Patent laws in some, but not all, jurisdictions allow the extension of the term of a patent (normally 20 years) for a pharmaceutical substance. Such provisions are enacted in recognition of the complexity and delay associated with developing and commercialising new drugs. The extensive time taken to bring a new drug to market can mean that a patentee has only a few years to exploit patented rights before the patent covering the drug expires. An extension of term therefore provides an increased incentive for drug manufacturers to invest in new drug research and development programs.
A recent decision by Japan’s Supreme Court (The JPO vs. Genentech, Inc., Supreme Court, No. 2014 (Gyo hi) No.356) may have lowered the threshold for obtaining patent term extensions in Japan. As a result, opportunities may now exist in Japan to extend the term of pharmaceutical patents based upon second or subsequent approved treatment or dosage regimes which would not be available in many other jurisdictions, such as Australia.”
Court-based interpretation of statue
Statutory interpretation by courts can be straightforward where the words of a statue have a plain and clear meaning. However, the opposite can be the case where words in a statute are ambiguous. In common law jurisdictions, such as Australia, the rules of statutory interpretation are affected by judge-decided cases (i.e. the doctrine of ‘stare decisis’ applies where the decision of a higher court is binding authority on a lower court). By comparison, in civil law jurisdictions, the extent to which judicial consideration of statute in higher court is binding on lower courts is different. That is, precedents are generally not binding, but serve a more persuasive role. This being the case, the decisions of the highest courts in civil law jurisdictions can have a binding effect.
A case in point is Japan where decisions of the country’s highest court, the Supreme Court, are binding on lower courts. Japanese Patent Office practice is also impacted by Supreme Court decisions. By comparison, the practices of the Australian and New Zealand Offices can be impacted by any relevant court and by hearing decisions rendered by the respective offices.
Patent Term Extensions
Australia vs New Zealand
The patent laws of Australia and New Zealand are in stark contrast when it comes to extensions of patent term – Australian law provides a maximum patent term extension of 5 years whereas New Zealand law does not provide for an extension at all.
The provisions governing patent term extension under Australian law have been recently discussed by a colleague. In short, certain requirements must be met before an extension of term is granted for a patent covering a ‘pharmaceutical substance’. Amongst other things, goods containing, or consisting of, a pharmaceutical substance disclosed in a granted patent must be approved by the Australian Therapeutic Goods Administration (‘TGA’) and included in the Australian Register of Therapeutic Goods (‘ARTG’). Notably, the term ‘pharmaceutical substance’ is not restricted to chemical compounds and includes substances such as antibodies and other proteins. Further, an application for an extension of term must be made within 6 months after the latest of the following dates:
- the date the patent was granted; and
- the date of the first regulatory approval.
Relevant to the discussion of extension of patent term in Japan is that the date of ‘first regulatory approval’ in Australia includes the date on which a substance is first listed in the ARTG (Pfizer Corp v Commissioner of Patents  FCAFC 190).
Similarly to Australia and other jurisdictions, pharmaceutical substances that are the subject of a patent must undergo regulatory approval by the relevant Japanese Authority before such substances can be sold in Japan. Japanese law provides for extensions of patent term where delay ‘working a patented invention’ has occurred from obtaining such approval.
In 2011, the Japanese Patent Office revised guidelines concerning patent term extensions based on previous decisions of the Japanese Supreme Court. Amongst other things, under the revised guidelines, the Office had construed ‘working a patented invention’ to mean ‘acts of selling, manufacturing or the like of a drug that is patented and the subject of an application for regulatory approval’.
The Supreme Court decision
The decision of the Supreme Court of Japan concerns applications by Genentech to extend the term of its patents for Avastin® (bevacizumab), which is an antibody for treating certain metastatic cancers (including metastatic colorectal, lung and breast cancers).
Genentech had obtained a first regulatory approval in Japan for bevacizumab which stipulated a specific dosage and administration regime. As is required under Japanese law, it was necessary for Genentech to obtain a second and subsequent regulatory approval for bevacizumab which was to be administered using a different dosage and administration regime from that contained in the first approval. Notably, the claims of the granted patents were not limited by dosage or administration regimes. Genentech sought patent term extensions based on the second and subsequent regulatory approval.
The patent term extension requests were rejected by the Patent Office on the basis that Genentech had ‘worked the patented invention’ before gaining the second regulatory approval. Genentech appealed to the Japanese Intellectual Property High Court, which overturned the Patent Office decision. In the appeal, the Intellectual Property High Court clarified that ‘working the patented invention’ is limited to selling, manufacturing or the like of a drug that is patented and specified by name, ingredients, quantity, dosage, administration, usage, indications and efficacy (as derived from Art. 14(1) and (9) of Japan’s Pharmaceutical Affairs Law). Consequently, given that the patent term extension requests specified the dosage and administration regime included in the second regulatory approval, the Court allowed the extension. The Patent Office appealed to the Supreme Court.
In reaffirming the decision of the Intellectual Property High Court, the Supreme Court confirmed that the criteria of dosage and administration regime were relevant to the assessment of ‘working the patented invention’ when determining the eligibility of a request to extend the term of patent. In doing so, the Supreme Court has implemented new criteria for the assessment of patent term extensions in Japan, such that the previous guidelines set by the Patent Office need further revision.
Extensions of patent term: Australia vs Japan
The decision by the Japanese Supreme Court highlights the contrast between the provisions of Australian and Japanese patent laws concerning extensions of patent term. Under Australian law, consideration of ‘working the patented invention’ is not relevant.
Further, were the above circumstances regarding Genentech’s applications for an extension of term decided under Australian law, the outcome may have been significantly different depending on the date that bevacizumab was first listed in the ARTG. Existing decisions by the Australian Patent Office (see Pfizer Italia S.r.l.  APO 2 and G.D.Searle LLC  APO 31) and Courts (see Pfizer Corp v Commissioner of Patents  FCAFC 190 and Alphapharm Pty Ltd v H Lundbeck A-S  HCA 42) have emphasised that an application for an extension of term can fail if the application is not based on the earliest listing of the pharmaceutical substance in the ARTG (i.e. if the application is made more than 6 months after the date of first regulatory approval).
The Japanese Supreme Court decision also highlights that the provisions relating to extension of term under Japanese law may be more relaxed that those under Australian law, and suggests that opportunity may exist for companies seeking to extend the term of Japanese patents covering pharmaceutical substances that would otherwise be unavailable in Australia.
The author acknowledges colleagues from Asamura Patent Office, p.c. for providing details of the Japanese Supreme Court decision.