Alcon’s Opthalmic Solution Patent Ruled Invalid in NOC Proceeding

Alcon’s Opthalmic Solution Patent Ruled Invalid in NOC Proceeding

Alcon Canada Inc. v Apotex Inc. [2012 FC 410]

 

Background

The patent at issue is Canadian Patent 2,195,094. The patent is for a topical ophthalmic solution containing olopatadine. It is used for the treatment of allergic eye reactions. There is no disagreement that if the ‘094 Patent is valid than the Apotex product will infringe.

 

The person of skill was agreed upon to be a pharmacologist, an ophthalmologist,  an immunologist or a medical doctor with an understanding of human allergies and their treatment. The relevant date in this regard is December 12, 1996.

 

The issue in this case is claims construction which is a question of law determined by the courts with the aid of expert witnesses.[18]

 

Claim 1 reads:

Use of a topically administrable ophthalmic composition comprising a therapeutically effective amount of 11-(3-dimethylaminopropylidene)-6, 11-dihydrodibenz[b,e]oxepin-2-acetic acid or a pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable carrier therefor, for treating allergic eye diseases.

 

Claim 8 reads:

The use of Claim 7 [ultimately dependent on Claim 1], wherein the amount of (Z)-11-(3-dimethylaminopropylidene)-6, 11-dihydrodibenz[b,e]oxepin-2-acetic acid is 0.1% (w/v).

 

Claim 13 reads:

A topically administrable ophthalmic composition for treating allergic eye diseases comprising a therapeutically effective amount of 11-(3-dimethylaminopropylidene)-6, 11-dihydrodibenz[b,e]oxepin-2-acetic acid, or a pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable carrier therefor.

 

Claim 20 reads:

The composition of Claim 19 [ultimately dependent on claim 13] wherein the amount of (Z)-11-(3-dimethylaminopropylidene)-6, 11-dihydrodibenz[b,e]oxepin-2-acetic acid is about 0.1% (w/v).

 

 

 

Analysis

Alcon only asserts two claims – claim 8 and claim 20. Claim 8 is a use claim while claim 20 is a composition claim. They are both dependent on claims 1 and 13 respectively.

 

The words “treating” and “allergic eye diseases” are disputed by the parties. Alcon’s position is that the ‘094 Patent claims a novel treatment of allergic eye diseases based upon its use of previously unrecognized mast cell stabilizing activity in the human eye.

 

The main disagreement is over how far a court can proceed construing claims based on the information provided in the disclosure. Apotex says information cannot be read to include missing essential elements where as Alcon argues that meaning can be drawn from the entire context of the patent. The law is clear that the Court must examine the language the way the patentee is presumed to have used it rather than via strict literalism.[27] Purposive construction is capable of expanding or limiting a literal statement. There does exist judicial concern about importing essential features from the disclosure to the claims particularly where the disclosure is unclear regarding scope of invention.[28]

 

It is only appropriate to resort to the disclosure to understand words or expression I nthe claims. Essential information from the disclosure that is not relevant to the meaning of claims language cannot be used to qualify claims.[30]

 

Alcon concedes that treatment of allergic eye diseases exceeds the scope of invention. Instead Alcon seeks to use the disclosure to restrict this expansive claim to more specific eye diseases linked to mast cell degranulation.[33]

 

Alcon argued that allergic eye diseases should be restricted to mast cell disorders since the only four examples in the disclosure are mast cell degranulation related. The disclosure passages Alcon attempts to rely upon do not clearly identify the nature or scope of the invention – the lack specificity. The language of the claims is very imprecise. The disclosure sometimes distinguishes between the words treating and therapeutic and other times conflates the two.

 

The plain reading leads to the conclusion that olopatadine can be used to treat a broad class of allergic eye diseases that includes the four examples in the disclosure but is not limited to those examples. The evidence points away from the conclusion that the ‘094 Patent claims are limited to treatment of allergic eye diseases involving mast cell degranulation.[49]

 

Alcon could have limited the monopoly to use as a mast cell stabilizer. The prior art disclosure is incomplete in the sense that it does not indicate to a person of skill that the word treating should be limited to mast cell stabilization and disclaimed olopatadine’s use as an antihistamine.

 

Alcon indicates that the mast cell stabilization effects only appear at dosages much higher than where the antihistaminic effect occurs. This is not disclosed in the patent – in fact the patent does not inform the reader of this distinction. Avoiding infringement in this way would be near impossible.[57]

 

There can be no reading into the claims as Alcon maintains. Consequently it fails on the ground of obviousness and is invalid. The application by Alcon for a prohibition order was dismissed.