Opposition to IL 201320 to Pfizer & limits to amending the Statement of Case

Patent Application IL 201320 to Pfizer is titled “CRYSTALLINE FORMS OF 6-[2- (METHYLCARBAMOYL) PHENYLSULFANYL]-3- E -[2- (PYRIDIN2- YL] ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS”.

On allowance, it published for Opposition purposes, and Unipharm submitted an Opposition.

Prior to publication following allowance, Applicants have very wide discretionary powers to amend claims or submit new claims, provided the claimed mater is supported from the specification. After publication, in response to Oppositions, or even after grant, the Applicant/Patentee is only allowed to correct obvious typographical errors or to narrow the scope of protection by cancelling claims or by amendments that clearly narrow the scope of protection. Nothing that protects matter previously not within the ambit of the claims can be allowed.

In this instance, during the Opposition proceeding, Pfizer requested a narrowing amendment to the specification to clearly define the term ‘substantially pure’ that appears in claim 2. Commissioner Alon allowed the amendment in a ruling of 5 March 2018, and gave the parties a window to amend their Statements of Case to take the amendment into account.

Unipharm, who had already submitted their evidence, decided not to amend the statement of claims, but Pfizer submitted an amended Statement of Claims that was wide ranging.  This included background to the development of the invention and eleven appendices.

Unipharm then requested that Pfizer’s amendment be struck from the record, arguing that amendments to the claims following amendments to the specification should be based on those amendments to the specification. Pfizer disagrees. They note that the Law does NOT require that amendments to the counter-statement of claims be related to the earlier amendments to the statement of claims at the start of the Opposition proceedings, or that they be based on the amendments to the specification. Furthermore, the interim ruling allowing amendments to the statement of case did not include such limitations.

The Applicant drew a parallel to civil court proceedings, however the Commissioner does not accept this since in civil court proceedings, when the plaintiff amends his Statement of Case, he can expect the defendant to be allowed to amend their Statement of Case, whether in direct response, or to broaden their position, and this is the risk taken when amending the Statement of Case once the proceeding is underway.

In contrast, in Patent Opposition proceedings, it is the Applicant that has a right to amend the specification, not the Opposer. In this instance, it is the Applicant that causes the Statement of Case to need to be amended, and he can therefore expect that the Opposer will also amend his Statement of Case , and will not restrict himself to amendments resulting from the Applicant’s amendment. If the Opposer does amend their Statement of Claims, the Applicant can make their amendments.

So what is the appropriate Law if the Opposer does NOT amend their Statement of Case? The Commissioner reasons that the Applicant can certainly correct their Statement of Case with respect to anything that needs correcting. Whenever the specification is amended, the main points of disagreement often shift. The Opposer deciding not to amend the Statement of Claims does not prevent the Applicant from relating to new issues raised by the amendment to the Specification, and to redirect his allegations to these issues. This serves the procedure and focuses the Statement of Case on the real issues. The Commissioner considers that the term “issues arising from the amendment” should be interpreted broadly, in light of the relevant case-law.

Nevertheless, where the amendment to the Statement of Case is totally disconnected to the amendment to the specification, it becomes a regular amendment to the Statement of Case which should be subject to the regular criteria. The submission should be accompanied with a statement justifying the amendments and explaining why they could not have been included originally, and why they should be allowable. This is necessary to prevent the amendment to the Specification becoming a technical tool for allowing unlimited amendments to the Statement of Case whenever the Specification is amended.

In this instance, the amendment to the Statement of Case was the addition of background relating to the development of the XLI formulation. From Examination of the amended Statement of Claims, the Applicant did not indicate any connection, even minimal, between the amendments to the specification and the amendments to the Statement of Case. Furthermore, the Applicant did not justify why the amendment was required now, and was not part of the original Statement of Case, or why the Statement of Case was not amended earlier.

In these circumstances, the Commissioner considers that the Opposer is correct, and the amendments as submitted should not be allowed. The Applicant is given 15 days to refile an amended Statement of Case whose claims are related to the amendment to the Specification, or to state that they do not wish to file an amended Statement of Case. Alternatively, the Applicant may submit a request to amend the Statement of Claims justifying the amendments submitted.

The deadlines for submitting evidence that were given in the interim ruling of 5 March 2018 are canceled. New deadlines will be given once the Applicant files his Statement of Case.

Costs for this will be considered when ruling costs for the main ruling.

Interim ruling by Commissioner Ophir Alon Concerning Unipharm’s Opposition to IL 201320 to Pfizer

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: