Monday, April 06, 2009

Ariad/MIT/Harvard smoked by CAFC in Lilly case

Ariad/MIT/Harvard lost: Ariad sought and obtained the broad claims we now hold to be invalid. For its
own reasons, Ariad maintained the breadth of these claims through claim construction
and into trial.
Although surviving an inequitable conduct charge, the
academics had patent claims which did not survive a written description challenge.

The "background" section began:

The technology in this case involves gene regulation. Transcription factors are
molecules found in cells that regulate the extent to which genes are expressed. There
are hundreds of different transcription factors that perform in concert with other
molecules in the cell to control cellular behavior. Unsurprisingly, this network of cellular
signals is fertile ground for the development of therapeutic compounds. In the mid-
1980s, the inventors of the ’516 patent discovered an important transcription factor that
they named NF-κB. NF-κB is akin to an all-purpose cellular paramedic.

As in the URochester / Searle matter, the academics were quick to sue:

Ariad filed its complaint on the day the ’516 patent issued, June 25, 2002.

Lilly did not get much traction at district court:

On April 28, 2006, the jury rendered a special verdict finding infringement of
claims 80 and 95 with respect to Evista and claims 144 and 145 with respect to Xigris.
The jury also found that the asserted claims were not invalid for anticipation, lack of
enablement, or lack of written description. The court denied Lilly’s renewed motion for
JMOL or, in the alternative, a new trial, again without opinion.

The CAFC homed in on written description:

The emphasized portion of § 112, the written
description requirement, “serves both to satisfy the inventor’s obligation to disclose the
technologic knowledge upon which the patent is based, and to demonstrate that the
patentee was in possession of the invention that is claimed.” Capon v. Eshhar, 418
F.3d 1349, 1357 (Fed. Cir. 2005). The requirement “serves 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., 358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v.
Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002))

Ariad claims methods comprising the single step of reducing NF-κB activity. Lilly
argues that the asserted claims are not supported by written description because the
specification of the ’516 patent fails to adequately disclose how the claimed reduction of
NF-κB activity is achieved.
Thus, to satisfy the written description requirement for the asserted claims, the
specification must demonstrate that Ariad possessed the claimed methods by
sufficiently disclosing molecules capable of reducing NF-κB activity so as to “satisfy the
inventor’s obligation to disclose the technologic knowledge upon which the patent is
based, and to demonstrate that the patentee was in possession of the invention that is
claimed.” Capon, 418 F.3d at 1357.

The specification of the ’516 patent hypothesizes three classes of molecules potentially capable of reducing
NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy
molecules. We review the specification’s disclosure of each in turn to determine
whether there is substantial evidence to support the jury’s verdict that the written
description evidenced that the inventor possessed the claimed invention.

The only example of a specific inhibitor given in the specification is I-κB, a naturally occurring molecule whose
function is to hold NF-κB in an inactive state until the cell receives certain external
influences. Id. at col.37 ll.48–49. Nearly all of Ariad’s evidence regarding the disclosure
of I-κB relies upon figure 43.

In the context of this invention, a vague functional description and an
invitation for further research does not constitute written disclosure of a specific
inhibitor.1 See Eli Lilly, 119 F.3d at 1566 (holding that written description requires more
than a “mere wish or plan for obtaining the claimed chemical invention”); see also id. at
1567 (“[A] description which renders obvious a claimed invention is not sufficient to
satisfy the written description requirement of that invention.”). And it certainly does not
constitute written disclosure of a method for reducing NF-κB activity using I-κB.

Footnote 1:

Moreover, the district court found, in the context of its inequitable conduct
ruling, that figure 43 is both incorrect and incomplete. Ariad Pharms., 529 F. Supp. 2d
at 123–25 (finding those errors material). That the inventors of the ’516 patent, among
the most skilled artisans in their field in the world at this time, failed to correctly disclose
the structure of I-κB even two years after the application was filed is a strong sign that
one of skill in the art could not be expected to provide this knowledge in 1989.

The ’516 patent
discloses no working or even prophetic examples of methods that reduce NF-κB
activity, and no completed syntheses of any of the molecules prophesized to be capable
of reducing NF-κB activity. The state of the art at the time of filing was primitive and
uncertain, leaving Ariad with an insufficient supply of prior art knowledge with which to
fill the gaping holes in its disclosure. See Capon, 418 F.3d at 1358 (“It is well-
recognized that in the unpredictable fields of science, it is appropriate to recognize the
variability in the science in determining the scope of the coverage to which the inventor
is entitled.”).

The generic claims did not hold up:

Whatever thin thread of support a jury might find in the decoy-molecule
hypothetical simply cannot bear the weight of the vast scope of these generic claims.
See LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005)
(holding that “[a]fter reading the patent, a person of skill in the art would not understand”
the patentee to have invented a generic method where the patent only disclosed one
embodiment of it);

Of the inequitable conduct:

In 1997, an employee of Ariad,
Sharon Hausdorff, informed Lisa Warren, an attorney with Hamilton, Brooks, Smith &
Reynolds, P.C., that figure 43 contained errors. Ms. Warren succeeded in deleting
figure 43 from at least one application on file with the USPTO.

Ms. Hausdorff knew, but there is no other evidence that Ms.
Hausdorff had any intent to conceal the errors from the USPTO. To the contrary, she
disclosed the errors to her attorneys. She was justified in her expectation that her
attorneys would determine the legal significance of the errors and take appropriate
actions. Dr. Clauss also knew of the errors, but the district court credited Dr. Clauss’s
testimony that she was following Foley, Hoag & Elliot LLP’s standard practice to make
the correction only after the PTO indicated the claims were allowable in any particular
related application. That knowledge of the errors was lost when Dr. Vincent moved to
Ropes & Gray LLP does not rise to the level of intent to deceive. See Kingsdown Med.
Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (holding
even gross negligence insufficient to prove intent to deceive).

Of concealed references, the CAFC opinion has a memorable line: There is no doubt that
Dr. Baldwin was aware of the references, because he authored them.

This is followed by another memorable line: Dr. Baldwin—who is a scientist and not a patent lawyer—was apparently aware of his duty to disclose, and also aware that it could be inappropriate to submit material that
might “inundate” the USPTO. His reasons for not submitting the references are
plausible, even if ultimately legally incorrect, and Lilly failed to show that deceptive
intent was the better explanation for Dr. Baldwin’s behavior.

And then: Lilly did not show that Dr. Baldwin appreciated the inherent anticipation
theory to which the references allegedly pertained. And even if Lilly had shown this
knowledge, it did not show that Dr. Baldwin had any knowledge of the historical uses of
the prior art compounds. Accordingly, we conclude that the district court did not clearly
err by finding no intent to deceive the USPTO on the part of Dr. Baldwin.

In reviewing the decision, one should keep in mind that other issues, such as inherent
anticipation, were NOT addressed: Because we hold that claims 80, 95, 144, and 145
of the ’516 patent are invalid for lack of written description, we need not address infringement
or the other validity issues on appeal.
This case was different from URochester.

See also:

The unsuccessful academics were represented by Fried Frank: Stephen S. Rabinowitz, Fried Frank Harris Shriver & Jacobson LLP, of New York, New York, argued for plaintiffs-appellees. With him on the brief were James W.
Dabney, John F. Duffy, Mitchell Epner, and Randy C. Eisensmith.

***Separately, on unsuccessful academic plaintiffs, see the post

Patent Reform In Action: Judge Rader Provides Damage Apportionment Clinic In District Court Case concerning

Cornell University v. Hewlett-Packard, 01-CV-1974 (N.D.N.Y., March 30, 2009)
at the 271 Patent Blog


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