Benefit of ‘safe harbor’ provision can be granted only to divisional patent applications and not to ‘continuation in part’ applications

United States Court of Appeals for the Federal Circuit: 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 ‘divisional application’ that has been altered from a prior patent application of ‘continuation in part’ 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.

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 ‘compound’, ‘composition’ and ‘method of use claims’. 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 ‘compound claims’  in the parent 594 application. In addition to the parent 594 application, Pfizer prosecuted ‘composition claims’  through a divisional application i.e. 059 of the 594 application that matured into a patent ‘165.

The dispute arises because Pfizer did not file a divisional application to prosecute the ‘method of use’ claims and instead proceeded with a ‘continuation in part’ 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 ‘continuation in part’ 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 ‘continuation in part’ application of both the 629 and the 594 applications. Pfizer during the restriction requirements chose to prosecute only claims related to ‘method of use’ that resulted in patent 068 being granted to Pfizer. The 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.

The nub of the matter is that Pfizer attempts to correct the error and alter the status of the application from ‘continuation in part’ to ‘divisional’. 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 ‘continuation in part’ to ‘divisional’ for which the PTO issued a new patent i.e. 048 patent in March 2003. Pfizer 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.

The court gives two reasons why the patent should be disallowed:

  • The ’113 application issued as the ’068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the ’594 application. For years thereafter, the public was not free to practice that new matter because of that patent protection. Pfizer cannot now identify the ’113 application as a divisional of the ’594 application and retroactively relinquish the new matter in the ’113 application, after having enjoyed years of patent protection for it. The court while extending the logic said that PCT ’720 identified itself as a continuation-in-part of the ’594 application and as a continuation-in-part of the ’629 application and added new matter which was absent in both applications of ‘594 and 629; Pfizer does not assert that the PCT ’720 application can become a divisional application of the ’594 application by disregarding all matter not present in the original ’594 application for the reason that altering the scope of the PCT ’720 application could call into question the proper scope of those foreign patents obtained by Pfizer. Thus, because the PCT ’720 application contains new matter not present in the original ’594 application, it cannot be a division of the ’594 application.
  • The ’059 application matured into the ’165 patent. It is undisputed that the ’165 patent is derived from the 1994 restriction requirement. The RE ’048 patent, on the other hand, identifies itself as being descended from the ’113 application and the PCT ’720 application. Both of those applications, as filed, contained three classes of claims: compounds, compositions, and methods of use. The record thus shows that two separate restriction requirements affected the chain of applications involved in this case. The 1994 requirement, which was imposed on the original ’594 application, led to the ’165 patent. The 1997 requirement, which was imposed on the ’113 application, led to the ’068 patent and ultimately to the RE ’048 patent. In order for invoking the safe harbor provision to protect the RE ’048 patent against the invalidating effect of the ’165 patent, the 1994 restriction requirement must have “carried forward” from the ’594 application to the ’113 application.

[G.D. Searle LLC, Pfizer Asia Pacific PTE. Ltd. v. Lupin Pharmaceuticals, INC., 2014-1476*,  decided on June 23, 2015]

*Appeal from the United States District Court for the Eastern District of Virginia in No. 2:13-cv-00121-AWALRL, Judge Arenda L. Wright Allen.

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