Non-invasive prenatal genetic testing based on maternal blood sampling is replacing older invasive forms of testing – a paradigm shift in prenatal medicine. The patent rights associated with these methods have been litigated in several jurisdictions, most notably to date the US, UK and Australia. This decision of Justice Beach in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, stands in clear contrast to the US Court of Appeals decision in Ariosa Diagnostics v Sequenom 788 F.3d 1371 (2015) (the Ariosa US decision), and the Supreme Court of the United States which subsequently denied Sequenom’s petition for a writ of certiorari.

The Patent Family

The patent family in question, with patents in the US, Europe and Australia, are in broadly similar terms and arose from research carried out by Professor Dennis Lo and colleagues at Oxford University. Professor Lo’s discovery demonstrated that cell-free foetal DNA (cffDNA) could be detected in the plasma and serum of pregnant women. The patents arising from this discovery are, generally speaking, to methods of detecting this cell-free foetal DNA, using standard techniques, for prenatal diagnosis of genetic anomalies and sex determination.

Sequenom began offering the non-invasive prenatal test in the US in 2011, with a number of other companies following suit, including Ariosa Diagnostics which provided its own “Harmony” test. Illumina, the other major player in the field, produced “Verifi” in the US, and the two companies settled their patent dispute by cross-licensing their patents in 2014.

Background to the Australian Litigation

Sequenom is the patentee of Australian Patent No 727919 entitled “Non-invasive prenatal diagnosis” (the Patent). The claims relate to a method of detecting the presence of nucleic acid of foetal origin in a maternal serum or plasma sample. Sequenom sought relief for infringement in relation to the Harmony test.

The respondents, Ariosa (together with two Australian pathology companies licensed by Ariosa to promote and supply the Harmony test) cross-claimed seeking revocation on several grounds. This article deals exclusively with his Honour’s findings in relation to patent subject-matter eligibility.

The Decision

Genetic Information v Practical Application 

Patent eligibility in Australia requires that the relevant subject matter be a “manner of manufacture”. The leading authorities on interpreting this requirement, High Court decisions in Research and Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) and D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (Myriad) make clear that there are two essential factors necessary to the characterisation of an invention as a “manner of manufacture”:

(a)   whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action (that is, an artificially created state of affairs); and

(b)   whether the invention as claimed has economic utility.

Ariosa conceded that where a new scientific principle is discovered, its practical application might be patented, even if that application is straight-forward once the new principle is known. However, Ariosa argued, in the instant case, the discovery of the location (in maternal serum) of a known product (foetal DNA), was not the discovery of a new principle, and that the Patent merely claims the use of the discovery for the purposes to which it is inherently adapted. In particular Ariosa contended that there was no claim in the Patent to any new method of detecting cffDNA once it was discovered to be present in the plasma or serum of a pregnant woman.

Second, Ariosa submitted that none of the claims involved the creation of an artificially created state of affairs. The outcome of each claim was merely genetic information about the DNA of the foetus, which is a naturally occurring phenomenon.

Beach J disagreed, finding that the Patent did not contain any claims to cffDNA as a product per se or as genetic information as it existed in nature (as was the case in Myriad), but rather to a method by which the discovery of the existence of cffDNA can be put to practical use. In this way the subject matter of the relevant claims can be seen to fall within the principles of NRDC and affirmed in Myriad, whilst not falling within the impermissible sequence claims rejected in Myriad.

His Honour articulated his reasons in the following terms:

“The invention is undoubtedly an artificial non-invasive detection method involving artificial DNA amplification methods and synthetic probes deriving from the presence of cfDNA in the maternal circulation from both the mother and developing foetus”. 

His Honour concluded that such a “process of detection and discrimination” could only be characterised as artificial and could not be naturally occurring information of a non-patentable character. While not required to do so, his Honour also considered the “other factors” outlined in Myriad and came to the same conclusions on subject matter eligibility.

This decision is not surprising given Justice Beach’s decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51 (MLA) discussed here.

The IP Landscape on Patentability

The position in the US

A series of recent decisions in the US have significantly narrowed the patent eligibility for inventions involving diagnostic methods, in particular Mayo Collaborative Services v Prometheus Laboratories Inc 566 US 66 (2012) and Alice Corp. v. CLS Bank International 573 US 208 (2014). The uncertainty and ambiguity created by these decisions for patentees has led the United States Congress to release draft legislation to address patentable subject matter. These matters and the Ariosa US decision are discussed here in further detail.

The position in Europe

The European Courts have taken a more permissive approach to subject matter eligibility, instead restrictively applying criteria for novelty, inventive step, and insufficient disclosure.

Under the European “Biotechnology Directive” (Directive 98/44/EC, Article 5 and Recitals 21-22) where a DNA sequence is isolated from the human body by means of a technical process, the sequence per se becomes eligible for patent protection, even where it is identical to that which exists in nature.

In keeping with this approach, Justice Henry Carr in the corresponding UK proceedings, Illumina, Inc v Premaitha Health Plc [2017] EWHC 2930 (Pat), concluded:

I do not accept that, properly construed, claim 1 is a claim to a discovery as such. The claims are not directed to information about the natural world, but rather to a practical process, namely a “detection method” which uses information about the natural world. Claim 1 is directed to the detection of foetal DNA in a sample of plasma or serum. Such samples do not exist in the natural world and must be artificially created. The claimed method of detection is also an artificial process which does not exist in the natural world. The claim is to a practical process of implementing a discovery, for practical applications. The actual contribution, as a matter of substance, does not fall solely within the excluded subject matter and is technical in nature.

