In a riveting tale of legislative sentence structure, history, and policy, the full Court of Appeals for the Federal Circuit held in Ariad v. Lilly, No. 2008-1248, that Ariad Pharmaceuticals’ patent claims were invalid because they did not contain a sufficiently detailed description of its claimed invention – a method for reducing activity of a gene transcription factor.
While the ruling didn’t come as much of a surprise to observers following the case, it will have an immediate impact on commercial and academic inventors, the attorneys who write their patent applications, and the litigators who make their case in court.
The story began when scientists from MIT, Harvard, and the Whitehead Institute for Biomedical Research, in partnership with Ariad, their licensee, discovered the NF-kB gene transcription factor, which has been called “an all-purpose cellular paramedic.” When bacteria or other foreign agents penetrate a cell, NF-kB becomes “activated” and spurs the cell nucleus to manufacture proteins that fight the bacteria. Yet these proteins can prove dangerous if over-produced, much like a fever combats infection but can be harmful if it persists too long. Thus, Ariad’s patent claimed a method of reducing NF-kB activity so as to mitigate the detrimental side-effects of protein over-stimulation.
On the day in 2002 that the Patent Office issued the patent, Ariad and its licensors sued for infringement by Eli Lilly & Co.’s Evista and Xigris drugs.
In response, Lilly contended that the patent never should have been granted because, among other reasons, the information Ariad supplied to describe the invention was inadequate by law. The law requires such disclosure to ensure that a patentee does not obtain coverage that is broader than what the patentee really invented.
Lilly argued that Ariad’s patent failed to describe in sufficient detail how NF-kB activity could be reduced. Initially, a three-judge panel of the Federal Circuit held that Ariad had not timely disclosed the DNA sequence of one of the three molecule types that inhibited NF-kB; that Ariad had failed to identify any examples of the second type of molecule; and that while Ariad did properly describe specific DNA sequences of the third molecule type, it failed to explain how that molecule actually reduced NF-kB activity.
Thus, as the panel found, because Ariad had claimed its invention so broadly – covering essentially all manner of curbing NF-kB activation – it needed to provide commensurately adequate support in the patent’s written description, but did not.
Ariad petitioned for an en banc rehearing to determine whether the written description requirement even exists independent of the statute’s requisite that a patent enable a skilled artisan to make the invention, which the court accepted.
Both requirements come from a common clause in Section 112 of Title 35, the section that defines the requirements for a patent document. The Federal Circuit itself has been of multiple minds regarding how to interpret this clause.
The central grammatical question is whether this statute contains a single requirement that the specification describe the invention in order to enable a skilled artisan to make and use the invention, or two separate requirements that the patent provide a written description of both: the invention; and the manner of making and using it in full and clear enough terms to enable a person of skill to make and use it. In many ways, the debate boils down to the placement of the word “of” and the comma following the word “it.”
The “unitary theory” of a single written description/enablement requirement was championed by Howard T. Markey, chief judge of the Federal Circuit’s predecessor court and first chief judge of the Federal Circuit, who wrote, in a 1977 opinion, In re Barker, 559 F.2d 588, 594 (CCPA 1977), that “Congress saved words by specifying, in a single prepositional phrase, that the description of the invention, and the description of the manner of making and using it, shall both be in ‘such full, clear, concise, and exact terms as to enable.'”
In contrast, and in ruling on the same case, Judge Giles Rich, a co-author of the present Patent Act, embraced the “dual approach,” contending that “[m]ere reading of the successive statutes quoted by the majority shows that the words of [the patent statute] derive from an era when it was the habit of the legal fraternity to indulge in redundancies.” In other words, our current understanding of comma usage and placement of prepositional phrases should not be conclusive in interpreting the meaning of the patent statute. Instead, Rich asserted, “the sufficiency of description and enablement…are distinct though commingled requirements” – related, but independent.
But the “comma war” also served as a proxy for a larger policy dispute. “Unitarists” focus on the need to simplify patent practice and empower institutions, such as universities, that discover and patent broad concepts they may not yet be able to fully describe in detail. Yet “dualists” contend that a separate written description requirement, by invalidating unduly broad patent claims, properly prevents a patentee from attempting to apply vague and inchoate patented concepts to future inventions developed by others; this stability function, they say, is crucial to our economy.
Squarely confronted with this rift, the full Federal Circuit landed firmly in the dualists’ camp.
Among other grammatical reasons, the Federal Circuit held that the parallelism between the “making and using” language in the second clause and the “make and use” verbiage in the enablement requirement reinforce the distinctness of the two standards. Conversely, the court reasoned, if Congress intended only a single requirement, it “could have written the statute to read, ‘The specification shall contain a written description of the invention, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.'”
The court then examined the policy reasons underlying the written description requirement and concluded that it’s important to explain to the public how to practice the invention, but it’s equally critical to put the public on notice of what exactly the invention is. Moreover, the court recognized the importance of stability, finding that “to change course now would disrupt the settled expectations of the inventing community, which has relied on it in drafting and prosecuting patents, concluding licensing agreements, and rendering validity and infringement opinions.”
As for research institutions’ broad discoveries, the court held that “[p]atents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.” While universities may now have slightly less incentive to innovate, the court observed that “claims to research plans also impose costs on downstream research, discouraging later invention.” Instead, patent laws seek a balance by “giving the incentive to actual invention and not attempt[ing] to preempt the future before it has arrived.” Because it reaffirmed this separate requirement, the court likewise affirmed the panel’s specific ruling that Ariad’s patent lacked an adequate written description.
Two dissenting judges took issue with the majority’s syntactical and policy conclusions and criticized what they saw as the court’s inability to articulate the contours of a separate written description requirement. Judges Randall R. Rader and Richard Linn argued that the claims themselves identify the scope of the invention and put the public on notice of what now belongs to the inventors. Judge Linn even pointed to an academic study indicating that “the impact of the separate written description requirement is negligible.”
So, what will the decision mean for inventors at universities and in industry alike?
First, the decision of the full court has better defined the scope of the written description requirement. It is now clear, once and for all – barring Supreme Court review, which remains a possibility – that the patent statute does entail this separate requirement, and inventors, attorneys, and others can now proceed accordingly.
Second, inventors should aim to draft as detailed a specification as is possible, especially when claiming a broad invention. It’s always a good idea for the inventor to include numerous “embodiments” or examples of the invention, laid out in detail, to ensure that the widest range of these embodiments will survive the Patent Office’s examination and future litigation.
Third, it’s generally wise to include in the patent application both broad and narrow claims, so that if a patent examiner or court finds that the broader claims lack an adequate written description to support them, the narrower claims may still withstand scrutiny.
In the end, even when it comes to patent law, be sure to describe your invention in words that convey your meaning.
Reprinted and/or posted with the permission of Daily Journal Corp. (2010).