By Debra Z. Anderson, Esq. of Meyer Unkovic & Scott LLPDebra Zuckerman Anderson is an intellectual property attorney at Meyer
Unkovic & Scott LLP, (412)456-2818, dza@muslaw.com.
A recent Federal Circuit decision, Aventis Pharma S.A. v. Amphastar
Pharmaceuticals, Inc. (decided May 14, 2008) emphasizes the need for heightened vigilance
required by attorneys and inventors in their efforts to be candid with the patent office.
In Aventis, the patent applicant submitted comparative data showing
that the claimed heparin compounds had an unexpectedly improved half-life in patients as compared to
prior art heparins, in order to overcome an obviousness rejection. The patent ultimately issued, but
during litigation it was revealed that the applicant failed to disclose that the comparative data was
obtained using different dosages, an omission that was found to be material to obtaining the patent. It
was Aventis’s position (and the dissent’s) that any such failure was inadvertent, and not
intentional. The Court of Appeals for the Federal Circuit disagreed and held the patent unenforceable.
An intent to deceive the patent office was inferred from the applicant’s behavior, because no
credible reason for comparing half-lives at different doses had been offered.
To hold a patent unenforceable for inequitable conduct, a court must find by clear
and convincing evidence that a patent applicant failed to disclose material information, or submitted
false information, with an intent to deceive the United States Patent and Trademark Office. In a
previous decision (M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co), the CAFC held
that lack of a good faith explanation for nondisclosure, standing alone, was insufficient evidence of
intent. Based on the Aventis case, intent can be inferred from inadvertent conduct, if no
credible reason for the conduct can be provided. How do we protect ourselves, and our clients, from
such inadvertent behavior?
Patent law is an extremely complex area of practice. Not only is the patent attorney
required to master complex technical or scientific information when writing a patent application, she
must also remember the numerous cases that affect not only how the language she uses will be
interpreted long after the document leaves her hands, but how her conduct will be perceived by the
client, the patent office and the jury.
I suggest that checklists can be used to help organize your patent practice.
This idea is not new, of course. Many attorneys use checklists to monitor the
contents of a file, for example. However, a finding of inequitable conduct can lead to unenforceability of
a patent, a dire consequence. Dire consequences can be prevented by the use of simple checklists, as
illustrated in a recent New Yorker magazine article.
As reported in The New Yorker, a doctor at Johns Hopkins Hospital
came up with a simple checklist of five steps to take to avoid intravenous line infection: doctors must 1)
wash their hands with soap, 2) clean the patient’s skin with antiseptic, 3) put sterile drapes over
the entire patient, 4) wear a sterile mask, hat and gown, and 5) put a sterile dressing over the site of
catheter.
The doctor, Peter Pronovost, asked the nurses in his ICU to observe the ICU doctors
for a month and record how often they completed each step. In more than a third of the patients who
had lines inserted, the doctors skipped at least one step.
Pronovost, with the support of his hospital administration, authorized the nurses to
stop doctors if they skipped a step on the checklist, and to remind them of the step. The performance
of the doctors, and the infection rate, was monitored for a period of one year. The results were
dramatic: the infection rate for IV-lines fell to zero.
There is an obvious lesson in this: checklists can raise the quality of our work, and
may be helpful (and necessary) even when the steps in the checklist seem so simple as to be stupid or
beneath us to write down. As the New Yorker article explains, when the level of
complexity of a task goes up, even a highly trained expert may be at risk for omitting a step that can
ultimately lead to failure.
Inequitable conduct cases usually arise out of a failure to notify the patent office of
relevant prior art or a prior public use, publication or sale of an invention. Other categories of
misconduct include submission of misleading comparative data during prosecution, or misleading the
patent office regarding the date of invention. A checklist addressing these areas would include the
following:
- Remind your client of the duty to disclose relevant prior art, including related copending
applications (and make sure to file this prior art with the United States Patent and Trademark Office).
Make sure that the examiner at the patent office is aware of activity in related cases, if handled by
other examiners.
- Ask about attendance at conferences, posters, and abstracts submitted to journals.
- Remember to file prior art uncovered in foreign searches.
- Ask about offers for sale or other public disclosures through use or publication.
- If you are filing a declaration, make certain that it is clear to the PTO where the
interests of the declarant lie. Do not conceal from the PTO facts known to you that are adverse to your
client’s position (such as negative data), in order to advance your client’s case.
- Discuss the date of invention and related evidence with your client.
Keeping a checklist permits one to easily keep track of new developments in the
law, by merely updating the checklist as new practice requirements (based on changes in the law)
develop. The above checklist is just a start.
I’m working on my next checklist, for drafting patent applications. The first
item on my checklist is 1) make sure the examples in the application fall within the ranges described in
the specification and in the claims.
