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August 26, 2014


"It is taken for granted within the profession that officially-issued regulations and guidelines will have been checked for compliance prior to issue."


Unfortunately, too often true, although less so after the GSK/Tafas suit which challenged the USPTO continuation/claim rules.

With respect to the Myriad-Mayo Guidelines, the USPTO acts oblivious to our treaty obligations under TRIPS. That's also true of Our Judicial Mounty Olympus who feel no obligation to even obey/construe correctly our patent statutes.


Contrast this with the deference given to Congress - and the international treaty effects in the Golan v. Holder case.

The difference is the animus to patents.


Your point is well-made. In Golan the Supreme Court said: "Yet the TRIPS accord, leading the United States to comply in full measure with Berne, was also a signal event. See supra, at 7–8; cf. Eldred, 537 U. S., at 259, 264–265 (BREYER, J., dissenting) (acknowledging importance of international uniformity advanced by U. S. efforts to conform to the Berne Convention)."

How can TRIPS be a signal event for copyright but of no consequence for patents?

I think that this is a great argument, and a really unassailable reason why the current Guidance must be drastically reformulated. Did anyone make this argument to the Supreme Court? I do not remember seeing this point raised in any of the briefs in Myriad.


You did ask, so here is the answer.

An amicus brief had been filed by the Institute of Professional Representatives before the European Patent Office (epi), whose opinion was that:

“In Europe, especially before the EPO, genetic material is not seen as a special case requiring treatment different from chemical compounds and other products. Thus far, this view has been shared by the patent offices of the United States and Japan. In the opinion of epi there is no reason to change this view.”

Subsequently Myriad filed a Respondents’ brief confirming the world-wide patentability of isolated genetic sequences and explaining that:

“ … Here, however, the established rule for over 100 years has been that isolates or extracts from natural materials that reflect human invention are eligible for patents, and the USPTO and courts have concluded for over 30 years that particular claimed isolated DNA molecules reflect patent-eligible human ingenuity…

Additionally this established rule harmonises with that of every other industrialised nation. Europe and Japan, for example, have officially pronounced their adherence to this rule. See EU Directive 98/44/EC, Art. 5(2) … Japanese Patent Office Examination Guidelines for Inventions in Specific Fields, Ch. 2, §2.2.1(1), …; Brief of Amicus Curiae The Institute of Professional Representatives before the European Patent Office (epi) in Support of Neither Party …

The Federal Court of Australia, too, has endorsed the rule in rejecting an identical attack on Myriad’s Australian patents. See Cancer Voices Australia v Myriad Genetics Inc., [2013] FCA 65 ¶ 108 (Austrl) … (‘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’ (emphasis added))”

These arguments were not dismissed as marginal but instead troubled at least some of the Justices of the Supreme Court as the following question taken from the argument transcript establishes:

JUSTICE GINSBURG: “General Verrilli, there's an assertion made in Respondents' brief that the United States would be in a singular position. That is, they suggest that in every other industrialized nation this could be patentable. Is that so?”

Solicitor General Verrilli’s reply was intended to establish that these assertions were false and to instruct the Court that this was a purely domestic issue about which the law of other regions and nations could offer no meaningful guidance.

GENERAL VERRILLI: “No. I think the picture is much more complicated than that. In many other nations it wouldn't be patentable and the patent law is different from nation to nation. I'll give one example I think helps illustrate the point. In Germany and France, for example, you can get a patent on isolated genomic DNA but only for a particular use. So you would get what is the equivalent of a use patent, which is a patent that we would think under our patent laws is acceptable, too".

General Verrilli's answer was thoroughly disingenuous since it ignores the EU Biotechnology Directive which has been written into the EPC Implementing Regulations. The exception in German and French national law refers only to human sequences, so that sequences from other organisms are patent-eligible, a point not explained to the judges. Furthermore, it appears from Monsanto Technology LLC v. Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BV, Alfred C. Toepfer International GmbH, Judgment of the Court (Grand Chamber), 6 July 2010, Case C 428/08 that the harmonisation effected by Article 9 of the Directive should be regarded as exhaustive and precludes national legislation from producing a different effect. So the German and French exceptions mentioned by General Verrilli were known well before the Myriad oral hearing to be arguably in conflict with the Directive and hence invalid.

