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News from Abroad: Revised Provisional Timetable for the Unitary Patent and Unified Patent Court

The Preparatory Committee of the UPC has published a revised timetable for the final stages of preparations for the opening of the Unified Patent Court (UPC).  The revised timetable indicates that the Sunrise Period during which existing European Patents can be opted out of the jurisdiction of the UPC could start in September 2017 and the UPC could start accepting cases in December 2017 when the Unified Patent Court Agreement (UPCA) comes into effect.

In order for the UPCA to come into effect, it remains for the UK and Germany to ratify the UPCA.  The UK recently announced its intention to proceed with ratification.  Germany was always expected to be the last state to ratify, in order to control the timing of the UPCA coming into effect.  Once the UPCA has come into effect, it will be possible for the EPO to grant Unitary Patents.

The Preparatory Committee has stressed that the revised timetable is conditional, and there is no guarantee that the timing will not slip further back again.  Patent users should bear in mind that the UPC could be operational by the end of 2017 and so may wish to make preparations to decide which of their granted patents should be opted out of the jurisdiction of the UPC during the Sunrise Period which might start in September 2017.

This article was reprinted with permission from J A Kemp.

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

By David Brown* --

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016.  This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the name Lyrica®, has been keenly followed as the first detailed analysis of infringement of "second medical use" patents by generically available medicines.  In Europe, generically available medicines can be marketed without an explicit statement of potential uses that are still under patent protection ("skinny" labelling).  The use of pregabalin to treat pain is currently protected by a Warner-Lamber patent, and Actavis's drug, Lecaent®, is marketed with labelling that does not refer to pain.

The Court of Appeal decided that the patent was invalid on the technical ground that "pain" was not a single disease and so the claim was not adequately supported by the relatively limited data in the patent, relating only to peripheral neuropathic pain.  Furthermore, the Court held that Warner-Lambert had not requested appropriate conditional amendment of the patent early enough, and therefore could not maintain the patent in the limited scope of peripheral neuropathic pain.  In these findings, the Court upheld the decision of the Patents Court, handed down on 10 September 2015.

As a result of the invalidity of the patent, Lecaent® was found to be not an infringing product.  The Court of Appeal, however, also provided detailed obiter comments on the circumstances in which a "second medical use" patent may in principle be infringed by a generically available medicine marketed with skinny labelling.  The Court stated (paragraph 216):

"... it is only essential [for infringement] that the [generic] manufacturer is able to foresee that there will be intentional use [of the generic product] for the new medical indication.  Intentional use is to be distinguished from use where the drug is prescribed for a different indication and, without it in any sense being the intention of the treatment, a pain condition is in fact treated."

This "foreseeability" test is a factual test.  If intentional use for the in-patent condition is foreseeable, then it is incumbent on the generic manufacturer to take all reasonable steps to mitigate the risk, taking into account the ways in which the intentional use by the patient might be facilitated (e.g., prescribing practices of doctors; national dispensing guidelines to pharmacists; individual dispensing practices of pharmacists).  The Court stated (paragraphs 207 and 208):

"... [W]hat is sufficient to negative the existence of intention?  In my judgment the absence of the patented condition from the label cannot conceivably be sufficient to negative the intention.  Mr Speck [counsel for Actavis] recognised that there could be objective factual circumstances where the absence of a label identifying the patented indication did not negative intention, for example a manufacturer who proposes to sell far more of the drug than the market for the non-patented indication could bear.

Viewed in this way I think the answer becomes clear.  The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring.  In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity."

This important decision establishes that the burden is largely on the generic manufacturers to mitigate the risks of their products being intentionally taken by patients for an in-patent treatment.

The extent to which the prescribing practices of doctors, National Health Service dispensing guidelines to pharmacists and the individual dispensing practices of pharmacists will need to be refined to assist the generic manufacturers in this endeavour will no doubt be explored in the future, as the healthcare system in the UK adapts to this new guidance from the Court of Appeal.

Importantly also, the decision establishes a relatively patentee-friendly regime for the UK enforcement of second medical use patents.  As discussed in the decision (paragraphs 190 to 201),a range of approaches is found in Europe, with the German courts taking the view that a generic manufacturer will not infringe unless it positively recites the patented use on its packaging.

We understand that permission to appeal to the Supreme Court is being sought.

Warner-Lambert Company, LLC v Generics (UK) Ltd & Others [2016] EWCA Civ 1006

• Mr. Brown is a Partner with Haseltine Lake LLP.

This article was reprinted with permission from Haseltine Lake LLP.  The article was originally published in the 21 November 2016 issue of Haseltine Lake's Chemistry and Life Sciences Newsletter.

News from Abroad: Antibodies in the European Patent Office

The following article was reprinted with permission from J A Kemp.

The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions.  However, some commentators have suggested that antibodies are regarded as a special case by the EPO when evaluating inventive step / obviousness.  It is implied that the EPO sets a higher patentability threshold for inventions in this field as compared to, for example, small molecule therapeutics.

This perception likely reflects no more than the crowded nature of the antibody field, which has matured rapidly in recent years.  As a result, EPO Examiners are able to make a large (and increasing) number of assumptions regarding the background knowledge of the skilled person.  For example, in the absence of evidence to the contrary, the EPO considers it to be routine to raise an antibody to a known target.  The EPO also considers it to be routine to optimise certain characteristics of an antibody, such as affinity or immunogenicity.

Although it is not unique to the field, the approach of the EPO can present significant challenges to applicants seeking to pursue claims to antibodies, particularly antibodies to known targets.  We have set out below our suggestions for how grant of antibody claims at the EPO might nonetheless be achieved in different factual scenarios.  We have also set out the types of supporting evidence that may be required in each case.  Figure 1 provided at the end of this briefing summarises the suggestions in the form of a decision tree, which may help to guide you to the most appropriate strategy at different stages in an antibody development project.

Scenarios likely to Result in Broad claims

Broad antibody claims typically arise from two basic scenarios.  In the first scenario, the target is a newly-identified molecule, or is a molecule to which it has previously proven difficult to raise an antibody.  In such cases, the antibody may be defined solely in terms of the target bound.  For example:

"An antibody which specifically binds to <target>"

In the second scenario, the target is found to have a previously unappreciated role in a disease.  That is, the target is found to be associated with a new medical use.  In such cases, the antibody may be defined by reference to the target bound and the new medical use.  For example:

"An antibody which specifically binds to <target> for use in a method of treating <new disease or condition>".

These two basic scenarios are discussed in more detail below.

Newly-Identified or Difficult Target

The extensive mapping of genomes and proteomes means that truly "new" targets are increasingly rare.  However, an applicant who identifies, for example, a new polypeptide (potentially including new mutant forms of a known polypeptide) can expect to obtain broad claims to any antibody that specifically binds to the new polypeptide.  It is not typically necessary to provide evidence that an antibody has actually been produced if the target is susceptible to routine methods of antibody production.

An applicant who develops a method allowing an antibody to be raised for a known target which was not susceptible to routine methods can also expect to obtain broad claims.  The EPO effectively views such a target as a special category of new target -- it is "newly available" for antibody production.  Inventions of this type are though increasingly rare.  Methods of antibody production have developed such that few targets are not now susceptible to them, and overcoming technical difficulties is frequently seen as routine.  If the EPO can be persuaded otherwise for a particular case, the patent application will need to include clear evidence that an antibody to the target has indeed been raised, as well as sufficient information to allow this to be repeated.

For antibodies to such newly-identified targets or difficult targets, medical use claims may be allowable even without direct evidence of a clinically-relevant functional effect.

New Medical Use

Where a known target molecule is found to have a previously unappreciated role in a disease, it may be possible to obtain claims directed to any antibody that specifically binds to the target for use in a particular method of treatment.  In a typical scenario of this type, the target has a known association with one disease, but is subsequently found to have a role in a different (new) disease that was not previously appreciated.  Under such circumstances the claims will be limited to an antibody for use in a method of treating the new disease, but will cover any anti-target antibody for the said use.

It will be necessary to establish that the new medical use is not obvious from any previous disclosure regarding the target or existing antibodies that bind to it.  It will also be necessary to establish that it is at least plausible that an antibody binding to the target will have a therapeutic effect.  At present this is a relatively low threshold at the EPO and in vitro functional data will likely be sufficient, particularly if it derives from a disease model or other assay relevant to the indication.  In vivo data from animal models is helpful but not required.  It is not normally expected that a patent application will include in vivo data from human clinical trials.

Similar considerations may apply if it was previously thought that the only antibodies that could be produced to a target were pharmaceutically irrelevant (for example due to low affinity), but it is subsequently found that they have a therapeutic effect¹.  In such cases a claim to a pharmaceutical composition comprising any antibody specific for the target may be possible.

Scenarios which may Result in Narrower Claims

It is unlikely that broad antibody claims will be available if both the target and associated medical uses are known.  However, grant of narrower claims may still be possible.  Such claims will likely need to incorporate limitations from either or both of the following categories.

New or Improved Characteristic of an Antibody

Limitations to specific functional characteristics of the antibody, such as a required level of affinity or a down-stream functional effect, likely also with at least some structural (sequence) characteristics.

New Development of a Known Medical Use

Limitations to specific aspects of the medical use, such as a particular patient group or a dosing/administration regime.

Both categories are discussed in more detail in the following section.  The categories are not mutually exclusive, and claims including both should be pursued wherever possible as part of a comprehensive filing strategy (see additional comments on filing strategy in the separate section below).  However, in our experience, at any given stage in development a particular antibody project is likely to favour limitations from one category over the other.

