Is Ariad v Eli Lilly Good or Bad?

Choate Alert

 | March 30, 2010

 | Intellectual Property and Life Sciences Groups

What you need to know:

The Court of Appeals for the Federal Circuit has raised the bar for biotech patents, and its decision has implications across industries.  Without officially changing the legal standard for patenting, the Court has added teeth to the so-called “written description” requirement and has stated that what might be good enough in a prior art reference to invalidate a patent is not good enough in a patent application to support claims.

What you need to do:

Every company and research institution should review its portfolio to assess which filings might be strengthened and which are called into question in light of this decision.  The heightened disclosure requirements warrant a reevaluation of internal strategies for deciding when and what to file.  Importantly, every company and research institution may also want to review  its competitors’ portfolios, as the relative strength of their pending and issued claims will also be affected.  Whatever disappointments the decision may generate respecting your own patent portfolio, it may also create opportunities with respect to others’.

 

The dispute in Ariad v Eli Lilly centered around Ariad’s assertion that the marketing of Eli Lilly’s Evista® and Xigris® products infringed patents that Ariad had licensed from the Massachusetts Institute of Technology, the Whitehead Institute and Harvard University.  The licensed patent claims were very broad, and covered any method for modifying a particular biological pathway in cells.  Eli Lilly argued that the claims were invalid for failing to satisfy the written description requirement imposed on all patents.  Ariad argued that there is no written description requirement separate from the so-called enablement requirement.  Since there was no dispute with regard to enablement, if Ariad were correct that written description was simply part of enablement, then the claims would necessarily be considered valid.

The Court agreed with Eli Lilly that there is a separate written description requirement.  Moreover, the court explicitly addressed what that requirement means.  It had long been understood that a patent applicant wishing to protect a large genus needed to include in the patent application a description of a “representative number of species” within the genus.  However, what constitutes a “representative number of species” has never been clear.  Without precisely answering that question, the Court in Eli Lilly did articulate some guidelines.

Perhaps most controversial is the Court’s holding that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.”  This statement alone makes it easier to invalidate a patent than it is to obtain one, and triggers the good news/bad news dichotomy embodied in the decision.

The Court also holds, contrary to some earlier decisions, that originally filed claims do not necessarily satisfy the written description requirement, even if they do put the world on notice of the boundaries within which the patent applicant intends to exclude others.  According to the Court,  “although many original claims will satisfy the written description requirement, certain claims may not.  . . . The question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.”  The Court then goes on to say that “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” 

This holding has generated particular concern among academic institutions and small companies, who fear that pressure to publish and/or limitations on financial resources will constrain their ability to meet this new articulation of the written description standard if it requires them (as it seems to) to include data in their specification for large numbers of species within a genus even if this is a matter of routine experimentation.

Ariad forcefully made the argument that the standard adopted by the Court disadvantaged universities, who would face new challenges in trying to protect their pioneering discoveries.  The Court had little sympathy for this position, pointing out that the patent system is designed to reward “those who actually perform the difficult work of ‘invention’ – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public.”  While there will certainly be ongoing disagreement over which sectors of the industry do more of the “difficult work of invention,” it is now clear that whoever wants to protect an invention needs to put a lot more evidence of that work into their application than perhaps they used to. 

Now would be a good time for patent applicants to review their portfolios, as well as those of their competitors, to assess which filings might be strengthened, and which perhaps called into question, by the ruling in Ariad v Eli Lilly.  Either way, the decision creates opportunities to reassess internal policies and to consider options for external interaction and collaboration.

 

 

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