![handle is hein.journals/bothnl28 and id is 1 raw text is: 28 Biotechnology Law Report 1
Number 1 (February 2009)
© Mary Ann Liebert, Inc.
DOI: 10.1089/bir.2009.9988
Paper
Getting Written Description Right in the Biotechnology Arts:
A Realist Approach to Patent Scope
KAREN G. POTTER, Ph.D.*
C OMPANY X, a small biotechnology start-up, filed
a patent application claiming their lead cancer
drug candidate CureCan, a uniquely modified protein
exhibiting astounding activity compared with current
therapeutics.1 Despite its potential as an innovative
and promising treatment for cancer, the United States
Patent and Trademark Office (PTO)2 issued a narrow
patent with claims directed only to the specific amino
acid sequence of CureCan.3 Competitor Company Y,
unsuccessful in its own research endeavors, decided
to use the disclosure of Company X's patent applica-
tion as a blueprint to develop a drug functionally
equivalent to CureCan, but with a slight difference in
its amino acid sequence resulting from several con-
servative mutations. With no dominating patent to
prevent Company Y from copying its protein to con-
tain functionally invariant mutations, and increasing
threats of additional similar knock-offs coming to
market, Company X had no chance of obtaining the
funding it needed for approval of CureCan.4 Company
X folded without ever seeing CureCan come to the
market.
Although the above hypothetical may be an exag-
geration of reality, it typifies the inherent unfairness
of the current written description requirement (WDR),
which has evolved to police patent scope.5 Although
the U.S. Court of Appeals for the Federal Circuit has
taken a fact-based approach when applying the WDR,
* Karen G. Potter, Ph.D., is a law student at California West-
ern School of Law and a registered Patent Agent.
1 In a patent application, the claims define the subject of the
technology and the scope of a patent owner's property rights.
Daniel A. Wilson, Narrow patent claims can have broad appeal,
Mass High Tech: J. New Eng. Tech. (July 25, 2005); available
at www.masshightech.com/stories/2005/07/25/daily27-Nar-
row-patent-claims-can-have-broad-appeal.html. For example, a
claim in CureCan's patent application could be: A polypeptide,
comprising a sequence of amino acids set forth in SEQ ID NO:1
[the sequence of amino acids of Company X's modified pro-
tein] or a sequence 95% identical to the sequence of amino acids
set forth in SEQ ID NO: 1, wherein the polypeptide binds to an
[exemplary receptor associated with cell proliferation in can-
cerous tumors] and inhibits proliferation of a tumor cell.
2 See Our Business: An Introduction to the USPTO; available at
www.uspto.gov/web/menu/intro.html (last visited Nov. 3, 2008).
3 The amino acid sequence of a protein is represented by ab-
breviations as set forth in IUPAC-IUB Commission on Bio-
chemical Nomenclature. A one-letter notation for amino acid
sequences (definitive rules) (1971). In a patent application, each
sequence is assigned a separate identifier (SEQ ID NO). Intel-
lectual Property Regulations, 37 CFR §1.821(c) (2005). A
patent or patent application that claims an amino acid sequence
must reference the sequence by the use of the identifier. Intel-
lectual Property Regulations, 37 CFR §1.821(d) (2005).
' Claude Barfield and John E. Calfee. Biotechnology and The
Patent System: Balancing Innovation and Property Rights
26-29 (2007). Patents are especially crucial to the innovative
R&D mounted by small startup biotechnology firms. Indeed,
they are typically the only assets those firms possess that are
sufficiently stable and valuable to attract the large amounts of
capital they need to exploit promising research toward new
drugs and diagnostics. Id. at 27.
5 Chris Holman, Federal Circuit decides important biotechnol-
ogy written description case, Holman's Biotech IP Blog, Sept.
10, 2008; available at http://holmansbiotechipblog.blogspot.
com/2008/09/federal-circuit-decides-important.html. The WDR
is reviewed by Robert L. Harmon, Specification and claim,
in Patents and the Federal Circuit 235, 267 (BNA Books
2007); available at http://books.google.com/booksid=
qbsQCpo8H74C&pg=PA267&lpg=PA267&dq=written+
description +purpose+ scope&source=web&ots =rUI94y
YVnW&sig = TNsperZoq110gowwZtrRyPXpQ8&hl=en&sa=
X&oi=bookresult&resnum=9&ct=result#PPA267,M1.
1](ViewImageLocal?handle=hein.journals/bothnl28&div=1&collection=&method=preview&ext=.png&size=3)
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