New or Improved Characteristic of an Antibody

Examples of the types of functional characteristic that applicants may seek to rely upon are described in more detail below.  These examples should not be viewed as exhaustive or mutually exclusive.  In practice a combination of these and other characteristics may well provide the best route to allowable claims.

Irrespective of the characteristic(s) relied upon, pursuit of this approach will likely require that applicants have provided a significant amount of structural information (primary amino acid sequences) in the patent application.  Whether a particular antibody is claimed directly or is recited as a reference antibody, the EPO often insists that structural detail be provided at a level at least sufficient to define the target binding region of an antibody.  It may alternatively be possible to meet these requirements by reference to a biological deposit of, for example, a hybridoma, provided the deposit is made in accordance with the Budapest Treaty.

Historically, the EPO has accepted structural definitions of antibodies which refer only to one or two CDR sequences.  However, EPO Examiners are likely now to insist upon all six CDRs as a minimum requirement, unless data is available to show that any characteristic relied upon is achieved with fewer CDRs.  There is though an increasing appreciation of the relevance of framework regions to target binding, and so there is a trend towards requiring that the heavy and light chain variable region sequences be recited in full.  In some cases it may even be necessary to specify the isotype of the constant region if this is relevant to the characteristic(s) relied upon.

By contrast to its approach for small molecule therapeutics, the EPO does not in general consider that a unique structure can confer inventive step on an antibody to a known target.  Thus, whilst an antibody comprising a unique primary sequence will be considered to be novel, structural non-obviousness arguments are unlikely to be accepted even when both variable region sequences are recited in full.

This means that applicants will generally be unable to rely upon, for example, the determination of unique CDR and framework sequences to provide an inventive step.

Instead, the EPO has developed a requirement that a new antibody to a known target must demonstrate "an unexpected effect" relative to pre-existing antibodies to the same target² in order for inventive step to be acknowledged.  It will therefore generally be necessary to demonstrate that the antibody as claimed possesses a functional characteristic (or combination of characteristics) which could not reasonably have been predicted from the prior art.

Ideally, at least some direct experimental evidence of the characteristic(s) relied upon will be provided in the patent application, for at least one exemplary antibody.

Under some circumstances it may be possible to rely upon supplementary data filed later, but there must be a connection to the characteristic(s) shown in the application.  The characteristic(s) relied upon must be at least plausible at the filing date³.

This test has been applied very strictly by the EPO on at least one occasion.  In a specific case⁴ the Board of Appeal held that a particular effect relied upon by an applicant to support inventive step could not be derived from the patent application itself, even though an arguably related effect was explicitly demonstrated in the Examples.  Accordingly the effect relied upon was considered to have been demonstrated only after the filing date of the application, and was not taken into account when assessing inventive step.

If the EPO is persuaded that "an unexpected effect" is present and plausible, the breadth of claim that is allowed will depend upon the circumstances of each case -- in particular the state of the prior art and the data available.

At the narrowest end of the spectrum, it may be necessary to limit the claims to the specific sequences of an antibody which has been shown to possess the unexpected effect.  For example:

"An antibody which binds specifically to <target> and which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."

At the opposite end of the spectrum, and more rarely, it may be possible to claim a general class of antibodies which achieves the said effect, defined solely in functional terms. For example:

"An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>."

It will be necessary for the application to include sufficient information such that the skilled person can generate further examples of an antibody which meets the functional definition.  The identification in the patent application of a specific, structurally-defined antibody which can be used as a reference / control in a screening method is usually acceptable.  However, it is not unusual for an Examiner to require that the claim also include some structural information about the claimed antibody or the reference antibody.  As such, allowable claims may be a hybrid of the two types shown above.  For example:

"An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>, wherein the antibody competes for binding to <target> with an antibody which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."

Examples of Possible New Characteristics

As mentioned above, the following examples should not be viewed as exhaustive or mutually exclusive.  In practice a combination of these and other characteristics may well provide the best route to allowable claims.  The goal is to establish that there is a technical effect or characteristic (or multiple such effects or characteristics) which can be shown to have been unexpected based on the relevant prior art.

Affinity

The EPO considers the generation of an antibody with nanomolar affinity to be achievable by routine methods for the vast majority of targets.  Whilst there may be exceptions for particularly difficult targets, high affinity alone is now unlikely to be sufficient to establish an inventive step.  However, high affinity in combination with another advantageous characteristic is nonetheless likely to be helpful.

Specificity

The EPO tends to view high specificity for target to be an inherent characteristic of all antibodies and so an increase in specificity alone is unlikely to be sufficient to establish an inventive step.  However, an increase in specificity which gives rise to an unexpected technical advantage, or which was previously thought to be difficult to achieve, may be enough.  For example if a new antibody is able to distinguish between closely-related targets to a greater extent than was previously possible.

Epitope

An antibody which can bind to an epitope in a target that was previously unrecognised and/or previously considered to be inaccessible is likely to be viewed as inventive.  Under certain circumstances this may even be seen as a sub-category of the "Newly-identified or difficult target" scenario described above.  If binding to the particular epitope also provides a functional advantage (e.g. enhanced specificity) this is likely to be helpful.

Manufacturability

Routine optimisation for improved solubility etc is unlikely to be viewed as inventive.  However, there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected.  For example, if a surprising increase in affinity or specificity occurs.

Immunogenicity

Humanisation of antibodies to reduce anti-isotypic or idiotypic responses is now largely viewed as routine, as is the production of fully human antibodies.  However, as with manufacturability there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected.

The Board of Appeal has held in one case⁵ that particular point mutations to introduce human sequences in the framework regions of a specific mouse antibody were sufficient to acknowledge inventive step for that antibody.  The evidence in that case persuaded the Board that the skilled person could not reasonably have expected that those specific mutations would reduce immunogenicity without significantly reducing affinity.

Down-Stream Functional Effects

Any improvement in down-stream function is likely to be helpful when seeking to establish an inventive step.  However, adaptations of an antibody to enhance down-stream functions such as ADCC are unlikely to be viewed as inventive where they rely upon known phenomena such as altered glycosylation of Fc regions.

New Development of a Known Medical Use

It seems it is becoming ever more challenging to persuade the EPO that a new or improved characteristic of an antibody is enough alone to establish inventive step.  However, in our experience antibody inventions are treated no differently to other therapeutics when assessing further developments of a known medical use, in which a new and unexpected technical effect can be demonstrated.

The scope of claim that may be available via this route will depend upon the data produced, since it will be necessary to show that the effect relied upon is achieved across substantially the whole scope claimed.  This may require limitation to an antibody defined by a complete structural definition (including constant regions), if the EPO do not accept that the effect relied upon applies more generally, for example to all antibodies possessing the same six CDRs.

Ideally the data showing the effect should be present in the patent application.  However, data generated post-filing may be used to supplement arguments later in prosecution, provided the effect relied upon is plausible at the filing date⁶.

Bearing this in mind, we consider that inventions of this type are generally in one of two categories:

Combinations

(Bispecific Molecules/Combination or Co-Administration with other Therapeutics/Conjugates)

Any form of therapy which combines an antibody with another functionality may give rise to allowable claims.  Examples include a combination with another binding functionality in the same molecule (a bispecific molecule), a combination with another effector functionality in the same molecule (a drug/toxin conjugate), or the co-administration of the antibody with another therapeutic (combination or co-administration), or any combination of these types.  In each case, as with any combination of known therapeutics, it will be necessary to establish that the combination results in a technical effect (typically an advantage) which was not obvious from the prior art (e.g. synergistic increase in efficacy).  It will likely be necessary to include experimental evidence of the technical effect in the patent application.

Treatment Methodologies

(Patient Group/Dose or Formulation/Administration Route or Regime)

The Enlarged Board of Appeal of the EPO has established⁷ that claims to second/further medical uses of a substance may be based not only on the treatment of a different disease, but also on the treatment of the same disease by a method which differs for example in the dosage, formulation, administration regime, group of subjects or route of administration.  In each case, as with any known therapeutic, it will be necessary to establish that the difference gives rise to a technical effect (typically an advantage) which was not obvious from the prior art (e.g. surprisingly enhanced efficacy for topical versus parenteral administration).  It will likely be necessary to include experimental evidence of the technical effect in the patent application.

New Types of Antibody

An invention which relates to a new type of antibody may give rise to broad claims which are not limited to a specific antibody or target.  Examples of possible inventions in this category could include a novel and inventive arrangement of the binding domains (a new antibody "format"), a novel and inventive effector region (such as a modified Fc domain), or an entirely different class of antibody molecule isolated from a newly-discovered species.

For inventions of this type, the assumptions that the EPO would otherwise make regarding production and optimisation of known antibody types should largely be negated.  The EPO should treat such inventions in the same way as any other technology, since normal considerations of novelty, inventive step and sufficiency of disclosure should apply.  As such the assessment of each case will depend upon its merits.

Comprehensive Filing Strategy

A typical antibody development project will pass through different stages, and at each stage it may correspond more closely to one or the other of the scenarios outlined above.  This briefing is intended to provide some suggestions as to how patentable claims may be achieved in each scenario.  These suggestions are also summarised in Figure 1.

However, the scenarios that are described are not mutually exclusive.  As with any therapeutic invention, a comprehensive filing strategy should seek to explore all of the available options for patent protection throughout the lifespan of the project and beyond.  For example, an initial broad filing to a new medical indication should be followed with multiple narrower filings to antibodies with improved characteristics and/or developments of the treatment methodology.

