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     T-195-94

BETWEEN:

     VISX INCORPORATED,

     Plaintiff,

     - and -

     NIDEK CO., LTD. and

     707284 ONTARIO INC.

     c.o.b. as INSTRUMED CANADA

     DR. HOWARD GIMBEL and DR. DONALD JOHNSON,

     Defendants.

     REASONS FOR ORDER

REED J.

     The plaintiff brings a motion to strike paragraphs from the Second Amended Statement of Defence and Counterclaim that has been filed by the individual defendants, Drs. Gimbel and Johnson (hereinafter "the defence"). The motion is brought pursuant to Federal Court Rule 419.1

     The paragraphs of the defence that are sought to be struck can be grouped into two separate categories: (1) those alleging that the patent claims are invalid because they claim a method of medical treatment or the use of an apparatus that involves professional skill; (2) those that allege that the claimed invention was not invented first by Dr. L'Esperance.

     The first category comprises paragraphs 16 and 17 of the defence:

     16.      Each of the 3658, 3732 and 3813 Patents contain claims with limitations directed to apparatus and the use of such apparatus. The apparatus limitations define known apparatus as shown by the patents and publications set out in Schedule A. The limitations as to the use of the apparatus define the way in which known apparatus is manipulated during surgery by a surgeon using his or her professional skill. Such use limitations are, therefore, directed to surgical procedures which do not constitute an invention as defined by section 2 of the Patent Act , R.S.C. 1985, c. P-4, as amended.                 
     17.      If the alleged inventions, defined by the claims of the 3658, 3732 and 3813 Patents have any novelty, which is denied, such novelty resides in an intended new use for, or in an intended advantage of, an apparatus that is not novel as shown by the patents and publications set out in Schedule A. The definition of invention in section 2 of the Patent Act requires novelty of structure in a machine or manufacture. Novelty of intended use or novelty of an unperceived advantage is a mere discovery.                 

     It is only necessary to review the first claim of the 3732 patent in order to assess the argument that paragraph 16 should be struck:

     1.      Apparatus for performing ophthalmological surgery by selective ablation of the anterior surface of the cornea with varied penetration up to a predetermined maximum penetration into the stroma to achieve an anterior-curvature change by volumetric removal of tissue within the optically functioning area of the cornea, said apparatus comprising: a laser producing a pulsed laser beam in the ultraviolet region of the electromagnetic spectrum; means for shaping, focusing and directing the beam toward the cornea with an intensity to produce tissue penetration to a depth per pulsed exposure which is but a fraction of said predetermined maximum; said means including means for selectively (a) determining and controlling one circular area of exposure to the extent of at least said fractional depth and (b) determining and controlling a different circular area of exposure to the extent of at least said fractional depth, each of said circular areas being within the optically functioning area of the cornea and concentrically disposed with respect to the optical axis of the cornea; whereby the cumulative penetration of the cornea for both said areas of exposure can effect a myopia-reducing corrective change in the curvature of the cornea.                 

     What is at issue are competing interpretations of this claim. The plaintiff states that it is a claim for an apparatus and only an apparatus and, therefore, a pleading that seeks to defend the infringement action on the ground that the claim is a medical method claim, or a claim for the use of an apparatus for medical treatment, clearly cannot succeed. Counsel for the defendants argues that, when interpreting patent claims, the courts look at the substance, and not merely the form of the claim. He argues that when one looks at the apparatus as defined in the claim (illustrated in the figures attached to the patent), it will become clear once the evidence has been adduced that all the elements of the apparatus are old " thus what the plaintiff is really claiming is a particular use of the apparatus, which use is based on the professional skill of the ophthalmologist. It is this proposition to which the pleading in paragraph 16 is addressed.

     Counsel for the defendants notes that there is a history to the patent that puts the issue in context. The invention originated in the United States and was patented there. In that country methods of medical treatment are patentable. They are not patentable under Canadian law. When the United States patent was sent to Canada for filing here, Canadian counsel redrafted the claims to remove, or attempt to remove, the method and use claims. Counsel for the plaintiff asserts that they were successful in their redraft. Counsel for the defendants asserts that they were not. Both counsel agree, I think, that this history explains why the invention, as described in the disclosure, is still framed as a medical method or use invention.

