2014 <Special News Flash>｜News Letter

IPHC Overturns Current JPO's Examination Guidelines on Patent Term Extension (PTE)Genentech, Incorporated v. Commissioner of JPO, Case Nos. 2013 (Gyo-Ke) 10195 to 10198 (Decisions rendered on May 30, 2014)

The Grand Panel1) of the IPHC (Chief Judge, Toshiaki Iimura) decided that a PTE examination should be conducted simply in accordance with Article 67tri(1) of the Patent Law, while the current Examination Guidelines2), which were revised on December 28, 2011, were apart from the terms of Article 67tri(1), and thus not acceptable.

Article 67tri(1) provides in effect that the examiner shall reject a PTE application if a regulatory approval is NOT necessary to work the patented invention, which would in other words mean that the examiner must give an allowance if a regulatory approval is NECESSARY to work the patented invention.

The issue in these cases is how to construe the meaning of a “patented invention” in the Article. The current JPO's Examination Guidelines and practice are based on the interpretation that the “patented invention” should be identified by the features recited in a claim. The JPO thus rejected the Genentech PTE applications based on the 2nd approval for bevacizumab (Avastin), an antibody used as an anti- colon or rectum cancer drug; said approval providing a new dosage/administration (i.e. 7.5 mg/kg of bevacizumab to an adult in every 3 weeks or more) which is however not the feature recited in the claim. According to the JPO's interpretation, the 1st approval (which provides administration of 5 or 10 mg/kg of bevacizumab to an adult in every 2 weeks or more) is sufficient to work the patented invention.

The Grand Panel however denied the JPO's Examination Guidelines and practice and ruled that the “patented invention” should be substantially evaluated in light of the purpose of the PTE system. Although the approved pharmaceutical products must be covered by the patented claims, it does not affect how to interpret the “patented invention” in Article 67tri(1). Instead, the “patented invention” should be identified simply by a marketing approval given by the pharmaceutical authority. Specifically, the meaning of a “patented invention” should be decided by “ingredients, amount, dosage/administration, and indication” specified in the approval. The Grand Panel is thus of the position that Genentech should obtain PTEs based on the 2nd approval, because the 1st approval is insufficient to work the patented invention identified by a new dosage/administration and the 2nd approval is necessary to work the patented invention.

In addition to the above, the Grand Panel provided another normative guideline on how to construe the protection scope conferred by a PTE application, though it did not directly affect the current dispute. The Grand Panel states that it is almost impossible to provide a single uniform guideline to decide the protection scope of a variety of individual patents, but in particular with regard to a patent related to an ingredient involved in a pharmaceutical product, the extended protection scope should be decided according to a product identified by the “ingredients”, which can include other ingredients than the active ingredient(s), and a use identified by the “indication and dosage/administration”, which are specified in the approval given by the pharmaceutical authority. This is quite different from the current JPO's interpretation that the use should be identified only by “indication” and thus the “dosage/administration” should be disregarded.

Conclusively, the IPHC upheld Genentech's appeals, and cancelled the JPO's decisions.

The JPO is entitled to bring the cases to the Supreme Court within 2 weeks after the mailing date of the judgment, and thus the decision is not final and binding to date.

1) Grand Panel: Grand Panel is convened to hear cases where it is necessary to virtually unify court decisions, or cases involving important issues, which is somewhat similar to en banc in CAFC of the U.S.A. Since the founding of the IPHC in 2005, 9 cases including the above case have been heard.
2) http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/Guidelines/6.pdf

K&P’s CommentsAccording to the above Grand Panel's decision, PTEs can be admitted substantially on the basis of every approval. Therefore, we strongly recommend considering filing an application for PTE with respect to each approval when at least any one of “ingredients, amount, dosage/ administration and indication” is different from the preceding approval(s).