Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. [2020] FCA 1333

Key takeaways:

  • For novelty purposes, expert evidence does not make up for a lack of sufficiently clear and unambiguous directions in the prior art or for a lack of teaching that would inevitably result in the invention
  • Invention was a “substantial departure” from known formulations, particularly in the face of a long-standing need for combination anthelmintic treatments and was thus not obvious
  • Lack of utility was not established in the circumstances

Background

Merial Inc (now Boehringer Ingelheim Animal Health USA Inc (Boehringer)) appealed from an opposition decision in respect of Australian patent application AU 2011268899 (the application).

The invention described in the application relates to injectable formulations comprising a macrocyclic lactone and levamisole for controlling parasites in animals, and the use of such formulations in the preparation of a medicament for controlling parasites.

The problem addressed by the application was that some parasites develop a resistance to anti-parasitic drugs. Combinations of known drugs had been used in the art to overcome this resistance, but it was desirable to develop an injectable formulation for a combination of a macrocyclic lactone and levamisole, two of the most widely used and effective antiparasitic (anthelmintic) drugs.

However, such combinations have been difficult to formulate, for three main reasons:

First, levamisole and macrocyclic lactones are chemically incompatible and tend to react with each other when combined.  Secondly, levamisole and macrocyclic lactones are stable under different pH conditions (levamisole requires a pH of about 3.0-4.0 to be stable, while macrocyclic lactones require a pH of around 6.0-7.0).  Finally, levamisole salts are soluble in water, whereas macrocyclic lactones are not water soluble but are soluble in organic solvents, and are commonly formulated in oils and organic solvents.

The invention in the application addressed these issues by adopting a non-aqueous solvent system comprising oil and an organic solvent, in which the macrocyclic lactone is in solution, and the levamisole is a salt in particulate form (that is, in suspension).  This type of formulation achieves a separation of the macrocyclic lactone and the levamisole, thus addressing the issue of chemical incompatibility.

Claim 1 of the application is as follows:

  1. An injectable formulation of a macrocyclic lactone and levamisole in a non-aqueous solvent system comprising oil and an organic solvent, wherein the macrocyclic lactone is in solution and the levamisole is a salt in a particulate form, and wherein the levamisole salt is present in the range of between 10-35% w/v.

The Appeal

Boehringer was unsuccessful in its opposition in the Patent Office and appealed on various grounds:

(a)          Lack of novelty.  Boehringer contended that various claims were not novel in light of Chinese patent application CN 1375291A (CN 291).

(b)          Lack of inventive step.  Boehringer contended that the claims did not involve an inventive step because they were obvious in the light of the common general knowledge considered alone, or the common general knowledge combined with CN 291.

(c)           Lack of utility.  Boehringer contended that the invention claimed in each of the claims was not useful, in that the claims of the application include embodiments that do not achieve the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole.

Novelty

CN 291 was a patent application published on 23 October 2002 for an invention titled “Veterinary Compound Injection Containing Levamisole or Salts thereof”.

Example 3 of CN291 set out an oil injection containing a combination of ivermectin (a macrocyclic lactone) and levamisole hydrochloride.  However, it was clear that the concentration of levamisole HCl in Example 3 at 5% w/v did not fall within the scope of claim 1 of the application, which specified 10-35% w/v.  Further, Example 3 did not set out any manufacturing steps, or any description of what was intended to be made.  Moreover, it did not describe the levamisole HCl as being in particulate form (or in a suspension).

Boehringer submitted that Example 3 of CN 291 was to be read in conjunction with claim 3 of CN 291, which discloses levamisole HCl in the amount of 10-20% w/v, and with page 3 of the specification, which discloses that preferably the levamisole HCl is present in the amount of 10-20% w/v.  Further, Boehringer submitted that a skilled person reading CN 291 as a whole would understand that CN 291 contained a direction, recommendation or suggestion to make the Example 3 formulation using 10-20% w/v levamisole HCl, because they would consider the 5% w/v concentration of levamisole HCl stated in Example 3 to be far too low for cattle, particularly in light of the other teaching in CN 291.

