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AIPPI Issues Position Paper On the Use of Post-Filing Data to Support Inventive Step

by John C. Todaro (Chair of AIPPI’s Standing Committee on Pharma and Biotechnology)

AIPPI recently issued a Position Paper urging patent offices and courts around the world to permit the use of post-filing data during patent prosecution or litigation, to support the inventive step of a patent or patent application.

The AIPPI Position Paper originated from the work of the AIPPI Pharma & Biotech Committee.  Between November 2015 and February 2016, the Committee surveyed its members about the use of post-filing data in member jurisdictions.  The Committee looked at the use of post-filing data for supporting several requirements for patentability, including inventive step, sufficiency and utility.  The Committee found variable practices around the world.  However, the Committee concluded that most jurisdictions allowed the use of post-filing data to support inventive step, particularly when the data related to properties of the invention that are disclosed in the specification of the application or patent.    Generally, post-filing data are submitted to national authorities in the form of an experimental report, a declaration, or a publication, which is dated after the effective filing date of the patent or patent application.

Although the use of post-filing data could be important to prosecution or litigation in any technological field, it is of particular importance in biotechnology and pharmaceuticals.  In these fields, early patent filing is important to secure investment for expensive development work.  Pharmaceutical and biotech inventions often have long development times, from 5 to 10 years, or longer.  Important data about the invention, such as in vivo data or clinical results, do not become known until after the filing of the patent application.

Committee members strongly favored permitting the use of post-filing data to support inventive step, and drafted a Position Paper for consideration by the AIPPI Bureau.  The Bureau approved the Paper in April 2017.

In the position paper, AIPPI called for jurisdictions around the world to allow consideration of post-filing data in the assessment of inventive step, in particular if the post-filing data elaborate on effects that are already apparent from the application or patent.  The Paper supports this practice both during prosecution and during post-grant challenges to validity.

The Paper recognizes some limitations to the use of post-filing data.  For example, the Position Paper acknowledges that the patentability of an invention should generally be evaluated on the basis of the statements and data in the application as it was filed.  Further, post-filing data should not be considered as an amendment or addition to the specification of the patent application, which should remain as it was prior to the submission of the post-filing data. Impermissible added matter has been defined and discussed in an AIPPI Resolution: “Added matter: the standard for determining adequate support for amendments” which was discussed and approved during the 2016 AIPPI World Congress.

Nevertheless, as noted by AIPPI, there is precedent for the consideration of additional data during prosecution.  For example, the Patent Cooperation Treaty allows taking into account of “any additional documents considered to be relevant in a particular case” (Art 33(6) PCT).  In line with this provision, patent offices in many jurisdictions currently allow applicants to provide “post-filing data,” or additional evidence during prosecution, which may help to establish the inventive character of an invention.  AIPPI is now on record favoring a uniform practice permitting the use of post-filing data to support inventive step.

Committee members who contributed to the drafting of the position paper include Martin Klok of the Netherlands, Carolyn Harris of Australia, Amy Feng of China, Hector Chagoya of Mexico and John Todaro of the United States.