Insight on Potential Extension of Patent Term for Pharmaceutical Products
On 17 November, 2015, the Supreme Court of Japan released a key decision that highlighted certain criteria which would allow an owner of a pharmaceutical patent to extend the term of its patent based on the time taken to obtain approvals from the Ministry of Health, Labour and Welfare under the Pharmaceuticals and Medical Devices Act (formerly known as the Pharmaceutical Affairs Act) (“PMDA”).
A patent term under the Patent Act (“Act”) of Japan is maximum twenty years from the date of the patent application. However, a patentee may request the Japan Patent Office (“JPO”) to extend such term for up to five years if the patentee is not working the patented invention for a certain period during the twenty-year term, because it needs to obtain government approval to work the patented invention (the JPO may reject such request if it finds that it is not necessary to obtain such approval to work such patented invention).
For pharmaceutical products, if a company intends to manufacture and sell them, it is required to obtain approval for the manufacture and sale of the product under the PMDA. Such approval focuses on items concerning the product’s quality, effectiveness and safety such as the ingredients, quantity, dosage, administration, effects, and side effects. Further, if the company intends to change these items, it is required to obtain additional approval for such change of the product.
In Genentech v. JPO, a U.S.-based pharmaceutical company (“Plaintiff”) applied for a patent (“Patent”) on 28 October, 1992 for a pharmaceutical product (genetic name: bevacizumab) (“Product”) and such Patent was registered on 14 February, 2003. On 18 April, 2007, the Plaintiff obtained the manufacture and sales approval of the Product under the PMDA (“Prior Approval”). In the Prior Approval, the Product’s dosage and administration for adults was to give an intravenous drip of 5 mg/kg of a patient’s body weight or 10 mg/kg of body weight and its dosage interval was two weeks or more. Based on the Prior Approval, the JPO, upon the Plaintiff’s request, extended the term of the Patent by four years, two months, and three days – i.e., the time it took to obtain approval from MHLW after the patent was registered.
On 18 September, 2009, the Plaintiff obtained subsequent approval (the “Subsequent Approval”) from MHLW to add a new dosage and administration of the Product. The new dosage and administration for adults was to give an intravenous drip of 7.5 mg/kg of patient and the amended dosage interval was three weeks or more.
On 17 December, 2009, the Plaintiff again applied to the JPO for an extension of the term of the Patent. The Plaintiff asserted that they had not utilized the Patent to manufacture and sell the Product under the dosage and administration stated in the Subsequent Approval for a certain period. The JPO, however, rejected the Plaintiff’s request on 6 January, 2011 on the ground that it was not necessary for the Plaintiff to obtain such Subsequent Approval since although the dosage and administration of the Prior Approval was different from that of the Subsequent Approval, the active ingredients and effects were identical, and therefore, the Plaintiff was able to use the Patent. On 18 April, 2011, the Plaintiff made an objection to the JPO, but the JPO did not change its position. The Plaintiff then appealed the JPO’s rejection to the Intellectual Property High Court (“IPHC”).
Intellectual Property High Court’s Decision:
On 30 May, 2014, the IPHC held in favor of the Plaintiff and determined that the purpose of the extension of a patent term under the Act is to prevent a patentee from suffering any disadvantages (e.g., the patentee would not likely be able to recoup any R&D expenses if the patent term was shortened due to the need of obtaining government approval). Also, since the dosage and administration of the Prior Approval were different from that of the Subsequent Approval, the Plaintiff could not manufacture and sell the Product under the dosage and administration written in the Subsequent Approval until the Subsequent Approval was obtained, and therefore, the JPO should have extended the term of the Patent based on the Subsequent Approval.
Supreme Court’s Decision:
On 17 November, 2015, the Supreme Court affirmed the IPHC’s decision and focused on: 1) comparing the substantial identity of a pharmaceutical product in a prior approval versus the identity of the product in a subsequent approval, and if the substantial identity was different; 2) whether the manufacture and sale of a pharmaceutical product under a prior approval would cover the manufacture and sale of the product under a subsequent approval.
Here, the Supreme Court ruled that with respect to a product invention which focuses on a pharmaceutical ingredient, the substantial identity of such pharmaceutical product should be determined by its ingredients, quantity, dosage, administration, and efficacy. The Supreme Court also found that the Product’s substantial identity was different (based on its dosage and administration) in the Prior Approval and Subsequent Approval, and since based on such difference the Product was not manufactured or sold during the period of trying to obtain the Subsequent Approval, the Supreme Court concluded that the request for extending the term of the Patent for the Subsequent Approval should be permitted.
In response to the Supreme Court decision, the JPO has announced that by spring 2016, it will consider revising their guidelines for the extension of a patent term.