Date: 20070829
Docket: T-773-06
Citation: 2007
FC 865
Ottawa, Ontario, August 29, 2007
PRESENT: The Honourable Mr. Justice Hugessen
BETWEEN:
ABBOTT LABORATORIES LIMITED
and TAP PHARMACEUTICALS INC.
Applicants
and
THE MINISTER OF HEALTH,
NOVOPHARM LIMITED
and TAKEDA PHARMACEUTICAL COMPANY LIMITED
Respondents
REASONS FOR ORDER AND ORDER
INTRODUCTION
[1]
There are two Rule 51
motions before me. The first is a motion brought by Abbott appealing the
Prothonotary’s decision which allowed Novopharm's motion to strike and
dismissed Abbott’s prohibition application under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (the Regulations),
(the Abbott appeal).
[2]
The second motion is
brought by Novopharm appealing the Prothonotary’s decision to grant Takeda’s
costs of the motion to strike (the Novopharm appeal).
BACKGROUND
[3]
Novopharm is a Canadian
generic drug manufacturer. Takeda is a Japanese drug distributor and patentee
of Canadian letters patent No. 2,286,753 (the ‘753
Patent) and the now expired ‘314 Patent for the lansoprazole compound. Tap
Pharmaceuticals Inc. (TAP) is a joint venture between Takeda and Abbott to sell
lansoprazole in Canada. Abbott
and TAP have been selling lansoprazole delayed release capsules in Canada since their first Notice of
Compliance (NOC) from Health Canada in 1995.
[4]
Novopharm sought
approval from Health Canada for
an Abbreviated New Drug Submission (ANDS), which referred to 3 patents on the
Register: the ‘314 Patent, the ‘548 Patent and the ‘741 Patent. On December 21,
2004, Novopharm served Abbott with a Notice of Allegation (NOA) alleging that
its capsules would not infringe the ‘548 or the ‘741 Patents. The ‘314 Patent
was not addressed because Novopharm was waiting for its expiry.
[5]
Abbott responded to the
NOA by commencing an application seeking an order prohibiting the Minister from
issuing a Notice of Compliance (NOC) to Novopharm. The application was allowed.
Novopharm appealed the decision, but the appeal was dismissed by the Federal
Court of Appeal on June 28, 2007.
[6]
On February 13, 2006,
Abbott caused the ‘753 Patent to be added to the Register for the Reference
Product and has since caused 3 other patents to be added to the Register. This
lead Novopharm to provide Abbott with another NOA which alleged that its
capsules would not infringe the ‘753 Patent. Abbott then brought a prohibition
application.
[7]
Novopharm responded by bringing a motion before
the Prothonotary to dismiss the application pursuant to subsection 6(5) of the Regulations
on 3 grounds:
1. The
‘753 Patent is irrelevant to the dosage form of its capsules and the reference
product (the relevancy argument).
2. The
‘753 Patent is not eligible for inclusion on the Register because it does not
contain a claim for the medicine itself or a claim for the use of the medicine
(the eligibility argument).
3. The
application is redundant, scandalous, frivolous, vexatious and otherwise an
abuse of process (the abuse of process argument).
[8]
Novopharm succeeded on
the second ground and was awarded costs. The Prothonotary also awarded costs to
Takeda against Novopharm for defending certain allegations brought against it.
THE PROTHONOTARY’S DECISION
[9]
By decision dated June
11, 2007, the Prothonotary dismissed Abbott’s prohibition application pursuant
to the first portion of paragraph 6(5)(a) of the Regulations by agreeing
with Novopharm’s second ground to dismiss, namely, that the '753 Patent was not
eligible for inclusion on the Register because it does not contain a claim for
the medicine itself or a claim for the use of the medicine.
[10]
The Prothonotary
expressly concluded that the claims referring to specific active ingredients
are merely narrow expressions of the patented delivery system and do not
constitute claims to those medicines or their use.
[11]
The Prothonotary
rejected the relevancy argument primarily because Novopharm’s arguments based
on the AstraZeneca decision were beyond the scope of the motion and the
application since Novopharm did not seek to amend its Notice of Motion to
include this point. Since I am in complete agreement with that reasoning, which
is also in accord with a subsequent decision of the Federal Court of Appeal in
another case involving the same applicant, (Abbott v. Minister of Health,
2007 FCA 251, at paras. 36-39), I would confirm the Prothonotary's conclusion
on the point. Thus, there is no need to consider the other reason given by him.
[12]
The Prothonotary also
dismissed the abuse of process argument since he was of the view that he did
not need to determine the issue because of his conclusion that the application
should be dismissed. The point was not pressed on the appeal before me and, in
light of my conclusion, I too need not deal with it further.
