By Paul Cole* --
Introduction
It is strongly arguable that insofar as the USPTO's Myriad-Mayo Guidance[1] dismisses as non-eligible newly isolated substances (including small molecules), nucleotide sequences and microorganisms having new utility (US parlance) or producing new technical effects (European parlance) it is in conflict with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)[2].
It is unsurprising that only 10 of the 83 comments published to date on the USPTO website[3] cover this issue. It is taken for granted within the profession that officially-issued regulations and guidelines will have been checked for compliance prior to issue. The mind-set of most prosecution or litigation attorneys therefore treats such compliance as a background issue for which an independent check is not normally needed. Also, some organizations and companies have been unwilling to allege TRIPS non-compliance in deference to the USPTO and to the Government. But silence about objectively plausible non-compliance arguments once they have been identified falls into the Emperor's New Clothes fallacy, delays necessary remedial action, and does the USPTO no service.
Nine of the relevant comments assert non-compliance either directly or implicitly within the broader topic of international harmonisation. Only the Australian commentator Luigi Palombi[4] asserts compliance based on his 2005 PhD thesis entitled "The Patenting of Biological Materials in the context of TRIPS"[5]. However, his brief comment to USPTO takes no account of subsequent developments including the opinion of the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics[6].
Policy considerations underlying the Guidance
Those IP organizations and associations that provided relevant comments viewed the Guidance as a serious setback to harmonization. The position of the American Bar Association (ABA)[7] typifies comments made by the International Bioindustry Association[8] (representing member associations in Canada, Europe, Japan and the US), AIPPI Japan[9], The International Federation of Intellectual Property Attorneys (FICPI)[10], and the Chartered Institute of Patent Attorneys (CIPA)[11]:
The United States and specifically the USPTO should remain a strong advocate for TRIPS. The U.S. would not take lightly a member state carving out certain technology from the patent eligibility requirements of Article 27, and therefore the USPTO should reflect carefully on whether the Guidance as written will result in an invention or a category of inventions being declared ineligible for patent protection inconsistently with the letter and principles of TRIPS. The IPL Section respectfully submits that it remains important that the USPTO continues to lead by example in following the letter and principles embodied in TRIPS and narrowly apply Myriad and Mayo to do so.
Damage created by the Guidance is summarised by the International Bioindustry Associations:
The U.S. Government, together with the governments of EU member states, Japan, Korea, Australia and other major U.S. trading partners have been making efforts over a considerable period of time to encourage more harmonization and the adoption of more uniform and consistent rules relating to intellectual property and, in particular, patents. Progress, although slow, has been significant. Such efforts have borne fruit through increased membership and use of the Patent Co-operation Treaty, the adoption of the Patent Formalities Treaty and Patent Law Treaty, and in the extension of WTO rules to intellectual property. Currently, in negotiations that are taking place, U.S. negotiators are hoping that other countries will sacrifice tradition for uniformity, for example by considering the adoption of harmonized grace periods for inventor disclosures. The effect of an unnecessarily broad interpretation of the Supreme Court's decisions such as is proposed under the new Guidance will be a serious setback to such efforts and to progress in achieving further steps on the road to harmonization and the benefits that this would bring to many countries, but in particular, to the United States.
Compatibility with TRIPS
Simon Elliott[12] of Foley and Lardner argues that the USPTO must not interpret 35 USC § 101 in a manner that violates TRIPS. He traces the requirement to avoid conflict with treaty obligations to observations of Chief Justice Marshall 210 years ago in Murray v. The Charming Betsy that "an Act of Congress ought never to be construed to violate the law of nations if any other possible construction remains." He goes on to explain that decisions giving deference to agency interpretation of statutes have less force because the USPTO has no substantive rule-making authority, and that such decisions do not support giving deference to USPTO Guidance that has a general and substantive impact across a broad swath of patent applications.