Implications 

The decision in this case, following on from his Honour’s decision in MLA, provides certainty that claims defining practical applications of genetic technologies that are the result of human action are patent eligible subject matter under Australian law. We note that Ariosa has until 18 July 2019 to file an appeal to the Full Court.

It is also evident that the patent eligibility of gene-based applications varies significantly across jurisdictions, and in particular the requirements in the US remain in a state of confusion and flux. It would be highly desirable to have consistency across jurisdictions in this regard, to provide patentees with greater commercial certainty and predictability for their gene and diagnostic based patent portfolios.

Steps are currently being taken by the United States congress to address the issue of patent eligible subject matter that has plagued the United States patent system in recent years.

How we got here?

There is no question that United States Supreme Court decisions such as Mayo Collaborative Services v Prometheus Laboratories Inc, 566 US 66 (2012) and Alice Corp. v. CLS Bank International, 573 US 208 (2014) have changed the Life Sciences patent landscape, particularly with regard to diagnostic inventions based on, for example, measuring various biological components (metabolites, genes, etc.) present in patient’s blood.

A leading example of the impact of these decisions is Ariosa Diagnostics, Inc. v. Sequenom Inc, 788 F3d 1371 (Fed Cir 2015) (“Ariosa”).  The patent at issue in Ariosa, US Patent No 6,258,540, concerned detecting cell-free fetal DNA (“cffDNA”) in maternal plasma to identify fetal characteristics and abnormalities.  This invention replaces invasive pre-natal techniques.  However, the cffDNA was deemed a “natural phenomenon” and its detection an application of routine methods.  Accordingly, the claims were found to be directed to non-patentable subject matter.  Judge Linn concurred in the decision but emphasized that the invention at issue was “truly meritorious” and “ground breaking”, highlighting the illogical result that no patent protection could be awarded despite no one having ever used maternal plasma to detect cffDNA.  As Judge Linn stated:

“But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute why this breakthrough invention should be deemed patent ineligible.”

Thus, research into diagnostic methods, which clearly have value to society, would no longer be rewarded with patent protection.

A small area of protection was clawed back by the Federal Circuit decision of Vanda Pharmaceuticals Inc v West-Ward Pharmaceuticals International Limited, 887 F3d 1117 (Fed Cir 2018).  At issue in Vanda was US Patent No 8,586,610, which included claims directed to a method of treatment comprising a diagnostic step based on the genotype of a patient and a step of administering a pharmaceutical in view of the outcome of that diagnostic analysis.  This claim format was enough to overcome the Mayo problem.  Although the tenuousness of this decision is apparent from the dissenting opinion of Chief Judge Prost, who stated that “the end result of the claimed process is no more than the conclusion of a natural law … I see no distinction from Mayo”.

The USPTO embraced the Vanda decision, providing guidance to applicants to formulate patent eligible claims based on a Vanda-style claim. However, since the Vanda claim format includes a diagnostic step and an administration step, the commercial relevance of such claims is questionable since different parties are likely to perform each of the steps.

Now, it seems even Vanda claims may be in danger as the case could be granted certiorari by the Supreme Court as the Supreme Court has requested that the Solicitor General file a brief expressing the view of the United States.

If the Supreme Court should grant certiorari, it would seem to be a negative indication, as it has declined to do so in about 40 post Alice cases.

What is Congress Doing?

In the face of this legal uncertainty, several members of the United States Congress released draft legislation to address the patentable subject matter issue.  The legislation seeks to base patent eligibility on the usefulness of the invention, which is defined to be “any invention or discovery that provides specific and practical utility in any field of technology through human intervention”.  Significantly, the legislation would abrogate the Supreme Court cases applying the natural phenomena criteria to patent eligibility.

The draft legislation served as a starting point for three days of public hearings before the United States Senate Intellectual Property subcommittee, which drew together testimony from a former Chief Judge of the United States Federal Circuit, heads of biotechnology and pharmaceutical concerns, law professors, former directors of the USPTO, and groups such as the American Civil Liberties Union.  Thus, parties on all sides of the patent debate were represented and heard.

The ranking members of the subcommittee released a statement capturing their thoughts on the hearing.  Despite having heard from both sides, the statement appears to weigh more heavily in favour of establishing a system that grants protection to inventions such as diagnostics based on a naturally-occurring correlation.  Significantly, the statement emphasized the misplaced concern surrounding the patenting of human genes and, rather, pointed to the protections afforded by other elements of patentability.  The subcommittee members recognized the need to “incentivize research and development into the exciting prospects of individualized diagnostics and precision medicine” and to “ensure the protections that will enable our innovators to bring these products to market while safeguarding research into the next generation of medical advances”.  Indeed, it should not go unappreciated that the statement refers to the Ariosa decision, which is characterized as the invalidation of claims to “a revolutionary prenatal test … that allowed doctors to avoid invasive procedures”, and quotes from Judge Linn’s concurring opinion.

Thus, the subcommittee appears to fully appreciate that maintaining the current law on patent eligibility is not an option.  While we are only at the beginning of this processes, a return to rewarding inventive effort may be on the horizon.  Stay tuned.

