The U.S. Court of Appeals for the Federal Circuit issued an en banc decision in Ariad's patent dispute with Lilly that limits how broadly patent claims can be written.

In a March 22 opinion, the full court reaffirmed a ruling by a three-judge panel that Ariad's patent claims relating to a transcription factor that regulates gene expression were invalid because they did not provide an adequate written description of what the patent covers ('The Pink Sheet,' Aug. 31, 2009).

At issue in the case was whether the requirement that a patent include a written description of the invention is separate from the requirement that the patent specification describe the invention so as to enable any person skilled in the art to which it pertains to make and use the invention. The en banc panel found that written description is separate from enablement.

Ariad claimed that Lilly's osteoporosis drug Evista (raloxifene) and its sepsis treatment Xigris (drotrecogin alfa) infringed its patent, which it contended covers all means of modulating the NF-kappa B pathway. Ariad acquired the patent from the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research and Harvard College, which joined Ariad in its suit.

In 2006, a jury found that the patent was valid and that Lilly was infringing it. The Federal Circuit reversed the verdict in April 2009 finding that the patent claims were too broad and that they should have adequately described the claimed methods for reducing NF-kB activity and the molecules necessary to do so.

Government, Tech Industry Support Lilly

The Federal Circuit granted Ariad's request for a rehearing to determine if a written description requirement is separate from an enablement requirement and if it is separate, what its scope and purpose is.

The Federal Circuit received 25 amicus briefs in the case, 17 of which were filed in support of Lilly, one in support of Ariad and seven in support of neither party. The United States, Abbott and GlaxoSmithKline were among those who filed briefs in support of Lilly. Google, Verizon and Cisco Systems also filed a joint brief in support of Lilly, stating that there is a separate written description requirement "to prevent patentees from claiming what they did not invent."

The en banc court made a distinction between the written description and enablement requirements. "Unlike Ariad, we see nothing in the statute's language or grammar that unambiguously dictates that the adequacy of the 'written description of the invention' must be determined solely by whether that description identifies the invention so as to enable one of skill in the art to make and use it," the Federal Circuit stated.

"Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions," the court said.

"Thus, although written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described," the Federal Circuit continued. "For example, a propyl or butyl compound may be made by a process analogous to a disclosed methyl compound, but, in the absence of a statement that the inventor invented propyl and butyl compounds, such compounds have not been described and are not entitled to a patent."

Circuit Judges Randall Rader and Richard Linn dissented in part from the ruling. They contended that "the separate written description requirement that the court petrifies today has no statutory support."

A proper reading of the statutory description requirement "recognizes that the enablement requirement identifies the invention and tells a person of ordinary skill what to make and use," they stated.

In a separate concurring opinion, Circuit Judge Pauline Newman addressed Ariad's argument that the written description requirement has adverse consequences for research universities because it prevents the patenting of basic scientific research. She noted that several amici pointed out that in no case has an invention of basic science been patented with not even one embodiment demonstrating its application and illustrating its breadth.

"The practical utility on which commercial value is based is the realm of the patent grant; and in securing this exclusionary right, the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right," Newman stated.

Circuit Judge Arthur Gajarsa also issued a concurring opinion, stating that while the majority's interpretation is reasonable, he disagrees that an independent written description requirement is a necessity of patent law.

-Brenda Sandburg (b.sandburg@elsevier.com)

Patent Claims Must Be Written Narrowly, Federal Circuit Reaffirms In Ariad v. Lilly

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