Based upon expert evidence, Boehringer further argued that the skilled person would expect the levamisole HCl in Example 3 to be suspended in the solvent system and to be present in particulate form, because the skilled person would expect that levamisole HCl will not dissolve in the solvent system of Example 3.  To support this view, Boehringer provided details of two formulations prepared by its expert witnesses following the guidance of CN 291 that fell within the scope of claim 1 of the application.

However, Moshinsky J was not convinced, finding that there was no sufficiently clear and unambiguous direction to modify Example 3 by applying the higher concentration level described elsewhere.  Further, the Court emphasised that Example 3 did not describe the intended formulation as one in which the levamisole HCl is in particulate form.

In addition, the appellant’s expert formulator conceded under cross-examination that the formulation in Example 3 could be a suspension or a solution.

The Court was not swayed by the experiments conducted by the appellant as they involved a number of departures from the teaching of Example 3, and did not establish that any steps used to manufacture a formulation having the composition of Example 3 would inevitably contain levamisole HCl in particulate form.

Inventive Step

Boehringer contended that that it would have been obvious to the notional skilled person or team, based on the common general knowledge alone, or in light of the common general knowledge together with CN 291, to make a suspension formulation using an oil or organic carrier as a base and a co-solvent such as benzyl alcohol (an organic solvent), in which the macrocyclic lactone was in solution and the levamisole salt was in suspension.  It submitted that the skilled person would appreciate that, in such a composition, the levamisole salt would be in particulate form, and that they would know to use a concentration of levamisole salt sufficient to achieve the desired dose in a product for cattle having a dose volume rate of 1 mL/25 kg, which results in a formulation in accordance with claim 1 of the application.

However, the Court found that an oily formulation with levamisole present as a particulate was a substantial departure from known formulations, particularly (and most significantly) in respect of levamisole.  The expert evidence had also shown that, in order to be effective, levamisole needed to reach a high peak concentration in the animal’s gut rapidly, and preferably underwent similarly rapid clearance from the animal to meet regulatory requirements.  As there were no existing formulations of levamisole as a particulate in oil, a carrier often used to slow down absorption of a drug, it was not clear in the common general knowledge whether an effective peak concentration of levamisole could be reached in the animal using such a formulation.  Further, the evidence showed that there is a risk that an active ingredient formulated as a suspension will not be dispersed evenly throughout the formulation, or may result in agglomeration of the particles.

Based upon the evidence, it was held that a solution appeared to be preferable to a suspension for an injectable formulation, and that the above uncertainties as to efficacy, as well as others, would point away from the adoption of such an approach.

Secondary evidence such as the long-standing need for combination treatments of levamisole and a macrocyclic lactone and the desirability of having such a combination in injectable form were also held to support the existence of an inventive step.

Moreover, it was held that CN 291 would not provide any direct assistance to the notional skilled team in addressing the known chemical incompatibility of levamisole and macrocyclic lactones, a finding that was conceded by experts for Boehringer during cross-examination.

Lack of Utility

Boehringer submitted that the stability data in Intervet’s patent application WO 2017/108954 A1 (WO 954) (which Intervet accepted disclosed formulations falling within the scope of claim 1 of the application in suit) demonstrates that not all formulations falling within the scope of the claims of the application achieve the promise of being physically and chemically stable.  In particular, Boehringer relied on data in Table 4 of WO 954 for 2 months, at which point a loss of stability was shown.

However, the figures in Table 4 for 3 months – this being the relevant period for the purposes of the promise – did not show such a loss of stability.  Accordingly, it was held that the data in Table 4 did not establish that the invention failed to meet the promise of stability (that is, stability for 3 months under accelerated conditions).  Moreover, it was found that the data in Table 4 was inherently unreliable, and, even if it had shown a loss of stability as at 3 months, the Court would not have been satisfied that the invention failed the promise of stability.

Costs of amendment applications

In a subsequent judgment (Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. (No 2) [2020] FCA 1433, The Court dealt with the costs of two interlocutory amendment applications.

In respect of each interlocutory application to amend, the Court found that “Intervet sought something in the nature of an indulgence.”  Referring to Les Laboratoires Servier v Apotex Pty Ltd (2010) 273 ALR 630 at [59]; cf Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234, the Court held that in such cases, the patentee may be ordered to pay the costs of the amendment application, regardless of the outcome.