Authored by Michael Christie, PhD

A recent decision by the United States Federal Circuit (AVX Corporation v Presidio Components, Inc (Fed Cir, No 2018-1106, 13 May 2019)) has clarified the requirements for standing to appeal from an inter partes review (“IPR”) before the Patent Trial and Appeal Board (“the Board”), but has left open the issue of estoppel.

AVX Corporation (“AVX”) lodged an IPR against all the claims of US 6,661,639 (the ‘639 Patent) relating to ceramic capacitors.  The Patentee of the ‘639 Patent, Presidio Components, Inc (“Presidio”), was a competitor of AVX.  An IPR is a trial proceeding conducted before the Board to review the patentability of one or more claims of a patent on the basis of lack of novelty or obviousness (i.e. a ground raised under §§ 102 or 103) based on patents or printed publications.

The Board ultimately upheld several claims of the ‘639 Patent, which led to AVX appealing the decision to the Court of Appeals for the Federal Circuit.  The first question that had to be addressed by the Federal Circuit was whether AVX had standing to appeal the IPR decision.

The judicial power of Federal Courts in the United States is derived from Article III of the United States Constitution.  Article III grants the Federal Courts judicial power over cases or controversies.  Accordingly, a party appealing to the US Federal Circuit from an IPR must demonstrate it has standing to appeal, namely it must demonstrate ‘(1) an “injury in fact,” (2) “a causal connection between the injury and the conduct complained of” and (3) a likelihood that “the injury will be redressed by a favourable decision.’” (citation omitted).

AVX argued two theories for establishing standing: (1) AVX is injured by The Board’s rejection of its challenge to the upheld claims as it is estopped from raising these invalidity challenges in a later non-Patent Office action or (2) AVX is injured because it reduces AVX’s ability to compete with Presidio.

AVX’s injury by estoppel theory was based on the estoppel provision of 35 USC § 315(e)(2), which states in part:

The petitioner in an inter partes review of a claim in a patent … may not assert in either a civil action … that the claim is invalid on any ground that the petitioner raised or reasonably could have raised during that inter partes review.

AVX argued that operation of §315(e)(2) effectively barred it from ever asserting in a district court, i.e. in a declaratory judgement action or as a counterclaim to an infringement action, that the upheld claims were invalid.  This argument was rejected by the Federal Circuit.  First, the Federal Circuit explained that estoppel itself does not create standing when a party is not already engaging in allegedly infringing activity.  Second, the Federal Circuit clarified that as yet no such decision as to the application of this section and the ramifications of estoppel had been issued.  The Federal Circuit also highlighted case law holding ‘“[i]t is axiomatic that a judgment is without preclusive effect against a party which lacks a right to appeal that judgment”’. Consequently, although the Federal Circuit declined to find standing on this issue, it left open the possibility that estoppel would not apply.  Therefore, in a subsequent action before a district court, AVX can “test whether § 315(e) bars it from raising the … challenges that the Board reviewed and rejected”.  

AVX’s second theory for standing was based on injury as a competitor of Presidio under a so called “competitor standing” theory where the actions of the government are implicated.  The Federal Circuit explained that “competitor standing” had been recognized in many non-patent related circumstances where the actions of the government, e.g. cancellation of a tax benefit, actions of the Federal Communication Commission, resulted in “a nonspeculative threat to a concrete interest of the challenger”.  In contrast to such cases, the government action here was the Board upholding claims “which do not address prices or introduce new competitors”.  Accordingly, the mere existence of patent claims does not constitute a harm for a competitor of the patentee.  However, the Federal Circuit opined that harm could be established where the challenger was “using the claimed features or nonspeculatively planning to do so”.  Despite evidence of Presidio’s past infringement suits against AVX and AVX’s suspicions that Presidio would assert the upheld claims, The Federal Circuit found that AVX did not establish any current use or nonspeculative plans related to the upheld claims and, therefore, did not establish standing.

Since no theory for Article III standing was found persuasive, the Federal Circuit dismissed the appeal from the IPR decision upholding claims of the ‘639 Patent.

Take-home lesson:  Petitioners clearing a path by proactively challenging patents in an IPR prior to engaging in or planning (potentially) infringing activity risk lacking standing to appeal adverse IPR decisions to the Federal Circuit.  However, despite the estoppel provisions of §315(e)(2), such Petitioners may not be subject to estoppel with regard to the arguments raised during the IPR.  However, the Federal Circuit was not definitive in this regard, noting that the issue of estoppel would need to be tested in a subsequent litigation.

Authored by Ean Blackwell

On May 1, Japan entered a new era, known as Reiwa, following the abdication of Emperor Akihito, and, consequently, ending the Heisei era.  You may be asking, “What does this have to do with Japanese patent numbers?”, and these days the answer is “not much”, but that hasn’t always been the case.

Prior to 2000, the Japanese patent numbering system used the Emperor year (the number of years since the current Emperor ascended the Chrysanthemum Throne) as part of its numbering system to indicate the year in which various events occurred.  The main events that affect those of us searching the Japanese patent database are the publication of patent or utility applications, and publication of the examined patent or utility applications.

The numbering format for these four publications is Yyy-nnnnnn, where Y refers to the Emperor era, yy refers to the Emperor year, and nnnnnn is a six-digit number.

Emperor eras relevant to us are Showa which ranges from 1926 to 1989, and Heisei which ranges from 1989 to 2019, although it is the period from 1989 to 2000 that is most of interest here.

