Guest Publish: Myriad-Mayo Guidance — Consistency With Worldwide Harmonization and Journeys


[guest author: Paul Cole]


USPTO Building Facade

It’s strongly arguable that insofar because the USPTO’s Myriad-Mayo Guidance[1] dismisses as non-qualified recently isolated substances (including small molecules), nucleotide sequences and microorganisms getting new utility (US parlance) or producing new technical effects (European parlance) it’s incompatible using the Agreement on Trade-Related Facets of Ip Legal rights (Journeys)[2].

It’s unsurprising that just 10 from the 83 comments printed up to now around the USPTO website[3] cover this problem. It’s overlooked inside the profession that formally-issued rules and guidelines may have been checked for compliance just before issue. Your brain-group of most prosecution or litigation attorneys therefore treats such compliance like a background problem for which a completely independent check isn’t normally needed. Also, some organizations and firms happen to be reluctant to allege Journeys non-compliance in deference towards the USPTO and also to the federal government. But silence about fairly plausible non-compliance arguments once they’ve been identified grouped into the Emperor’s New Clothing fallacy, delays necessary remedial action, and will the USPTO no service.

Nine from the relevant comments assert non-compliance either directly or unconditionally inside the broader subject of worldwide harmonisation. Just the Australian commentator Luigi Palombi[4] asserts compliance according to his 2005 PhD thesis titled “The Patenting of Biological Materials poor Journeys”[5]. However, his brief comment to USPTO takes no account of subsequent developments such as the opinion from the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics[6].

Policy factors underlying the Guidance

Individuals IP associations and organisations that provided relevant comments viewed the Guidance like a serious setback to harmonization. The positioning of the Aba (ABA)[7] typifies comments produced by the Worldwide Bioindustry Association[8] (representing member associations in Canada, Europe, Japan and also the US), AIPPI Japan[9], The Worldwide Federation of Ip Attorneys (FICPI)[10], and also the Chartered Institute of Patent Attorneys (CIPA)[11]:

The U . s . States and particularly the USPTO should remain a powerful advocate for Journeys. The U.S. wouldn’t take gently an associate condition carving out certain technology in the patent eligibility needs of Article 27, and then the USPTO should reflect carefully on if the Guidance as written can lead to an invention or perhaps a group of inventions being declared ineligible for patent protection inconsistently using the letter and concepts of Journeys. The IPL Section professionally submits it remains essential that the USPTO is constantly on the lead by example in following a letter and concepts embodied in Journeys and narrowly apply Myriad and Mayo to do this.

Damage produced through the Guidance is summarised through the Worldwide Bioindustry Associations:

The U.S. Government, along with the governments of EU member states, Japan, Korea, Australia along with other major U.S. buying and selling partners happen to be making efforts more than a considerable time period to inspire more harmonization and also the adoption more uniform and consistent rules associated with ip and, particularly, patents. Progress, although slow, continues to be significant. Such efforts have borne fruit through elevated membership and utilisation of the Patent Co-operation Agreement, the adoption from the Patent Formalities Agreement and Patent Law Agreement, as well as in the extension of WTO rules to ip. Presently, in negotiations which are happening, U.S. negotiators are wishing that other nations will sacrifice tradition for uniformity, for instance by thinking about the adoption of harmonized elegance periods for inventor disclosures. The result of the unnecessarily broad interpretation from the Supreme Court’s decisions for example is suggested underneath the new Guidance is a serious setback to such efforts and also to progress in achieving further steps on the path to harmonization and also the benefits this will bring to a lot of countries, however in particular, towards the U . s . States.

Compatibility with Journeys

Simon Elliott[12] of Foley and Lardner argues the USPTO mustn’t interpret 35 USC § 101 in a fashion that violates Journeys. He traces the necessity to avoid conflict with agreement obligations to observations of Chief Justice Marshall 210 years back in Murray v. The Charming Betsy that “an action of Congress ought not to be construed to violate what the law states of nations or no other possible construction remains.” He procedes to explain that decisions giving deference to agency interpretation of statutes tight on pressure since the USPTO doesn’t have substantive rule-making authority, which such decisions don’t support giving deference to USPTO Guidance which has a general and substantive impact across an extensive swath of patent applications.

The Worldwide Bioindustry Associations put down their thoughts about the Guidance in generalised but nonetheless forthright terms:

By submitting such inventions to some increased patentability analysis, the Guidance conspicuously departs from worldwide recognized standards of patent-eligibility. Many valuable inventions that might be patentable within the patent offices from the U.S.’s major buying and selling partners will nonetheless be rejected within the USPTO simply because they neglect to pass an extrastatutory “significant variations” test which has no equivalent within the patent laws and regulations of other industrialized countries. Doing this results in a deep disparity in substantive patent law whereby whole groups of socially advantageous inventions would face obstacles to patent protection within the U . s . States but remain patentable among its major buying and selling partners, with attendant dangerous effects around the flow of investment, trade, and mix-border change in innovation.

The ABA argues that “as written the Guidance and also the exclusions for patent eligibility under Journeys don’t seem to be consistent”. FICPI takes that position, as also do Joe Liebeschuetz and Joe Storella commenting as individuals. Cole and Roberts[13] reason that any administrative or judicial interpretation from the provisions associated with a statute, including 35 USC § 101, which places the united states ready where it doesn’t satisfy the obligations of the worldwide agreement through which it’s guaranteed is prima facie incorrect and needs reconsideration, and additional that:

These factors appear particularly compelling with regards to the final Court opinions mainly trusted for that extended interpretation used in the Guidance. Individuals opinions include Hartranft v. Wiegmann, 121 U. S. 609, 615, 7 S. Ct. 1240, 30 L. Erectile dysfunction. 1012 (1887), Funk Siblings Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) and Gemstone v. Chakrabarty, 447 U.S. 303 (1980). Individuals opinions were well-known to and understood by the federal government, the USPTO and US patent attorneys at that time once the Journeys Agreement was negotiated. The Federal Government will not have negotiated that Agreement when there was at that time any reasonable ground for thought that US domestic law was sporadic using the terms being negotiated. There’s no basis in law or perhaps in logic for presuming the rulings in individuals lengthy-established opinions have altered between your time once the Journeys Agreement was negotiated and today.

The conflicting examples

The eligibility of isolated natural products, including small molecules, lies in the centre from the Guidance. It’s strongly arguable that each one of the examples the following brings about potential conflict with Journeys.

Example B concerns purified amazonic acidity, a hypothetical cancer-fighting chemical obtained from the leaves from the Amazonian cherry tree. It’s not made obvious whether it’s a little molecule or, for instance, a protein. The appropriate amount of wholesomeness isn’t made obvious, so that as pointed through the Coalition for twenty-first century Medicine[14], the wording could cover purities lacking to make a preferred therapeutic effect. The choice rapamycin-based example provided by Cole[15] features a claim indicating that antibiotic like a colourless crystalline compound of defined melting point.

Example A concerns a reliable energy-generating plasmid which supplies a hydrocarbon degradative path. This wording is unrepresentative because, as pointed out above in recent comments through the Coalition for twenty-first century Medicine the claim encompasses, among its distinct embodiments, an all natural plasmid relaxing in an all natural bacteria. More typical may be the claim recommended by Cole that is forwarded to a plasmid isolated in the organism that happens in nature and that is divisible into particular fragments by named restriction enzymes.

Example E recites a set of primers, the very first getting the succession of SEQ ID NO: 1 and also the second getting the succession of SEQ ID NO: 2. Eligibility of the primer pair under US law is recognized as through the Coalition for twenty-first century Medicine at pages 30-31 of the comments. They aver that there’s no obvious natural product by which to check the claimed set of primers, the term ” a set of primers” signifies that the 2 primers are made like a coordinated set of molecules able to catalyzing a polymerase squence of events and therefore doesn’t encompass just any two random oligonucleotides, and they have new utility insofar as that they’ll prime a DNA polymerase squence of events, your coordinated interactive method to amplify a particular sequence of great interest. An admission in dental argument in Myriad that no ruling concerning using a DNA probe or primer was necessary is reproduced at page 32 of the comments.

Example D concerns a composition of matter, and in cases like this the claim in Funk Siblings v Kalo, forwarded to an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of various types of bacteria from the genus Rhizobium, stated strains being unaffected by one another according for their capability to fix nitrogen within the leguminous plant that they’re specific. The Guidance takes the positioning that since the bacteria are structurally just like naturally sourced bacteria, they aren’t markedly various and hence ineligible. An identical position was drawn in the current Federal Circuit opinion in Roslin[16].

