Digests

AB Hassle v. Genpharm Inc.

T-2005-01

2003 FC 1443, Layden-Stevenson J.

22/12/03

86 pp. + Schedules "A" to "G"

AB Hassle, AstraZeneca filed notice of application under Patented Medicines (Notice of Compliance) Regulations seeking declaratory relief re: Genpharm's notice of allegation (NOA) or order prohibiting Minister from issuing notice of compliance (NOC) to Genpharm re: nine Canadian patents for omeprazole, inherently unstable inhibitor of gastric acid secretion--At hearing, four patents remained in controversy-- Genpharm alleges invalidity re: 693, 377, non-infringement re: 668, 762--Invention claimed by 377 is addition of inorganic salts for stabilization--688 claims new use for omeprazole as antimicrobial agent--762 concerns combina-tion of substance inhibiting gastric acid secretion and acid-degradable antibacterial compound-- Three previous proceedings involving same parties, drug were withdrawn-- One discontinued after F.C.A. held second person could not rely on further evidence not in NOA--Others discontinued when Minister advised Genpharm omeprazole approval submission was considered withdrawn--But Genpharm's appeal within Department, succeeded and it delivered new NOA-- Generic drug producer Genpharm (second person) wishes to distribute omeprazole drug by comparison with Astra's, which has ministerial approval--S. 6 proceedings unlike validity, infringement actions-- Purpose: determine whether Minister free to issue NOC--Issue: whether allegations by second person sufficient to support conclusion for administrative purposes that applicant's patent not infringed if second person's product marketed-- Applicant, in effect, gets interlocutory injunction just by commencing proceeding--S. 6 proceedings not treated as res judicata-- Open to patentee to enforce rights by infringement action-- Genpharm's complete NOA attached to reasons as Schedule "A"--693 patent has 19 claims (attached to reasons as Schedule "B")--Genpharm's allegation: claimed invention obvious, not inventive--Invalidity also alleged for anticipation, lack of novelty--Order to go prohibiting Minister from issuing Genpharm NOC until patents expire-- Party moving under s. 6 bears initial burden of proof-- Difficult burden to discharge as must disprove some or all allegations in notice of allegation--First step in analysis: construe patent claims --Reference to F.C.T.D. decision in Canamould Extrusions Ltd. v. Driangle Inc. (2003), 25 C.P.R. (4th) 343 (F.C.T.D.)--Reference to F.C.A. decision in AB Hassle v. Apotex Inc. (2003), 312 N.R. 288 (F.C.A.), which involved 693 patent--As for claim 1, F.C.A. concluded patent claim clear, inappropriate to look at disclosure for construction purposes: Dableh v. Ontario Hydro, [1996] 3 F.C. 751 (C.A.)--F.C.A.'s construction of claim binding-- F.C.A. decision in Beloit Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.) cornerstone authority as to anticipation, obviousness tests--Person skilled in art is skilled formulator lacking imagination, but reasonably diligent in keeping up with advances in field--Difference between anticipation, obviousness: former requires exact prior description in single source while latter can be based on single disclosure, "mosaic" of prior art--Expert opinion as to obviousness treated with extreme care--Court, in end, must decide--Court not satisfied, on balance of probabilities, person skilled in art would, directly and without difficulty, arrive at invention--Astra has discharged burden of establishing Genpharm's NOA as to invalidity for obviousness not justified--While Court's conclusions regarding obviousness, anticipation foreclosed Genpharm's hopes for success, submissions as to insufficiency, ambiguity of certain claims carefully considered--No legal, factual basis for these submissions found in Genpharm's NOA--Nothing turns on this submission--Insufficiency of disclosure attack based on Patent Act, s. 34--Technical attack not defeating patent for meritorious invention--But attack will succeed if invention not disclosed such that person skilled in art could put it into practice--Question whether (1) claim can be construed in meaningful way, (2) there is sufficient description to enable invention's utilization--As to anticipation, Genpharm argued EP 495 (published November, 1984) anticipated 693 patent by disclosing 3 elements of claim 1--495 failing to teach application of inert