Figure 1

¹ Board of Appeal decision T601/05: claims to a pharmaceutical composition comprising human anti-TNFα antibodies were found to be inventive. At the time only low affinity human antibodies to the target could be generated, and it was thought that these were not suitable for pharmaceutical use.
² Board of Appeal decision T735/00
³ Board of Appeal decision T1329/04
⁴ Board of Appeal decision T2637/11
⁵ Board of Appeal decision T0067/11
⁶ Board of Appeal decision T1329/04
⁷ Enlarged Board of Appeal decision G2/08

This article was reprinted with permission from J A Kemp.

News from Abroad: Not One But Two Decisions Fine Tune the Australian Patent Office's Approach to Life Science Technologies

By Chris Vindurampulle* --

Two recent Australian Patent Office decisions have provided clarity as to the patentability of isolated nucleic acid sequences following the High Court's decision in D'Arcy v Myriad Genetics¹ ('Myriad').  The first decision is perhaps not such a surprise, however the second decision represents a clear contradiction in Patent Office practice following Myriad until now.  The outcome of both decisions is greater certainty, at least for those in the life sciences industry seeking patent protection in Australia.

Brief Background

The October 2015 High Court decision in Myriad has been covered extensively.²  While isolated DNA is different on a chemical and structural level to DNA as it naturally exists, the key point from the High Court's decision was the determination that the substance of a patent claim directed to an isolated mutant 'breast cancer gene' was the information embodied in the claimed molecule.  That information was deemed to be naturally occurring.  Consequently, the Court found claims directed to the isolated mutant gene were not eligible for patent protection in Australia.

Subsequent to Myriad, the Australian Patent Office issued updated examination practice guidelines for considering eligibility of patent claims directed to isolated nucleic acid sequences.  The guidelines set out several questions which enables examiners to make a call on whether a claim directed to an isolated nucleic acid is patent eligible.  These questions include an assessment of:

• the 'substance' of a claim (not merely its form),
• whether that substance is 'made' or 'artificial', and
• whether the claimed invention has economic utility.

Notably, the guidelines state that certain subject matter is to be clearly excluded from patent eligibility.  This includes isolated, naturally occurring nucleic acid molecules, whether DNA or RNA, human or non-human, or coding or non-coding.  Further, relevant to the second case below is the statement in the guidelines that claims to isolated interfering/inhibitory nucleic acids (which merely replicate genetic information of a naturally occurring organism) are also to be excluded from patent protection.

Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 ('Cargill')

This decision concerns Cargill Incorporated's opposition to Dow Agrosciences' patent application which broadly relates to the production of oil in genetically engineered canola.

Claim 31 of the opposed application is directed to an isolated DNA sequence coding for an enzyme derived from a fungus.  Expressing the fungus-derived gene in canola causes a modification to the oil which provides a health benefit.  Although claim 31 was not opposed by Cargill, the hearing officer invited both parties to provide submissions in light of the High Court's findings in Myriad.  Only Dow provided submissions.

Although not expressly stated, the unique feature of claim 31 was that the 'information' embodied in the isolated fungal nucleic acid had been altered from that which normally exists (codon optimised for those technically inclined) such that, when the gene is expressed in an oil producing plant, the corresponding gene product is more efficiently produced, albeit that the gene product itself is not different from that which naturally exists.

The hearing officer concludes at paragraphs [44] to [45] that the 'substance' of claim directed to the altered fungal gene is different from the mutant breast cancer gene in Myriad.  Specifically, the officer's view was that the genetic information embodied in the isolated fungal nucleic acid had been modified, and that its economic utility in oil production in genetically engineered canola was clear.

Accordingly, claim 31 was considered to comprise patent eligible subject matter.

Arrowhead Research Corporation [2016] APO 70 ('Arrowhead')

Arrowhead concerns a patent application which relates to interfering RNA (or iRNA) compositions.  The outcome of using iRNA compositions is specific targeting and modification of gene expression.  In Arrowhead's application, the iRNA compositions were directed to treating inflammatory conditions such as allergic conjunctivitis, ocular inflammation, dermatitis, rhinitis, and asthma by way of controlled gene expression.

Prosecution of Arrowhead's application had stalled given the examiner's insistence that the claims directed to iRNA compositions were not patent eligible.  Specifically, it was the examiner's view that RNA interference is only possible because the sequence of nucleotides is the same to that which occurs in the genome.

The attorney for the applicant exercised the option of requesting an ex parte hearing on the matter which provides the option of having an independent assessment of any outstanding objections.

Bearing in mind that Patent Office examination guidelines have, until now, provided that iRNA molecules are to be excluded from patent protection, the key points as argued by Arrowhead's attorney was that the claimed iRNA molecules do not normally exist in nature, and the manner in which iRNA-mediated gene silencing works is not solely dependent on the sequence of nucleotides in an iRNA molecule.  Further distinguishing the claims from patent ineligible subject matter was the fact that it was a 'composition' that was claimed rather than an isolated RNA molecule per se.

The hearing officer concludes at para [29] that based on a consideration of how RNAi-mediated gene silencing works, the substance of the claims was more than genetic information alone, and the claimed compositions were products having economic utility.

Accordingly, the claims directed to compositions comprising iRNA molecules were found to be patent eligible.

Conclusion

The above decisions not only provide clarity for those prosecuting nucleic acid-based product claims in Australia, but also support for arguing against patent eligibility objections raised against such claims during examination.  Clearly, if a claim directed to a nucleic acid molecule provides more than genetic information alone (by modification or otherwise), there is now greater opportunity for arguing in support of patent eligibility and obtaining a broader scope of protection.

This is good news for those in the life sciences industry seeking patent protection in Australia.

The Arrowhead decision also highlights that an ex parte hearing can be a useful strategy for prosecuting Australian patent applications where the applicant faces examination hurdles.

_______________________________________________________________________________________

¹ D'Arcy v Myriad Genetics Inc [2015] HCA 35
² See for example "Australian High Court Nukes Biotech Industry from Orbit: "It's the Only Way to be Sure"" by Dr. Mark Summerfield, and "Patent eligibility in Australia: the winding road ahead" by Dr. Tania Obranovich.

* Dr. Vindurampulle is an Associate with Watermark.

This article was reprinted with permission from Watermark.

News from Abroad: Canada's Federal Court Questions No File Wrapper Estoppel on Claim Construction

By Junyi Chen --

The Supreme Court of Canada in Free World Trust v Électro Santé Inc, 2000 SCC 66 rejected the use of extrinsic documents such as file wrappers (patent prosecution histories) for claim construction, on the basis that allowing such evidence would undermine the public notice function of the claims and increase uncertainty.  Hence, there is no equivalent of U.S. file wrapper estoppel in Canada.

Recently, in Pollard Banknote Limited v Scientific Games Products (Canada) ULC, 2016 FC 883, Justice Locke of the Federal Court questioned whether it was time to revisit the principle of no file wrapper estoppel for claim construction, as file wrappers, like claims, are now publicly available and hence give public notice of the contents of the prosecution history.  Nevertheless, Justice Locke re-affirmed that, at present, it is settled in Canada that file wrappers are irrelevant to claim construction and therefore, in the present case, the patentee (Scientific Games) was not estopped from presenting a claim construction that contradicted its previous submissions to the Canadian Patent Office during prosecution.  In obiter, Justice Locke noted that had this case been tried in the U.S. where the principles of file wrapper estoppel apply, Scientific Games would unlikely have been allowed to argue a claim construction that attempted to recapture grounds conceded during prosecution of the application to avoid prior art.

Justice Locke found however that Scientific Games' Canadian Patent No. 2,752,551, relating to a two-dimensional authentication barcode hidden under a scratch-off area on print instant lottery tickets, was invalid for ambiguity and obviousness; in the alternative, Pollard did not infringe the patent.  This is the first time in forty years that a claim was held invalid for ambiguity in Canada.

With respect to obviousness, Justice Locke held that a patent should not be granted to a skilled person simply making an obvious change to what was known in the art, even if that art would probably not have been located in a diligent search.  He noted that concerns regarding a diligent search may be more relevant where the obviousness allegation combines two references, neither of which is part of the common general knowledge.

In light of Justice Locke's comments on revisiting the principle of no file wrapper estoppel, applicants would be advised to limit their representations and amendments before the Canadian Patent Office only to the extent necessary to overcome examiners' objections.  It would also be advisable for a party assessing the merits of a Canadian patent, to review the file wrapper for potentially problematic representations and amendments made during prosecution.

Dr. Chen is an associate with Deeth Williams Wall.

News from Abroad: IP Australia Releases Myriad Examination Guidelines

By Claire Gregg & Martin O'Brien --

Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by the decision.

The full Examination Guidelines, which can be found here, apply immediately to pending applications, and will be incorporated into the Examiner's Manual of Practice and Procedure on 11 January 2016.

IP Australia received and considered a broad range of submissions on the issue of patentability of nucleic acids, and has ultimately maintained a fairly narrow interpretation of the High Court's decision.

Blanket exclusions from patentability apply to isolated naturally occurring DNA and RNA, whether human, non-human, coding or non-coding.

Synthetic nucleic acids (including cDNA), probes, primers and isolated interfering/inhibitory nucleic acids are only excluded where they "merely replicate the genetic information of a naturally occurring organism".

In circumstances where subject matter which may be affected by the decision is not expressly excluded from patentability, the new Guidelines call for a case by case consideration of the following factors:

1. What is the substance of the claim (not merely its form)?
2. Has the substance of the claim been "made" or changed by man, or is "artificial"?
3. Does the invention have economic utility?
4. Does the invention as claimed represent a new class of claim?