I am inclined to think that the Justices of the Supreme Court disregarded General Verrilli and instead paid attention to what was said in the above briefs, and that the holding of Justice Thomas was carefully crafted to avoid harmonisation issues and possible TRIPS incompatibility.


It was raised early in the Myriad proceedings, but gained no traction.

The jokes about Mickey Mouse and his influence on copyright law should be compared to the loathing from the Court towards "scriviners" who can write claims that meet the actual words of Congress, and yet - to the Supreme Court - "reach too far."

How can anyone NOT see that the Supreme Court has overstepped its bounds and is fully playing in a policy role expressly reserved for Congress is beyond me.

From Mayo:

"...process is more than a drafting effort designed to monopolize the law of nature itself ..."

If only some of the claims reaching the Supreme Court or the Federal Circuit were the result of brillant and subtle drafting! But the sad truth is that well drafted documents, whether wills, contracts or patents do not reach the courts. It is the casualties where things go wrong that the courts see.

While I share the concern with over-interpreting Mayo and Myriad, arguing that TRIPs compels the United States to interpret patentability of "isolated" DNA molecules the say way Europe and Australia have done is unlikely to be persuasive, or news to the Supreme Court. (And we await the final word from Australia.) The S Ct was fully aware of the 1952 Patent Act and unanimously decided Mayo and Myriad (and now Alice) anyway. At some point, it is probably time to find distinctions between antibiotics and vaccines and vitamins and other things that should be patentable despite being found in nature (but not in useful form) from discoveries like diagnostics whose purpose is to extract information about DNA sequences in living bodies. There are lots of ways to do that, but asking for anything "pure" or "isolated" to be patent-eligible seems unlikely to persuade members of our highest court. Saying 102 and 103 and 112 will do the trick does not seem to have worked with Justice Breyer. There *are* real problems with letting exclusive rights move so far upstream. Time for the hard work of making distinctions, not more moaning about how the S Ct disdains the epistemology of the patent bar.

Finding a way to distinguish naturally occurring DNA molecules that are not patentable from those that are (and some probably are--if the case that went to S Ct were a naked DNA vaccine or therapeutic, the decision would probably have been different) seems much more promising than arguing that TRIPS compels the US to change its law to reverse a series of unanimous S Ct decisions.

@ Bob

Please refer to my comment at 10.37.

It is common ground that mere isolation does not suffice. But isolation accompanied by new utility might. That is entirely consistent with the language of Myriad and Hartranft which was the tariff case cited in Chakrabarty. An earlier article of mine discusses the point in more depth.

I repeat my contention that Justice Thomas and his colleagues were fully aware of international issues and tailored their opinion around them So I am not asking for any change in substantive US law or any reversal of Supreme Court opinions that have been handed down, merely their prudent and correct interpretation.


Professor Palombi practiced law in Australia between 1982 and 1997.

He also advises that the appeal in Cancer Voices was argued in 2013, and that a decision is awaited.

Dear Dr. Cole,

Thank you for your response to my question. I was not as clear as I could have been. When I asked about "this argument," I did not mean arguments about particular EC directives or Australian Federal Court cases. The question that I meant to ask was more particularly concerned with our TRIPS obligations.

Did anyone point out to the Supreme Court that the US has treaty obligations to extend patent eligibility to "any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application"? This might not have made a difference in Mayo (because I see that Art. 27.3(a) allows the exclusion of diagnostic methods), but the citation of the treaty language might have made a difference in Myriad.

"I am inclined to think that... the holding of Justice Thomas was carefully crafted to avoid harmonisation issues and possible TRIPS incompatibility."

Really, so you think that TRIPS Art. 27.1 does not require that isolated DNA be patent eligible? Based on the original post about, this surprises me. How do you read the treaty text so as to leave open the possibility that isolation (or as some would have it "mere" isolation) is not enough to establish subject-matter eligibility?

"I am inclined to think that... the holding of Justice Thomas was carefully crafted to avoid harmonisation issues and possible TRIPS incompatibility."