Comments supporting conflict

Examples A, B, and D and also the quoted passage from Roslin markedly vary from the EPO Examination Guidelines at G II, 3.1 so it is posted encapsulates what the law states and exercise that’s relevant in many industrialised countries:

To locate a formerly unrecognised substance occurring anyway can also be mere discovery and for that reason unpatentable. However, if your substance present in nature could be proven to make a technical effect, it might be patentable. A good example of this type of situation is an ingredient occurring anyway that is found with an antibiotic effect. Additionally, if your microorganism was discovered to appear in nature and also to provide an antibiotic, the microorganism itself can also be patentable as you part of the invention. Similarly, a gene that is discovered to appear in nature might be patentable if your technical effect is revealed, e.g. its use within creating a certain polypeptide or perhaps in gene therapy.

Insofar because the Guidance is narrower and excludes isolated naturally sourced substances from protection it is not easy to prevent the final outcome that such technologies have been arbitrarily created out of the eligibility needs of the.27 incompatible with Journeys.

For biotechnological inventions, Cole and Roberts explain that Exclusions are handled by Articles 27.2 and 27.3 of Journeys. They cover the security of ordre public or morality, protection of human or plant existence or health insurance and avoidance of significant prejudice towards the atmosphere. Additionally they cover diagnostic, therapeutic and surgical methods to treat humans or creatures and basically biological approaches for producing plants and creatures. Not one other exclusions are supplied for. Particularly there’s no provision for excluding natural products or processes involving natural products or ‘laws of nature’. They will continue to reason that:

The scope of Article 27 is shown by EU Directive 98/44/EC around the legal protection of biotechnological inventions. It was drafted inter alia to become compliant using the Journeys Agreement that it can make no under five specific references. Article one of the Directive mandates that member states shall safeguard biotechnological inventions under national patent law and it is without prejudice towards the unconditionally over-riding obligations underneath the Journeys Agreement. Article 3.3 provides that biological material that is isolated from the natural atmosphere or created using a technical process could be the subject of the invention even when it formerly happened anyway. Article 5.2 provides that the element isolated from the body or else created using a technical process, such as the sequence or partial sequence of the gene, may constitute a patentable invention, whether or not the structure of this element is similar to what natural element. That’s susceptible to the provisions of Article 5.3 the industrial use of a string or perhaps a partial sequence of the gene (i.e. its utility) should be disclosed within the patent application. We submit the Directive precisely reflects the needs from the Journeys agreement, which national law supplying any lesser eligibility fails to deliver of compliance with this Agreement.

Cole and Roberts express particular worry about coverage within the Guidance of naturally sourced microorganisms contributing to the exclusion expressed within the Roslin opinion:

Article 27.3 particularly provides that microorganisms and microbiological processes will be patent-qualified. Any prohibition through the USPTO or even the US courts around the grant of patents for recently isolated strains of bacteria or any other microorganisms getting new utility comes down to discrimination regarding field of technology unlike Articles 27.1 and 27.three of the Journeys Agreement. Example D from the guidance and also the recent Federal Circuit opinion in In re Roslin Institute put the US outdoors the scope of this Article simply because they purport to exclude naturally sourced microorganisms from eligibility. Example D identifies naturally sourced microbial strains as falling within judicial exceptions and therefore ineligible under §101. Exactly the same position is taken through the Federal Circuit in Roslin:

“Before the final Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Corporation., 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 obvious that naturally sourced microorganisms aren’t patentable.”

. . . we dispute the proposition that the three reported cases led to the holding related to them even under US domestic law. As Chakrabarty made obvious, patents for naturally sourced microorganisms were granted routinely through the USPTO — a minimum of since 1873 when Louis Pasteur acquired US Patent 141072 forwarded to: “Yeast, free of organic germs of disease, being an piece of manufacture” — and ongoing to allow such patents a minimum of as much as 1970. The EPO routinely grants patents for strains of naturally sourced bacteria. So if the USPTO.

Comments denying conflict

A contrary view is expressed by Luigi Palombi who practiced patent law around australia between 1982 and 1987 and it was much involved with litigation concerning gene-related patents. In the 2005 PhD thesis he contended that the device he known as “isolation contrivance” have been produced by the patent community to categorise “isolated” biological materials as “inventions”. He avers the EU directive conflicts using the provisions of Journeys, and supports that proposition with regards to decisions from the United kingdom courts in Genentech v Wellcome (tPA) [1987] R.P.C 553, [1989] R.P.C. 147-205, Kirin-Amgen v Hoechst Marion Roussel Limited [2005] R.P.C. 169 (erythropoietin), and Chiron Corporation yet others v Murex Diagnostics Limited yet others (No 12) [1996] R.P.C. 535.

