By
Donald Zuhn —

With
oral argument before the Supreme Court in In
re Bilski now concluded, patent practitioners can begin to turn their
attention toward the next big patent case awaiting oral argument:  the Federal Circuit's en banc rehearing of Ariad Pharmaceuticals, Inc. v. Eli Lilly &
Co., which is scheduled for December 7th.  Last month, Plaintiffs-Appellees Ariad Pharmaceuticals,
Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research,
and the Presidents and Fellows of Harvard College ("Ariad") filed
their principal brief for rehearing en
banc.  In response to the two
questions presented by the Federal Circuit's en banc order, Ariad answered that "§ 112, ¶ 1, does not contain
a written description requirement separate from an enablement requirement [and
that] it necessarily follows that the statute provides no scope or purpose for
a separate written description requirement."

Ariad
contends that "[u]nder a plain reading of [§ 112, ¶ 1], a patent
specification must be in writing and must contain a description (i) of the
invention, and (ii) of the manner and process of making and using it."  According to Ariad, the first paragraph
of § 112 can thus be represented as follows:

The
specification shall contain

[A]
a written description

[i]
of the invention, and

[ii]
of the manner and process of making and using it,

[B]
in such full, clear, concise, and exact terms as to enable any person skilled
in the art to which it pertains, or with which it is most nearly connected, to
make and use the same . . . .

Under
the above construction:

[C]lauses
[i] and [ii] are components of [A]; they are both parts of the "written
description."  The final
prepositional phrase [B] ("in such full . . . terms as to enable") modifies the
noun [A], "a written description," and thereby provides the standard to assess
the legal adequacy of the whole of the written description.  This construction has the important benefit
of following ordinary rules of English grammar.

Instead of construing § 112 in this manner, Ariad argues that the Federal
Circuit's written description cases "tend to truncate the statutory
language after the phrase 'written description of the invention,' and solely
focus on only this one phrase, ignoring the remaining language in the
paragraph."  Ariad notes that
the Federal Circuit's approach yields an alternate construction, which can be
represented as follows:

The
specification shall contain

[A]
a written description

[i]
of the invention, and

[ii]
of the manner and process of making and using it,
[B]
in such full, clear, concise, and exact terms as to enable
any person skilled in the art to which it pertains,
or with which it is most nearly connected, to make
and use the same . . . .

Ariad
asserts that there are three significant problems with the above
construction:  (1) "the
statute provides no standard for testing the legal adequacy of the 'written
description of the invention,'" (2) "this alternate construction of
the statute does not make sense as a matter of grammar because, in the context
of the sentence, the prepositional phrase [B] ('in such . . . terms') can only
modify the word 'description,'" and (3) "under the alternative
reading of the statute, the addition of a comma between the phrases 'the manner
and process of making and using it' and 'in such . . . terms' is inexplicable."

In
its brief, Ariad also argues that none of the four earlier major revisions of
the patent laws (i.e., the Patent
Acts of 1790, 1793, 1836, and 1870) support a separate written description
requirement.  It contends that
the Patent Acts of 1790 and 1793 "required a written description that
served two purposes: (i) to distinguish the invention from the prior art, and
(ii) to enable those of ordinary skill in the art to make and use the
invention."  Ariad asserts
that beginning with the Patent Act of 1836, the first purpose was eliminated
from the written description requirement and transferred to the claims and
"the 'written description' henceforth served a single purpose: enablement."

According to Ariad, neither Supreme Court nor CCPA precedent supports the existence of
a separate written description requirement.  Noting that Federal Circuit opinions focusing on the written
description requirement primarily rely on the Supreme Court's decision in Evans v. Eaton, Ariad states that "Evans interpreted the 1793 Patent Act
which . . . differs from the 1836 and subsequent Patent Acts in that the 1793
Act required the written description of the invention to serve two purposes."

As
for the CCPA, Ariad argues that "[f]or at least the first fifteen years
after adoption of the 1952 Patent Act, cases interpreting § 112, ¶ 1 'did not
differentiate written description from enablement.'"  Ariad cites two examples of CCPA cases
in which it contends the CCPA so interpreted the statute:  In
re Gay and In re Wilke.  In both cases, Ariad asserts that
"the CCPA explained that § 112, ¶ 1 had just two aspects – (i) to describe
the invention so a person of ordinary skill can make and use it, and (ii) to describe
the best mode contemplated by the inventor for carrying out the invention."  Ariad also argues that a "careful
reading" of the CCPA's decision in In
re Ruschig, "frequently cited as the leading case construing § 112, ¶
1 as containing separate written description requirement separate from
enablement," demonstrates that this case has been misread.  Finally, noting
that Judge Markey once observed (in In re
Barker) that he could not see how one may, in "full, clear, concise
and exact terms," enable the skilled artisan to practice an invention and
still have failed to describe it, Ariad states that it is "in complete
agreement with Judge Markey's opinion in Barker
and believe[s] it should be adopted by this Court en banc."

As
for the Federal Circuit's creation of a separate written description
requirement (and a standard for assessing compliance with this separate
requirement), Ariad argues that:

Enablement
is clearly provided for in the statute, whereas a separate written description
doctrine requiring evidence of "possession" is not.  Yet many patents challenged under §
112, first paragraph are resolved under the non-statutory written description
doctrine rather than under statutory requirement of enablement.  The present case is simply one such
example.

The
reason for this is simple.  Once
written description was de-linked from enablement, it was necessary to frame
some other test for determining whether the judicially-construed "separate
written description requirement" was satisfied.  For this purpose, the Court created a new standard: "the
applicant must convey with reasonable clarity to those skilled in the art that, as
of the filing date sought, he or she was in possession of the invention."

Ariad
also contends that the Federal Circuit's separate "written
description-possession" requirement has severe adverse
consequences for research universities.  Noting that university patentees were involved in Ariad, Regents of the University of California v. Eli Lilly & Co., and
University of Rochester v. G.D. Searle
& Co., the Ariad brief states that the university's patents "were
held invalid under the 'separate written description' doctrine at the behest of
pharmaceutical companies whose commercial activities are downstream of, and
benefit from, the type of discoveries that universities make."

In
the last portion of its brief, Ariad explains how the specification of the
patent-in-suit would satisfy a properly construed written description
requirement.  In particular, Ariad
argues that:

[T]he
inventors of the patent-in-suit discovered a previously unknown protein in
cells, NF-κB, that plays a crucial role in regulating the immune response to
inflammatory stimuli.  They
realized the important benefits that would flow from reducing NF-κB activity in
cells and promptly published their discoveries both in the scientific
literature and in patent applications that described how to achieve such
reduction.  Other scientists promptly
practiced these teachings and expressly cited and referred to the publications
of the present inventors as the basis for their own results.

Contending
that the proper test for assessing the adequacy of a description is not
possession, but rather whether the description enables any person skilled in
the art to make and use the claimed invention, and further that this test
"is well illustrated in the Supreme Court cases, which focus on whether the
claimed scope matches the inventor's contribution," Ariad asserts that "[t]he
claimed methods [of the patent-in-suit] encompass no more than the important
contribution that these inventor[s] described in the 1989 priority application."

For additional information regarding this and other related topics, please see:
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Amgen, Inc. v. Ariad Pharmaceuticals, Inc. (Fed. Cir. 2009)," June 1, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009