Now things start getting a little more complicated, but stick with me.  The numbering of years within each era restarts with each era, so 1926 is year one of the Showa era, or S01, and so on, up to 1989, which is S64.  1989 is also the first year of the Heisei era, so it’s also known as H01.  2000 is therefore H12, and H30 has just concluded.

One more thing, the six-digit number, nnnnnn, restarts each year at 000001, and the number for the unexamined application is different to the number for the equivalent examined application.  What this means is, for a random number such as H01-066151, this could be the publication number for the unexamined or the examined application.

That’s generally fine within the Japanese system as it only takes one or two searches to find what you’re looking for, but here in the West we removed the Emperor era symbol, and we also took to removing, and I’m not sure it was consistent, some of the leading zeros within both the Emperor year, and the six-digit number.  So the number above became JP 1066151.  Is that H01-066151 or H10-066151? Is it examined or unexamined? Is it a clamp for a sofa or an antidepressant or even a piece of radio telephone equipment?  Thankfully the European Patent Office realised there was a level of confusion, and now insist on the Emperor era as part of the number, although the leading zeros thing is still an issue.  Many other sources of Japanese patent information haven’t made this leap.

After 2000, the numbering system moved to yyyy-nnnnnn, where yyyy is the Western year, and the application keeps this number until grant, regardless of where it is in the application process.  It’s a much more straightforward system.

I also haven’t mentioned anything about granted patent numbers.  They are numbered consecutively, regardless of a change in year or Emperor, although there have been a couple of jumps forward to a round number when the law changes.  The last was to JP 2 500 000 in 1996 for patents.

What you need then, in order to locate older Japanese publications, is a sense of what the Emperor era is, a kind code such as A or U for an unexamined application or B or Y for an examined application, and an applicant name or an idea of the subject matter to help pinpoint the right one.

If not, there’s always this for afterwards.

Authored by Frazer McLennan and Charles Tansey, PhD

IAM Patent 1000: The World’s Leading Patent Professionals 2019 results have been announced.  Shelston IP have again been Highly Recommended for their patent prosecution.

Those who have been commended, are to be congratulated.

“Shelston IP is head and shoulders above the rest, for its holistic service and deep reserves of knowledge. The team is super proactive and always one step ahead of the opposition; they work around the clock, never missing a deadline and will go above and beyond to ensure the work is first-rate.” An example of the firm’s innovative tendencies is its recent launch of OneAsia, a business solution aimed at providing clients with seamless one-stop shop protection across the Association of Southeast Asian Nations. Paul Harrison leaves both clients and peers in awe. As one patron enthuses: “Paul fuses his technical knowledge in chemical engineering with his legal expertise and sound commercial thinking, to produce great work. He has strong patent searching and analysis skills and his overall strategic approach makes him a stand out. Paul is proactive and his ability to understand complex processes and distil it into simple and easily digestible language is extremely valuable.” Patent attorney Greg Whitehead has a broad mechanical engineering practice; he possesses detailed and unique knowledge of robotic systems, automation equipment and industrial drying and heating machine patents. Commercial law department spearhead Chris Bevitt comes “highly recommended for his finesse in transactional matters. He has the ability to take intricate commercial arrangements involving the past, present and future rights and obligations of parties and draft meticulous, concise and effective clauses to reflect them perfectly. Chris’ turnaround is fast and his communication extremely effective – he proposes alternative solutions to achieve the best possible outcome. He is courteous and always available to answer questions too.”

Authored by Paul Harrison, Greg Whitehead and Chris Bevitt

The requirement that a patent specification sufficiently enables the subject matter of the claims is particularly relevant to pharmaceutical inventions and can be a hurdle for innovators even if a claimed invention is deemed novel and inventive. In the absence of any prior art, the claimed invention can fail the enablement requirement if it is not plausible at the date of filing that the invention would work across the full scope of the claims in the eyes of a person skilled in the art. As reported previously, the majority of the UK Supreme Court disagreed with the principle that plausibility is a “low, threshold test” and required that the patent specification itself provides a reasonable basis for the scope of the claims. However, a recent decision of the Patent Office in Gary B Cox v MacroGenics, Inc. [2019] APO 13 (MacroGenics) suggests that plausibility is still a low threshold in Australia, and that the common general knowledge can be drawn upon to enable the claims.

The Invention 

Australian Patent Application No. 2012259162 owned by MacroGenics, Inc. relates to a protein-based therapeutic with extended serum half-life. More specifically, it is directed to a polypeptide comprising a portion of a de-immunized albumin-binding protein capable of binding to serum albumin. The de-immunized albumin-binding protein is a variant of a wild-type albumin-binding domain (ABD) of Streptococcal Protein G. The application disclosed that specific mutations of the ABDs not only extended serum half-life but also decreased immunogenicity relative to the unmodified proteins. Such protein properties are likely to maximize therapeutic efficacy without triggering a heightened immune response.

Plausibility and Undue Burden 

In considering the requirement of “plausibility” under section 40(2)(a) as amended by the Raising the Bar Act 2012, the Delegate noted the absence of Federal Court authority on this provision, and cited the approach from an earlier Patent Office decision Evolva SA [2017] APO 57 (Evolva) which stated that enablement of a claim should be determined according to a 2-step test (emphasis added):

Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular: 

(a) Is it plausible that the invention can be worked across the full scope of the claim?