An Australian answer

A far more balanced Australian view might have covered the opinion in Cancer Voices Australia v Myriad where the court denied the opinion of Lord Hoffmann in Kirin-Amgen was authority for that proposition that the isolated protein was inherently not patent-qualified and reaffirmed that something that includes an artificially produced condition of matters that has economic significance will constitute a “types of manufacture”. Because basically exactly the same issues came about prior to the US Top Court and also the reasoning is useful to comprehending the holding of Justice Thomas, the Court’s reasoning is placed out in more detail below:

Whether a composition of matter (together with a micro-organism) is really a “types of manufacture” should be made the decision in compliance using the concepts put down within the NRDC situation. The result is (departing aside any relevant statutory exception) that the composition of matter may constitute patentable subject material whether it includes a man-made condition of matters, with a discernible effect, and that’s of utility inside a field of monetary endeavour . . . .

Poor biological material, a man-made condition of matters may present itself diversely. The physical qualities from the naturally sourced material might have altered because of it getting been isolated. But whether or not the physical qualities from the material haven’t altered, removing the fabric from the natural atmosphere and it is separation using their company cellular components can always produce what could reasonably be referred to as a man-made condition of matters.

For me the patentability from the isolated nucleic acids known within the disputed claims doesn’t turn upon what changes happen to be designed to caffeine composition of these substances because of them getting been isolated. Particularly, the issue of whether these substances constitute patentable subject material doesn’t rely on the kind of chemical bond that might have been damaged while isolating them. It’s inevitable that some bonds is going to be damaged throughout isolating nucleic acids, but it’s not apparent in the evidence these will always include covalent bonds. When I have previously described, the disputed claims don’t require the isolated nucleic acids they describe vary from individuals based in the cell within this or other respect to date his or her chemical composition is worried.

Accordingly, the problem within this situation turns upon whether a remote nucleic acidity, which can be assumed to possess the same chemical composition and structure as that based in the cells of some people, constitutes a man-made condition of matters meaning individuals words ought to be understood in our context. You will find three factors which lead me to consider it does.

First, in explaining the idea of types of manufacture as you involving the development of a man-made condition of matters, it’s apparent the High Court in NRDC was deliberate in the utilization of very expansive language. Not just did our prime Court emphasise the “broad sweep” from the concept involved, additionally, it made obvious that metaphorical analysis might not be useful in figuring out whether something constitutes patentable subject material.

Next, even without the human intervention, naturally sourced nucleic acidity doesn’t exist outdoors the cell, and “isolated” nucleic acidity doesn’t exist within the cell. Isolated nucleic acidity may be the product of human intervention relating to the extraction and purification from the nucleic acidity based in the cell. Extraction of nucleic acidity requires human intervention that always leads to the rupture from the cell membrane and also the physical destruction from the cell itself. And purification from the extracted nucleic acidity requires human intervention that leads to removing many other materials that have been also initially contained in the cell. It is just after these two steps are carried out the extracted and purified product might be correctly referred to as “isolated” meaning that word can be used within the disputed claims.

Thirdly, as Dann’s Patent demonstrates, the isolation of the particular micro-organism may need immense research and intellectual effort. For the reason that situation, it had been only because of a rigorous research effort the isolated micro-organism under consideration might be provided to be used within the output of the brand new antibiotic. It had been fortuitous for that patentee it had become its employees who have been first to isolate the brand new micro-organism and first to deploy it within the output of the brand new drug. That won’t continually be so. It might result in very odd results if an individual whose skill and energy culminated within the isolation of the micro-organism (a fortiori, a remote DNA sequence) couldn’t be individually rewarded through the grant of the patent since the isolated micro-organism, regardless of how practically helpful or economically significant, occured to become inherently non-patentable. In my opinion it might be an error, and sporadic using the purpose of the Act, to not give full effect such situations towards the broad language utilized by our prime Court in NRDC.

Concluding remarks

It will likely be apparent the overwhelming most of the relevant comments identifies worry about Journeys conflict, although detail from a lot of commentators with regards to the particular examples within the Guidance could have been useful. The dissenting comment is efficacious not just in drawing focus on the older situation law but additionally in prompting restored focus on the observations in Cancer Voices so it is posted have great knowledge and insight. A man-made condition of matters with a discernible effect and that’s of utility inside a field of monetary endeavour is across the same lines as Hartranft/Chakrabarty in america and wouldn’t be a poor beginning point for revision from the Guidance.

* Mr. Cole is a European Patent Attorney and Partner with Lucas & Co. in Warlingham, Surrey, UK and Visiting Professor at Bournemouth University.





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