Accordingly, Boehringer’s request that each party bear its own costs was appropriate, particularly in circumstances where there was no adjudication on the merits of either application because Boehringer had ultimately consented to the amendments.

Authored by Ean Blackwell and Katrina Crooks

Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 (16 September 2020)

Background

Australia’s Patents Act provides a patent term extension (PTE) to account for the delays that can occur when obtaining regulatory approval for a pharmaceutical substance.   The extension can last for up to five years and is available when the following requirements are met:

  • the patent, in substance, discloses and claims a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
  • goods containing or consisting of the pharmaceutical substance are included in the Australian Register of Therapeutic Goods (ARTG); and
  • the first regulatory approval for the pharmaceutical substance occurred more than five years after the filing date of the patent.

The length of a patent term extension is equal to the period between the filing date of the patent and the date of the earliest first regulatory approval, reduced by five years.

The decision

Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 concerned a request to extend the term of a patent covering anti-PD-1 antibodies.  The patent included claims for two blockbuster drugs; Merck Sharp & Dohme’s KEYTRUDA and the patentee’s OPDIVO, both of which received regulatory approval in Australia, but on different dates.  The question at issue, then, was which regulatory approval date was relevant for deciding the patentee’s PTE request.

The patentee hedged its bet, filing two PTE requests; one based on KEYTRUDA, which received regulatory approval on 16 April 2015, and another based on OPDIVO, which received regulatory approval on 11 January 2016.  From the patentee’s perspective, the request based on OPDIVO was preferred as it would result in a longer extended term (an additional 8 months, 26 days).  However, the Patent Office refused that request, finding that KEYTRUDA was included on the ARTG first and therefore should form the basis of the request.  The patentee disagreed and requested to be heard.

In the hearing, the patentee submitted that the “first regulatory approval date” should be the approval date of their own product, OPDIVO.  This, they argued, was consistent the purpose of the extension of term provisions, that being to restore the time lost by patentees in gaining marketing approval, and to compensate the patentee for the additional time, expense and difficulty in developing and commercialising a new drug.

The patentee argued that the reference to “first” regulatory approval in the Act was only important when multiple regulatory approval dates existed for the same substance, such as for different delivery forms (e.g. capsules, gel capsules, tablets, slow-release, different amounts, etc) that manifested in different ARTG registrations.  According to the patentee, it was only logical, given that the regime is intended to be beneficial and remedial, that it can only be about rewarding patentees for their work and, by implication, not the work of others.  If not, the patentee would not receive the full extension of term for their product.

The Delegate accepted that the PTE regime was designed to encourage the development of new drugs, but rejected the patentee’s broader purposive construction of the Act.  Such a construction, the Delegate noted, would encourage companies to develop a substance that is not new and seek regulatory approval as late as possible, secure in the knowledge that a PTE will be granted for the (not new) substance.  According to the Delegate, this type of scheme would not incentivise new drugs. Rather, it would incentivise new extension applications.

The Delegate acknowledged that there is some ambiguity in the words of the Act insofar as they do not say one way or the other whether the relevant pharmaceutical substance is only that belonging to the patentee, or whether it includes other, equivalent substances owned by third parties.  But the Delegate also noted that this ambiguity had been dealt with previously by the Patent Office in G.D. Searle LLC [2008] APO 31.  In that case, the Patent Office held that an application for PTE must be based on the earliest inclusion on the ARTG of a pharmaceutical substance falling within the scope of the claims, irrespective of the sponsor of the goods.  Moreover, in Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176, the Federal Court of Appeals held that “the term of the extension is based on the earliest inclusion, regardless of the identity of the sponsor. It is not open to the Commissioner to calculate the term of the extension only on the basis of goods sponsored by the Patentee.”

The Delegate therefore found that the substance with the earliest regulatory approval date for the purpose of the PTE request was KEYTRUDA, not OPDIVO.  As such, the patentee’s request for a PTE based on OPDIVO was refused.