(b) Can the invention be performed across the full scope of the claim without undue burden

In Evolva, the Deputy Commissioner stated that the threshold for plausibility is a low one, and may be based on the slimmest of evidence, citing Human Genome Sciences Inc v Eli Lilly & Co [2011] UKSC 51 in which Lord Neuberger indicated that in some cases a “plausible” or “reasonably credible” claimed use, or an “educated guess”, can suffice.

The Delegate in MacroGenics also cited Warner-Lambert v Generics & Anr [2018] UKSC 56 (Warner-Lambert), a recent UK Supreme Court judgement, regarding the plausibility aspect of enablement. In Warner-Lambert the majority of the Supreme Court found that plausibility should be derived from the disclosure of the specification read through the eyes of the skilled person in light of their common general knowledge. Although the disclosure need not definitively prove the assertion that the product works for the designated purpose, there must be something that would cause the skilled person to think that there was a reasonable prospect that the assertion would prove to be true. In contrast, the minority of the Supreme Court thought such a standard for plausibility was too high and that the patentee should not have to demonstrate within its patent a prima facie case of efficacy.

While the Delegate observed “it is clear that the Supreme Court has adopted a higher threshold with respect to plausibility…” (emphasis added) the Delegate did not see this as inconsistent with the decision in Evolva. The Delegate stated “It remains the case that, as set out in Evolva, the consideration is one of technical credibility or believability. Plausibility may be a low threshold, but it is a threshold nonetheless, and is not satisfied by mere speculation or assertion”.

With regard to “undue burden” the Delegate referenced the following statements from Evolva and Eli Lilly & Co v Human Genome Sciences, Inc. [2008] EWHC 1903 respectively:

My understanding of these authorities is that the emphasis in relation to undue burden has been on the nature of the work that is required by the skilled person in view of the guidance in the specification. To this end, one approach has been to ask whether the skilled person would be required to undertake a ‘research programme’ in order to perform the invention.”

“… patent specifications need not set out every detail necessary for performance, but can leave the skilled man to use his skill to perform the invention. In so doing he must seek success. He should not be required to carry out any prolonged research, enquiry or experiment. He may need to carry out the ordinary methods of trial and error, which involve no inventive step and generally are necessary in applying the particular discovery to produce a practical result. In each case, it is a question of fact, depending on the nature of the invention, as to whether the steps needed to perform the invention are ordinary steps of trial and error which a skilled man would realise would be necessary and normal to produce a practical result.”

In MacroGenics, lack of enablement was asserted in two ways. Firstly, that the conjugation of the ABD to any polypeptide was not enabled as the specification was largely directed to diabodies; and secondly that the claims were not enabled with regard to variants of the specific ABDs exemplified. With regard to the first of these, the Delegate found it plausible that fusion of a deimmunised ABD as defined in the claims to any polypeptide would extend the serum half-life of that polypeptide and that there was no undue burden on the skilled person in working the invention in this respect. As to the second issue, the Delegate found that ABD variants satisfying the functional requirements of the claim could be identified and used to extend polypeptide half-life. However, the Delegate considered that, given the large number of possible mutations to ABD, identification of variants with the desired properties would be unpredictable in light of the limited guidance provided in the specification.  While such work would be routine, the Delegate was of the opinion that it would be an undue burden to work the invention across the full scope of the claims. The specification was thus found to lack enablement under section 40(2)(a).

The findings of the Delegate provides confirmation that the standard for “plausibility” is low in Australia. To satisfy this standard, the patent was not required to demonstrate a prima facie case that fusion of the claimed ABD to anypolypeptide would extend serum half-life or that the ABD variants claimed are deimmunized and could be used to extend polypeptide half-life. The Delegate stated that plausibility is a low threshold not requiring definitive proof and the Delegate appeared to notably rely on evidence of the common general knowledge rather than drawing from the disclosure in the patent specification itself. Nevertheless, due to the unpredictable nature of this technology, it was deemed an “undue burden” to perform the invention particularly because the specification provided no indication on what is and is not likely to work or guidance on how to proceed when confronted with failures.

The Delegate further noted that the present circumstances were quite different from the one contemplated in Evolva, where the claimed polypeptide was limited by sequence homology and by structure-function. MacroGenics, Inc. has been given two months from the date of the decision to amend the claims to overcome the findings of the Delegate and have filed amendments to limit the claimed ABD variant by sequence homology.

Conclusion 

Biotechnology and pharmaceuticals are areas of technology often struck by unpredictability. While the assessment of enablement will continue to be a case-by-case approach, the Evolva and MacroGenics decisions provide some guidance on how the Australian Patent Office is likely to assess plausibility.

A recent precedential decision by the United States Federal Circuit (Nuvo Pharmaceuticals v DR. Reddy’s Laboratories (Fed Cir, No 17-2473, 15 May 2019) has provided valuable advice on the balance between obviousness and written description.  The decision reversed a final judgement of a District Court Bench Trial that found function-limited claims in US 6,926,907 and US 8,557,285 to be non‑obvious and to satisfy the written description requirements.

The claims at issue related to a tablet containing a nonsteroidal anti-inflammatory drug (NSAID) core and an enteric coating containing an acid inhibitor (such as a protein pump inhibitor (PPI)) in an amount effective to increase the pH of the gastrointestinal tract to at least 3.5 and prevent NSAID-related gastric injury.  Importantly, neither patent specification provided any experimental data indicating that the result specified by the functional limitation was achieved.

The lower Court found that the written description requirement was satisfied and that it was non-obvious to use a PPI to prevent NSAID-related gastric injury, and that persons of ordinary skill in the art were discouraged by the prior art from using uncoated PPI and would not have reasonably expected it to work. However, in the absence of experimental data, this reasoning was detrimental to the issue of written description before the Federal Circuit, which stated:

In light of the fact that the specification provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed. It does not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed. (emphasis added)

In reaching the decision, the Federal Circuit confirmed that complying with the written description requirement, while not requiring experimental data ‘demonstrating effectiveness’, requires more than a mere statement in the specification.  Rather, the specification must demonstrate that the inventor was in possession of the claimed invention.  The Federal Circuit carefully explained that even in cases where written description has been found to be inherently established by way of the enablement of the claim (i.e. the specification described the making and using of an invention), there was some experimental evidence in the specification supporting written description.

In the case at issue, in view of the lack of experimental data and the lack of expectation of the person of ordinary skill in the art, written description could not be established.  As stated by the Federal Circuit:

Based on the specific facts of certain cases, it is unnecessary to prove that a claimed pharmaceutical compound actually achieves a certain result. But when the inventor expressly claims that result, our case law provides that that result must be supported by adequate disclosure in the specification. In this case, the inventor chose to claim the therapeutic effectiveness of uncoated PPI, but he did not adequately describe the efficacy of uncoated PPI so as to demonstrate to ordinarily skilled artisans that he possessed and actually invented what he claimed. (emphasis added)

Thus, Patent Practitioners should carefully consider the inclusion of functional features in a claim if there is insufficient relevant experimental evidence included in the specification (or provided by the inventor at the time of drafting).

Best Practice Tip:  Claims reciting functional features upon which the non-obviousness of the subject could ultimately turn should be supported by at least some experimental evidence related to achieving the result claimed.  In other words, a functional feature in a claim should be drafted in consideration of supporting experimental evidence.

Authored by Ean Blackwell

Allira Hudson-Gofers is a Senior Associate at Shelston IP and Team Leader of the Engineering and ICT team. She is also an elite athlete who has represented Australia in the sports of handball and beach handball, competing in the Handball World Championships in 2007, 2009 and 2011, and in the Beach Handball World Championships in 2012, 2014 and 2016. Allira is currently training for the 2019 Beach World Games to be held in San Diego, California, USA from 9-14 October 2019. Allira has also contributed to the sport by coordinating New South Wales beach handball activities, managing the administration of the emerging Australian junior beach handball program, and assisting with junior training camps.

Question

As an Australian representative in handball and beach handball, you would know all about this year’s World IP Day theme Reaching for Gold. As a Patent Attorney how do you think innovation has played a part in sport over the years?

Answer

There are many examples of innovation in sport, beach handball being a perfect one. This sport was developed to be a “spectacular” version of team handball. With a number of changes, including the playing surface, court size, number of players, and the ball, the most innovative aspect to beach handball is the introduction of two spectacular shots, the spin and the alley. Subsequently, alley shots have become regular features of the original team handball game.

Living in Australia, we are somewhat sport obsessed and, as a result, we see a number of sporting innovations come to life in Australia. Over the years, a wide range of sporting innovations have developed in Australia, including dash-mounted cameras in motor racing, stump mounted cameras in cricket, Ben Lexcen’s winged keel design for yacht racing, Speedo® swimwear, and the game of Australian football.

Question

You have been involved and supported Girl’s Invent through Shelston IP’s pro bono program. Can you tell us a bit about how you have been involved, and in particular with the filing of an Australian and US patent application for a group of students at Camberwell Girls Grammar School for their Score Buddy invention?

Answer

Girl’s Invent currently offer programs in 150 Australian schools. Through these programs, CEO Mark Glazebrook, runs specifically designed workshops to guide girls through the process of developing new products. These workshops range in topic from idea generation through to commercialisation and market entry.
Shelston IP support Girl’s Invent through our pro bono program and I have been able to speak with several the school groups about intellectual property and commercialisation, often specifically relating to a product that they are developing.

The Score Buddy was developed by three year 8 students at Camberwell Girls Grammar School: Alice Wilson, Susannah Lutze and Mikayla Lee. This device straps to the throat of a tennis racquet and has the potential to solve a problem on the social tennis court: keeping track of the score!

Shelston IP looked after the preparation and lodgement of a provisional application for the young inventors over 12 months ago. We have now progressed to having pending patent protection in both Australia and the United States.
It is very rewarding to assist the Score Boddy team and all of the girls in the Girl’s Invent program as they explore the innovation process. I can’t wait to see what fantastic products are developed in the next program!

Question

Not only are you an Australian handball player, you have three Masters degrees including Master of Biomedical Engineering, Master of Industrial Property and an MBA. Can you attribute your role as an elite athlete to your success in business?

Answer

There is research which supports the parallels between elite level sporting competition and success in the business realm.

Some of the more obvious parallels are the discipline of time management, performing under pressure, working with team mates, and the setting and pursuit of goals.
In particular, I have found that developing my ability to work under pressure and time management through elite sport has been instrumental in allowing me to complete the above degrees, while working and competing. Importantly, I think that in developing these skills I have become more adept at managing pressure and am able to comfortably take on a greater scope and variety of tasks.