subcoating or separating layer when confronted with degradation of enteric coating--Allegation of invalidity on basis of anticipa-tion not justified--377 Takeda patent--377 patent application claimed priority from Japanese application filed February, 1986--Formulation patent consisting of active ingredient, inorganic salt stabilizing agent, enteric coating--Claims of 397 patent are Schedule "D" to reasons herein--Prior art regarding Takeda patent appears as Schedule "E"--Disclosures of Takeda patent, degradation problems explained-- Invention's object to solve two stability problems: that of omeprazole itself and its stability when in contact with ingredients used in oral solid dosage form, including enteric coatings-- Essence of Takeda patent: addition of basic stabilizing inorganic salt to stabilize omeprazole--Allegation of obviousness not justified-- 668 is new use patent--Omeprazole as antimicrobial agent for treating infection caused by bacterium colonizing in gastric mucosa--Patent 668 claims found in Schedule "F"-- Genpharm submits its drug to be used for "old" purposes, not as antimicrobial agent so will not infringe--But Astra relied on affidavits that even if Genpharm's drug was labelled only for "old" use, doctors would prescribe it for "new" use-- Pharmacists dispense cheapest brand available and that of Genpharm will likely be less costly--Question whether various provincial formularies permit substitution--As to Genpharm's intentions, Astra relies on Genpharm's product monograph but latter suggests excerpts referred to by Astra were taken out of context--Under Regulations, infringement of use patent not limited to generic drug producer, extends to infringement by patients even if not induced by producer-- Mere selling not establishing infringement but is made out if evidence second person's actions inevitably leading to new use of first person's product where second person granted NOC--For prohibition order, first person must prove if NOC issued, second person sells generic drug, patients or other third parties will infringe use patent--Requirements for expert evidence--Importance of product monograph (PM)-- Provided to manufacturer granted NOC--Limits indications, is available on Compendium of Pharmaceu-tical Specialties, reference work listing dosages, ingredients, directions for drugs--Widely used by physicians, pharmacists--Court concludes: Minister does not promulgate indications for drug when NOC issued--Most doctors don't know whether generic had same approval--Some pharmacists will assume generic approved for same uses as brand name drug--No mechanism (except formulary) alerts pharmacists generic approved for fewer uses--Certain passages in Genpharm's PM evidence of intent product for new use--If NOC issued, patients would infringe Astra's new use patent--That Genpharm's NOA re: 668 patent states its capsules to be labelled, marketed for inhibiting gastric acid secretions not enough--Would be otherwise if label or PM specifically stated not approved for H. pylori treatment--Genpharm's non-infringement allegation not justified--762 patent--New use patent-- Combination of substance which inhibits gastric acid secretion and acid-degradable antibacterial compound--By combining components of this invention, synergism of antibacterial effect of antibiotic compounds is achieved resulting in improved therapeutic efficacy-- 762 has 77 claims, attached as Schedule "G"-- Combination of substance with inhibiting effect on gastric acid secretion--Astra's argument, NOA not addressing claims where omeprazole taken in combination with antibiotic other than as single composition, well taken--Not open to generic producer to ignore patent claims describing basic invention--If it does so, fails to demonstrate no claim for use of medicine infringed and Regulations, s. 5 not complied with--NOA cannot be found to be justified-- Unnecessary to deal with Astra's abuse of process argument re: Genpharm's NOA--In conclusion, Genpharm's various allegations of invalidity, infringe-ment not justified and Astra entitled to order prohibiting Minister from issuing NOC--Astra, Takeda awarded costs taxed on ordinary scale as against Genpharm-- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5 (as am. by SOR/98-166, s. 4; SOR/99-379 , s. 2), 6 (as am. by SOR/99-379, s. 3)--Patent Act, R.S.C., 1985, c. P-4, s. 34 (rep. by S.C. 1993, c. 15, s. 36).