Conclusion

In circumstances where a patent claims more than one registered pharmaceutical substance, this decision confirms that the earliest registered substance will be used to determine eligibility for a PTE and to calculate the length of the extension, irrespective of whether the registered substance is owned by the patentee or by a third party.  Patentees should therefore be aware of all pharmaceutical substances covered by their claims, not just those they are seeking to commercialise. If a patent application covers more than one pharmaceutical substance, an applicant may be well-advised to file one or more divisional applications to ensure that each registered substance is quarantined within its own patent, thus enabling maximum extensions to be sought for each patent separately.

Authored by Ean Blackwell and Katrina Crooks

Register here

Authored by Michael Christie, PhD and Ean Blackwell

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

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

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

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

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

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

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

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

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

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

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

Authored by Ean Blackwell

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

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

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

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

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

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

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

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

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

Authored by Ean Blackwell

The Australian medical cannabis industry is growing rapidly, and cannabis-related businesses are starting to look to intellectual property rights to secure a competitive advantage. This article discusses the history of medicinal cannabis, the Australian market and the types of IP that can be utilised.

Medicinal cannabis – an evolving story

Cannabis has been cultivated for thousands of years to produce fibre and for various medicinal uses.  Records of its use date back as far as 2737 BC, when Emperor Shen Neng of China was said to have used it for the treatment of various medical conditions, and by the mid-19th Century, cannabis plant extracts were mentioned in the British and US Pharmacopoeia.  Later on, fears in relation to the wanton use of the plant as a recreational drug led to strict laws being implemented against its use.

In recent years however, international sentiment has been rapidly changing as strong evidence of the medical efficacy of chemical compounds extracted from the plant has been accumulating.  As a result, many major jurisdictions including the USA, Germany, the UK, Canada, Turkey and Australia have broadly legislated in favour of legalising cannabis for various medical purposes.

Cannabis extracts are now widely recognised for their potential in the treatment of chronic pain, Crohn’s disease, sickness related to cancer medication, spasticity related to multiple sclerosis, Alzheimer’s disease and many other conditions.  The plant contains over 400 unique chemical compounds, many of which are known to interact with specific receptors in the human body.  Of these compounds, tetrahydrocannabinol (THC) and Cannabidiol (CBD) are currently of most interest to researchers.

In much of Europe, Mexico and North America, two drugs containing synthetic THC, Dronabinol (Solvay Pharmaceuticals) and Nabilone (Valeant Pharmaceuticals International), are currently approved for medical use as anti-emetics.  Dronabinol and Nabilone also ease chronic pain and have been used to increase appetite in patients suffering from AIDS.

The Multiple Sclerosis drug Nabiximols (GW Pharmaceuticals) has also been made available on prescription in several major jurisdictions.  Nabiximols is formulated from purely non- synthetic plant- derived cannabinoids, and is the first such medicine to receive regulatory approval.

In light of the rapid global legislative and regulatory changes, the outlook for the market potential of medicinal cannabis is vast, with many analysts expecting the global medicinal cannabis market to reach $55.8 billion by 2025.  The global hemp fibre market for clothing and cosmetic products, which analysts expect will rise to $10.6 billion by 2025, should also not be forgotten.

The largest player in the sector is currently Canada, with an industry worth over $6.2 billion.  However, the United States is expected to be the world’s most lucrative market going forwards, and acceptance of medical cannabis in Europe is also growing rapidly.

Against this kind of background, it is easy to see that investment in this field is set to grow exponentially in the coming years.

Australia set to become a major player

In 2017, the Federal Government of Australia allowed the import and sale of medicinal cannabis products.  Today, the Australian medical cannabis industry is worth around $18 million, and as of early 2018, there were 19 companies listed on the ASX involved in the field.  However, many experts predict that the industry will explode into a multi-billion-dollar market over the next 10 years, especially since the Government has recently made clear its plans to make Australia a major player in the medicinal cannabis export market.

Although it is still a complicated procedure in Australia to obtain a licence to grow and export cannabis-related products, this looks set to change in line with the sentiment of other leading markets.  Australia would also face challenges in relation to export distance and logistics, but has world class facilities for the production and testing of medicinal cannabis that should ensure its potential is not overlooked by investors.  Indeed, Australia is positioning itself to be to be an exporter of premium grade product to overcome these issues, mirroring its position in other sectors such as the wine industry.

