Holding
In BMS v.
Background
BMS sued
BMS asserted claims 13 and 104 of the '208 patent against
A compound according to claim 8 [see below], wherein the compound is:
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
or a pharmaceutically acceptable salt form thereof.
That is, claim 13 recites apixaban or a pharmaceutically acceptable salt form of apixaban. Claim 104 of the '208 patent recites:
A compound according to claim 13 [recited above], which is a crystalline compound.
Non-asserted claim 8, from which claim 13 depends, recites "[a] compound according to claim 1, wherein the compound is selected from [41 chemical compounds] or a pharmaceutically acceptable salt form thereof." Non-asserted claim 1, from which claim 8 depends, recites a structure that includes many chemical compounds, one of which is apixaban.
BMS asserted claims 21 and 22 of the '945 patent against
12. A solid pharmaceutical composition comprising a therapeutically effective amount of apixaban and a pharmaceutically acceptable diluent or carrier,
wherein apixaban comprises crystalline apixaban particles,
wherein the crystalline apixaban particles have a D90equal to or less than about 89 ?m, and
wherein, as measured using a USP Apparatus 2 at a paddle rotation speed of 75 rpm in 900 ml, of a dissolution medium at 37° C., at least 77 wt % of apixaban in the pharmaceutical composition dissolves within 30 minutes in the dissolution medium, and the dissolution medium is 0.05 M sodium phosphate at a pH 6.8 containing 0.05% sodium lauryl sulfate.
Asserted claims 21 and 22 depend from claim 12 and add that the compositions comprise 2.5 or 5 mg of apixaban, respectively.
Defendants brought counterclaims of invalidity against the '208 and '945 patents. Specifically, the defendants argued that the '208 patent is invalid for improper dependency, lack of enablement, and lack of written description support. The '945 patent was alleged to be invalid for lack of enablement, lack of written description support, and obviousness.
District Court
After a nine-day bench trial involving numerous expert witnesses,
District Court's Infringement Decision
BMS responded:
[T]hese ring limitations specify how many R groups can be replaced in the rings of the claimed chemical structure. For example, to BMS, claim 1 requires that ring M contain 0-2 R1a; so a compound that (in addition to meeting all other claim limitations) contains 0, 1, or 2 R1agroups is within the scope of claim 1.
***
The claim language expressly provides that the M, A, and Q rings can be 'substituted with' zero R groups. This plainly means that the claim language covers situations in which zero hydrogens are replaced with R groups.
Id.
The district court agreed with BMS:
The plain and ordinary meaning to a POSA of "substituted with [N] R" is "replaced with [N] R," where N is a number; it is not "must include [N] hydrogen substituents." The plain and ordinary meaning of "substituted" is "replaced with." The claim language, which does not refer to "substituents," provides no grounds to ignore this plain and ordinary meaning.
Id. Based on that claim construction, the district court determined that BMS showed, by a preponderance of the evidence, that claims 1, 13, and 104 of the '208 patent do cover apixaban.
Because
The district court also found infringement of the asserted '945 patent claims based on its claim construction. Id. "BMS proved by a preponderance of the evidence that
The district court concluded that BMS proved by a preponderance of the evidence that the other proposed ANDA products contain crystalline apixaban particles having a D90equal to or less than 89 microns. Id. at 347-351.
District Court's Validity Decision
Regarding the alleged § 112 deficiencies,
The district court also concluded that the asserted claims in the '945 patent had sufficient enablement and written description support:
The claims cover solid pharmaceutical compositions having crystalline apixaban with the claimed particle size and claimed dissolution rate. ...The '945 patent provides working examples of the claimed solid pharmaceutical composition. ... As
Id. at 333. The district court also agreed with BMS that undue experimentation would not be required for a POSA to determine if the crystalline apixaban in the formulated tablet is within the claims, pointing to the example in the specification that measured D90of apixaban via laser light scattering priori to dry granulation. Id.
Regarding the alleged § 103 issues,
Federal Circuit
In a one paragraph decision, the Federal Circuit complimented and affirmed the lower court decision, specifically noting its adoption of the court's claim constructions.
Take-aways
Patent litigation is often dependent on expert testimony, analyses, and experiments. The lower court decision and subsequent Federal Circuit affirmance demonstrate the importance of expert testimony. These decisions serve as excellent examples of the detail oriented nature of complex drug
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