The Guidelines elaborate on the application of these factors, but ultimately, in the absence of legislative changes, it will be up to the courts to determine the breadth of the ramifications of the Myriad decision. In the meantime, the Guidelines have indicated that the following remain patentable subject matter:

• Recombinant or isolated proteins;
• Pharmaceuticals and other chemical substances;
• Methods of treatment;
• Methods of applying herbicides; and
• Applications of computer technology.

Substance of the Claim

In Myriad, the High Court expressed concern that the claims at issue elevated form over substance in that "the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated".

The Examination Guidelines set out a number of factors to be taken into account in determining the substance of the claim:

• The form of words and breadth of the claim;
• The size of the class of compounds covered by the claim;
• Does the compound embody or convey genetic information that is of importance to the utility of the claimed invention;
• The emphasis of the claim; and
• What did the applicant invent, is the product a step along the way to a process or method that is the real invention.

"Made" vs "Artificial"

The High Court in National Research Development Corporation v Commissioner of Patents (NRDC) stipulated that, in determining whether a claim relates to a manner of manufacture, consideration must be given to whether that claim relates to an artificially created state of affairs.  The High Court in Myriad clarified that artificiality per se is not sufficient -- the substance of the claim must have been created or "made" by human action.

The factors to be considered during examination include:

• Whether the substance of the claim was '"made" (i.e., created or modified, by human action).  It is not enough that the subject matter of the claim is artificial;
• What are the physical differences between the claim and the natural state;
• What was the labour required to produce the product;
• "Made" can include created or modified but not merely through replication; and
• Isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.

New Class of Claim

The High Court in Myriad indicated that the principles laid down in NRDC are only two of the relevant considerations before the Court when determining whether a claim relates to patentable subject matter.  NRDC requires consideration of the following:

1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and
2. Whether the invention as claimed has economic utility.

However, when a new class of claim involves "a significant new application or extension of the principles of patentability", the following must also be taken into account:

1. Whether patentability would be consistent with the purposes of the Act;
2. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability;
3. Relevancy to Australia's place in the international community of nations; and
4. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.

Examiners will look to Myriad and other established case law to determine whether a claim represents a new class and, under the new Examination Guidelines, raise an objection where "the substance of the invention lies outside an established category of patent eligible subject matter".  No doubt this will lead to significant judicial consideration of the above factors in relation to new classes of claims in the future.

Dr. Gregg is a Patent Scientist and Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia.

This article was reprinted with permission from Spruson & Ferguson.

Top Stories of 2015: #11 to #15

By Donald Zuhn --

After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories.  For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  Last week, we counted down stories #20 to #16, and today we count down stories #15 to #11 as we work our way towards the top five stories of 2015.  As with our other lists (2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2015" on January 21, 2016 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories, can be found here.

15. Federal Circuit Decides Biosig v. Nautilus on Remand

In April, the Federal Circuit considered the question of indefiniteness on remand from the Supreme Court's reversal in Nautilus v. Biosig and found again that the Biosig's claims were not indefinite.  In the earlier proceedings in the case, the District Court found the term "in spaced relationship" indefinite as a matter of law, and the Federal Circuit reversed, using its "insolubly ambiguous" test to hold that the claim was amenable to construction and thus not indefinite.  The Supreme Court rejected the Federal Circuit's standard, holding that "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty those skilled in the art about the scope of the invention," and reversed and remanded for reconsideration by the Federal Circuit under this standard.  On remand, the Federal Circuit again reversed the District Court's indefiniteness determination, noting that that "an ordinarily skilled artisan would be able to determine this language requires the spaced relationship to be neither infinitesimally small nor greater than the width of a user's hands," and concluding that "[t]he term 'spaced relationship' does not run afoul of 'the innovation-discouraging 'zone of uncertainty' against which [the Supreme Court] has warned,' and to the contrary, informs a skilled artisan with reasonable certainty of the scope of the claim."

For information regarding this and other related topics, please see:

• "Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)," April 27, 2015

14.  Supreme Court Decides Kimble v. Marvel

In August, the Supreme Court let stand its fifty-year ban on royalties post patent expiry (Brulotte v. Thys Co., 1964).  The case involved U.S. Patent No. 5,072,856 to Kimble, directed to a toy that simulated the web-shooting devices used by the fictional Spiderman, which Kimble attempted to license to Marvel (which owns the rights to the Spiderman character, comic books, movies, and ancillary merchandise).  Marvel instead chose to copy the invention, bringing their own version of the toy to market, and the parties subsequently settled the resulting patent infringement lawsuit on terms wherein Marvel purchased the patent for a lump sum (~$500,000) plus a 3% royalty; the settlement containing no limit on this royalty obligation with regard to patent expiry.  Marvel brought a declaratory judgment action against paying post-expiry royalties in which it prevailed, and the Supreme Court majority refused to overrule the Brulotte rule.  Although the majority recognized that royalty plans like the one at issue here can have advantages including "draw[ing] out payments over time and t[ying] those payments, in each month or year covered, to a product's commercial success," the majority believed that the principle of limiting the exclusive right to the statutory term is sufficiently important to require patentees and their licensees to "find ways around Brulotte" using other means.

For information regarding this and other related topics, please see:

• "Kimble v. Marvel Entertainment, LLC (2015)," August 20, 2015

13.  FDA Approves First Biosimilar

In January, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN^® biologic drug, making Sandoz's application the first to be accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA), which was part of the healthcare reform package passed in 2010 and commonly referred to as "Obamacare."  Two months later, the FDA approved the biosimilar version of Neupogen® for sale in the U.S. -- thus becoming the first biosimilar to be approved under the BPCIA (a mere ten months after Sandoz filed its biosimilar application).  Sandoz (a division of Novartis) began selling its biosimilar product in September under the brand name Zarxio™.  Sandoz also avoided the disclosure provisions of the BPCIA in 2015, successfully arguing that those provisions were optional before the District Court and the Federal Circuit (but that's a "top story" for another day).

For information regarding this and other related topics, please see:

• "Sandoz' NEUPOGEN® Biosimilar Now on the Market," September 7, 2015
• "The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?" March 12, 2015
• "FDA Approves Sandoz Filgrastim Biosimilar," March 8, 2015
• ""No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval," January 14, 2015

12.  Patent Reform Stalls in Congress

The year began with Rep. Bob Goodlatte (R-VA), the Chairman of the House Judiciary Committee, introducing his "Innovation Act" bill (H.R. 9), which sets forth several "reforms" of U.S. patent law, in substantially the same form as in the last Congress.  In July, Rep. Goodlatte released a 200-page Report on H.R. 9.  While many considered eventual passage of H.R. 9 to be a near certainty, the bill did not come to the House floor for a vote before the August recess and the year concluded with the bill sitting on the House calendar.  Although the Innovation Act is primarily directed to addressing the "problem" of so-called "patent trolls," over the course of 2015 a different patent reform issue (especially in the biopharm sector) started to gain traction.  In an article published last fall on Medium, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood highlighted this issue, urging Congress to modify the inter partes review (IPR) system, which he argued had "turn[ed] the serious business of medical innovation and entrepreneurial risk-taking into a casino."  In a letter sent to the Senate and House Committees on the Judiciary, 101 patient organizations also expressed "concern[] that, as currently written, H.R. 9 falls short of preserving important patent protections for the biopharmaceutical innovation our communities rely on to achieve a better quality of life."  The group of patient organizations contended that "IPR[s] opened the door to abuses that threaten the unique and specialized mechanisms under the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA)."  Whether the Innovation Act moves to a House vote, and whether that bill (or an alternative) proposes any reforms to the IPR system, will begin to play out as Congress reconvenes this week.

For information regarding this and other related topics, please see:

• "BIO CEO: IPR System Threatens Medical Innovation," December 6, 2015
• "Pigs Fly, Hell Has Frozen Over, and the New York Times Supports Small Inventor and University Patenting," October 28, 2015
• "101 Patient Organizations Ask Congress to Curb IPR Abuse," October 11, 2015
• "PTAB Denies Inter Partes Review Petitions Against Two Acorda Patents," August 24, 2015
• "Ferrum Ferro Capital Files Motion to Strike Allergan's Complaint Alleging Misuse of IPR Process," August 12, 2015
• "Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act," August 6, 2015
• "Rep. Goodlatte Releases Report on H.R. 9," August 4, 2015
• "CBO Provides Cost Estimate to Government to Implement Innovation Act," July 27, 2015
• "Allergan Fights Back, Files Complaint Against Venture Fund That Filed IPR Petition," July 13, 2015
• "A Sea Change for IPRs? -- Part II," June 10, 2015
• "A Sea Change for IPRs?" June 9, 2015
• "Senate Judiciary Committee Passes PATENT Act," June 4, 2015
• "Group of National and State Organizations Asks Congress to Enact Legislative Reforms to Maintain Strong Patent System," June 1, 2015
• "A Modest Proposal (or Two)," April 22, 2015
• "Legislation Introduced in House to Eliminate Uncertainty Regarding AIA Grace Period," April 20, 2015
• "STRONG Patents Act of 2015 -- An Alternative Patent Reform Bill," March 4, 2015
• "Rep. Goodlatte Introduces His Patent Reform Bill (Again) -- Part II," February 9, 2015
• "Rep. Goodlatte Introduces His Patent Reform Bill (Again)," February 5, 2015
• "Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees," January 29, 2015
• "Big Ten Lobbies Congress to Tread Lightly on "Patent Reform"," January 29, 2015

11.  Australia Follows U.S. Lead on DNA Claims

In June, the High Court of Australia heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids.  In October, the High Court of Australia handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims of Myriad's patent, which related to isolated nucleic acid sequences of the BRAC1 gene.  In reaching that decision, the majority judgment characterized the claimed invention as "information" rather than a chemical product, because it was defined as a code for the BRAC1 gene, which can be stored in various products, such as the isolated DNA of a person or cDNA where the introns in the sequence have been excised.  The product was merely the medium in which that information resides.  The High Court's decision marked a dramatic departure from the Australian Parliament's position on "gene patents" in recent years.  Australia Patent Law only expressly excluded from patentability "human beings and biological processes for their generation", and in 2010 the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which sought to exclude not only DNA and RNA, but all biological entities from patentability, failed to pass after the Senate Legal and Constitutional Affairs Legislation Committee (SLCALC) recommended against the Bill.  As one of Patent Docs correspondents noted, the High Court's decision in D'Arcy v Myriad Genetics Inc brought Australia's position on isolated DNA and RNA in line with that of the United States, while representing a marked deviation from major trading partners such as Europe and the U.S. on the issue of patentability of cDNA.

