Guest Post by Paul Cole: ASSOCIATION FOR MOLECULAR PATHOLOGY v MYRIAD GENETICS – an isolated decision?

Guest Commentary by Paul Cole,Professor of Intellectual Property Law, Bournemouth University, and European Patent Attorney, Lucas & Co, Warlingham, Surrey, UK.  


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.

316 thoughts on “Guest Post by Paul Cole: ASSOCIATION FOR MOLECULAR PATHOLOGY v MYRIAD GENETICS – an isolated decision?

  1. 313

    There is no requirement to disclaim a claim that has been found invalid by the court. You don’t see many disclaimers other than terminal disclaimers.

  2. 312

    can anyone point to case law that supports the assumption that claims that were not litigated are not invalid by reason of a finding of invalidity on other claims

    in-house, that’s pretty fundamental to people who do this every day, so I’m not sure any recent case would bother saying so. Here’s the first part of 35 USC 282, though – it seems pretty clear on this point to me:

    (a) In General.— A patent shall be presumed valid. Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.

    Also, is there a procedural mechanism by which Myriad must inform the public that claim 1 is invalid? (other than telling them to read the opinion) Like changing the font to include a strike through of claim 1 as in a reissue?


  3. 311

    I found my answer to my “notice” question:

    35 U.S.C. 253 Disclaimer.
    Whenever, without any deceptive intention, a claim of a patent is invalid the remaining claims shall not thereby be rendered invalid. A patentee, whether of the whole or any sectional interest therein, may, on payment of the fee required by law, make disclaimer of any complete claim, stating therein the extent of his interest in such patent. Such disclaimer shall be in writing, and recorded in the Patent and Trademark Office; and it shall thereafter be considered as part of the original patent to the extent of the interest possessed by the disclaimant and by those claiming under him.

    37 CFR 1.321(a) Statutory disclaimers, including terminal disclaimers.
    (a) A patentee owning the whole or any sectional interest in a patent may disclaim any complete claim or claims in a patent.

  4. 310

    OK. with those premises, I assume then that Myriad could still assert its cDNA patent claims against others selling their diagnostic BRCA1 testing. Isn;t this then a Pyrrhic victory to the “anti-gene” patent crowd.

    Also, is there a procedural mechanism by which Myriad must inform the public that claim 1 is invalid? (other than telling them to read the opinion) Like changing the font to include a strike through of claim 1 as in a reissue?

    One more “also,” can anyone point to case law that supports the assumption that claims that were not litigated are not invalid by reason of a finding of invalidity on other claims(other then IC as NWPA and anon believe)?

  5. 309

    That is definitely not true. Each claim must be invalidated except 0unenforceability will kill the entire patent. But, it is true that sometimes the details are skipped.

  6. 308

    Your post does show some thought, so I will not dismiss it out of hand.

    I can break your post into two main thoughts:

      1) Criteria for intervention of a top level court (i.e. Supreme Court)
      2) An opinion of recent Supreme Court cases.

    Working backwards, you will not receive too much argument that the Supreme Court has been really flubbing patent law and making a general wholesale mess of 101. Indeed, the trend of making facts into opinions and the fact that the Supreme Court will not be denied their opinion is a powerful driver of why the court actually created with the purpose of making sense of patent law has thrown up their hands in disgust (go ask Alice).

    However, and this is a big however, your first part of the post is rife with error, and as mentioned several times now, exhibits a rather immature understanding of “our field,” particularly in U.S. jurisprudence.

    While you list five criteria, these criteria can be readily combined into merely two items:

      1) Does the highest court have the skills and understanding to judge the case (your points 1 and 3)
      2) Should new law be written (your points 2, 4, and 5).

    As to the first set, ALL courts – and not just the highest court have the possibility (even the duty) to obtain their own expert opinion such that they do have the skill and understanding to judge a case. In this sense, your point here does not support your position as it is universally applicable.

    As to the second set, you indulge in the very vacuity that infects the top Court itself. Phrases like “serious wrong”, and “reasonable chance” as well as “needs of those closely connected” all scream out for legislative action – not judicial action. Clearly what you may view as reasonable, others of honest intellect will heartily disagree. What you end up with is every bit as patchy because you are actually delving into general policies (explicitly ones not of a constitutional nature) that have ardent advocates an many sides.

    And to the express point of which you insist on disregarding, the U.S. Constitution expressly delegates which branch of the government has the authority to write the law that you advocate our judiciary to do (or to do in a certain manner). Only when the existing law is so seriously wrong as to raise a constitutional issue should the Court say something – and even then, the occasion is NOT for the Court to write law that it wants – but to inform Congress that CONGRESS needs to rewrite the law. ANY sense of advocating for arriving at NEW law violates our US sovereignty. Simply put, the Court is not the proper authority to even have the “appearance of embracing populism rather than rationality” (a cute and misleadingly loaded phrase implying that the popular embrace is of necessity an irrational embrace). I would dare say that even your view of “legal certainty” and “law of expectation” may be BOTH a popular (to some) and irrational (given the lack of constitutional question and the direction of constitutional authority) embrace. What you want is the very thing that you would complain about.

    I give you a C-

  7. 307

    Typically, when one claim of a patent is found invalid, the entire patent is found invalid.

