March 11, 2014

The ICOS Affair: Opposition to Patent Application Ends in Settlement, and Following Further Review, Application Eventually Allowed

Lihi Goldenberg, Partner
Lihi Goldenberg

Partner

Gilat, Bareket & Co.

In this precedential decision, the Intellectual Property Adjudicator of the ILPO wanted to reject ICOS’ Patent Application because of lack of inventive step, in light of evidence discovered during an opposition proceeding, which was resolved in a settlement agreement. Following ex-parte proceedings under Section 34 of the Patents Law, it was proven to the satisfaction of the Adjudicator that the invention meets the requirements of novelty and inventive step and she consequently retracted her rejection, accepted the application, and granted the patent. This decision was appealed to the District Court by a 3rd party, not originally involved in the opposition, and this appeal was dismissed in limine. 

ICOS Corporation submitted a patent application (No. 147642) for a pharmaceutical preparation comprising the active ingredient tadalafil, which is a poorly soluble substance, and the active ingredient in the blockbuster drug CIALIS®. The claimed pharmaceutical preparation comprises tadalafil in free particulate form, within a defined particle size, the particle size of 90% of the particles being less than 40 microns, and by preferred embodiments less than 25 microns and even less than 10 microns. The patent application discloses that the preparation is intended for treating sexual dysfunction.

During an opposition proceeding against ICOS’ patent application– which was later withdrawn – cross examination of experts of both parties was conducted before the Patent Adjudicator. According to Section 34 of the Patents Law, once an opposition is submitted and later withdrawn, the Registrar may refuse grant of the patent if, in the course of the opposition, material was discovered according to which the patent application should not have been accepted in the first place. Before exercising its power under section 34 to refuse the grant of a patent in the aftermath of an opposition withdrawal, the Registrar must allow the applicant to be heard ex parte.

In this case, after the Adjudicator notified the parties that she was considering exercising the Registrar’s authority under Section 34, ICOS submitted its pleadings in support of its position that the application is patentable.

In her eventual decision, the Adjudicator held, inter alia, that the prior art publications that were submitted within the framework of the opposition did not disclose the invention in full, and therefore the novelty requirement was met.

As for inventive step, the adjudicator noted that there is no dispute that even before the priority date, decreasing the particle size of poorly-soluble drugs would have been conceived as an acceptable way of increasing the dissolution rate of a material, thereby causing an increase in its bioavailability. She also noted that the method for grinding active materials to a particle size, such as that claimed in the patent application, was known to a person skilled in the art on the relevant date. 

However, while noting that on the determining date, other ways of increasing dissolution rates for tadalafil, such as the use of systems for producing solid dispersions, the use of wet particles in order to increase the overall surface area of a given material, etc. were known, the Adjudicator held that it could not have been concluded prior to the priority date that reducing the particle size of tadalafil to achieve this goal would be the first and undisputed technique that a person skilled in the art would choose to implement before other techniques. It was further held that it was not unlikely that a person skilled in the art on the relevant date would have chosen to adopt another technique for increasing the bioavailability of such a drug (for instance, a co-precipitation technique). For one, it is likely to assume that on the priority date, a person skilled in the art did not have comprehensive information regarding the entire relevant properties of the active material, tadalafil. Second, there is no reason to assume that processes applied on other, even similar active ingredients, would yield the same results in relation to the dissolution rate and bioavailability of tadalafil as well.

Accordingly, it was ruled that on the relevant date, it was not obvious to a person skilled in the art to turn first to the technique of reducing the particle size of tadalafil in free form, in order to improve its bioavailability.

Following the Adjudicator’s decision to grant the patent, a third party, not involved in the opposition, submitted an appeal to the District Court of Jerusalem to overturn the adjudicator’s decision. ICOS submitted a motion to dismiss the appeal in limine under the ground that a third party does not have the right to appeal over an adjudicator’s decision in an essentially ex parte proceeding to which it was, obviously, not a party. The District Court accepted ICOS’ motion and dismissed the appeal in limine.

ICOS was represented by Gilat Bareket & Co., from the Reinhold Cohn Group.

This article is provided for general information only. It is not intended as legal advice or opinion and cannot be relied upon as such. Advice on specific matters may be provided by our group’s attorneys.

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