Written Description Requirement: Ariad v. Eli Lilly

Burt MagenI recently had the opportunity to listen in on PLI’s one hour briefing titled Ariad v. Eli Lilly and the Separate Written Description Requirement. This briefing was conducted by Vera M. Elson, a partner in the international law firm McDermott Will & Emery and Burt Magen, a partner in the law firm Vierra Magen Marcus & DeNiro LLP.  Ms. Elson focuses her practice on intellectual property trial and counseling for her firm’s technology clients.  Mr. Magen focuses his practice on intellectual property counseling and patent prosecution for his firm’s technology clients.

Elson began by explaining that pre-Ariad § 112, ¶1 focused on two underlying purposes behind a separate written description.  The first was Possession:  “The purpose of the written description requirement is broader than to merely explain how to make and use; the applicant must also 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.” Vas-Cath, Inc. v. Mahurkar, 935 F. 2d 1555 (Fed. Cir. 1991).  In other words, what you claimed you actually invented.  The second was Meaningful Disclosure: “A patent specification must convey the detailed identity of an invention, thereby serving a teaching function as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. Univ. of Rochester v. G.D. Searle & Co., Inc. 358 F. 3d 916, 921 (Fed. Cir. 2004).  That is to say, you actually invented what you say you invented and you taught it to us.  But, everything came to a head with the Ariad case.

The questions presented in Ariad rehearing En Banc were as follows: 1) whether the first paragraph of 35 U.S.C. 122 contains a written description requirement separate from the enablement requirement; and 2) If a separate written description is set forth in the statute, what is the scope and purpose of the requirement.  Mr. Magen said that when he saw the first question he panicked because it had the potential of having major disruptive change to practice of patent prosecution.  Obviously, he was not alone as there were over twenty amicus briefs filed in the En Banc proceedings.

There were five different opinions written.  On March 22, 2010, the U.S. Court of Appeals for the Federal Circuit released its order in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.  In a 9–2 en banc decision (Judge Lourie wrote the majority opinion), the court reaffirmed that the U.S. Patent Laws (35 U.S.C. § 112, ¶1) impose a written description requirement separate and apart from the enablement requirement and that requirement applies to all claims.  The court explained that in terms of the written description requirement, whether a person of skill in the art is enabled to make the claimed invention is “besides the point”; the question is whether the specification discloses the claimed invention as “something [the inventors] actually invented.” The court also clarified the purpose and scope of the written description requirement as requiring the patentee to show meaningful disclosure of the invention, and not merely for policing priority.

After discussing the decision in detail, Magen and Elson spent some time discussing the implications of the Ariad decision. According to Elson, the Court made it clear that this opinion applies everywhere.  She said there is a sense that the outcome may have significant impact on chemical and biotechnology patents in ‘unpredictable’ arts.  Specifically, according to Elson, a “heightened” written description requirement for chemical and biotechnology patents may inhibit progress and research.  For example, extra time will likely be needed to provide descriptions of every possible species of a broad genus.  The patent drafter must ensure that the descriptions cover the full breadth of the claims.  Elson said that entities that file patent applications on research would need to show that they have figured out how to use the new technology.

Magen explained that the Court focused on the issued patent and whether the specification stands and falls on its own.  In his opinion, the patent office will use the Ariad decision to put a little more scrutiny to § 112, ¶1  and really require that patentees only claim what they taught in their specification.  Magen believes we’ll start to see in future litigations the Court using Ariad to focus what the claims really mean and only allow patentees to include what is written in the specification.  In other words, what does it sound like the inventor meant at the time of the invention?

Both Magen and Elson raised an interesting question: when should § 112, ¶1 issues be dealt with?  Magen suggests there is a lot of interplay between claim construction and written description and that perhaps it is more efficient to deal with § 112, ¶1 issues at Markman stage rather then spending money later during written description claims.  Elson points out that in the first dissent written by Judge Rader, he discusses the interplay between claim construction and invalidity claims and raises the question as to when to deal with invalidity claims.  According to Elson, commentators have suggested that perhaps we should deal with over breadth at claim construction. Elson agrees with Magen that it is difficult to draw the line between claim construction and written description and that it just may make more sense to deal with § 112, ¶1 issues in Markman hearing.

Does it make more sense to deal with § 112, ¶1 issues at Markman, what is your opinion?

This was a great program– I highly recommend checking out the full briefing on CLE Now.

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