In part 1 of this series, we outlined the basics for regulatory approval in relation to pharmaceuticals, along with the term for patent extension in Australia. In the following article, we go into more detail about eligibility in major jurisdictions, including Australia, United States of America and Europe.
In Australia, the eligibility criteria for which patent term extensions can be applied for, can be found under section 70 of the Patents Act, which states that:
- The patent must disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
- Any goods containing or consisting of that particular pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and
- The first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the filing date of the patent application.
A pharmaceutical substance may encompass a mixture or compound of substances for therapeutic use whose application involves:
a) A chemical interaction, or physico-chemical interaction, with a human physiological system; or
b) Action on an infectious agent, or on a toxin or other poison, in a human body.
In understanding what is meant by the terms “a pharmaceutical substance per se”, the case of Boehringer Ingelheim International v Commissioner of Patents  FCA 1918 has been authoritative in Australia. In essence, the pharmaceutical product or substance itself must be new and inventive. Thus, a pharmaceutical substance that is produced by a particular method or process (product by process claims), or pharmaceutical substances used in a novel and inventive way for treatment, will not be eligible for an extension of term, unless that process by which the pharmaceutical substance is produced involves the use of recombinant DNA technology (See also Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129 at para ).
However, in some circumstances whereby a novel and inventive pharmaceutical substance can only be defined when also considering the process by which it was made, which may be the case when the exact chemical composition or structure of the substance is not fully characterised, it may then be possible to obtain an extension of term, when using claims in the format of “a pharmaceutical substance of X obtainable by the process or methods of Y” (Zentaris AG  APO 14, and also Pharmacia Italia SpA v Mayne Pharma Pty Ltd  FCA).
Further examples of case law that have discussed the meaning of the terms “a pharmaceutical substance per se” include Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd  FCA 658. In this case, the patent claims were directed towards a controlled release oxycodone formulation, characterised by dosage amounts, excipients and/or release profile. It was ruled in this case that the pharmaceutical substance per se was the mixture of oxycodone and the relevant excipients that enabled the pharmaceutical substance to achieve the claimed result.
In comparison, the case of iCeutica Pty Ltd  APO 76, involved a composition containing nanoparticulate diclofenac, which was listed on the ARTG. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to commonly treat pain and inflammation. While diclofenac was the substance responsible for the chemical interaction, it was found that instead its physical form constituted a pharmaceutical substance per se, as it was determined by the Commissioner that the particle size of diclofenac contributed to the solubility and activity of the diclofenac.
In Australia, claims for protecting a pharmaceutical substance per se, must be drafted in an appropriate form if the Applicant intends to apply for an extension of term. The case of Biogen International GmbH v Pharmacor Pty Ltd  FCA 1591, exemplified that claims drafted in Swiss-style form, wherein “substance X for use in the treatment of disease Y”, are purpose limited product claims, and thus are not suitable for protection of a pharmaceutical substance per se.
ii. United States
In the US, patent term extensions are provided by the Hatch-Waxman Act 1984, under section 35 U.S.C § 156, and covers drug products for human use, medical devices and veterinary products. The eligibility criteria in the US, requires that at least one claim in the granted patent must cover the approved drug product, the approved product must not have been commercially sold prior to regulatory approval, the patent must also be in force, the application must have been made during the time that the patent is in force, and the patent should not have already received a previous extension of term.
In clarifying the meaning of the requirement that “at least one claim in the granted patent must cover the approved drug product”, this can include the product itself, a method of using the product or a method of manufacturing the product.
Interestingly, despite the FDA classifying combination drug-device products to be either a drug or a medical device, this would make no difference for the purposes of applying for a patent term extension, under 35 U.S.C. § 156 of the Act. This is because, if either the drug or the device is eligible for a patent term extension, this eligibility will extend to the drug-device combination, which is similar to the considerations given to products containing a combination of drugs.
With respect to patent term extensions on drug-device combinations, the case of Angiotech v Lee, 191 F.Supp.3d 509 (E.D. Va. 2016) has been of significant interest in the US. In this case, the patentee sought an extension of term on their patent for a drug-device combination, which included claims directed towards a method of biologically stenting a blood vessel to prevent narrowing of mammalian arteries. The request for an extension of term was ultimately denied on the grounds that the patent did not claim a method of using the stent to administer the drug. It was stated that in order for the patent to claim a method of using the device, the patent “must recited one or more structural elements of the device… to the exclusion of chemical features”. The claim in question, was considered to focus on biological rather than physical stenting, and therefore did not recite the structural elements of the stent, as required by the Act. Thus, the patent did not qualify for the extension, since there were no claims covering a method of using the stent device.
The types of claims in a patent for which an extension of term is sought in the US, is therefore different from those considered acceptable in Australia.
In Europe, the equivalent to a patent term extension is a supplementary protection certificate (SPC), which is applicable to medicinal, veterinary or a plant protection product. The provisions that govern SPCs are outlined under Regulations (EC) No. 469/2009 for medicinal products and (EC) No. 1610/96 for plant protection products.
Unique to European practice, SPCs are currently national rights, and therefore must be applied for separately in each country for which protection is sought. SPCs are available in all European Union countries, as well as in some non-European Union countries, such as Switzerland, Norway, Iceland, Bosnia, Serbia and several others. With the European Unified Patent Court due to commence on 1 April 2023, it is likely that the European Commission may seek to introduce a new unitary SPC in the near future, especially since application of the Regulations often differs between different European countries, depending on the interpretations applied. For example, medical devices have been granted SPCs in Germany, whereas the same is not considered eligible for an SPC in the UK, France, Spain and Denmark.
When applying for an SPC in Europe, the product on which the patent is based must have valid marketing authorisation. In addition, there must be at least one claim in the granted patent covering the product, and the patent must be in force in the country for which the SPC is sought.
In Europe, the requirement of having “at least one claim in the granted patent covering the product” includes claims that not only cover the active ingredient(s) of the authorised commercial product, but also include claims directed towards use of that product, for example, in the treatment of a particular disease, or a method of manufacturing said product, and in the case of plant protection products, a preparation containing the active ingredient(s). Thus, the claim does not necessarily need to be restricted to the product per se, as is the case in Australia.
Post-Brexit, the processes associated with applying for an SPC in the UK remains largely the same, as though the UK was still a member state of the European Union. Applicants will still require a valid UK patent covering the regulatory approved product, the product claimed in the patent must be received the first authorisation in the UK, and the marketing authorisation must have been granted by either the European Medicines Agency (EMA) or the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
In part 3 of our guide, we will cover Australian Register of Therapeutic Goods (ARTG) requirements: Major cases, applications and appeals.