Thursday, August 26, 2010

Written description and the doctrine of equivalents?


Merely for contemplation:

Determining whether a patent application's written description is sufficient
to support its scope can be quite difficult. Some protection beyond the text of
its claims almost always must be given to the inventor in order for patents to
have value. Leeway is necessary to prevent copycats from avoiding
infringement liability by making only a slight, inconsequential change to the
invention specified in the application. A patent on a washing machine, for
example, would be of little value if an imitator could legally copy the patent
holder's design merely by adding a single bolt. This example illustrates the
doctrine of equivalents, which the courts evolved to make sure that
insubstantial differences would not allow copycats to escape an action for


The fact that no ESC patents have been issued since the ‘780 and
‘806 patents hints that their composition of matter claims are broad and that it
is hard to invent around them.303 If so, this situation would be undesirable on
policy grounds, for it could hinder downstream innovations. Yet law and
public policy are not the same. The ‘780 and ‘806 patents could have wide
scope as a matter of law, even if their scope were regrettable as a matter of


An important recent decision by the U.S. Supreme Court, however, creates
a research exception to patent infringement that could prove quite important
for stem cell research. Integra Lifesciences I, Ltd. (“Integra”) and the
Burnham Institute (“Burnham”) owned five patents relating to the tripeptide
sequence Arg-Gly-Asp, known in single-letter notation as the RGD peptide.
This peptide promotes cell adhesion. Meanwhile, Merck KGaA (“Merck”)
funded research on angiogenesis by Dr. David Cheresh at the Scripps
Research Institute (“Scripps”). Dr. Cheresh discovered that the RGD peptide
could inhibit angiogenesis and thereby shrink tumors. Eventually, Merck
shared the research with the National Cancer Institute (NCI). The NCI
sponsored clinical trials and filed an investigational new drug (IND)
application. Integra and Burnham sued Merck, Cheresh, and Scripps for patent

Writing for a unanimous Court in Merck KGaA v. Integra Lifesciences I,
Ltd., Justice Scalia held that the defendants’ use of the RGD peptide was
permissible under the Patent Act’s provision that it is not “an act of [patent]
infringement to . . . use . . . or import into the United States a potential
invention . . . solely for uses reasonably related to the development and
submission of information under a Federal law which regulates the . . . use . . .
of drugs.”308


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