For information regarding this and other related topics, please see:

• "Australian High Court Has Ruled in Myriad Gene Patent Case," October 8, 2015
• "High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia," October 8, 2015
• "Isolated Nucleic Acids Not Patentable in Australia," October 7, 2015
• "Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia," October 7, 2015
• "High Court of Australia Hears Myriad Appeal," June 16, 2015

News from Abroad: The UPC: to Opt Out or Not to Opt Out, That Is the Question

By Liz Cohen --

Did you know that in the Unified Patent Court (UPC) a patentee will be able to get an injunction covering a market much bigger than the entire USA, in a procedure that lasts no longer than a year, at a hearing which lasts a day, by Judges who will largely be without the benefit of expert testimony or discovery?  And if it all goes badly wrong a patentee could lose its patent for almost the whole of Europe all at once?

If this sounds scary, then you probably haven't paid enough attention to the new patent litigation system which will be shortly coming into effect in Europe.  Current estimates suggest that the new Unified Patent Court will be open for business in the first half of 2017, and whilst there is provision for a transitional period for at least the first seven years of its existence, crucially, if owners of European Patents do nothing before the system comes into effect, their existing and pending European Patents automatically become part of the system.

During the transitional period and for a short time before the UPC comes into existence (known as the sunrise period), a proprietor of a granted European patent and all future European patents can choose to register an opt out of the UPC for the patent.  There is a fee payable for doing so and each patent must be opted out individually by the proprietor (or proprietors if applicable).  It is understood that the opt-out could last for the life of the patent.

So why might a patentee choose to opt out its European Patent?  For many patentees the reason is simple: the system is just too untried and untested to risk putting the crown jewels at its mercy. Whilst the governing Treaty and the latest draft of the rules provide some comfort as to how future patent litigation is intended to be carried out in the new court system, until the court starts rendering decisions, and those decisions are considered by the new Court of Appeal in Luxemburg, a patentee simply does not know what stance the Judges of the UPC will take on weighty issues such as claim construction, preliminary injunctions or final relief.  There is also the issue of opening up your patent to the possibility of a pan European revocation action.  With this in mind and recognising that a patentee has the ability to opt its patent back in (although a patentee can only opt out and back in again once), some patentees have indicated that they intend to opt out their patents, wait and see how the system beds down and opt back in, only when it would be beneficial for obtaining pan European relief.

Sounds sensible.  So what's the downside to opting out?  Well, there is a school of thought that thinks that the wording of the transitional provision provides that, if during the period of the opt out, a third party starts a revocation or declaration of non-infringement proceedings under the patent in a national court for which the patent is designated, then this will block the patentee's ability to opt back into the UPC system when it chooses.  As a result, a patentee may find that as a result of its opting out decision and the subsequent action of a third party, it is permanently excluded from the UPC system for the life of the patent.  Further a decision not to opt out of the system does not necessarily mean that the UPC has exclusive jurisdiction over the opted out patent.  The wording of the transitional provision appears to explicitly provide for national proceedings to take place in relation to a non-opted out patent during the transitional period arguably providing competitors with many more options as to where and how to challenge a patent that has not been opted out.  Finally, those more seasoned litigators, who are used to creating law and testing legal systems, can see the downside of not having an opportunity to stress test the UPC system in those early years.  Surely, they say, that unless the system is used, we will never know whether it is any good and a viable option for us in the future?

Despite many years of doubt about whether a pan European Patent Litigation Court would ever come to fruition, the reality is that it is coming and soon.  The transitional provisions, introduced in recognition of the fact that the system was not even in contemplation when many patent proprietors chose to apply for patents in Europe provides some options for patentees and challengers of patents in the immediate future.  However, once the transitional period has ended, this will be the only system in Europe for litigation of European Patents.  Whatever your view as to whether the new Court achieves its aims or not, the new Court is coming, and you can't afford to ignore it.

Liz Cohen is a Patent litigation Partner with Bristows LLP

This article was reprinted with permission from Bristows.

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

By Karen Sinclair --

The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences, but also to go further to rule out the patent-eligibility of cDNA.  The Court bought the same 'substance over form' argument that was successful at the U.S. Supreme Court, but has heavily overlaid matters of public policy on the law to come to its decision.

The summary of the decision overwrites the application of the seminal 1959 Australian decision in NRDC as follows:

'This Court in National Research Development Corporation v Commissioner of Patents("NRDC") held that the terminology of "manner of manufacture" taken from s 6 of the Statute of Monopolies was to be treated as a concept for case-by-case development13. It thereby mandated a common law methodology for its application. It did not confine that methodology to the use of any verbal formula in lieu of "manner of manufacture". Nor, in the case of a new class of claim, did the decision of the Court in NRDC preclude consideration of policy factors informed by the purpose of the Act and considerations of coherence in the law.' (emphasis added)

The lead decision comments:

Identification of the subject matter of the claims as a class of chemical compounds is the premise upon which the Full Court's conclusion is based. It is a premise which, with respect, elevates form over substance to the detriment of the developmental function entrusted to the Court as explained in NRDC and reflected in the continuing use of the "manner of manufacture" formula in s 18(1)(a) of the Act.

The code in the invention as claimed refers to the sequence of nucleotides which, in a cellular environment, can ultimately be translated into the BRCA1 polypeptide. That sequence can properly be described as "information", the ordinary meaning of which includes125:

"Without necessary relation to a recipient: that which inheres in or is represented by a particular arrangement, sequence, or set, that may be stored in, transferred by, and responded to by inanimate things".

Used in that sense, the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. It is the existence of that information which is an essential element of the invention as claimed. The product is the medium in which that information resides. That characteristic also attaches to cDNA, covered by the claims, which is synthesised but replicates a naturally occurring sequence of exons.

Some commentators are of the view that policy considerations have been allowed to influence the bench.  The Australian Government's Department of Health has made anti-patent noises in the past, and of course, the Australian Minister for Trade just had a significant win against the US in the TPP negotiations in respect of the US contention that data protection for biologics needed to be mandated at 12 years.  The affordability of medical care in this country has become a significant political focus, and this, despite the new Prime Minister's focus on innovation and science, may hold medical science back in this country.

In addition, there's a passage that strongly infers that leaving  Government to legislate on patent-eligibility is a thing of the past in Australia:

'The proposition that a broad statutory concept applies to a new class of case on the boundaries of existing judicial development of that concept requires consideration of the limits of judicial law-making inherent in common law methodology.  Where an affirmative application of the concept is likely to result in the creation of important rights as against the world, to involve far-reaching questions of public policy and to affect the balance of important conflicting interests, the question must be asked whether that application is best left for legislative determination.'

The Court appears to go on to answer its own 'question' in a long exposition on whether it is the courts or the parliament which should decide patent-eligibility, opining:

In Australia, the Parliament has left it to the courts to carry out a case-by-case development of a broad statutory concept according to the common law method in a representative democracy.

Given the history of this matter, and the long debate in Australia including in public senate hearings and in government commissioned reports on so-called 'gene patenting', this is a surprising outcome.

The full decision can be found here.

Ms. Sinclair is a Principal at Watermark.

This article was reprinted with the author's permission.

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

By Tania Obranovich –-

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has today handed down a unanimous judgement overturning this decision.  This highly anticipated decision reverses decades of accepted practice in relation to the patentability of genes in Australia and now sets Australian law at odds with that of many other jurisdictions, such as Europe and China, where isolated nucleic acid molecules remain patentable.

The BRCA patents, which claim both breast and ovarian cancer diagnostic methods and the mutated BRCA DNA molecules themselves, have courted significant controversy both in Australia and the US in recent years.  In terms of the US, this resulted in litigation which culminated in the US Supreme Court ruling that naturally occurring DNA molecules are a product of nature and not eligible for patenting merely by virtue of having been isolated from their natural environment.  In terms of the Australian situation, the attempts of the Australian licensee to centralise the BRCA testing led to the establishment of two Senate enquiries which considered the impact of granting gene patents, this being followed by Federal Court litigation which challenged the patentability of the claims to the BRCA DNA molecules.  The outcomes from both the Senate enquiries and the two initial Federal Court hearings unequivocally supported maintaining the patentability of isolated nucleic acid molecules.

The High Court of Australia decision mirrors the essence of the US Supreme Court Decision . . .

The Full Federal Court of Australia, being expressly wary that oversimplification of the facts and underlying scientific principles can lead to incorrect conclusions, clarified that the isolation of DNA is more than just a mere discovery.  The Court held that the BRCA gene molecule is not the same as its naturally occurring counterpart, there being both structural and functional differences which result from its isolation, thereby giving rise to the "artificial state of affairs of economic significance" which, for decades, has been understood to be the threshold that must be met in Australia for subject matter to be patentable.  The High Court, however, has effectively retreated from what has been regarded as a definitive legal principle in relation to the test for patentability, arguing that this principle should merely be interpreted as a guide in relation to deciding patentability and should not be used as a strict formula.