The International Bioindustry Associations set out their views on the Guidance in generalised but nevertheless forthright terms:
By subjecting such inventions to a heightened patentability analysis, the Guidance conspicuously departs from internationally accepted standards of patent-eligibility. Many valuable inventions that would be patentable in the patent offices of the U.S.'s major trading partners will nevertheless be rejected in the USPTO because they fail to pass an extrastatutory "significant differences" test that has no equivalent in the patent laws of other industrialized countries. Doing so creates a deep disparity in substantive patent law whereby whole categories of socially beneficial inventions would face obstacles to patent protection in the United States but remain patentable among its major trading partners, with attendant harmful effects on the flow of investment, trade, and cross-border transfer of innovation.
The ABA argues that "as written the Guidance and the exclusions for patent eligibility under TRIPS do not appear to be consistent". FICPI takes that position, as also do Joe Liebeschuetz and Joe Storella commenting as individuals. Cole and Roberts[13] argue that any administrative or judicial interpretation of the provisions of any statute, including 35 USC § 101, which places the US in a position where it does not meet the obligations of an international agreement by which it is bound is prima facie incorrect and requires reconsideration, and further that:
These considerations seem particularly compelling in relation to the Supreme Court opinions mainly relied on for the extended interpretation applied in the Guidance. Those opinions include Hartranft v. Wiegmann, 121 U. S. 609, 615, 7 S. Ct. 1240, 30 L. Ed. 1012 (1887), Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) and Diamond v. Chakrabarty, 447 U.S. 303 (1980). Those opinions were well known to and understood by the US Government, the USPTO and US patent attorneys at the time when the TRIPS Agreement was negotiated. The US Government would not have negotiated that Agreement if there was at the time any reasonable ground for belief that US domestic law was inconsistent with the terms being negotiated. There is no basis in law or in logic for assuming that the rulings in those long-established opinions have changed between the time when the TRIPS Agreement was negotiated and now.
The conflicting examples
The eligibility of isolated natural products, including small molecules, lies at the heart of the Guidance. It is strongly arguable that each of the examples listed below gives rise to potential conflict with TRIPS.
Example B concerns purified amazonic acid, a hypothetical cancer-fighting chemical extracted from the leaves of the Amazonian cherry tree. It is not made clear whether it is a small molecule or, for example, a protein. The relevant degree of purity is not made clear, and as pointed by the Coalition for 21st Century Medicine[14], the wording could cover purities too low to produce a desired therapeutic effect. The alternative rapamycin-based example given by Cole[15] includes a claim specifying that antibiotic as a colourless crystalline compound of defined melting point.
Example A concerns a stable energy-generating plasmid which provides a hydrocarbon degradative pathway. This wording is unrepresentative because, as pointed out in recent comments by the Coalition for 21st Century Medicine the claim encompasses, as one of its distinct embodiments, a natural plasmid sitting in a natural bacterium. More typical is the claim suggested by Cole which is directed to a plasmid isolated from the organism in which it occurs in nature and which is divisible into particular fragments by named restriction enzymes.
Example E recites a pair of primers, the first having the sequence of SEQ ID NO: 1 and the second having the sequence of SEQ ID NO: 2. Eligibility of a primer pair under US law is considered by the Coalition for 21st Century Medicine at pages 30-31 of their comments. They aver that there is no clear natural product against which to compare the claimed pair of primers, that the term " a pair of primers" implies that the two primers are designed as a coordinated pair of molecules capable of catalyzing a polymerase chain reaction and thus does not encompass just any two random oligonucleotides, and that they have new utility insofar as that they can prime a DNA polymerase chain reaction, working in a coordinated interactive way to amplify a specific sequence of interest. An admission in oral argument in Myriad that no ruling concerning the use of a DNA probe or primer was necessary is reproduced at page 32 of their comments.
Example D concerns a composition of matter, and in this instance the claim in Funk Brothers v Kalo, directed to an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific. The Guidance takes the position that because the bacteria are structurally identical to naturally occurring bacteria, they are not markedly different and hence ineligible. A similar position was taken in the recent Federal Circuit opinion in Roslin[16].
Comments supporting conflict
Examples A, B, and D and the quoted passage from Roslin markedly differ from the EPO Examination Guidelines at G II, 3.1 which it is submitted encapsulates the law and practice that is applicable in most industrialised countries:
To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect. In addition, if a microorganism is discovered to exist in nature and to produce an antibiotic, the microorganism itself may also be patentable as one aspect of the invention. Similarly, a gene which is discovered to exist in nature may be patentable if a technical effect is revealed, e.g. its use in making a certain polypeptide or in gene therapy.