Intellectual property rights available for cannabis

In Australia, cannabis-related products and the plants they are obtained from are eligible for protection by a range of IP rights.  In particular, both patents and plant breeder’s rights may be held simultaneously for cannabis plants when the requirements discussed below are met.

Plant patents

Under Australian law, subject matter relating to plants is eligible for patent protection, only if it provides a practical solution to a technical problem and meets the usual patentability requirements.  To be eligible, the subject matter must be novel and involve an inventive step, and must have involved the technical intervention of a person in its development.  The specification must enable a person skilled in the art to reproduce the subject matter, which may require the deposit of plant reproductive material at a recognised depositary prior to filing the application.

Providing the above requirements are met, Australian patent legislation provides exclusive rights for up to 20 years from the application filing date in relation to plants per se or any part thereof, including reproductive material, genetic material, seeds, cells, or harvested material.  Products derived from a qualifying plant including oils, fruits and pharmaceutical compounds are also eligible for protection as are methods and uses involving plant-based subject matter, such as breeding methods, tissue culture or transgenic methods and plants produced therefrom.

Plant Breeder’s Rights

Plant Breeder’s Rights (PBR) are also available for plant varieties in Australia, providing that the application is filed within 12 months of any commercial exploitation in Australia, or within four years (for most varieties; six years for trees or vines) of commercial exploitation overseas.  Thus, PBR protection may still be available for a plant variety following commercial exploitation.

To be eligible for protection, a new plant variety must be distinct from other known varieties by at least one or more characteristics.  These characteristics must be uniform across a tested batch of the variety and must be stable over multiple generations.  In order to establish distinctiveness, uniformity and stability (DUS), it is necessary to engage the services of an accredited “Qualified Person”, who is an expert in testing new plant varieties and can certify DUS before the Plant Breeder’s Rights Office.  Shelston IP has in-house Qualified Persons who can assist you with any aspect of a PBR application.

Australian plant breeder’s rights legislation provides exclusive rights over the production or reproduction, sale, conditioning for sale, importation or exportation of propagating material of the protected variety.  In certain circumstances, harvested material and essentially derived varieties may also be covered under the Act.

Importantly, plant breeder’s rights offer a longer term of protection than patent rights.  PBR protection essentially begins at formal acceptance of the application when provisional protection is provided, and extends for 20 years for most plant varieties from the date of grant (not filing) of the PBR.  Again, trees and vines are treated differently, and are eligible for up to 25 years of protection from the date of grant.

Finally, Australian plant breeder’s rights legislation also provides protection for the name of a protected variety for the life the PBR registration.

Contrary to Law

Until recently, it was difficult to obtain patent protection for subject matter relating to cannabis plants, since under the Patents Act 1990, a patent may not be granted for subject matter that would be contrary to law.  However, due to the recent changes to the law relating to the use of medicinal cannabis in Australia, patents relating to cannabis-related subject matter may now be granted since it can be argued that there is a legal use for the invention.  In relation to plant breeder’s rights, there are no barriers under PBR legislation preventing protection for cannabis plant varieties.  However, the requirement to prove DUS through field trial data would require obtaining a special license under the Narcotic Drugs Amendment Act 2016 if the field trials are held in Australia.

How we can help

Businesses seeking to capitalise on the booming cannabis market in Australia currently need to negotiate complex legislative and regulatory hurdles before they can establish their business, whether it be in relation to import and export of cannabis related products or production on site.  During this process, appropriate management of your intellectual property is crucial for your success.  At Shelston IP, our Agribusiness team includes patent attorneys with industry experience in Agribiotech and plant-based patents, trade mark attorneys, design right attorneys, litigators and PBR Qualified Persons, and is uniquely positioned to offer strategic advice help you achieve your business goals.

Shelston IP is helping agriculture and food businesses, farmers, plant breeders and research organisations to unlock the value of their innovations and find opportunities in the growing Agribusiness space.  Our clients include some of the world’s largest providers of agricultural and food products, specialist agricultural biotech companies, grain handlers, plant breeders, seed producers, chemical suppliers, and government-owned research organisations.

If you have any questions or require advice in relation to any aspect of your intellectual property, do not hesitate to contact us.

Authored by Ean Blackwell