"...highly anticipated decision reverses decades of accepted practice."

Still further, the Court has stated that where the subject matter in issue involves a significant new application or extension relative to the types of subject matter which have been considered and settled as being patentable, through the case law evolution process, then other factors connected to the purpose of the Australian Patents Act 1990, including the "encouragement of industry, employment and growth other than just to the inventor for his intellectual percipience" may assume importance.  This is a significant shift in the jurisprudential approach to determining patentability in Australia.  Ultimately, the application of this principle by the High Court to its conclusion that the correct approach to analysing the BRCA claims is to focus on the genetic information contained in the DNA sequence, rather than the characteristics of the DNA molecule itself, has led the Court to a finding that the genetic information in the isolated BRCA DNA molecule is the same as that contained in the DNA of the person from whom the DNA was isolated and is therefore not patentable.

. . . yet it also goes much further

The decision of the High Court takes essentially the same approach as that of the US Supreme Court, with the exception that the High Court has, unfortunately, taken its reasoning even further than the US Supreme Court.  Specifically, the US Supreme Court expressly stated that a DNA molecule in which the order of the nucleotides differs from that of the corresponding naturally occurring molecule, such as a cDNA molecule which inherently excludes the genomic intron sequences, continues to be patentable.  The High Court, however, has ruled against the patentability of cDNA on the basis that cDNA reproduces a naturally occurring sequence of exons, even though a DNA molecule of this type does not exist in nature.  The implications of this finding are extremely concerning.  For example, the generation of new versions of naturally occurring molecules which omit functionally unnecessary regions, but which may provide highly useful benefits such as those which are inherent in generating and using a cDNA molecule rather than the large and unwieldy corresponding genomic molecule, may nevertheless lack patentability.  The crucial issue will be determining at what point the structural changes to a molecule are sufficient to render it patentable.  This now introduces a significant element of uncertainty to the issue of the patentability of modified natural products.

"This now introduces a significant element of uncertainty to the issue of the patentability of modified natural products."

Impact of the Myriad decision on biotechnology patents in Australia

From a practical point of view, in terms of isolated nucleic acid molecules this decision is likely to have relatively little impact since the advent of the sequencing of the genomes of many species has effectively destroyed the novelty of claims directed to nucleic acid molecules which form part of these genomes.  Accordingly, the fact is that patents are now rarely granted to isolated nucleic acid molecules.  It is in respect of other "products of nature" however, that this decision may lead to more serious consequences.

The outcomes which have been observed in the United States since the Supreme Court Myriad Decision have confirmed our worst fears, with all isolated molecules, cells and other natural products being deemed to lack patent eligibility.  That is, there was no basis upon which to confine the precedent created by this decision to nucleic acid molecules alone.  There is little reason to believe that IP Australia, which will now have to consider how it instructs its examiners to apply this judicial decision, will not adopt a similar approach to the US Patent and Trademark Office, since the legal reasoning that the High Court has applied to dismissing the patentability of isolated DNA molecules applies equally to all other isolated naturally occurring substances.

Unwanted consequences . . .

In 2012, a Senate enquiry was established to provide a recommendation to the Government in relation to a Private Members Bill which had been introduced into the Federal Parliament that year.  This Bill proposed banning the patenting of all biological materials.  The Senate Committee considered at some length the potential consequences that the enactment of such legislation might cause.  These included:

• The potential exclusion from patentability of not only biological materials which resemble their naturally occurring counterparts but, also, their corresponding medicinal forms.  Specifically, where medicines essentially comprise the biological material itself, such medicines would arguably also be excluded from patentability.

• That most other developed countries would continue to grant patents to biological materials and Australia therefore ran the risk of an adverse impact on accessing new patented medicine.  Ultimately, the decision by patentees to pursue regulatory approval in Australia, and to release a product in competition with other companies, would be made case by case.  However, Australia is a small market when considered globally and preventing the patentability of natural products, such as biological materials, could effectively make it less desirable as a potential market.

• The withdrawal of clinical trials from Australia in relation to molecules no longer patentable.

• That the Bill would introduce uncertainty as its language would require interpretation to clarify its actual scope.  In the present case, the question of the patentability of non-naturally occurring modified molecules, such as cDNA, is entirely unclear in terms of where the boundary lies between what types of molecules are patent eligible versus those which are not.

• The potential to drive investment and therefore research and development overseas, where that research relates to non-patentable biological materials.

• The possibility that Australia would breach it's international obligations under various treaties, such as TRIPS.  The question of the impact of this decision on the recently negotiated TPP is highly relevant.

The fact is that today's High Court decision has effectively achieved the same end point that the enactment of the aborted Private Member's Bill would have achieved.  Accordingly, what were previously theoretical concerns in relation to unwanted outcomes may have now become a reality.

Where to now?

A decision of the High Court of Australia represents the last step in the judicial process.  There is no further avenue of appeal.  Accordingly, unless another case concerning the question of the issue of the patentability of natural products is brought before the High Court, or the Australian parliament enacts legislation to clarify the issue of patentability, the fact is that the patentability of natural products in Australia has been dealt a significant blow, one that could now be potentially used to retrospectively invalidate currently granted patents which claim natural products.  The uncertainty which this now creates for the Australian biotechnology and pharmaceutical sectors is concerning and could undermine future investment and innovation.

And the irony is . . .

The BRCA patents were filed in the mid-1990's and the earliest of these patents has already expired.  In July 2008, Myriad's Australian licensee announced that it intended to centralise the diagnostic testing in house.  This caused great public concern and triggered the events that have led to today's decision.

In terms of the justification for the Australian Myriad litigation, much has been asserted publicly that it's purpose was to ensure widespread, ongoing and reasonably priced access to this important diagnostic method.  No-one disagrees with this objective.  However, today's decision has had absolutely no impact on the existence or functioning of the patent rights which have been granted to Myriad in Australia in relation to the BRCA diagnostic method.  The monopoly to this method remains intact and in place.  Accordingly, the very justification that was used to underpin the importance of Cancer Voices pursuit of the invalidation of the claims directed to the BRCA gene molecules has done nothing to improve access to current or future diagnostic methods, which will continue to be separately patentable in Australia.

Even in relation to the issue of access to the BRCA molecules for research, some years ago Australia enshrined in its legislation one of the broadest research use exemptions in the world.  Accordingly, focusing our time and energy on the creation and implementation of appropriate technology neutral safeguards to prevent abusive monopolistic behaviour would do more to improve any perceived problems in relation to fair and reasonable access to technologies, whether they be drugs, diagnostics or some future medical technology that has not yet even been envisaged, than restricting patentability in an ad hoc manner.

Dr. Tania Obranovich is Special Counsel at Watermark, working as a Patent Attorney and Lawyer.

This article was reprinted with permission from Watermark.

News from Abroad: Isolated Nucleic Acids Not Patentable in Australia

D'Arcy v. Myriad Genetics Inc & Anor [2015] HCA 35

By Claire Gregg & Martin O'Brien --

The High Court of Australia today handed down its decision in D'Arcy v Myriad, deciding once and for all that isolated nucleic acids do not define patent-eligible subject matter in Australia.

Following a five-judge unanimous decision of the Full Federal Court to allow Myriad's claims to isolated genetic material, the High Court granted Ms D'Arcy Special Leave to appeal the decision on the grounds that the Full Court erred in its finding that isolated nucleic acids define a manner of manufacture within the meaning of s 6 of the Statute of Monopolies, as required by section 18(1)(a) of the Patents Act 1990 ("the Act").  We refer you to our articles of 5 September 2014 and 13 February 2015 for a more detailed overview of these decisions.

As foreshadowed in our article of 16 June 2015, the High Court appears to have confined its decision specifically to the patentability of the claims in suit, directed to isolated nucleic acids, including cDNA.  The unanimous decision was delivered in three separate judgements, the majority stating that the Court "is not concerned in this appeal with 'gene patenting' generally, but whether the invention as claimed in Claims 1 to 3 [of Australian Patent No. 686004, owned by Myriad Genetics] falls within established applications of the concept of manner of manufacture".

The test for "manner of manufacture" was defined by the High Court in National Research Development Corporation v Commissioner of Patents (NRDC), and requires that the claimed invention involves an artificially created state of affairs in a field of economic utility.

The key issue before the High Court was whether isolated nucleic acids constitute an artificially created state of affairs.  In this regard, the majority (French CJ, Kiefel, Bell and Keane JJ) set the tone of the judgment at [6], stating:

As appears from s 6 of the Statute of Monopolies, an invention is something which involves "making".  It must reside in something.  It may be a product.  It may be a process.  It may be an outcome which can be characterised, in the language of NRDC, as an "artificially created state of affairs".  Whatever it is, it must be something brought about by human action.  The requirement, in each claim, that the sequence in the isolate bear specified mutations or polymorphisms raises the same problem in a particular way.  Satisfaction of that integer depends upon a characteristic of the human being from whom the nucleic acid is isolated, a characteristic which is not shared by all human beings.  It has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence.

In reaching their decision, the majority rejected the reasoning of the Full Federal Court that isolated nucleic acids should not be treated differently to any other claim to a chemical compound, stating at [88]:

Identification of the subject matter of the claims as a class of chemical compounds is the premise upon which the Full Court's conclusion is based.  It is a premise which, with respect, elevates form over substance to the detriment of the developmental function entrusted to the Court as explained in NRDC and reflected in the continuing use of the "manner of manufacture" formula in s 18(1)(a) of the Act.