Insofar as the Guidance is narrower and excludes isolated naturally occurring substances from protection it is difficult to avoid the conclusion that such technology has been arbitrarily carved out from the eligibility requirements of a.27 in conflict with TRIPS.
For biotechnological inventions, Cole and Roberts point out that Exclusions are covered by Articles 27.2 and 27.3 of TRIPS. They cover the protection of ordre public or morality, protection of human or plant life or health and avoidance of serious prejudice to the environment. They also cover diagnostic, therapeutic and surgical methods for the treatment of humans or animals and essentially biological processes for the production of plants and animals. No other exclusions are provided for. In particular there is no provision for excluding natural products or processes involving natural products or 'laws of nature'. They go on to argue that:
The scope of Article 27 is demonstrated by EU Directive 98/44/EC on the legal protection of biotechnological inventions. This was drafted inter alia to be compliant with the TRIPS Agreement to which it makes no less than five specific references. Article 1 of the Directive requires that member states shall protect biotechnological inventions under national patent law and is without prejudice to the implicitly over-riding obligations under the TRIPS Agreement. Article 3.3 provides that 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. Article 5.2 provides that an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. That is subject to the provisions of Article 5.3 that the industrial application of a sequence or a partial sequence of a gene (i.e. its utility) must be disclosed in the patent application. We submit that the Directive accurately reflects the requirements of the TRIPS agreement, and that national law providing any lesser eligibility falls short of compliance with that Agreement.
Cole and Roberts express particular concern about coverage in the Guidance of naturally occurring microorganisms and about the exclusion expressed in the Roslin opinion:
Article 27.3 specifically provides that microorganisms and microbiological processes shall be patent-eligible. Any prohibition by the USPTO or the US courts on the grant of patents for newly isolated strains of bacteria or other microorganisms having new utility amounts to discrimination as to field of technology contrary to Articles 27.1 and 27.3 of the TRIPS Agreement. Example D of the guidance and the recent Federal Circuit opinion in In re Roslin Institute place the US outside the scope of that Article because they purport to exclude naturally occurring microorganisms from eligibility. Example D identifies naturally occurring bacterial strains as falling within judicial exceptions and hence ineligible under §101. The same position is taken by the Federal Circuit in Roslin:
"Even before the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), the Court's opinions in Chakrabarty and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), made clear that naturally occurring organisms are not patentable."
. . . we dispute the proposition that any of the three cited cases resulted in the holding attributed to them even under US domestic law. As Chakrabarty made clear, patents for naturally occurring organisms were granted routinely by the USPTO -- at least since 1873 when Louis Pasteur obtained US Patent 141072 directed to: "Yeast, free from organic germs of disease, as an article of manufacture" -- and continued to grant such patents at least up to 1970. The EPO routinely grants patents for strains of naturally occurring bacteria. So should the USPTO.
Comments denying conflict
A contrary view is expressed by Luigi Palombi who practiced patent law in Australia between 1982 and 1987 and was much involved in litigation concerning gene-related patents. In his 2005 PhD thesis he argued that a device that he called "isolation contrivance" had been developed by the patent community to categorise "isolated" biological materials as "inventions". He avers that the EU directive conflicts with the provisions of TRIPS, and supports that proposition with reference to decisions of the UK courts in Genentech v Wellcome (tPA) [1987] R.P.C 553, [1989] R.P.C. 147-205, Kirin-Amgen v Hoechst Marion Roussel Ltd [2005] R.P.C. 169 (erythropoietin), and Chiron Corporation and Others v Murex Diagnostics Ltd and Others (No 12) [1996] R.P.C. 535.
An Australian answer
A more balanced Australian view would have covered the opinion in Cancer Voices Australia v Myriad in which the court denied that the opinion of Lord Hoffmann in Kirin-Amgen was authority for the proposition that an isolated protein was inherently not patent-eligible and reaffirmed that a product that consists of an artificially created state of affairs which has economic significance will constitute a "manner of manufacture". Because essentially the same issues arose before the US Supreme Court and the reasoning is helpful to understanding the holding of Justice Thomas, the Court's reasoning is set out at length below:
Whether or not a composition of matter (including a micro-organism) is a "manner of manufacture" must be decided in accordance with the principles set out in the NRDC case. It follows (leaving aside any relevant statutory exception) that a composition of matter may constitute patentable subject matter if it consists of an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour . . . .
In the context of biological material, an artificial state of affairs may manifest itself in different ways. The physical properties of the naturally occurring material may have changed as a result of it having been isolated. But even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs.
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.
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.
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.
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.
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.
Concluding remarks
It will be apparent that the overwhelming majority of the relevant comments identifies concern about TRIPS conflict, although detail from more of the commentators with reference to the specific examples in the Guidance would have been helpful. The dissenting comment is valuable not only in drawing attention to the older case law but also in prompting renewed attention to the observations in Cancer Voices which it is submitted are of great wisdom and insight. An artificial state of affairs that has some discernible effect and that is of utility in a field of economic endeavour is along the same lines as Hartranft/Chakrabarty in the US and would not be a bad starting point for revision of the Guidance.
* Mr. Cole is a European Patent Attorney and Partner with Lucas & Co. in Warlingham, Surrey, UK and Visiting Professor at Bournemouth University.
[1] http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf
[2] http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
[3] http://www.uspto.gov/patents/law/comments/myriad-mayo_guidance_comments.jsp
[4] http://www.uspto.gov/patents/law/comments/mm-f-palombi20140409.txt
[5] http://works.bepress.com/luigi_palombi/4/
[6] http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2013/2013fca0065
[7] http://www.uspto.gov/patents/law/comments/mm-a-abaipl20140731.pdf
[8] http://www.uspto.gov/patents/law/comments/mm-a-bio20140731.pdf
[9] http://www.uspto.gov/patents/law/comments/mm-a-aippijapan20140731.pdf
[10] http://www.uspto.gov/patents/law/comments/mm-a-ficpi20140730.pdf
[11] http://www.uspto.gov/patents/law/comments/mm-a-cipa20140730.pdf
[12] http://www.uspto.gov/patents/law/comments/mm-f-elliot20140730.pdf
[13]http://www.uspto.gov/patents/law/comments/mm-f-coleroberts20140729.pdf
[14] http://www.uspto.gov/patents/law/comments/mm-a-coalitionfor21stcenturymed20140806.pdf
[15] http://www.uspto.gov/patents/law/comments/mm-f-cole20140615.pdf
[16] http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1407.Opinion.5-6-2014.1.PDF
"It is taken for granted within the profession that officially-issued regulations and guidelines will have been checked for compliance prior to issue."
Paul,
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.
Posted by: EG | August 27, 2014 at 07:42 AM
EG,
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.
Posted by: Skeptical | August 27, 2014 at 08:47 AM
Skeptical,
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?
Posted by: Paul Cole | August 27, 2014 at 09:20 AM
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.
Posted by: GrzeszDeL | August 27, 2014 at 09:35 AM
GrzeszDei,
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.
Posted by: Paul Cole | August 27, 2014 at 10:37 AM
GrzeszDeL,
It was raised early in the Myriad proceedings, but gained no traction.
Posted by: crelboyne | August 27, 2014 at 11:15 AM
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.
Posted by: Skeptical | August 27, 2014 at 11:27 AM
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.
Posted by: Paul Cole | August 27, 2014 at 12:07 PM
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.
Posted by: Bob Cook-Deegan | August 27, 2014 at 03:30 PM
@ 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.
ERRATUM
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.
Posted by: Paul Cole | August 27, 2014 at 04:25 PM
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.
Posted by: GrzeszDeL | August 27, 2014 at 04:46 PM
"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?
Posted by: GrzeszDeL | August 27, 2014 at 04:56 PM
"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.
Posted by: Simon Elliott | August 27, 2014 at 09:19 PM
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.
Posted by: Skeptical | August 27, 2014 at 09:47 PM
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.
Posted by: Luigi Palombi | August 29, 2014 at 03:14 PM
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.
Posted by: Skeptical | August 30, 2014 at 12:54 PM
@ 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.
Posted by: Paul Cole | August 31, 2014 at 01:45 AM