Apotex Inc. v. Wellcome Foundation Ltd.
T-3197-90 / T-2983-93 / T-2624-91
Wetston J.
25/3/98
161 pp.
Challenge to validity of patent by plaintiffs, generic drug manufacturers, and allegation of infringement by defendant Wellcome-Patent, owned by Wellcome, relating to pharmaceutical formulations containing 3'-azido-3'-deoxythymidine for use in treatment or prophylaxis of human retrovirus infections including AIDS; known under trade names zidovudine or retrovir, commonly known as AZT-Issues as to validity: (1) whether alleged invention method of medical treatment and not, therefore, valid subject-matter for obtaining patent; (2) whether patent claims more than what was invented at claimed date of invention; (3) if invention, whether plaintiffs Apotex and Novopharm (A&N) estopped from raising issue of inventorship; (4) if invention, whether proper inventors disclosed in patent; (5) whether invention described in patent obvious; (6) whether claims of patent overbroad, insufficient or ambiguous; (7) whether certain terms contained in claims ambiguous; (8) whether phrase "3'-azido-3'-deoxythymidine" overbroad or ambiguous-Issues as to infringement: (1) whether Wellcome Foundation Limited and Glaxo Wellcome Inc. have right to sue; (2) if patent valid, whether A&N infringed patent-Validity-Presumption of validity in Patent Act, s. 45-Attacking party must adduce some evidence patent invalid before Court will turn to consider issue of invalidity-How much proof required depending upon circumstance of each case-Several points in patent process of possible relevance to considerations of validity, including: date of invention, application date, priority date, date patent issued-Patent here construed as of filing date of Canadian patent application: March 16, 1986-Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536 establishing: patent available for new use for known compound (as here); inventive ingenuity underlying patent is discovery of new use of compound; patentee will obtain patent for idea and method of carrying it out; method of carrying out patent, or practical embodiment, not requiring inventive ingenuity-However, method of medical treatment patents not available in Canada-But patent herein not falling within prohibited area of method of medical treatment-Question of whether patent for invention within meaning of Act, s. 2 raising issue of utility-Utility question of fact which Court determines on basis of person having technical skills and knowledge required-Canadian patent law requiring, for invention, inventor reduce idea to definite and practical shape-Doctrine of sound prediction not applicable herein, and, as such, not determinative of question as to whether patent claims more than was invented at claimed dated of invention-In reviewing evidence associated with discovery of claimed utility of AZT, Court not satisfied that as of February 6, 1985, inventors discovered utility for compound-Not sufficient evidence at this time to understand how compound would be taken up by human cell or utilized in human body-Conception by Glaxo as of February 6, 1985 no different than theory, idea or belief, for which no patent protection-Glaxo had not deduced complete invention at that time-Scientists did not then understand critical aspects of disease or pathogenesis, nor direct relationship between in vitro results and clinical manifestation of disease-Therefore, despite reduction to writing, no invention as claimed made as of February 6, 1985, since claims, at this time, exceeded invention-However, as of March 16, 1985, patent satisfied, subject to obviousness, requirements of Act, s. 2 and did not exceed invention claimed-Idea, hypothesis or theory had, at this time, been reduced to definite and practical shape-Inventorship-A&N not estopped from arguing issue by virtue of doctrine of issue estoppel (U.S. decision on matter)-Procedure therein different (motion for partial summary judgment refused on basis summary procedure inappropriate venue by which to decide issue), in contrast with full body of fact and opinion evidence adduced herein-U.S. litigation involved six patents and Court not satisfied law on inventorship same in Canada and U.S.-Issue of co-inventorship relating to characterization and role of outside screeners-On evidence, inventors in AZT patent including Dr. Rideout, Marty St. Clair, as well as Dr. Furman, Dr. Barry and Dr. Lehrman, and Drs. Broder and Mitsuya (latter two not named as inventors in patent)-However, failure to name Drs. Broder and Mitsuya as co-inventors in patent not material allegation, therefore insufficient to render patent invalid according to Act, s. 53-No false or misleading petition with respect to inventorship in matter-Courts should strive to protect rights of true inventors and innocent errors in inventorship should not be allowed to defeat presumption of validity of patent-Invention for use of AZT as therapeutic for treatment of HIV joint effort of many eminent scientists-Work performed by Glaxo scientists central to invention-Obviousness-Prior art, individually or taken together, would not have led unimaginative skilled technician to invention without undue experimentation-Claims may be invalid where they are broader than what was invented or broader than invention described in specification-Claims for use of AZT in treatment and prophylaxis of HIV/AIDS invented by named inventors-Construction of claims fact specific-Claims and disclosure must be read as whole-Pharmaceutical formulation comprising AZT with carrier providing means of administering drug for therapeutic purposes and thus claim 1 not overbroad-Claims for prophylaxis not broader than invention made or broader than invention disclosed-Claims for treatment or prophylaxis of all human retroviral infections overbroad-Not co-extensive with invention and speculative-Phrase "AIDS infection" ambiguous: AIDS infection can mean either opportunistic infections associated with HIV infection or simply HIV infection-However, AZT directly treating HIV infection, nothing in disclosure or claims suggesting drug will assist in treating opportunistic infections associated with disease-Term "effective amount" not ambiguous; sufficient to enable person skilled in art to determine suitable dosage without further inventive ingenuity-Phrase "peak plasma concentration on administration" not ambiguous-"Unit dose" not ambiguous-Term "3'-azido3'deoxythymidine" not overbroad and ambiguous-As to infringement, question whether Glaxo Wellcome Inc. (GWI) entitled to bring action-No written licence produced to establish licensee-No implied licence by virtue of parent/subsidiary relationship herein-However, GWI had implied licence under patentee in Canada by virtue of corporate practices with respect to implied licensing within group of companies under care and control of Glaxo Wellcome plc-Wellcome Foundation Limited, as owner of patent, entitled to sue under Act, s. 55-Moreover, Glaxo Wellcome Inc. entitled to relief for patent infringement as person claiming under patentee under Act, s. 55-Burden on Glaxo to show infringement on balance of probabilities-Question of patent infringement mixed question of fact and law-Finding 28 claims infringed; 16 claims not infringed-Appropriate relief damages, not accounting of profits-Patent Act, R.S.C., 1985, c. P-2, ss. 2, 45 (as am. by S.C. 1993, c. 15, s. 42), 53, 55 (as am. idem, s. 48).