    I don’t think so. Perhaps for inequitable conduct, but not for issues of validity (or subject matter).

  8. 306

    Typically, when one claim of a patent is found invalid, the entire patent is found invalid. Here, the Supremes expressly invalidated the non-CDNA claims, and in addition, expressly identified the cDNA as being patent eligible.

    Given the age of the patent, is there anyway for Myriad to rescue the cDNA claims?

    Or, is this a policy that one invalid claim takes down all the other valid claims in a patent?

  9. 305

    That is a very good summary, Paul, of why I find the SCOTUS’s opinion disturbing. I would add that they ignored the structure of the 1952 Patent Act.

    After Prometheus, I think it was obvious that the SCOTUS doesn’t care about science or patent law. Their view of science is about an eight year old’s. They view concrete objects only. Really odd that science has taken such a back seat in a country that is build on engineering and science.

  10. 304

    Did you read the link Paul before replying?

    My guess is that you did not (so much for your balanced view and witty repartee – making jabs about reading the Beauchamp article [which I did, btw], and you not reading the link I provided).

    That link addressed the so-called settled expectation argument (as did the Myriad case).

    There is a difference between having your hand on the pulse of law and sitting back and expecting the same to continue. It appears that you are in the latter group. Your response then, immature as it is, to strike out at what you perceive to be an injustice, and your advocating that the US Judiciary simply write the law you expect to have further belies a seemingly lack of respect for the law. I merely point out that you are out of line and your response is to YELL rather than to listen.

    As I asked above, (since you seem intent on doing so), where in the implicit words do you find the sub-implicit ability to parse out part of the judicial exceptions? Where does this implicit within implicit within implicit writing end?

    And please, this type of ‘lucidity’ – no matter how helpful some misguided soapboxers feel it may be – is not helpful and in fact is highly disrespectful of US sovereignty. I have courtesy and respect for other nations who have decided their laws as they see fit. I hope you recognize the ‘taint’ of the desire for one world law for patents (long an agenda item of the large multi-nationals). MaxDrei is infamous for lacking common sense as to what the useful arts means – and he too would seek to subjugate US Sovereignty (and does so on a regular basis).

    Let’s see a little more respect from our friends overseas.

  11. 303

    Many thanks Paul, for your refreshing lucidity. But nevertheless you leave me thinking that what goes around comes around, and about those worried about the “creep” of IPR into areas beyond what common sense says ought to be patrentable.

    I suspect that SCOTUS feels this creep, in the CII area, and in Myriad is reacting irrationally to it, in the “absolut Stoffschutz” area.

    Germany used to decline to award patent monopolies on chemical compounds per se. It is not so “off the wall” as you would have us believe. Even recently, there has been discussion in Germany, about re-introducing purpose limitation to claims to chemical compounds. Of course, you and I know that one deals best with that area under the heading of “Utility”. One way or another though, SCOTUS has to find the optimal balance and, sadly, as you note, it is not briefed well enough to find it.

  12. 302

    The following comment that I made at the end of 2012 on both the Patently-O and IP Watchdog blogs bears repeating:

    What should be the criteria for the intervention of a non-specialist court of final appeal in a specialist legal area?

    Firstly that the non-specialist court has the skills to resolve the matter in dispute. Secondly that the existing state of the law amounts to a serious wrong. Thirdly that the non-specialist court has a reasonable chance of truly understanding the underlying technical facts and legal principles and of producing an opinion that is both correct in outcome and correctly reasoned (the Kalo case, for example, being a clear instance of a correct outcome based on reasoning that it is difficult to support). Fourthly that there is a reasonable chance of arriving at a new rule of law which is preferable to that which existed formerly. Fifthly that there is a reasonable chance that the new rule of law can be expressed in a way that meets the needs of those closely connected with the subject matter in dispute without major but unintended collateral damage in situations unforeseen when the opinion was written, especially by ill-advised and over-broad dicta.

    Although there have been outstanding decisions from the Supreme Court e.g. in Festo, its recent record in our field could most charitably be described as patchy. Did the opinion in Bilski leave the law in a clearer or a more uncertain state? Can anyone determine what the rule of law underlying Prometheus actually was?

    Is Myriad a case where intervention was justified? Two concurrent Federal Circuit decisions were well reasoned, have been generally welcomed in the profession and compelling reasons for disturbing them are difficult to discern. If it was a matter of legal certainty then refusing certiorari would have been the wiser course. An ill thought-out decision could be profoundly damaging to the chemical, pharmaceutical and biotechnology industries at least, could cut US law off from a century of legal thought concerning the patenting of new chemical entities and from international standard practice on this topic. In the present case, the decision to grant certiorari is not grounds for confidence but for the reverse.

    Coincidentally, the current edition of Scientific American carries a lengthy article by Shawn Otto warning of the dangers of science denial when carried into politics, warning that “When facts become opinions, the collective policymaking process of democracy begins to break down.” There appear to be real dangers of science denial being carried into law also, and the decision for certiorari in this case highlights the dangers of this happening. In appearing to support the wish of The Association for Molecular Pathology (which self-evidently has an axe to grind), Breast Cancer Action and Boston Women’s Health Book Collective, amongst others, that the public should have free access to the fruits of difficult and costly research, the Court has the appearance of embracing populism rather than rationality.

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