[13]
Upon dismissing the
prohibition application, the Prothonotary also granted Takeda its costs and
disbursements of the motion because Takeda had appeared at the hearing to
defend its reputation and rebut certain allegations of abuse of process made
against it by Novopharm, notably that Takeda had misused confidential information
received in a different proceeding during the prosecution of the ‘753 Patent.
Those allegations had been abandoned by Novopharm at the start of the hearing
before the Prothonotary.
THE ABBOTT APPEAL
[14]
Abbott's principal
submission on the appeal was that the Prothonotary erred by dismissing the
application pursuant to paragraph 6(5)(a) of the Regulations on the
basis of his finding on “the balance of probabilities” that the ‘753 Patent did
not contain a claim to the medicine itself and that he thus failed to apply the
test established by the most recent case law of this Court (Pfizer Canada
Inc. v. The Minister of Health, 2007 FC 187 and Wyeth Canada v.
Ratiopharm Inc., 2007 FC 340), which held
that the Court has a duty to decide if a determination can be made based on a
modified “plain and obvious” test. Within a week of the close of the hearing of
this motion and prior to submissions by both parties of all their materials,
the props were knocked out from under this argument by a decision of the
Federal Court of Appeal delivered August 1, 2007, reversing the trial judgment
in the latter case (2007 FCA 264).
[15]
Speaking for a unanimous Court, Justice Sharlow
had this to say on this point:
...The factual elements of the motion must be decided on the basis of
the normal standard of proof in civil matters, the balance of probabilities. As
to the burden of proof, it lies where it normally does, on the party filing the
motion (the generic drug manufacturer).
[16]
I granted both parties leave to file further
written submissions on the effect of the Court of Appeal's judgment and Abbott
now concedes that, subject to its right to raise the point on a further appeal,
its previous argument cannot be sustained before me.
[17]
Abbott's second argument
is to the effect that the Prothonotary erred in wrongly construing claim 7 of
the ‘753 Patent as a delivery system and holding that the claim was a narrow
expression of such a system; instead it is said that he should have considered
and construed that claim individually and that, if he had done so, he would
have correctly concluded that it was a claim to the medicine itself and as such
eligible for inclusion on the Register.
[18]
Claim 7 of the ‘753 Patent is as follows:
7. The
solid preparation according to any one of claims 1 to 6, wherein the
pharmaceutically active ingredient is lansoprazole.
[19]
In discussing the proper construction of this
claim the Prothonotary said as follows:
[46] Even
applying the purposive construction proposed by the Applicants, the result
would be the same. Without having to refer to the abstract, I am satisfied on a
plain reading of ‘753 Patent as a whole that it protects a delivery system in
which seemingly any active compound can be packaged and delivered in a rapidly
dissolving oral form.
[47] Lansoprazole
is not mentioned in claim 1 or dependent claims 2-6, 8 or 9. Therefore, these
claims are not claims for lansoprazole itself or the use of lansoprazole.
Further, claims 1-6 relate solely to a delivery system that can be used with
the 190 or more Active Ingredients described in the disclosure. They are
therefore solely directed to a means of administering any medicine. Claims 7-9
relate to lansoprazole, voglibose and candesartan cilexetil respectively.
Claims 10 or 11 do not mention lansoprazole or its use. Both claims relate
solely to the delivery system applicable to the numerous Active Ingredients
mentioned in the disclosure. The only “use” described in these claims is the
“use of L-HPC having hydroxypropoxyl group contents of 7.0 to 9.9 percent by
weight.” This is not a use of lansoprazole
[48] As
lansoprazole is not mentioned in claim 12, this is not a claim for the medicine
lansoprazole or its use. Depending from claim 10, it too is related solely to
the aspects of a delivery system applicable to the numerous Active Ingredients
mentioned in the disclosure. While claims 13-17 mention lansoprazole, they are
not claims to the medicine lansoprazole itself. The uses referred to in claims
13-20, are not uses of lansoprazole but uses of L-HPC. Specifically, they are uses
of L-HPC having a hydroxypropoxyl group content of 7.0 to 9.9 percent by weight
for the manufacture of a pharmaceutical preparation capable of buccal
disintegration or dissolution. Depending from claim 10, these claims are
related solely to the patented delivery system which can be used to deliver the
numerous Active Ingredients mentioned in the disclosure.
[49] I
am not satisfied that the experts put forward by the Applicants took a proper
approach to the claims construction of the ‘753 patent. Instead, they
incorrectly focused on lansoprazole to the exclusion of all the other medicines
covered by this patent. I prefer the evidence of David Graham who asserts that
the ‘753 Patent does not seek to protect the medicine lansoprazole any more
than it protects the other 189 Active Ingredients described in the disclosure.
