Next Up: Ariad v. Lilly Rehearing En Banc

    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

Comments

[Susan]

I note from the Federal Circuit's docket sheet that Lilly's brief on rehearing was filed November 9. Will you be posting it? Attorneys I work with are following the case.

[Donald Zuhn]

Susan:

We plan to report on Lilly's brief early next week. We also plan to report on each of the amicus briefs submitted in this case before the en banc hearing on December 7th.

Don

[Charanjit Sehgal]

Instead of different sections viz specification and description to ensure enablement of the claimed invention if the dexcription as such contains sufficient information which ensures enablement should br considered enough

[Charanjit Sehgal]

If the description like the example enables the working of claimed invention then it should be OK