What is, maybe less obvious, is that elite sport provides an environment where failure is commonplace. Games are lost, and perfection of skills can lie many hours away or even out of reach. Success is often defined by the ability to bounce back and try again, and to receive feedback (on both positive and negative performances) and develop from it. I have found that training and competing at elite level provides many opportunities to practice such skills. Transferring these to the business environment allows the confidence to try something new without fear of failure, then going on to seek feedback and assess performance, and try again. Personally, I have found the greatest enjoyment in putting my hand up for a broad variety of projects in the workplace, giving the opportunity to develop new skills and knowledge and to work with many different people.

Question

Do you believe playing sport can help women develop motivational skills and team building skills — does it equip women with the competitive spirit that’s essential for success both on the playing field and in the workplace?

Answer

Yes, I think sport can help women, and men, to develop motivation and team-building skills. In addition, I believe that sport and sporting achievement at whatever level, supports the development of confidence which is transferable to other areas.

In a team sport environment, the blend of communication and coordination is key. Success on the field requires athletes to understand the team goals and how to navigate their individual place. With experience, athletes develop the ability to understand their team member’s roles, and to assess their own and others’ strengths and weaknesses.
On the sporting field, time is often limited, and communication needs to be succinct and to the point. The recipient also needs to process instructions quickly and effectively and, if they disagree, resolve the point before the game has moved on. The workplace may not have the time pressure dictated by a game clock nor have the distraction of trying to communicate in the midst of a fast-moving game, however it does have other performance pressures. The sporting field is a low risk arena for practicing team work and communication skills that can then be used in the workplace.

Question

Finally, what was the greatest lesson you learned from sports that has helped you succeed in your professional career?

Answer

I think the greatest lesson I have learned from sports relates to continuous development.
For me, this includes placing an appropriate perspective on performance, the willingness and ability to assess performance, and to put in the time and effort to improve and develop new skills. Over my career, this has seen me take on new areas of study, such as the Masters of Business Administration, and get involved in a variety of projects ranging from process improvements to the fit-out of our new office space.

I believe that my proactive approach to personal and professional development and my willingness to get involved in new and different projects encourages further interesting opportunities to be made available to me and is a major contribution to my professional success.

Authored by Allira Hudson-Gofers

April 26 is World IP Day for 2019, with the theme of “Reach for Gold – IP & Sports”. Shelston Intellectual Property and Shelston Lawyers, congratulate Australian Rugby League Commission Limited (ARLC) and its related entities including New South Wales Rugby League Limited and Queensland Rugby Football League Limited for their sustained and successful efforts in relation to the application of IP in the sporting arena.

ARLC

ARLC is the peak body responsible for the governance, growth and development of the sport of rugby league throughout Australia. ARLC and its related State entities operate and control all the major professional rugby league competitions in Australia including the renowned National Rugby League (NRL) competition and the annual State of Origin series.

Rugby league in Australia

Rugby league can trace its history back to as early as 8 August 1907, when New South Wales Rugby League (NSWRL) was founded. The first season of the Sydney rugby league premiership took place in 1908, and was contested by nine teams.

NSWRL ran the major rugby league competition of New South Wales, and subsequently Australia, from 1907 to 1994. In 1995, control of the Australian rugby league competition passed from NSWRL to ARLC. ARLC has controlled professional rugby league competitions in Australia since that time (together with News Limited during the period 1998 to 2012).

The NRL competition is a competition between professional rugby league clubs in Australia and New Zealand. It has been sponsored by Telstra Corporation Limited (Telstra) since 2001, and is called the NRL Telstra Premiership. It is contested by sixteen teams, fifteen of which are from clubs based in Australia, and one of which is from a club based in New Zealand.

The NRL competition is regarded as the world’s elite rugby league club competition. The NRL Grand Final is one of Australia’s most popular sporting events, and one of the largest attended club championship events in the world.

The State of Origin series is contested between rugby league teams representing Queensland and New South Wales and is comprised of elite players from the NRL competition. Accordingly, the State of Origin series is widely regarded as the pinnacle of the sport of rugby league worldwide as it comprises the best players from the most competitive and highest quality rugby league club competition in the world. The series is also widely considered to be one of Australia’s greatest sporting rivalries and premier sporting events, attracting extensive game attendance and high rating television viewing.

ARLC’s trade mark portfolio

ARLC and its predecessors have established a substantial portfolio of trade marks, some of which date back decades. The trade mark portfolio comprises the names, logos and official mascots of all participating league clubs along with the names and brands of ARLC and its associated entities including the names of the various competitions. Shelston Lawyers has had the privilege of assisting ARLC and related entities with their trade mark registration, prosecution, enforcement and defence work for more than 10 years.

ARLC’s trade mark portfolio serves various purposes. First, it protects the valuable intellectual property of ARLC and related entities in club and competition names and brands, many of which have been established for decades or longer. ARLC uses its registered trade marks to prevent other sporting codes from adopting club or competition names which are too similar to those associated with ARLC. ARLC has also successively opposed many trade mark applications by third parties wishing to unfairly capitalise on ARLC’s strong reputation in its names and brands.

Secondly, ARLC’s trade mark portfolio enables ARLC to commercialise its brands and reputation through licensing arrangements with authorised producers and distributors of official ARLC and NRL merchandise and through media rights deals. ARLC generates substantial revenues from its licensing and merchandising programs and media rights deals. A related purpose is to prevent unauthorised third-party merchandisers from seeking to pass off their rugby league merchandise as official merchandise sanctioned by ARLC.

ARLC makes very active use of its trade marks including in media promoting the competitions, on club jerseys and other official match paraphernalia, on ground signage and on commercial merchandise. Likewise, the trade marks are frequently referenced by television, print, radio and internet media.

A key victory for ARLC through its trade mark program

As indicated above, one of the purposes of ARLC’s trade mark registration program is to successfully establish and defend its title to its names and brands.

In recent years, ARLC (and its associated entities) have opposed various third-party applications for, and defended their own applications for, trade marks related to the State of Origin series. ARLC has been successful in every matter to date. In a decision confirming ARLC’s successful defence of one of its applications for STATE OF ORIGIN, the hearing officer stated that “In the present matter, the Applicant [ARLC] has provided overwhelming and continual evidence of use of the Trade Mark from well before the Relevant Date. This evidence is of such an extent that it establishes in fact that the Trade Mark distinguishes the Applicant’s Goods from the goods of other traders. An endorsement to this effect will be added to the Register.”

To assist the hearing officer in reaching this conclusion, ARLC submitted hundreds of pages of evidence of its use of the trade mark over an extended period together with evidence of substantial match attendance figures and media coverage involving ARLC’s use of State of Origin-related branding. ARLC has subsequently used the findings from this hearing to successfully oppose other third-party applications and support its own further applications for State of Origin related trade marks. ARLC’s clear title to those trade marks is now beyond doubt as a result of its vigorous prosecution of its own applications and vigorous opposition of third party applications. Shelston Lawyers is proud to have acted for ARLC in all of these matters.

ARLC Reaching for Gold

While ARLC’s primary goal will always be the promotion and ongoing development of rugby league, it can be justifiably proud of its long history of successfully using its trade mark portfolio to protect its reputation, and monetise its brands through merchandising and media rights licensing.

Authored by Chris Bevitt and Michael Deacon

Under Australian practice, both method of treatment and Swiss-style claims, in the format use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]” are permitted. As reported previously, method of treatment and Swiss-style claims are directed to different infringing acts in Australia. This highlights the importance of pursuing both these claim types in Australian pharmaceutical patents

The construction of Swiss-style claims was recently considered again in Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28. The Federal Court confirmed that infringement of a Swiss-style claim requires the patentee to establish that the manufacturer has made (or will make) the relevant medicament with the “objective intention” that it be used to treat the condition defined in the Swiss-style claim.

In this case, the applicants’ product, fenofibrate (marketed under the name Lipidil), was indicated for the treatment of retinopathy, in particular diabetic retinopathy, and covered by Swiss-style claims of Australian Patent No. 2006313711. The allegedly infringing products, collectively referred to as “the Ranbaxy Products” were originally approved for the same indication as the applicants’ product. However, the product information (PI) for the Ranbaxy Products was subsequently amended to remove reference to diabetic retinopathy.

The infringement case submitted by the applicants relied on the following points at [105]:

(a)    the amended PI for the Ranbaxy Products asserts that the Ranbaxy Products are bioequivalent to Lipidil;

(b)    the PI for Lipidil expressly states that Lipidl is indicated for the reduction in the progression of diabetic retinopathy and includes details of the FIELD and ACCORD trials relevant to that indication; and

(c)    the PI for the Ranbaxy Products does not assert that the Ranbaxy Products are not indicated for diabetic retinopathy or that it is somehow not relevantly bioequivalent for that purpose.

Nicolas J acknowledged that the Ranbaxy Products are suitable to be administered for the therapeutic use designated in the Swiss-style claims yet he rejected the submissions above and said at [106]:

“[i]n my view the evidence does not support a finding that the Ranbaxy products will be manufactured with the intention that they be used for the prevention or treatment of diabetic retinopathy. The infringement case based on the Swiss-style claims must fail.” (emphasis added)

In reaching the decision, Justice Nicolas was guided and accepted the observations of the UK Supreme Court in Warner Lambert Company LLC v Generics (UK) Ltd [2018], including:

  • that a Swiss-style claim is “purpose limited” and that the monopoly claimed is for the preparation or manufacture of a medicament for the treatment of a particular medical condition; and
  • as a matter of construction, a Swiss-style claim required a “mental element” involving an “objective intent” or a “subjective intent” of the manufacturer.

The test of “subjective intent” questions whether the manufacturer made the product with the intention of targeting the patent-protected market while “objective intent” asks whether the alleged infringer knew or could foresee that at least some of the prescriptions for the claimed drug for the claimed indication would actually be fulfilled by their own product. While Nicolas J did not find it necessary to decide in the present case whether the Swiss-style claims are concerned with the objective or subjective intention of the manufacturer, he found the reasons given by the UK Supreme Court who favoured the “objective intention” more persuasive and evidently, he stated at [103]:

“[o]f course, it is for the applicants to establish that the manufacturer has made (or will make) the relevant medicament with the objective intention that it be used to treat the condition designated in the Swiss-style claims. The fact that it may be reasonably foreseeable or even likely that a substantial portion of the product manufactured will be used to treat that condition is certainly not determinative at least not where the product is also used extensively in the treatment of other non-designated conditions.” (emphasis added)

The Court’s decision suggests that establishing the “intention” of a potentially infringing manufacturer may be difficult particularly when the product has a wide range of indications. Importantly, simply because the products are bioequivalents does not establish an intention nor does a lack of disclosure excluding the claimed indication on the PI. As such, innovators should include all possible medical indications of a product in a Swiss-style claim as sufficiently supported and enabled by the specification.

Authored by Michael Christie, PhD