Perhaps, but I don't see much evidence of it.
I'd add that the Supreme Court, in interpreting a statute, is not constrained by international treaties. Citing a treaty appears to be red flag to at least Scalia.

One item that I will put on the table: the Justices appear to be holding their patent line in 101, but basing their exceptions on constitutional grounds.

There is no treaty that will ever trump the constitution. If push comes to shove, the treaty will simply lose.

1. I practised law in Australia between 1982 and 1997 (not 1987 as is stated in your blog). I was an advisor in patent law in Europe and the United States between 1997 and 2001. I was a PhD candidate between 2001 and 2004. I practiced law in 2005 at Minter Ellisons in Sydney. I undertook my post-doc research at the Regulatory Institutions Network, Australian National University with Prof Peter Drahos between 2007 and 2011. Between 2011 and 2013 I advised generic pharmaceutical companies in regard to patent law reform in Australia. I returned to full-time legal practice in 2013.

2. My PhD thesis was submitted in 2004. It was examined by three external examiners, one of whom was Emeritus Professor William Cornish at Cambridge. Another was Prof Peter Drahos at the Australian National University. I was awarded my doctorate in 2005. The research for my candidature formally commenced in July 2001. Immediately prior to that I was an expert patent consultant to a number of international organisations and corporations who had retained me to advise on the validity of various patents over hepatitis C virus in Europe and elsewhere. I played a significant role in the successful opposition before the Technical Appeal Board in 2000 of Chiron's principal European patent over HCV proteins and protein diagnostics. And between 1993 and 1996 I was the lead attorney in the first Australian gene/protein patent challenge. The patent at issue was Chiron's HCV patent. My legal team's success in that litigation enabled my client (Murex) to continue to produce HCV diagnostic assays around the world. Unfortunately, Chiron got to keep its Australian patent. Such is the price of commercial expediency.

3. The Cancer Voices & D'Arcy v Myriad litigation remains alive. The first instance decision that you refer to is awaiting a decision of the Full Federal Court sitting with five judges, including the Chief Justice. Justice Nicholas's decision is therefore not settled law in Australia. Oral argument in the appeal was heard in August 2013. It is unusual for a Court to take this length of time to hand down a decision, but it is not unheard of. In any event, I expect a decision shortly. It is relevant to note that the appeal decision will be subject to a possible further appeal to the High Court of Australia (the highest court of appeal). I expect that it will be some time before the law is settled in Australia.

4. Your assertion that my thesis has not been influential is without merit. Indeed, if you carefully study the central argument in my thesis and compare it to the U.S. Supreme Court decision on isolated genetic material in Myriad you will note, even though the Justices do not cite my thesis, that their decision and reasoning are consistent. My thesis is the first publication in the world that sets out the legal argument that was adopted by the U.S. Supreme Court unanimously in Myriad.

5. Whether my thesis is influential in Australia has yet to be seen. There is an appeal pending and a further appeal possible before the matter is settled.

6. In regard to Europe, you will note that I am the first in the world to raise and discuss in a learned publication the issue that art 27.1 TRIPS is critical to the patentability of isolated biological materials. You and I diverge in our opinions.

7. In my opinion the Biotechnology Directive, not the U.S. decision in Myriad, is vulnerable. My thesis makes the argument that patent law in the U.S., the U.K., Europe and Australia prior to TRIPS did not allow for the patenting of isolated biological materials (see In re Genentech Court of Appeal 1989). My argument has been vindicated by the U.S. Supreme Court in Myriad, which reversed a 30 year policy that was erroneously adopted by the USPTO, EPO and JPO in 1988. It is therefore the case that as at 1995 when TRIPS came into operation patent law in the U.S., the U.K. and Europe was clearly not in favour of the patenting of isolated biological materials. That changed in Europe in 1998 when the Biotechnology Directive was passed by the European Parliament. Unfortunately, at the time no one in Europe was alive to the problem that this created in view of TRIPS because at that time no U.S. court had ruled on the issue that was ultimately determined by the U.S. Supreme Court in Myriad. The assumption was made that the Directive was consistent with U.S. patent law simply because the Directive's provisions were consistent with the policy adopted by the USPTO (and which has been decisively overruled in Myriad). In my opinion, it is the Directive that contravenes art 27.1 TRIPS, not U.S. patent law as interpreted by the U.S. Supreme Court in Myriad because it was patent law as at 1995 that the TRIPS negotiators codified in art 27.1. And the Directive came into operation in 2000. May I ask: if European patent law unequivocally permitted the patenting of isolated biological materials prior to 1995 then why was the Directive even necessary? The answer is that it was necessary to change European patent law. It was not simply a matter of clarification as some commentators propound, it was absolutely vital in light of the U.K. Court of Appeal's decision in In re Genentech. The Directive effectively overruled In re Genenetech.

8. It is relevant to note that the European Patent Office decisions are not judicial decisions. Decisions of the Opposition Division, Technical Appeal Board and the Enlarged Appeal Board are administrative. While it is true that EPO decisions are required to be given judicial notice under the EPC, they are not judicial decisions and therefore cannot be be given that status.

9. In any event, whether my thesis is cited or not, my thesis has played a role in clarifying patentable subject matter in the United States. My book, Gene Cartels, in Chapter 6 takes the central argument from the thesis and explains it in a non-academic manner. My book was presented to the ACLU's lead attorney, Chris Hansen in October 2009. I personally gave him a signed copy. You will note that Mr Hansen is not an expert patent lawyer.

10. Finally, the majority view on any subject at any point in time is not necessarily the correct view. If that were the case then the U.S. Supreme Court got it wrong in Myriad. Thankfully, the views of a very vocal majority of patent attorneys do not sway the minds of the Justices.

11. I was very much a lone voice in 2004 when I submitted my thesis. And I remained a lone voice for sometime thereafter. It took another 9 years for the U.S. Supreme Court to agree with me. Whether the Australian courts will follow the lead of the U.S. Supreme Court has yet to be determined. I believe that the decision you so confidently assert to be "more balanced" will be eventually overruled.

Personally, I would not only pause as to whether any change proposed by the Office fits within existing treaty obligations, I would pause for two additional considerations:

1) Given the history of the Office for overreaching its rule making authority, are the rules proposed within the scope of power of the Office? Here, the scope seems beyond their authority.

2) Given that patent law is territorial in nature, I would also question whether any rule goes too far in pursuit of harmonization. I fully reject the notion that unfettered harmonization is something in patent law that is up to the executive branch to put into play. The executive branch may suggest such moves, and may negotiate treaties for such, but here in the States, these types of treaties have almost exclusively been non-self-actuating.

@ GrzeszDeL

Apologies for the delay in answering your question.

In paragraph 32 of his declaration at first instance in Mryiad, Josepf Straus said: "In fact, the World Trade Organization (“WTO”) Trade Related Intellectual Property Rights (“TRIPS”) Agreement requires patent protection to be available for process and product claims in all branches of technology, without discrimination. TRIPS Agreement at Article 27(1))." The Straus declaration was referred to and approved by the EPI in their brief in Myriad. The answer, therefore, is that the Justices indeed had notice of TRIPS.


"I am inclined to think that... the holding of Justice Thomas was carefully crafted to avoid harmonisation issues and possible TRIPS incompatibility."

Really, so you think that TRIPS Art. 27.1 does not require that isolated DNA be patent eligible? Based on the original post about, this surprises me. How do you read the treaty text so as to leave open the possibility that isolation (or as some would have it "mere" isolation) is not enough to establish subject-matter eligibility?

The ANSWER is to be found in the note 5 to Article 27:

For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively.

The link between industrial application and utility firstly requires more than mere isolation but isolation + utility and directly alludes to the rule of law derivable from Hartranft as explained in Chakrabarty that a difference accompanied by new utility avoids the ruling in Myriad and suffices for eligibility under US national law. Such a position would, I believe be TRIPS compliant and compliant with practice in other countries and the EPO. I believe that there is NOTHING accidental about the words in which the ruling was expressed in Myriad, especially having regard to the fact that Justice Thomas majored in English Literature.

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