In a lawsuit filed by a Swiss-based drug manufacturer claiming that a generic anti-cancer drug manufactured by Towa Pharmaceutical Co., Ltd. (headquarters in Osaka Prefecture) has infringed on its patent and requesting the suspension of the production and sales of the generic drug, Chief Judge Ryuichi Shitara of the Intellectual Property (IP) High Court upheld the lower court decision and issued a ruling on Jan. 20 that Towa is not in violation of the patent.
The plaintiff, Debiopharm International, alleged that Towa’s anti-cancer treatment drug infringes on the patent of the company’s anti-cancer medication Elplat, which it manufactures and sells in Japan.
The patent duration for drugs (20 years) can be extended up to a maximum of five years. Extensions are allowed because of the length of time it takes to obtain government approval for the manufacture and sales of drugs. During the extended period, however, the scope of patent protection is narrower than the scope under the initial protection. This has been the focus of discussions surrounding the litigation. The IP High Court assembled an expanded council of five judges, two more than usual, to deliberate on the issue, and presented the first ever guideline on the scope of protection during the extended patent protection period.
In practice, the patent during the extended period protects the drug if the generic is 1) using previously known technology to achieve 2) identical technical characteristics and effects, 3) different only in ways that are irrelevant in terms of quantity, etc., and 4) regarded as the same drug in terms of usage instructions and dosage.
On the basis of this understanding, the council discussed whether Towa’s generic drug falls within these criteria. The judges came to the conclusion that because Towa’s generic drug contains a stabilizer as an additive in addition to the Debiopharm’s drug ingredients, it is “not regarded as the same product in effect” as the anti-cancer drug developed by Debiopharm.
Decision may affect drug manufacturers’ strategies
The decision by the expanded council of the IP High Court will likely affect generic drug manufacturers’ drug development and market launch strategies.
So far, the main discussions concerning patent extension have been on “conditions under which extension should be approved” and “the scope of the extended protection.” Although academic arguments and Patent Office’s evaluation standards already existed, there had been no guidelines for legal judgment on “the scope of protection.” The lack of standards apparently forced drug manufacturers to proceed with the development and sales of drugs without any assurance that their products would not infringe on patents.
The IP High Court decided in 2014 that an extension of patent protection should be approved for drugs whose components are the same as another cancer drug already approved for an extension but whose usage instructions and dosage are different, because they are considered to be different medications. The decision gives approval to broader range of cases than the standard set by the Patent Office. The ruling was supported by the Supreme Court and led the Patent Office to change its evaluation guidelines.
The High Court’s ruling on Jan. 20 is the first case in which the court clarified the standards concerning the narrowed scope of extended protection.
Nihon University Graduate School Professor Hiroshi Kato (Intellectual property law) previously worked for the Patent Office as an evaluator. He pointed out: “Now that the court has established a standard, generic manufacturers will need to conduct research and development of drugs that will avoid controversy over whether they are identical to other drugs.” Representative Director of the Japan Society of Generic Medicines, Masaki Muto, is optimistic about the development, “This will offer an opportunity for the manufacturers of generic drugs to innovate and create new technologies.”