The majority accepted the argument by the Appellant that none of the chemical, structural or functional differences between isolated nucleic acids and nucleic acids in the cellular environment play any part in the definition of the invention as claimed.  The Court considered that the claims at issue did not relate to an artificially created state of affairs because the information stored in the sequence of nucleotides was an essential element of the invention as claimed, and that information is the same information as that contained in the DNA of the person from which the nucleic acid was isolated.  The majority also extended this reasoning to cDNA on the basis that, although synthesised, cDNA replicates a naturally occurring sequence of exons.

The High Court's decision marks a dramatic departure from the Australian Parliament's position on "gene patents" in recent years.  The Act only expressly excludes from patentability "human beings and biological processes for their generation", and in 2010 the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which sought to exclude not only DNA and RNA, but all biological entities from patentability, failed to pass after the Senate Legal and Constitutional Affairs Legislation Committee (SLCALC) recommended against the Bill because:

[The] proposed amendments in the Bill, which are focused on addressing a specific issue, could have a large number of unintended consequences across the entire patent system with indeterminate impacts on a range of industries and sectors.

The Australian Law Reform Commission (ALRC) also issued a report on gene patenting in 2004, in which it recommended that changes to the patentability of genetic materials were not necessary at that time.  A number of other reports have emerged in recent years addressing the issue of gene patenting and rejecting the need for legislative reform.

Notably, there was no explicit exclusion from patentability of genetic material in the otherwise wide-ranging reforms to the Act introduced by the recent "Raising the Bar" amendments.

In considering the relevance of the legislative history to the issue at hand, the majority stated at [7] that:

The proposition that a broad statutory concept applies to a new class of case on the boundaries of existing judicial development of that concept requires consideration of the limits of judicial law-making inherent in common law methodology.  Where an affirmative application of the concept is likely to result in the creation of important rights as against the world, to involve far-reaching questions of public policy and to affect the balance of important conflicting interests, the question must be asked whether that application is best left for legislative determination.  The patentability of nucleotide sequences derived from human DNA is in that category.  The inherent patentability of the invention as claimed would powerfully imply patentability of any claim for an isolated nucleic acid coding for a specified polypeptide.

The High Court majority considered that the legislative history did not imply that inventions relating to isolated nucleic acids coding for particular polypeptides were necessarily patentable, and that judicial consideration on a case-by-case basis of whether the claimed invention involves an artificially created state of affairs is required.

Today's decision brings Australia's position on isolated DNA and RNA in line with that of the United States, while representing a marked deviation from major trading partners such as Europe and the US on the issue of patentability of cDNA.

Dr. Gregg is a Patent Scientist and Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia.

This article was reprinted with permission from Spruson & Ferguson.

News from Abroad: Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia

D'Arcy v Myriad Genetics Inc [2015] HCA 35

By Bindhu Holavanahalli* and Gary Cox** --

The High Court of Australia has today handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims of Myriad Genetics Inc's (Myriad) patent.  Those claims related to isolated nucleic acid sequences of the BRAC1 gene, mutations of which have been implicated as a risk factor for breast cancer and ovarian cancer.

Myriad's Patent

Myriad was responsible for locating the BRCA1 gene in the human genome and identifying certain mutations or polymorphisms in the BRCA1 gene that were indicative of a predisposition to breast cancer and ovarian cancer.

Myriad's patent covered various aspects of this finding, including the isolated nucleic acid itself, probes, vectors, methods of producing mutant BRCA1 polypeptides, preparations and uses of polypeptides, and various methods of diagnosis.

Only the claims in respect of the isolated nucleic acid (claims 1 to 3) were in issue in the appeal -- all other claims of the invention (claims 4 to 30) were not challenged.  Indeed, the Court went to significant lengths to confine its decision only to isolated nucleotide sequences (claims 1 to 3), even holding in one instance that probes (the subject of claim 4) were patentable.

Claim 1 of the Myriad patent provided:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No.1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12 A and 14 and the polymorphisms set forth in Tables 18 and 19.

The High Court's Decision

This decision was on appeal from the Full Federal Court of Australia decision handed down last year, where the Full Federal Court of Australia upheld the claims of the patent for the isolated nucleic acid.

The issue before the High Court was whether the isolated nucleic acid coding for the mutant BRCA1 polypeptide was a 'manner of manufacture' as required under section 18(1)(a) of the Patents Act 1990.

Questions of novelty, inventive step and usefulness were not in issue.

Manner of Manufacture

The leading case on what is patentable subject matter in Australia was and still is in many respects National Research Development Corporation v Commissioner of Patents[1] (NRDC).  That case set out the framework for whether a claimed invention was a manner of manufacture.  That decision was modified by today's decision but not overturned.  Instead the present decision seeks to add its gloss to NRDC.

In NRDC, the Court upheld the validity of a patent for the use of previously unknown properties of a known chemical to effect a new purpose.  The Court stated that in order for an invention to be a "manner of manufacture", the invention needs to create an 'artificially created state of affairs', which is of economic significance.

Consideration by the High Court

The High Court considered the NRDC case, and found that the statement of the test in NRDC was not intended as an exhaustive formula of the concept of manner of manufacture.

The majority judgment found that the satisfaction of the integers outlined in the NRDC case will ordinarily be sufficient to conclude that an invention falls within the existing concept of manner of manufacture, where the claim in question falls within existing boundaries of the "manner of manufacture".

However, where the claim in question involves a significant new application or extension of the concept of "manner of manufacture", other factors may assume importance, such as:

(a)   whether patentability would be consistent with the purposes of the Patents Act, and in particular whether the invention, if patentable would give rise to a large new field of monopoly protection with potentially negative effects on innovation;

(b)   whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes;

(c)   Australia's obligations under international laws and the patent laws of other countries; and

(d)   whether to accord patentability to the type of invention as claimed would involve law making of a kind which should be reserved for the legislature.

In applying this reasoning to the Myriad claims, the majority judgment characterised the claimed invention as "information" rather than a chemical product, because it was defined as a code for the BRAC1 gene, which can be stored in various products, such as the isolated DNA of a person or cDNA where the introns in the sequence have been excised.  The product was merely the medium in which that information resides.

Accordingly, the High Court considered that the genetic information claimed in the patent was subject matter that lies at the boundaries of the concept of manner of manufacture, and the additional factors identified above were relevant to the question of patentability.

In determining that the relevant claims were not a manner of manufacture, the High Court considered the following points:

(a)   the claims could be infringed without the infringer being aware of that fact -- the invention only claimed certain mutations of the BRAC1 gene, but this state of affairs could not be identified unless the DNA was isolated from the human and tested for the mutation;

(b)   the class of nucleic acids which all bear the requisite information was vast and unquantifiable.  This therefore raised the risk of a chilling effect on legitimate innovative activity outside the formal boundaries of the monopoly, and created a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors.

Conclusion

This unanimous decision of the High Court makes it clear that claims for isolated nucleic acid sequences may not pass the requirement "manner of manufacture".

Other types of claims such as those relating to methods of diagnosis, and methods of preparing polypeptides are however not directly affected by this decision.

Further, the High Court clearly confirmed that the appeal was not concerned with "gene patenting" generally.

The decision leaves it open to consider factors other than whether the invention is an "artificially created state of affairs of economic significance" in determining whether the invention is a manner of manufacture.

However, as per the majority judgment of French CJ, Keifel, Bell and Keane JJ, these other considerations only come into play when the invention under consideration falls outside the boundaries of what is currently defined as a "manner of manufacture".

[1] (1959) 102 CLR 252

* Ms. Holavanahalli is a Lawyer with Wrays, and Mr. Cox is Chairman & Principal with Wrays.

This article was reprinted with permission from Wrays.

News from Abroad: Ariosa Diagnostics V Sequenom and Isis Innovation -- A European View

    By Paul Cole* --

The June 12, 2015 decision of the Federal Circuit in the above case has been discussed by Kevin Noonan in his posting of 22 June, but it is believed that the factual and legal background could benefit from further discussion.

It is convenient to consider claims 1 and 2 of US Patent No. 6,258,540 together since PCR is the technique exemplified and both claims 1 and 2 were held not to be patent eligible.

The kernel of the opinion of Judge Reyna is contained in the two passages set out below:

It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.  Sequenom does not contend that Drs. Lo and Wainscoat created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before Drs. Lo and Wainscoat found them.  The method ends with paternally inherited cffDNA, which is also a natural phenomenon.  The method therefore begins and ends with a natural phenomenon.  Thus, the claims are directed to matter that is naturally occurring.

Like the patentee in Mayo, Sequenom contends that the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997.  The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA.  Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful.

It is useful to consider the steps of the claimed method against these statements to determine the extent to which they can legitimately be held to fall within the natural phenomenon exclusion.  Detail in addition to the express wording of the claim is believed to indicate what would be implicit to a skilled reader.

The first step requires the use of a maternal serum or plasma sample from a pregnant female.  In Example 1, 10μl of centrifuged and heated plasma or serum are placed into a 0.5 ml Eppendorf tube.  While the presence of cffDNA in the maternal serum or plasma is a natural phenomenon, the decision to make use of the serum or plasma sample for amplification and detection is arguably a step towards an application of that phenomenon.

