A recent Supreme Court decision in Japan (JPO v Genentech, Supreme Court, No. 2014 (Gyo hi) No.356) 1 confirms that the Japanese Patent Office (JPO) was incorrect in the way it applied the law relating to patent term extensions (PTE), and that the ‘identity’ of the pharmaceutical products which are the subject of earlier and later authorisations is key to determining whether a subsequent PTE is to be granted. As a result, the JPO is reviewing its guidelines, and expects to issue new guidelines in the Spring.
Patent term extensions (PTEs)
The term of a Japanese patent may be extended by up to five years in cases where the patented invention is a pharmaceutical product, and where part of the full 20 year term of protection under the patent could not be utilised because it was necessary to first obtain from the relevant regulatory body authorisation (disposition) to put the pharmaceutical product on the market.
In such cases, once the necessary marketing authorisation has been obtained, the patentee can apply to the JPO for an extension to the patent term. The procedure for obtaining such an extension is set out in Articles 67 and 68 of the Japanese Patents Act, and the extensions so provided are known (unsurprisingly) as Patent Term Extensions or PTEs. The PTE system provides an effect similar to Supplemental Protection Certificates that are available in other countries, though there are differences in the mechanism for obtaining them.
The wording of the Japanese Patent Act (JPA) states that the JPO shall refuse the request for a PTE, where the disposition (market approval) is not deemed to have been necessary for the working of the patented invention. The JPA also states that the effect of a PTE is that:
“where the duration of a patent right is extended […], such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition […] which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).”
The JPO appears to have narrowly interpreted the wording of sections 67 and 68 of the Japanese Patent Act, essentially taking the view that “product” meant “active ingredient” and that the word “usage” meant “effect or efficacy” of the pharmaceutical product. As a result, the JPO position was that PTEs should only be granted for new active ingredients or for new applications of active ingredients, and that PTE extensions for patents relating to new formulations or new dosages of active ingredients should be refused, where market authorisation for the active ingredient and effect had already been granted, even though such new formulations and dosages were separately patentable, and more significantly, even though the Japanese Pharmaceutical Affairs Act required a separate authorisation for the new formulations or dosage regime before the new product could be put on the market.
The first challenge: takeda
In 2011, the Supreme Court decision in JPO v. Takeda Pharmaceutical; Japanese Supreme Court 2009 (Gyo-Hi) No. 326 2,3, the Supreme Court found that that the JPO was wrong to refuse a PTE request on the grounds that the patentee had already obtained approval for another drug product that was different in dosage and form but identical in active ingredient and effect. Doing so, the JPO had ignored the primary purpose of the PTE system, which was to compensate a patentee for any loss in the term of protection arising from a need to obtain authorisation.
Takeda’s patent for a drug in sustained release capsule form issued in May 2005, four months before they were able to secure regulatory approval. However, the JPO refused Takeda’s request for a PTE on the basis that approval had already issued in March 2005 for the same drug and effect, but administered in an Oral Solution.
The Supreme Court found that the JPO position was unreasonable, particularly as the claims of the patent for which the PTE had been requested did not cover the product which was the subject of the earlier authorisation. The Supreme Court stated that:
“if the pharmaceutical product covered by the earlier approval is not included in the technical scope of the patented invention specified by any of the claims for the patent right pertaining to the application for registration of extension, it is unreasonable to deny that it was necessary to obtain the approval, which gave rise to the necessity to file said application for registration of extension, [and therefore unreasonable to deny the request for the PTE].”
As a result of the Takeda decision the JPO changed its guidelines in 2011 but continued to place emphasis on consideration of the claim scope. Thus, the subsequent JPO guidelines stated that “a PTE application shall be rejected where the approved drug to be subjected to the latter PTE application is inclusive within the claim of the patent subjected to the former PTE as to the approved drug of the first approval”. Notably, the Takeda decision did not consider what would happen if the claims of the patent covered the product specified in the earlier authorisation, as well as the later authorisation. Thus, the stage was set for a further challenge by Genentech.
The second challenge: genentech
Genentech had a patent granted in February 2003 for the drug Bevacizumab (Avastin). The patent claims did not specify a dosage regime for the drug. Genentech obtained a first market authorisation in April 2007 for the product to be administered in doses of 5mg/kg or 10mg/kg of the body weight of the patient by intravenous drip injection with a dosage interval of two weeks or more. On the basis of the first approval, and on application by Genentech, the JPO granted a PTE of four years and a little over two months, reflecting the period between 2003 and 2007 in which Genentech were unable to benefit from their patent.
In 2009, Genentech obtained a subsequent approval for new dosage regime of 7.5mg/kg of the body weight of the patient by intravenous drop injection, administered every three weeks or more, and applied for a further PTE on the ground that they had not been able to work the patent in respect of the later dosage regime until the second authorisation had been allowed.
Genentech’s 2003 patent was directed to the product Bevacizumab, but did not specify the dosage regime. The JPO refused the second PTE noting that although the dosage and administration regime of the new authorisation were different, the active ingredients and effect were identical to those specified in the first authorisation, and Genentech had therefore been able to benefit from the patent. Irrespective of the different dosage regimes, the JPO’s took the view that as both pharmaceutical products specified under the first and the second authorisations fell within the claims of Genentech’s patent, the further authorisation was not necessary to benefit from the patent.
Genentech appealed the JPO refusal to the Intellectual Property High Court (IPHC), which found that the JPO had been wrong to refuse the second PTE. The IPHC noted that as the dosage regime and administration of the first approval were different to those of the second approval, Genentech had not been able to manufacture and sell the second pharmaceutical product under the patent until the second authorisation had been granted, and that it would therefore be unreasonable to deny them the further PTE. The JPO appealed this decision to the Supreme Court.
The supreme court decision
The Supreme Court decision of 17 November 2015 upheld the IPHC’s decision. The Supreme Court focussed on two factors for determining whether a PTE should be granted, namely, 1) the identity of the pharmaceutical products that are the subject of the different approvals, and 2) whether the prior authorisation would have allowed the manufacture and sale of the product covered by the second approval. Further, the Supreme Court stipulated that the identity of a pharmaceutical product is to be understood as being determined by its ingredients, quantity, dosage, administration and efficacy.
As a result of the decision, the determination of whether a PTE should be granted now focusses less on whether the patent in question can be worked and more on whether there is a product covered by the patent for which a new authorisation is required. The expectation is that following the Supreme Court’s decision, it should become easier to obtain PTEs in Japan.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.