29:
333:
The generic drug manufacturers also sought to have the patent declared invalid on the grounds that the NIH researchers who did the human cell screening were not identified in the patent as co-inventors. Justice Binnie concluded that, to be considered a co-inventor, a person must have participated in
299:
to determine whether the invention was useful. There are three elements. First, there must be a factual basis for the prediction at the date that it was filed. Second, the inventor must have a sound line of reasoning from which the desired result can be inferred from the factual basis. Third, there
324:
had both prophylactic and treatment properties. The generic manufacturers attacked the patent on the grounds that there was no sound basis to predict that the drug had any prophylactic properties. The Court did not accept this argument, instead holding that the definition of "prophylaxis" includes
300:
must be proper disclosure. As
Justice Binnie believed that predictability is a question of fact, he relied on the trial judge's findings and determined that all three requirements for sound prediction were satisfied. At the time the patent application was filed,
225:
began researching an anti-AIDS drug. The team hoped to develop a chain terminator to halt HIV in the reverse-transcription stage of its HIV life cycle. Drugs selected on the basis of their chemical structure were screened starting in 1984.
311:
In applying the doctrine of sound prediction, Justice Binnie noted that the doctrine is can be applied generally but that steps should be taken to ensure that it is not abused by " to include a lucky guess or mere speculation."
343:
405:
374:
410:
420:
304:
knew that AZT was suitable for prolonged treatment of humans, that compounds of its class could act as chain terminators, and that
233:. This drug was originally synthesized by cancer researchers in 1964, in a project that was eventually abandoned. Since that time,
348:
296:
108:
54:
Apotex Inc. and
Novopharm Ltd. v. Wellcome Foundation Limited, Glaxo Wellcome Inc., Interpharm Inc. and Allen Barry Shechtman
325:"prevention of the development of signs and symptoms of the disease without necessarily eradicating the causal factor ".
260:
415:
425:
131:
361:
186:
86:
34:
387:
28:
369:
278:
The validity of this patent was brought into question by the appellant generic drug manufacturers.
124:
147:
365:
263:
for this work. In
February 1985, the NIH reported the positive results of their screening to
292:
135:
259:
was not equipped to do testing of the drug on human cell lines, so it contracted with the
139:
301:
268:
264:
256:
234:
222:
202:
399:
155:
143:
60:
194:
159:
321:
272:
248:
238:
230:
206:
151:
193:
in Canada. The Court rejected a challenge by the generic drug manufacturers
291:
The generic manufacturers claimed that the patent did not satisfy the
198:
190:
82:
252:
210:
229:
One of the drugs screened at that time is what is now known as
295:
requirement. Justice Binnie, for the Court, considered the
344:
List of
Supreme Court of Canada cases (McLachlin Court)
334:
the inventive concept and not merely its verification.
111:
is a valid way of determining the utility of a patent.
170:
165:
115:
101:
93:
77:
69:
59:
49:
42:
21:
8:
375:Text of the Federal Court of Appeal decision
271:filed a patent application for a new use of
189:decision on the utility requirement for a
308:efficacy had been shown in human cells.
380:
18:
247:testing on mouse cells revealed that
7:
182:Apotex Inc v Wellcome Foundation Ltd
22:Apotex Inc v Wellcome Foundation Ltd
388:SCC Case Information - Docket 28287
251:was potentially effective against
14:
27:
349:Utility in Canadian patent law
185:, 4 S.C.R. 153, is a leading
1:
406:Supreme Court of Canada cases
261:National Institutes of Health
221:Beginning in 1983, a team at
297:doctrine of sound prediction
16:Supreme Court of Canada case
43:Hearing: February 14, 2002
442:
267:, and, on March 16, 1985,
65:2002 SCC 77, 4 S.C.R. 153
45:Judgment: December 5, 2002
411:2002 in Canadian case law
213:-fighting drug, invalid.
120:
106:
26:
421:Canadian patent case law
320:The patent claimed that
275:in the United Kingdom.
390:Supreme Court of Canada
362:Supreme Court of Canada
187:Supreme Court of Canada
87:Federal Court of Appeal
35:Supreme Court of Canada
364:decision available at
241:as an anti-bacterial.
132:Claire L'Heureux-Dubé
282:Reasons of the Court
237:had been developing
171:Unanimous reasons by
416:History of HIV/AIDS
426:GSK plc litigation
125:Beverley McLachlin
316:Covetous Claiming
178:
177:
148:Michel Bastarache
97:Appeal dismissed.
81:Judgment against
433:
391:
385:
136:Charles Gonthier
129:Puisne Justices:
116:Court membership
109:sound prediction
107:The doctrine of
31:
19:
441:
440:
436:
435:
434:
432:
431:
430:
396:
395:
394:
386:
382:
357:
340:
331:
318:
289:
284:
219:
140:Frank Iacobucci
127:
44:
38:
17:
12:
11:
5:
439:
437:
429:
428:
423:
418:
413:
408:
398:
397:
393:
392:
379:
378:
377:
372:
356:
355:External links
353:
352:
351:
346:
339:
336:
330:
327:
317:
314:
302:Glaxo Wellcome
288:
285:
283:
280:
269:Glaxo Wellcome
265:Glaxo Wellcome
257:Glaxo Wellcome
235:Glaxo Wellcome
223:Glaxo Wellcome
218:
215:
205:'s patent for
203:Glaxo Wellcome
176:
175:
172:
168:
167:
163:
162:
122:Chief Justice:
118:
117:
113:
112:
104:
103:
99:
98:
95:
91:
90:
79:
75:
74:
71:
67:
66:
63:
57:
56:
51:
50:Full case name
47:
46:
40:
39:
32:
24:
23:
15:
13:
10:
9:
6:
4:
3:
2:
438:
427:
424:
422:
419:
417:
414:
412:
409:
407:
404:
403:
401:
389:
384:
381:
376:
373:
371:
367:
363:
360:Full text of
359:
358:
354:
350:
347:
345:
342:
341:
337:
335:
328:
326:
323:
315:
313:
309:
307:
303:
298:
294:
286:
281:
279:
276:
274:
270:
266:
262:
258:
254:
250:
246:
242:
240:
236:
232:
227:
224:
216:
214:
212:
208:
204:
200:
196:
192:
188:
184:
183:
173:
169:
166:Reasons given
164:
161:
157:
156:Louise Arbour
153:
149:
145:
144:John C. Major
141:
137:
133:
130:
126:
123:
119:
114:
110:
105:
100:
96:
92:
88:
84:
80:
78:Prior history
76:
72:
68:
64:
62:
58:
55:
52:
48:
41:
37:
36:
30:
25:
20:
383:
332:
329:Inventorship
319:
310:
305:
290:
277:
244:
243:
228:
220:
181:
180:
179:
128:
121:
53:
33:
201:to declare
160:Louis LeBel
400:Categories
217:Background
152:Ian Binnie
70:Docket No.
195:Novopharm
174:Binnie J.
61:Citations
338:See also
306:in vitro
245:In vitro
293:utility
287:Utility
102:Holding
85:in the
370:CanLII
199:Apotex
191:patent
94:Ruling
83:Apotex
73:28287
366:LexUM
209:, an
368:and
253:AIDS
211:AIDS
197:and
322:AZT
273:AZT
249:AZT
239:AZT
231:AZT
207:AZT
402::
255:.
158:,
154:,
150:,
146:,
142:,
138:,
134:,
89:.
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