The second step involves addition of pair of primers to the blood or serum sample.  In Example 1 of the patent in issue these are Y1.7 andY1.8 which are specific for the Y-chromosome which is passed only from father to son and determines the sex of the fetus.  Those primers enable amplification of a sequence of the Y-chromosome of length 198 base pairs.  The experimental details in Example 1 are less than complete, but comparison with Example 2 shows that ~300 nM of each amplification probe would have been added and 200μM each of dATP, dCTP, dGTP and dUTP to provide the monomeric nucleotides needed for polymerisation, together with polymerization enzyme and incidental materials.  The serum or plasma samples were then subjected to 60 cycles of polymerase chain reaction in a PCR machine, 30-40 cycles being generally regarded as sufficient for the reaction to go to completion.  As explained at page 3 of the slip opinion, amplifying cffDNA results in a single copy, or a few copies, of a piece of cffDNA being exponentially multiplied across several orders of magnitude, generating thousands to millions of copies of that particular DNA sequence to reach detectable levels.  If a sample originally contains one or more parentally-derived Y-chromosomes, then after amplification thousands or millions of copies of the selected 198 bp short sequence are present in it.

The product of the second step could therefore most appropriately be described as a composition of matter which is for that reason inherently within the realm of patent-eligibility, said composition comprising the blood or serum of the sample, the naturally occurring cffDNA, thousands to millions of copies of the the Y-chromosome short sequence and residual primer, nucleotides, enzyme and other starting materials.  Even if concentration is focused on the short sequences to the exclusion of other relevant process and composition of matter features, the short sequence copies are a wholly artificial creation, being the result of the synthetic chain reaction and to describe them as a natural product gives rise to an error, on the figures of the slip opinion, of 10³-10⁶ which is on any view an exuberant margin.  They have new utility compared to the original blood or serum sample insofar as they are present at levels that are detectable in subsequent test procedures whereas the original cffDNA is not.

Furthermore in equating the selected and amplified short sequences with a natural product, the Court is implicitly disregarding long-established precedents such as Parke-Davis & Co. v. H. K. Mulford Co (adrenalin), Kuehmsted v. Farbenfabriken of Elberfeld Co. (aspirin) and Merck & Co. v. Olin Mathieson Chemical Corp (Vitamin B12) which show that an isolated or purified natural product having new utility is patent-eligible.  By the same logic, the amplified short sequences are a new and different product having new utility in that they have been brought to detectable levels and cannot be equated simply with the corresponding region of the Y-chromosome as a natural product.

The third step involves detecting the presence of the paternally inherited nucleic acid, and although specified at a high degree of generality is not unduly broad having regard to the range of tests that can be performed.  In Example 1, the mere presence of a Y-positive signal distinguishes a male fetus from a female fetus.  In Example 2, quantitative PCR is used as a screening marker for aneupoloid pregnancies e.g. Downs syndrome, Example 3 describes tests for RhD, Example 4 describes tests for pre-eclampsia and Example 5 provides data showing the very high concentration of fetal DNA in serum or plasma compared to the cellular fraction of maternal blood.

Prometheus requires the claim to be considered not merely as an isolated aggregation of features but as an ordered combination.  If that is done, the new result emerges of a test of high sensitivity for a range of medical conditions that can be applied early in pregnancy and avoiding the risks to the fetus inherent in amniocentesis and that starts from a new and hitherto overlooked starting material and that, in the words of Judge Reyna "revolutionised medical care."  The question in Prometheus was whether the described processes added enough, and it is submitted that the benefits achieved should not have been dismissed as adding nothing of significance.

The proposition that because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful verges on the incomprehensible.  Essentially the same claim was examined by the EPO Appeal Board T 0146/07 ISIS/Prenatal diagnosis.  The closest prior art was a paper from one of the inventors, Dr Lo.  That paper describes a method for the detection of foetal RhD sequences in peripheral blood of sensitized RhD-negative pregnant women.  In the earlier method described, antecubital venous blood was collected from pregnant women and DNA was extracted from the buffy coat fraction, i.e., peripheral blood mononuclear cells (PBMC) isolated from maternal peripheral blood.  Foetal RhD sequences were detected by PCR using specific primers.  The method therefore differed from that now claimed in that the presence of nucleic acid of foetal origin was detected in buffy coat cells rather than in maternal serum or plasma.  As explained in the patent in issue, it was surprisingly found that foetal DNA is enriched in maternal plasma or serum compared to the amount present in the cellular fraction.  The Opposition Division found that a skilled person starting from the cited document and confronted with the problem of providing a more sensitive method for detecting foetal blood cells would not have derived the solution claimed.  In affirming this finding, the Appeal Board held that even of the technical problem were reformulated to the lesser task of finding an alternative source of foetal nucleic acid a skilled person starting from Dr Lo's paper would not have been motivated to consider serum or plasma samples.  Lack of industrial applicability was not a ground of opposition, but nevertheless it is disturbing that subject matter held inventive by the EPO should be summarily dismissed as ineligible in the U.S. under §101.

The steps quoted from the Prometheus opinion recur in Alice and to that extent may reflect a settled view within the Supreme Court.  However, it is submitted that it is inappropriate to select specific passages from these opinions without taking into account the caution with which they were originally expressed, and the warning at the end of the Prometheus opinion that a new protective rule that seems to suit the needs of one field might produce unforeseen results in another.  It is difficult to avoid the conclusion that in Ariosa the Court is extending the second part of the two-part Prometheus test beyond the original intention of the Supreme Court and has fallen into the trap of making its findings of fact to fit the earlier opinions on which it wished to rely, rather than straightforwardly finding the objective facts and then applying the appropriate jurisprudence to them.

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

News from Abroad: High Court of Australia Hears Myriad Appeal

By Claire Gregg & Martin O'Brien --

The High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids¹.

The question before the High Court is whether the invention claimed in claims 1-3 of Australian Patent No. 686004,² owned by Myriad Genetics, is a manner of manufacture within the meaning of s 6 of the Statute of Monopolies, as required by section 18(1)(a) of the Patents Act 1990.  The test for "manner of manufacture" was defined by the High Court in NRDC,³ and requires that the claimed invention involve an artificially created state of affairs in a field of economic utility.

Today's hearing follows yesterday's decision by the High Court to deny leave to the Institute of Patent and Trade Mark Attorneys (IPTA) to be heard as amicus curiae.  IPTA made submissions to the Court on the basis that section 51(xviii) of the Constitution is broad enough to cover isolated nucleic acids, and that in the absence of explicit exclusions the Patents Act should be interpreted to "occupy the full permissible landscape given by section 51(xviii) of the Constitution".⁴

The Commonwealth, through the Attorney-General, also sought to intervene in the event that the High Court granted IPTA leave to be heard.  Whilst explicitly stating that the Commonwealth makes no submissions on the ultimate question of whether isolated nucleic acid is patentable, the Attorney-General was critical of IPTA's submissions, noting that the question before the Court "can be decided fully and completely on the proper construction of the Patents Act without the need to examine the reach of the grant of power under s 51(xviii) of the Constitution".⁵  Further that the "Court should not resolve the appeal by deciding a constitutional question in circumstances where this not necessary of the matter".⁶

The decision of the High Court to deny IPTA leave to be heard meant that the Court only heard from the original two parties today and no new arguments were heard.

In today's hearing, counsel for the Appellant, Mr Catterns QC, argued that, while the isolation of the BRCA1 gene by Myriad may be a "fine and laborious piece of science", claims to isolated nucleic acids without any limitation to a useful application are claims to products of nature, which Mr Catterns submitted is the "antithesis of an artificially created state of affairs" and therefore excluded from patentability.

The Appellant's arguments relied heavily on the reasoning of the US Supreme Court in AMP v Myriad Genetics⁷, asserting that the isolated nucleic acids are in substance identical to the corresponding sequences in nature.  Contrary to Myriad's submissions that isolated nucleic acids are chemically, structurally and functionally different from the naturally occurring nucleic acids and have new applications which do not apply to the sequences as found in nature,⁸ Mr Catterns argued that the isolated polynucleotide sequences code for the same polypeptides as encoded by the gene as found in nature and are therefore, in substance, the same.

Following the Appellant's submissions, counsel for Myriad, Mr Shavin QC, argued that claims 1-3 of the Myriad patent are not to genetic information, rather they are claims to a new chemical entity and that there is "no jurisprudential basis or normative principle upon which claims to isolated nucleic acids should be treated differently from any other technology".⁹

Myriad's arguments centered on the notion that the isolated nucleic acids have utility in isolated form that they do not possess in their native form inside a cell.  Accordingly, Mr Shavin argued that an isolated nucleic acid is "different from nature in the critical sense that it has utility".  The Court accepted that utility is inextricably linked to what is isolated, however the Court also noted the utility needs to be linked to the artificiality in order to define patentable subject matter.  In light of the fact that the sequence of nucleic acids is substantially unaltered by the isolation process, the Court did not appear to consider that the utility was sufficiently linked to the artificiality of the isolated material.

While Mr Shavin cautioned the Court against "carving out" from the principles of NRDC, it may not be necessary for the Court to do so in order to find that the claims at issue do not relate to an artificially created state of affairs.  Further, the day's proceedings suggest that the Court's consideration will be confined to claims to isolated nucleic acids, leaving aside any broader question of patentability of isolated biological material.

The decision, expected later this year, will be keenly awaited.

---

¹ D'Arcy v Myriad Genetics Inc. [2014] FCAFC 115.
² Due to expire on 11 August 2015.
³ National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; endorsed by the High Court in Apotex Pty Ltd v Sanofi Aventis [2013] HCA 50.
⁴ IPTA Submissions at [34].
⁵ Attorney-General's Submissions at [6].
⁶ Ibid at [10].
⁷ Association for Molecular Pathology v Myriad Genetics 569 US 12-398 (2013)
⁸ First Respondent's Submissions at [48]-[50].
⁹ Ibid at [45]

Dr. Gregg is a Patent Scientist and Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia.