This article outlines the main findings in Apotex v Sanofi-Aventis1, Cancer Voices Australia v Myriad Genetics2, Research Affiliates3 and RPL Central4 each of which have important implications for patent law in Australia.
Apotex v Sanofi Aventis - Methods of Medical Treatment
The highest court of Australia confirmed the patentability of methods of medical treatment of humans in Apotex v Sanofi-Aventis5.
In this case, Apotex appealed to the High Court on the basis that the Sanofi-Aventis patent claims a method of medical treatment and was therefore not patentable subject matter. Sanofi-Aventis claimed a method for preventing or treating psoriasis by administrating an effective amount of leflunomide. Leflunomide was already known and registered for use in the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). It was held (by a 4:1 majority) that a patent for administration of a pharmaceutical substance (with prior therapeutic uses) for a hitherto unknown therapeutic use was patentable subject matter.
For more information see our article; Pharmaceutical companies breathe a sigh of relief: Australia’s highest court confirms that methods of medical treatment are patentable.
Apotex v Sanofi Aventis - Contributory Infringement
The High Court decision in Apotex v Sanofi-Aventis6 is also important for its finding on indirect or contributory infringement. Sanofi-Aventis had sought an injunction against Apotex to prevent them from supplying Apo-Leflunomide. Apotex planned to market leflunomide only for its known uses, namely RA and PsA. Their proposed product information included the statement “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.” The High Court of Australia held that :
- the product information amounted to an emphatic instruction to recipients of Apo-Leflunomide from Apotex to restrict use of the product to uses other than use in accordance with the patented method; and
- Apotex had no reason to believe that the unpatented pharmaceutical substance would be used by recipients in accordance with the patented method, contrary to the indications in Apotex's approved product information document.
In doing so, the High Court overturned the lower court’s finding of indirect infringement. This decision indicates that carve outs in product information leaflets are a legitimate way of avoiding indirect infringement. For more information see our article; “Australia’s highest court takes a knife to indirect infringement: “carve-outs” in product information leaflets are a legitimate way of avoiding indirect infringement”.
Cancer Voices Australia v Myriad Genetics - Gene patenting
In Cancer Voices Australia v Myriad Genetics7, the court considered for the first time whether an isolated nucleic acid is patentable subject matter.
Myriad Genetics’ claims are directed to an “isolated nucleic acid” encompassing both DNA and RNA. In particular, the patent covers the mutations in the breast cancer gene BRCA1 associated with an increased risk of breast cancer. The Federal Court of Australia held that any nucleic acid found in cells, whether it be DNA or RNA, that has been removed from the cellular environment in which it naturally exists (i.e. that has been isolated), is patentable.
An appeal has already been heard by the Full Federal Court and we now await its decision. For more information see our article; Isolated nucleic acids are patentable – what does the “Myriad” decision in Australia mean for patent applicants?
Research Affiliates and RPL Central - Computer Implemented Inventions
There were two contrasting lower court decisions handed down in 2013 relating to the patentability of computer implemented inventions. Both decisions dealt with patents directed to a computer implemented method involving retrieval and processing of information. Whereas in the first decision, Research Affiliates8, the judge found that the method was not patentable subject matter, in the latter decision, RPL Central9, the method was found to be patentable.
In Australia, a current test for patentable subject matter is whether a physical effect, in the sense of a concrete effect, phenomenon, manifestation or transformation, is provided. In Research Affiliates, Justice Emmett’s main consideration was whether the output of the invention, namely, an index produced by the claimed method, gave rise to the required physical effect. He held that the index is nothing more than information and that information is not, of itself, patentable. He also stated that using a computer to implement a scheme or method does not automatically confer patentability if the substance of the invention was an unpatentable scheme or method. In contrast, in RPL Central, Justice Middleton found that the computing steps did not need to be a central or substantial part of the invention and that claimed computing steps are to be taken into account when considering patentable subject matter. He also held that computer implemented operations, such as retrieving, processing, and/or presenting information were patentable, as each of the steps gives rise to a change in state or information in a part of a machine, and therefore produces the required physical effect.
Both decisions are currently under appeal. We are keenly awaiting judgement in relation to the Research Affiliates appeal which was heard in November last year.
More information on Research Affiliates see our article; Australian Federal Court clarifies patentability of computer inventions.
More information on RPL Central see our article; Encouraging developments for computer implemented inventions in Australia