Friday, April 10, 2009

Wegner, USPTO both scorched by CAFC in Takeda

A process patent issued as U.S. Patent No. 5,583,216 (the ’216 process patent to Takeda) on December 10, 1996 led to the double patenting issue in the appeal of the Takeda case, argued for Takeda by Harold C. Wegner.

The opinion written by Judge Rader began:

The United States District Court for the District of Columbia held that later
developments in the art may inform the “patentably distinct” determination for double
patenting. Double patenting doctrines and case law permit this court to agree in part,
but only to the extent that the subsequent developments predate the secondary
application that triggers a double patenting rejection. Because genuine issues of fact
cloud the date of availability of materially distinct processes, as well as the viability of
those processes, this court vacates and remands.

The CAFC gave background:

Double patenting generally prevents a patentee from receiving two patents and
extending the term of exclusivity for a single invention. See Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1372 (Fed. Cir. 2005). The proscription against double
patenting takes two forms: statutory and non-statutory. Id. Statutory, or “same
invention,” double patenting finds its origin in the statutory grant of “a patent” for any
new and useful invention. 35 U.S.C. § 101; Perricone, 432 F.3d at 1372-73. Non-
statutory, or “obviousness-type,” double patenting is a judicially created doctrine
designed to foreclose “claims in separate applications or patents that do not recite the
‘same’ invention, but nonetheless claim inventions so alike that granting both exclusive
rights would effectively extend the life of patent protection.” Perricone, 432 F.3d at
In other words, the double patenting doctrine is designed to prevent “unjustified
timewise extension of the right to exclude.” In re Van Ornum, 686 F.2d 937, 943-44
(CCPA 1982). For instance, the doctrine bars an applicant from obtaining separate
patents with separate terms for both a product and process for making that product,
unless the product and process are “patentably distinct.”

The issue-->

The parties agree that product and process claims are patentably distinct if
multiple processes for creating a product exist at the time of the invention. See, e.g., In
re Cady, 77 F.2d at 109 (finding that the process of manufacturing roofing material was
patentably distinct from roofing composition when “appellant’s product as defined in the
appealed claims may be produced by processes other than the processes patented”).

The novel legal question in this case asks if later-developed alternative
processes are relevant in the product-process “patentably distinct” inquiry. The PTO
contends that the date of invention, in this case December 19, 1974, governs the
relevance of products and processes in the double patenting context. Thus, the PTO
submits that the date of invention governs the timing of double patenting analyses
because other issues relating to patentability are judged from the date of invention. For
example, the patentability requirements set forth in §§ 112, 102, and 103 are judged as
of the date of invention or filing. See 35 U.S.C. §§ 112, 102, 103. (...)

Takeda, on the other hand, argues that the PTO’s approach is too limited. In its
view, processes developed after the date of invention deserve a role in the double
patenting calculus.

Of the Takeda approach-->

The approach provides the patentee with the best of
both worlds:

the applicant can use the filing date as a shield, enjoying the earlier priority
date in order to avoid prior art, and rely on later-developed alternative processes as a
sword to defeat double patenting challenges. Here, the primary application, directed to
certain cephem compounds, was filed in the United States on December 19, 1975. The
secondary application, directed to the process for making these cephem compounds,
was filed in 1990. Yet the district court relied on patent applications published several
decades later to show a patentable distinction between the product and process.

The CAFC accepted NEITHER argument:

This court is not persuaded by either approach. Neither approach addresses the
policies underlying the double patenting doctrine. The secondary application (in this
case, the process application of January 8, 1990) actually triggers the potential of an
“unjustified extension of patent term.” When filing the secondary application, the
applicant essentially avers that the product and process are “patentably distinct.” Thus,
the relevant time frame for determining whether a product and process are “patentably
distinct” should be at the filing date of the secondary application. In this case, Takeda
filed the ’216 process patent application on January 8, 1990.

Lemelson came up in a footnote:

The dissent’s hypothetical is a stretch. It assumes nineteen years of co-
pendency. Today, patent terms are triggered by the filing date, not the grant date. In
other words, both the product and process patents will expire around the same time
(although there may be slight variance due to patent term adjustment). As such, an
applicant is less likely to maintain co-pendency for nineteen years. Moreover, this
court’s prosecution laches doctrine “may render a patent unenforceable when it has
issued only after an unreasonable and unexplained delay in prosecution.” Symbol
Techs., Inc. v. Lemelson Med., Educ. & Research Found., 422 F.3d 1378, 1384-85
(Fed. Cir. 2005).

Judge Schall was against the Takeda approach:

I believe that tying the inquiry to the invention date is most
commensurate with patent law as a whole and the policy goals relating to obviousness-
type double patenting. (...)

In a difficult case, the majority settles upon what I would characterize as a not-
unreasonable attempt at compromise. (...)
However, while the majority’s approach is more restrictive than that urged by Takeda, it still allows
Takeda to exclude sixteen years of prior art for invalidity purposes (such as 35 U.S.C.
§§ 102, 103), while simultaneously taking advantage of that art to overcome a double-
patenting rejection. This is what troubles me about the majority’s understandable desire
to find a middle ground in this case. It allows Takeda to have it both ways. In addition,
as far as I can tell, there is no other doctrine or rule that allows unpatentable material to
spring back into patentability based on later developments in the field.


Wegner, USPTO both scorched by CAFC in Takeda


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