United States District Court, E.D. Texas, Marshall Division
CLAIM CONSTRUCTION OPINION AND ORDER
PAYNE, UNITED STATES MAGISTRATE JUDGE
these consolidated patent infringement lawsuits, Allergan
Sales, LLC (“Allergan”) and Qualicaps Co., LTD.
(“Qualicaps”) allege that Teva Pharmaceuticals
USA, Inc. (“Teva”), Mylan Pharmaceuticals, Inc.,
Mylan Laboratories Limited, and Mylan, Inc. (collectively
“Mylan”) are seeking FDA approval to market and
sell a generic version of Allergan's branded Delzicol
drug product in violation of U.S. Patent No. 6, 649, 180
(“the '180 patent”). Before the court is the
matter of claim construction. The parties submitted
technology tutorials and claim construction briefs, and the
Court held a claim construction hearing on August 30, 2016.
'180 patent was filed April 13, 2000, issued November 18,
2003, and is scheduled to expire April 13, 2020. See
'180 patent, Dkt. 1-2; 35 U.S.C. § 154(a)(2). The
background of the patent describes problems with hard gelatin
capsules used in the pharmaceutical and health food fields.
Id. at 1:10-11. Gelatin capsules are films formed
from gelatin, a plasticizer, opacifying agent, dye, pigment,
and other ingredients. Id. at 1:12-14. The capsules
are made by dipping a pin (or mold) into an aqueous solution
of the capsule forming ingredients, drawing the pin out of
solution, allowing the solution adhering to the pin to dry,
and, once the solution forms a hard shell, separating the
shell from the pin. Id. at 1:15-20; 4:54-5:4. The
shell is then cut to size and mated with a complementary
shell to form a capsule. Id. at 4:67-5:4.
capsules made in this way are affected by residual water
content. Id. at 1:21-34. A capsule with too little
water is not flexible enough to withstand the stress
encountered when the capsule is filled with drug.
Id. at 1:22-24. Problems associated with too little
water may worsen over time as a capsule dries and loses water
during storage, resulting in contraction of the capsule.
Id. at 1:24-26. A capsule may contract to the point
where the shell cap disengages from the shell body.
Id. To prevent these problems, maintaining a water
content of about 13 to 15% by weight is optimal. Id.
relatively high amount of water content limited the use of
gelatin capsules to certain drugs. Id. at 1:28-35. A
hygroscopic or water-absorbing drug, for example, would draw
too much water from the capsule, thus leading to problems
associated with drying. Id. Gelatin capsules worked
best with hydrophobic or non-water-absorbing drugs.
known in the prior art that capsules made from cellulose
ether compositions were more versatile. Id. at
1:38-42. Capsules made of hydroxypropyl methyl cellulose
(HPMC) were known to maintain sufficient strength even with
low water content while otherwise performing similarly to
conventional gelatin capsules. Id. at 1:47-50. HPMC
capsules could be manufactured using the dipping method.
made from cellulose ether compositions nevertheless had their
own problems. Chief among them was the tendency of the
gelling agent to precipitate out of the capsule film during
long-term storage, causing cloudiness and making the capsule
“unpleasant to look at it.” Id. at
1:53-56, 2:1-6. When a polysaccharide such as HPMC was used
in combination with potassium chloride or calcium chloride as
a gelling aid, for example, residual potassium or calcium
ions would precipitate out onto the film surface as water
content dropped during long-term storage. Id. at
purpose of the invention claimed in the '180 patent is
“to provide a novel and improved cellulose ether film
of a composition comprising a cellulose ether as a base, a
gelling agent, and a gelling aid, which prevents the gelling
aid from precipitating out and maintains a favorable outer
appearance during long-term storage.” Id. at
2:9-15. The inventors' discovery, according to the
patent, is that precipitation of the gelling aid can be
prevented with a cellulose ether that has no more than 37.6%
cellulosic alkyl or hydroxyalkyl groups substituted in place
of cellulosic hydroxyl groups. Id. at 2:26-32. By
limiting the amount of cellulosic alkyl or hydroxyalkyl
groups, the inventors believed that there were enough
hydrophilic hydroxyl groups to ensure the film held enough
water, thus preventing potassium or calcium from
precipitating. Id. at 2:41-49.
'180 patent has one independent claim (claim 1), and it
A hard capsule formed of a film composition comprising a
hydroxypropyl methyl cellulose as a base, a gelling agent,
and a gelling aid, wherein said hydroxypropyl methyl
cellulose has a content of hydroxypropoxyl groups of at least
4% by weight of the hydroxypropyl methyl cellulose and a
content of methoxyl groups and hydroxypropoxyl groups
combined of 23 to 37.6% by weight of the hydroxypropyl methyl
Id. at 6:38-45. In other words, the HPMC used in the
film composition has at least 4% by weight hydroxypropoxyl
groups (a type of hydroxyalkyl group), and the combined
amount of hydroxypropxyl and methoxyl groups is 23 to 37.6%
by weight. Id. at 6:38-45, 2:62-3:7. The other claim
at issue for purposes of claim construction is claim 4, which
depends from claim 1 and specifies, “the content of
methoxyl and hydroxypropoxyl groups combined is 29 to 37% by
weight of the hydroxypropyl methyl cellulose.”
Id. at 6:55-58.
ultimate claim construction inquiry is a question of law.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct.
831, 837 (2015) (citing Markman v. Westview Instruments,
Inc., 517 U.S. 370, 388-91 (1996)). “It is a
bedrock principle of patent law that the claims of a patent
define the invention to which the patentee is entitled the
right to exclude.” Phillips v. AWH Corp., 415
F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks
omitted). “[T]here is no magic formula or catechism for
conducting claim construction.” Id. at 1324.
Instead, the court is free to attach the appropriate weight
to appropriate sources “in light of the statutes and
policies that inform patent law.” Id.
words of a claim are generally given their ordinary and
customary meaning . . . [which is] the meaning that the term
would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the
effective filing date of the patent application.”
Id. at 1312-13 (internal citations and quotation
marks omitted). “[T]he ordinary meaning of a claim term
is its meaning to the ordinary artisan after reading the
entire patent.” Id. at 1321 (internal
quotation marks omitted). The patent specification “is
always highly relevant to the claim construction analysis.