     I have not been persuaded that it is plain and obvious that paragraph 16 of the defence cannot succeed. The validity of the claim as an apparatus and only an apparatus claim, or as a claim that in substance contains use limitations is a matter better left for the trial judge to determine, after evidence has been heard. The question is one of textual interpretation. The retention of paragraph 16 in the defence will not add any additional burden in terms of the calling of evidence, or render the trial or the preliminary proceedings more complex. Removing the paragraphs at this stage, arguably, could prejudge the issue of the proper interpretation of the patent " a matter better left to a decision after trial. It is not appropriate to strike the paragraph at this stage.

     It was argued that paragraph 16 should be struck because it is similar to a paragraph in the corporate defendant's (Nidek Co., Ltd.) defence that was struck out by Mr. Justice Rothstein on March 13, 1996. Paragraph 16 is not the same as that paragraph.2 In addition, while Mr. Justice Rothstein characterized the patent as not constituting a claim for a method of medical treatment, he did characterize it as being a claim for "a medical apparatus and its use". Paragraph 16 of the defence directs its attention to the use limitations within the claims defining the invention. As such, it accords with Mr. Justice Rothstein's analysis that the claims are for a medical apparatus and its use.

     The challenge to paragraph 17 is essentially similar to that to paragraph 16 although counsel for the plaintiff frames it slightly differently. He argued that paragraph 17 is immaterial and redundant because the plaintiff is not claiming intended use. In my view this argument is tied to that made with respect to paragraph 16 and a disposition of the motion as it relates to paragraph 17 should follow that made with respect to paragraph 16.

     The second category of paragraphs in the defence that it is sought to strike comprises paragraphs 18, 19, 25 and 26. Counsel for the defendants states that they were added as an afterthought to this motion, by amendment,3 because on August 7, 1997, the prothonotary struck similar paragraphs from the pleadings of the corporate defendant Nidek. Counsel for the plaintiff argues that the paragraphs in question do not disclose a reasonable cause of action because they plead that Dr. L'Esperance was not the first inventor but do not plead that the invention was publicly disclosed or made known by others before the patent application was filed by Dr. L'Esperance (refer section 61 of the Patent Act). Counsel for the defendants argues that the plaintiff's argument is based on a misconstruction of the pleading. He states that there is no allegation that others made the invention public before a certain date but merely that Dr. L'Esperance was not the inventor or sole inventor since he derived the invention from the suggestions or writings of others. As such the pleadings do not raise a question of priority as between two inventors, each of which invents independently. It is to this latter situation that section 61 is addressed.

     The paragraphs that it is sought to have struck are:

     18.      (a)      Claims 1 and 2 of the 3732 Patent are invalid and void in that the invention as claimed in said claims, if any, was not made by the alleged inventor Francis A L'Esperance, the sole inventor named in the patent was not the first and true inventor of the subject matter claimed therein, but rather derived the same from one or more of Stephen L. Trokel, Rangaswamy Srinivasan and Olivia Serdarevic and that they jointly and severally and not L'Esperance, or alternatively they in addition to L'Esperance, should have been the named inventors.                 
         (b)      Further particulars of paragraph 18(a) are as follows: The original concept for changing the optical properties of the eye by using an excimer laser operating at 193 nm came from John Taboada who disclosed this information to Steven Trokel. As between L'Esperance and Trokel, Trokel was the first person to conceive and reduce to practice the following methods:                 
             1.      The method of changing optical properties of an eye by operating solely upon the anterior surface of the cornea of the eye, which method comprises selective ultraviolet irradiation and attendant ablative photo decomposition of the anterior surface of the cornea in a volumetric removal of corneal tissue and with depth penetration into the stroma and to a predetermined curvature profile, and;                 
             2.      The method of changing the anterior surface of the cornea of an eye from an initial curvature having defective optical properties to a subsequent curvature having correctively improved optical properties, which method comprises using ultraviolet laser radiation to selectively ablate the anterior surface of the cornea by photo decomposition, with penetration into the stroma and volumetric sculpturing removal of corneal tissue to such penetration depth and profile as to characterize the anterior surface of the cornea with said subsequent curvature.                 
                 Said methods correspond to those methods claimed in claims 1 and 2 of L'Esperance U.S. Patent No. 4,665,913. By letter dated December 17, 1990 to the U.S. Patent Office, during the course of Interference No. 102, 026, L'Esperance, on behalf of the real party in interest in the Interference, VISX, admitted through attorney W. Edward Bailey, that Trokel was the prior inventor of claims 1 and 2 of U.S. Patent No. 4, 665,913, which patent issued from U.S. patent application S.N. 552,983 upon which Canadian Patent No. 1,243,732 was based.                 
                 The invention described is the same invention as the claimed in claim [sic] 1 and 2 of the 3732 patent. By reducing to practice said methods, Dr. Trokel anticipated the apparatus claims of claims 1 and 2 of the 3732 patent.                 
                 The work of Dr. Trokel was performed at the Columbia Presbyterian Medical Center, 635 West 165th Street, New York, New York, U.S.A. between January and July, 1983. The method described above was used on a machine as described below in paragraph 18(1)(c).                 
         (c)      Stephen L. Trokel & Rangaswamy Srinivasan                 
             Trokel and Srinivasan used a machine for performing ocular surgery which had:                 
             i.      a laser producing a pulsed laser beam in the far-ultraviolet electromagnetic spectrum (150 to 200nm). They used a Lambda Physik Model 201E excimer laser which had a pulse energy density of more than 400mJ/cm2 at a repetition rate of up to 25 pulses per second.                 
             ii.      The laser light was shaped into a square or elongated slit covering the corneal surface. Masks were used to restrict the laser energy to narrowly defined areas: both slits and holes. A series of pulses were used until the desired energy was sufficient to achieve the desired depth of ablation. Concentric rings were made to control the shape of the corneal apex.                 
             The work of Dr. Srinivasan was performed at the IBM Thomas J. Watson Research Center, Yorkton Heights, New York between January and June, 1983.                 
             L'Esperance derived his invention from Trokel and Srinivasan and derived his information as to Dr. Trokel's development either directly or through others including Bernard Klimt and Dr. R. Thyzel.                 
     19.          The alleged invention claimed in claims 2 [sic] and 2 of the 3732 patent was known or used by another person before any invention date of L'Esperance contrary to section 27(1)(a) of the Patent Act, R.S.C. 1985, as shown by:                 
         a)      the facts stated above in paragraph 18;                 
         b)      the prior art listed in schedule A;                 
         c)      the common knowledge in the art.                 
     25.          Claims 10, 11, 16 and 17 of the 3813 patent are invalid and void in that the invention as claimed in said claims, if any, was not made by the alleged inventor Francis A. L'Esperance but rather the one or more of the persons named in paragraph 18, who, alone, together with each other, should have been named as an inventor or co-inventor of the subject matter of said claims, based upon the facts set out in paragraph 18 above.                 
     26.          The alleged invention claimed in claims 10, 11, 16 and 17 of the 3813 patent was known or used by another person before any invention date of L'Esperance contrary to section 27(1)(a) of the Patent Act , R.S.C. 1985, as shown by:                 
         a)      the facts stated above in paragraph 23 [sic 18];                 
         b)      the prior art listed in Schedule A;                 
         c)      the common knowledge in the art.                 

     There is considerable similarity between the two paragraphs 18 and 25 in the individual defendants' defence and the two paragraphs 18 and 22 of the Third Amended Statement of Defence and Counterclaim of the corporate defendant Nidek. The two sets of paragraphs are not, however, completely identical. Paragraphs 18 and 22 of the corporate defendant's Third Amended Statement of Defence and Counterclaim were struck out by order of the prothonotary on August 7, 1997. Leave to amend was given, to provide for the pleading of public disclosure. The plaintiffs appeal of that order was heard by Mr. Justice Wetston on September 22, 1997. The appeal was against that part of the prothonotary's order that allowed for the filing of another amended statement of defence and counterclaim by the corporate defendant. The plaintiff argued that the pleading in question was the fourth attempt by the corporate defendant to properly plead a reasonable cause of action4 and therefore the prothonotary should have exercised his discretion and struck the paragraphs without leave to amend. Mr. Justice Wetston dismissed the appeal. There was no determination on the merits of the prothonotary's decision to strike the paragraphs since the defendant did not appeal that order. The corporate defendant filed a Fourth Amended Statement of Defence and Counterclaim instead.

     Despite the similarities between the paragraphs struck in the August 17, 1997 order and paragraphs 18 and 25 above, I am not prepared to strike those paragraphs. The deficiencies that exist in the pleading can be cured by particulars. Mr. Justice Wetston's order only dealt with whether or not the corporate defendants should be allowed to amend their pleading. He found that the order allowing them to do so should stand.

     As noted, I am not prepared to strike the paragraphs in question. If I had come to an opposite conclusion, however, I would have been prepared to allow for amendment. The pleading that the person who is alleged to be the inventor was not an inventor at all is a reasonable defence.

     As I indicated to counsel at the hearing of this motion, this appears to be one of those patent cases that is getting bogged down in interminable, interlocutory, procedural wrangling. The computer print out of recorded entries is already 60 pages in length. I urge both counsel to adopt an approach that will see the action determined on its merits, in an expeditious fashion.

     For the reasons given the motion is dismissed.

OTTAWA, Ontario.

October 16, 1997.

    

                                     Judge

__________________

1.      Rule 419 of the Federal Court Rules states:
             (1) The Court may at any stage of an action order any pleading or anything in any pleading to be stuck out, with or without leave to amend, on the ground that              (a)      it discloses no reasonable cause of action or defence, as the case may be,              (b)      it is immaterial or redundant,              (c)      it is scandalous, frivolous or vexatious,              (d)      it may prejudice, embarrass or delay the fair trial of the action,              (e)      it constitutes a departure from a previous pleading, or              (f)      it is otherwise an abuse of the process of the Court,          and may order the action to be stayed or dismissed or judgment to be entered accordingly.
             (2) No evidence shall be admissible on an application under paragraph (1)(a).
             (3)      In this Rule "departure" means that which is prohibited by Rule 411.

2.      The defence of the corporate Defendants that was struck out read as follows:
         30. All patents at issue contain claims directed to apparatus only. A method performed by that apparatus involves treatment of the human body. No patent monopoly can be obtained in Canada in respect of the treatment of the human body. Therefore the Plaintiff is not entitled to any relief by way of injunction, delivering up, damages, profits, costs or otherwise in respect of any use of the apparatus at issue.

3.      The motion was originally filed on July 15, 1997. It was amended on September 10, 1997.

4.      The plaintiff's argument used this wording although it was probably meant to read "no reasonable defence".


FEDERAL COURT OF CANADA TRIAL DIVISION

NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD

COURT FILE NO.: T-195-94

STYLE OF CAUSE:VISX INCORPORATED v. NIDEK ET AL.

PLACE OF HEARING: TORONTO, ONTARIO

DATE OF HEARING: SEPTEMBER 29, 1997

REASONS FOR ORDER OF MADAME JUSTICE REED DATED OCTOBER 16, 1997

APPEARANCES:

Mr. Stephen Shoshan FOR PLAINTIFF

Mr. T. G. O'Neill FOR DEFENDANTS

SOLICITORS OF RECORD:

Piasetzki & Nenniger FOR PLAINTIFF Toronto, Ontario

Gowling, Strathy & Henderson FOR DEFENDANTS Ottawa, Ontario

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