you single out this one judicial exception, what of the others? Do they rise and fall together? Why or why not? If the Court is WRITING based on policy and ‘implicit’ is not good enough, then all the judicial exceptions rise and fall together. What differentiation is there in the implicit words? Is that differentiation a sub-level down, implicitly found within the implicit words? As the Court itself would have it, they are NOT free to rewrite, and quite frankly, ANY foreign view – no matter how much comity one would like to have, would be a clear indication that the Court was in fact writing law – and thus the Court itself would be violating the Constitution.
That’s a rather important legal thing here, no matter which political stream you want to swim in. And certainly, one which I would not be willing to sacrifice just to fit in with ROW.
Ned,
Your mind may have more ‘influence’ if you did not fall behind in the conversation and you addressed my replies rather than your desired end result.
You seem to have a hydra of questions, but you don’t seem to be able to come back to mine or address the points I raise (except with questions).
‘Unprecedented’ would be seeing you answer questions, acknowledge points, provide cases (on point) as requested and generally refrain from jumping to your conclusion in midstream.
anon, assume I first invented the method of isolating specific DNA sequences from cells.
I claim the method.
That claim covers isolated DNA per 102(g).
Is the method claim barred by 101?
I hardly think not.
Yet, that seems the result of Myriad.
Paul, the word “unprecedented” also comes to mind.
Anon, I invent a new form of data compression. How can I claim it, that is the real question, is it not?
But Night, we agree that useful applications are eligible. Where we do not seem to agree is on your notion that we can patent information processing per se, not applied o anything.
As to the title, see mu post below.
On the whole, the Biotech industry will, I hope, take a longer and more pragmatic view of where to locate its research.
And overall, my purpose is to point out the difference between US law as it now stands and that of other countries.
In reply to Anon’s question, “isolated” in the title encapsulates three things. Firstly the subject matter in dispute. Secondly the effect of the Myriad decision on the relationship between US law and that of other countries. Thirdly a stream of American political thought. In a single word it encapsulates the subject matter in dispute and what is wrong with the outcome, at least as viewed from outside the US.
Ned – there is not on eword because the case was not about that.
There was not one word about divided infringement. Does that mean jurisprudence on divided infringement has been all thrown out?
Another few steps behind, you have fallen.
I am not following you on this jump Ned.
Your comments on ‘use’ and my replies to your comments have nothing to do with any NEW ‘real question’ you are moving the goalposts to in your 3:33 comment.
Ned,
As I mentioned, I had not thought of the 271(g) statute in relation to this case.
But as I also mention, that statute does not directly touch on the 101 question at all, does it?
That is why I stressed Rantanen’s comment. Rather than having been decided (in whatever way), the 271(g) portion appears to still be ‘virgin’ territory.
But if I think about it for a moment, as to any actual product of nature and product made by a process under patent, don’t you think that Dynacre Holding Corp v. U.S.Philips Corp (363 F.3d 1263) might have something to say about the product? Don’t you think that the policy driver of 101’s product of nature has a lot to say? How much more substantial can you get than free to all men? How much more noninfringing can you get if there is no infringement possible by law (by policy winkwink)?
How can an idea drive a car or detect J. Lourie’s wife breast cancer?
How can an idea be a machine? How can you say that a machine that is driving a car is an idea?
Functional claims in information processing are a recitation of structure.
It really is funny Ned that you don’t get the relationship between your statements and you being confounded on this recent decision.
Frankly, it is hilarious. Your employer must update their talking points.
Night, in order to infringe, the one must make something, use something or sell something.
How can one infringe an idea?
anon, the real question is whether the use has to be claimed, or whether examples in the specification might be sufficient.
The statute, 271(g) reads in material part:
Whoever … sells, or uses within the United States a product which is made by a process patented in the US shall be liable as an infringer.
Ned,
Just because the argument was not used in Myriad does not mean that the argument cannot be used in a case where that fact pattern presents itself.
You are starting to do that thing again – mis-citing cases by over and under reading them.
And I asked you for a case.
And I pointed out that the statute does not help your 101 argument because it applies to non-101 items with equal force.
C’mon Ned – you are falling way behind again.
“applied to some use”
Ned, you have not answered me regarding your very dependence related to ‘use.’
Why is that?
Benson used a judicial exception that is supposed to applied as narrowly as possible to swallow all information processing methods. That was the attempt that partially succeeded. Benson is based on saying that anything that computes a number (a mathematical algorithm) is a natural law, which is not true.
Benson also tried to hold that anything that takes all possible uses on a computer is abstract. This is also outrageous in being against both patent law and common sense and in expanding a judicial exception as if it was passing a law.
And, you still just can’t get your head around how Benson relates to this case can you?
“This is a pretty typical post of string of yours MM”
It’s like you know the workings of his inner mind…!
Well, that and he has played out his stale bag of tricks ad nauseum ad infinitum
Always great for quality blogging.
/eyeroll
C’est La Vie
“This is a pretty typical post of string of yours MM”
It’s like you know the workings of his inner mind…!
Well, that and he has played out his stale bag of tricks ad nauseum ad infinitum
Always great for quality blogging.
/eyeroll
C’est La Vie
Night, Benson only required that the math be applied to some use. There is nothing really wrong with Benson.
Invade?
I think we have treaties and discovery, even when the defendants may not be in the US. They have to respond to interrogatories. They have to respond to subpoenas. They have to respond to every discovery order on penality that sanction may be entered against them, including a finding of infringement.