The use of lansoprazole, and indeed any other Active Ingredient in the ‘753
Patent, is included in the patent simply to show how an Active Ingredient, with
its known uses, can be delivered by the patented invention. In fact, the uses
of the Active Ingredients appear to be included merely to explain the rather
obvious point that the appropriate dosing of even a single Active Ingredient
will vary depending on the disease state and the subject being treated. I
concur that the claims referring to specific active ingredients are merely
narrow expressions of the patented delivery system and do not constitute claims
to those medicines or their use.
[50] Lansoprazole,
enteric coatings, enterically coated lansoprazole, delayed release enterically
coated granules of lansoprazole and the uses for all of these were known for
many years prior to May 26, 1997, the earliest relevant date for the ‘753
Patent. Lansoprazole and its uses were known long before the Relevant Date.
Therefore, the invention of the ‘753 Patent cannot subsist in describing this
particular Active Ingredient and its known uses. Instead, the ‘753 Patent
explains that various medicines can be used with the delivery system invention.
[51] Lansoprazole
is merely one of several “payloads” which can be used in the delivery system.
The claims mentioning lansoprazole are no more than a narrow expression or
embodiment of the delivery system which is the patented invention, applied to 1
of at least 190 possible Active Ingredients.
[52] Based
on the above, it is clear that the ‘753 Patent does not contain a “claim for
the medicine itself” or a “claim for the use of the medicine” and is therefore
not eligible for listing on the Register. Pursuant to the first portion of par.
6(5)(a), this application should be dismissed.
[20]
In my respectful view the Prothonotary has in this passage
displayed a thorough grasp of the proper principles of patent claim
construction. He has read the entire patent, including the disclosure. He has
looked at all the claims together, reading each one in the light of the others,
and has neither failed to distinguish between them nor gone outside their terms
or had recourse to some ephemeral notion of the “nature of the invention”. He
has informed his analysis by reference to the disclosure and the expert
evidence before him without allowing himself to be held prisoner by the latter.
While not, strictly speaking, a finding of fact since claim construction is
always at bottom a question of law, it was his duty in the face of conflicting
expert evidence to decide which view was the more convincing on a balance of
probabilities. My own reading of the ‘753 Patent leads me to the same
conclusion.
[21]
The Abbott appeal will be dismissed.
THE NOVOPHARM APPEAL
[22]
Novopharm principally
argues that the Prothonotary misapprehended the facts and misapplied the law in
concluding that Takeda should have its costs. Novopharm argues that the
Prothonotary found allegations which were not made in the Des Islet affidavit,
that he awarded costs to a party against whom no relief had been sought, who
achieved no success on the motion, who had interests in common with the losing
party, who made no substantive submissions, and who appeared solely to argue for
costs.
[23]
At the outset I would
say that although the impugned order is one that results from the exercise of
the Prothonotary's discretion, it is on a wholly ancillary matter and is in no
way vital to the final issue in the case. Interference on appeal is accordingly
only justified in the event of patent or palpable error.
[24]
Rule 400(1) accords full discretionary power to
the Court in the matter of costs. The Prothonotary explained his costs decision
in these terms:
[54] Takeda
appeared on this motion to counter certain allegations of abuse of process levelled against them by Novopharm. At paragraphs 15 to 17,
and 36 to 40 of his affidavit sworn August 11, 2006, Brian Des Islet, Executive
Director of Research and Development at Novopharm, states that Takeda added 18
new claims to the ‘753 Patent application in August 2005, within 12 days of
Novopharm’s disclosure of its formulation to the Applicants and Takeda in Court
No. T-214-05, and began “vigorously prosecuting” its patent application that
had laid dormant in the Patent Office for two years. Takeda views the
allegations as serious since they insinuate that Takeda misused confidential
information received from a different proceeding during the prosecution of the
‘753 Patent, and abused the Regulations in an attempt to delay
Novopharm’s entry in the workplace [sic].
[55] Novopharm
did not pursue the allegations in its written submissions and abandoned them at
the start [of] the hearing of the motion. Although I disagree with Takeda’s
characterization of Mr. Des Islet’s evidence as tantamount to charges of
“dishonesty, fraud, breach of a Court Order, and conspiracy”, the allegations
were serious and needed to be rebutted. In the circumstances, I conclude that
Takeda should be entitled to its costs and disbursements associate in defending
its reputation.
[25]
In my view the
Prothonotary's characterization of Novopharm's conduct and his interpretation
of the materials before him were properly open to him. There is no basis for me
to interfere.
CONCLUSION
[26]
The two appeals will be
dismissed with costs to Novopharm and Takeda respectively.
ORDER
THIS COURT ORDERS that
1. Abbott's appeal of
the Prothonotary's decision of June 11, 2007, is dismissed with costs to
Novopharm.
2. Novopharm's
appeal of the costs portion of the said Order is
dismissed with costs to Takeda.
“James
K. Hugessen”
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