The Arnold Partnership v. Rogan, 246 F.Supp. 2d 460 (E.D.Va. 2003)
Facts: Plaintiff is the current owner of the ‘252 patent which claims “a
pharmaceutical composition which comprises hydrocodone or pharmaceutically
accetable acid addition salth therof and ibuprofen or a pharmaceutically
acceptable acid addition salt thereof.†Vicoprofen, the commercial embodiment
of the invention claimed in ‘252 was the first FDA approved combination
compound of ibuprofen and hydrocodone (cough and pain reliever). The ‘252
patent expires on December 18, 2004. On November 20, 1997, the plaintiff filed
with the U.S. Patent Office an application to extend the patent under 35 U.S.C.
156. The U.S. Patent Office denied the application on November 20, 2001 finding
that it failed to satisfy the “first commerical marketing†requirement of 156
(a)(5)(A) because both hydrocodone and ibuprofen had previously been approved
by the FDA for commercial marketing purposes.
Issue: Whether the U.S. Patent Office correctly interpreted 35 U.S.C. 156 to
require a drug composed of multiple active ingredients to claim at least one
active ingredient that has previously not been approved for commerical
marketing, before an extension is granted?
Holding: Yes, limiting extension of patent protection to combination drugs that
claim at least one new active ingredient that has not previously been approved
for commerical marketing is consistent with the Drug Price Competition and
Patent Restoration Act.
Reasoning: Under 35 U.S.C. 156 (5)(A), a patent cannot be extended unless “the
permission for the commercial marketing or use of the product after such
regulatory review period is the first permitted commercial marketing or use of
the product under the provison of law which such regulatory review period
occurred.†Plaintiff argues that the term “product†means the comibnation of
the active ingredients. If this is true, because the plaintiff never
commercially marketed the two compounds together, the plaintiff is entitled to
the extension. However, the Court finds that plaintiff’s argument is not
supported by the plain and unambiguous language of the statue and policy.
Patent law grants protection to each compound separately and independently.
Extending the protection that each of these patented compounds enjoy
separately,simply because they are combined in a single commercial marketing,
goes beyond the scope of 35 U.S.C. 156. Congressional intent would actually be
subotaged by the plaintiff’s argument because it would reward old inventions
with further patent protection and consequently reduce the incentive for new
innovation. Congress intended 35 U.S.C. 156 to grant protection in the narrow
class of combination drugs where one active ingredient belongs to an expired
patent but works in a mutually beneficial relationship with another newly
formulated active ingredient.
Critical Analysis: The plaintiff in this case has a good argument that
“product†could be interpreted as meaning an article newly marketed as a single
commerical entity when formerly marketed as separate commerical entities. From
a policy perpective this could lead to drug manufactures making innovations in
combination drugs that were formerly marketed separately. Perhaps the
combination drug works better and is more cost effective than the separately
marketed compounds. However, this contention seems to be more than outweighed
by the price drop that occurs after drug patents expire and the innovation that
will likely occur if what is truly awarded with a patent extension are only
those combination drugs with a new active compound.
Facts: Plaintiff is the current owner of the ‘252 patent which claims “a
pharmaceutical composition which comprises hydrocodone or pharmaceutically
accetable acid addition salth therof and ibuprofen or a pharmaceutically
acceptable acid addition salt thereof.†Vicoprofen, the commercial embodiment
of the invention claimed in ‘252 was the first FDA approved combination
compound of ibuprofen and hydrocodone (cough and pain reliever). The ‘252
patent expires on December 18, 2004. On November 20, 1997, the plaintiff filed
with the U.S. Patent Office an application to extend the patent under 35 U.S.C.
156. The U.S. Patent Office denied the application on November 20, 2001 finding
that it failed to satisfy the “first commerical marketing†requirement of 156
(a)(5)(A) because both hydrocodone and ibuprofen had previously been approved
by the FDA for commercial marketing purposes.
Issue: Whether the U.S. Patent Office correctly interpreted 35 U.S.C. 156 to
require a drug composed of multiple active ingredients to claim at least one
active ingredient that has previously not been approved for commerical
marketing, before an extension is granted?
Holding: Yes, limiting extension of patent protection to combination drugs that
claim at least one new active ingredient that has not previously been approved
for commerical marketing is consistent with the Drug Price Competition and
Patent Restoration Act.
Reasoning: Under 35 U.S.C. 156 (5)(A), a patent cannot be extended unless “the
permission for the commercial marketing or use of the product after such
regulatory review period is the first permitted commercial marketing or use of
the product under the provison of law which such regulatory review period
occurred.†Plaintiff argues that the term “product†means the comibnation of
the active ingredients. If this is true, because the plaintiff never
commercially marketed the two compounds together, the plaintiff is entitled to
the extension. However, the Court finds that plaintiff’s argument is not
supported by the plain and unambiguous language of the statue and policy.
Patent law grants protection to each compound separately and independently.
Extending the protection that each of these patented compounds enjoy
separately,simply because they are combined in a single commercial marketing,
goes beyond the scope of 35 U.S.C. 156. Congressional intent would actually be
subotaged by the plaintiff’s argument because it would reward old inventions
with further patent protection and consequently reduce the incentive for new
innovation. Congress intended 35 U.S.C. 156 to grant protection in the narrow
class of combination drugs where one active ingredient belongs to an expired
patent but works in a mutually beneficial relationship with another newly
formulated active ingredient.
Critical Analysis: The plaintiff in this case has a good argument that
“product†could be interpreted as meaning an article newly marketed as a single
commerical entity when formerly marketed as separate commerical entities. From
a policy perpective this could lead to drug manufactures making innovations in
combination drugs that were formerly marketed separately. Perhaps the
combination drug works better and is more cost effective than the separately
marketed compounds. However, this contention seems to be more than outweighed
by the price drop that occurs after drug patents expire and the innovation that
will likely occur if what is truly awarded with a patent extension are only
those combination drugs with a new active compound.