{"id":66051,"date":"2016-09-02T13:10:56","date_gmt":"2016-09-02T07:40:56","guid":{"rendered":"http:\/\/www.scconline.com\/blog\/?p=66051"},"modified":"2017-01-18T16:38:04","modified_gmt":"2017-01-18T11:08:04","slug":"benefit-of-safe-harbor-provision-can-be-granted-only-to-divisional-patent-applications-and-not-to-continuation-in-part-applications","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2016\/09\/02\/benefit-of-safe-harbor-provision-can-be-granted-only-to-divisional-patent-applications-and-not-to-continuation-in-part-applications\/","title":{"rendered":"Benefit of ‘safe harbor’ provision can be granted only to divisional patent applications and not to ‘continuation in part’ applications"},"content":{"rendered":"

United States Court of Appeals for the Federal Circuit:<\/strong> Chief Judge Prost, Bryson and Hughes, Circuit Judges ruled on a case involving patent protection of a product by Pfizer Asia Pacific (used as Pfizer ahead) used for the treatment of pain and inflammation without the harmful side effects associated with certain traditional anti-inflammatory drugs. The question before the court was whether a \u2018divisional application\u2019 that has been altered from a prior patent application of \u2018continuation in part\u2019 can be allowed so as to avail the benefit of the safe harbor provision. The United States District Court for the Eastern District of Virginia had invalidated the claims for patent 048 and Pfizer has preferred an appeal against the judgment.<\/p>\n

The appellants\/Pfizer claimed new compounds, composition and method of use through an application 594. The Patent and trademark office (PTO ahead) imposed a restriction requirement on \u2018compound\u2019, \u2018composition\u2019 and \u2018method of use claims\u2019. On the basis of unity of invention, Pfizer had to choose a singular claim per application and in order to prosecute all three claims had to file separate divisional applications of the parent application. They chose to prosecute \u2018compound claims\u2019\u00a0<\/em> in the parent 594 application. In addition to the parent 594 application, Pfizer prosecuted \u2018composition claims\u2019\u00a0 through a divisional application i.e. 059 of the 594 application that matured into a patent \u2018165.<\/p>\n

The dispute arises because Pfizer did not file a divisional application to prosecute the \u2018method of use\u2019 claims and instead proceeded with a \u2018continuation in part\u2019 application of the parent 594 application called the 629 application. The 629 application had new matter in addition to the parent 594 application and had all three claims i.e. compounds, composition and method of use to which a patent was granted in May 1996. Pfizer had also filed an International patent application (PCT 720) in 1994, which was designed as a \u2018continuation in part\u2019 application of the 629 application and parent 594 application. When PCT 720 became a national application in the United States i.e. 113, it was designed as a \u2018continuation in part\u2019 application of both the 629 and the 594 applications. Pfizer during the restriction requirements chose to prosecute only claims related to \u2018method of use\u2019 that resulted in patent 068 being granted to Pfizer.\u00a0The fault is highlighted when Pfizer litigates on the infringement of 068 patent and the claims of 068 patent are invalidated on account of obviousness-type double patenting of the 165 patent (granted to Pfizer earlier on account of a divisional application 059 from the parent application of 594). Pfizer unsuccessfully argued the applicability of the safe harbor provision but the court held that the benefit of the provision can be granted only to divisional applications and not continuation in part applications. As patent 068 has been issued under a continuation in part application it would not be eligible to the safe harbor provision.<\/p>\n

The nub of the matter is that Pfizer attempts to correct the error and alter the status of the application from \u2018continuation in part\u2019 to \u2018divisional\u2019. The grant of the 068 patent originated from a continuation in part application of the parent application of 594 and 629 application. After the changes are made the examiner allows the change in status of the application 113 of Pfizer from \u2018continuation in part\u2019 to \u2018divisional\u2019 for which the PTO issued a new patent i.e. 048 patent in March 2003.\u00a0Pfizer filed infringement cases against 5 generic drug manufacturers alleging violation of the 048 patent. The court finds that the 048 patent is invalid on account of the 165 patent and the transition from a continuation in part application to a divisional application cannot be cured.<\/p>\n

The court gives two reasons why the patent should be disallowed:<\/p>\n