By Donald Zuhn --
As we reported
on May 9, 2007, the United States Patent and Trademark Office (USPTO)
asked for comments on ten topics related to international patent law
harmonization. On Wednesday, the USPTO posted the 48 submissions it received, including comments from the Biotechnology Industry Association (BIO) (here), Intellectual Property Owners Association (IPO) (here and here), Generic Pharmaceutical Association (GPhA) (here), and American Intellectual Property Law Association (AIPLA) (here).
In BIO's 24-page submission, the biotechnology trade association argues
that "total and complete harmonization is an unrealistic goal," and
believes that "[a] more realistic short-term target is a treaty that
achieves 'true harmonization' of those elements of patent systems that
are necessary to create a streamlined global patent granting system."
According to BIO, such a treaty would "capture the best elements of the
U.S., European and Japanese patent systems," and allow "an applicant .
. . to obtain a patent after a first substantive examination in a major
examining office (i.e., the USPTO, the EPO or the JPO)."
With regard to the questions specifically posed in the USPTO's notice, BIO provided the following comments:
A. BIO supports the adoption of a first-to-file system provided that such a system incorporates sufficient protections against derivation of inventions.
B. BIO opposes a treaty requiring the U.S. to exclude subject matter presently eligible to be patented under U.S. law (i.e., plant or animal inventions, human or animal cell lines, process inventions related to diagnosis or treatment of humans or animals, or any form of chemical compound, e.g., nucleic acids and proteins), and opposes an interpretation of the "industrial applicability" standard that would require utility in an identified "industrial" application or field.
C. BIO supports a disclosure requirement consistent with the U.S. written description and enablement requirements and opposes the inclusion of a best mode requirement.
D. BIO supports the minimal U.S. requirements applicable to claiming.
E. BIO supports reforming U.S. patent law to recognize a foreign priority date for both priority and prior art purposes (i.e., eliminate the rule established in In re Hilmer).
F. BIO supports a treaty provision that confers a prior art effect for patents and published patent applications as from the effective filing date for both novelty and nonobviousness determinations.
G. BIO strongly supports the inclusion of a grace period for prior art determinations that is personal to the applicant (i.e., linked to information emanating from the inventor or applicant).
H. BIO supports a definition of prior art as being publicly available in the sense of being reasonably and effectively accessible to persons of ordinary skill in the art.
I. BIO supports a reduction in the number of "loss of right" conditions as compared to U.S. law and practice (e.g., abandonment of the invention or public use or sale of the invention).
J. BIO supports a definition of novelty that provides that an invention lacks novelty if each element of the invention is disclosed in a single item of prior art, and which allows the use of other references to interpret the meaning of the prior art reference being asserted against an application (e.g., to demonstrate inherent characteristics of subject matter disclosed in the reference).
K. BIO supports the use of U.S.-style nonobviousness determinations (i.e., Graham factors) as opposed to the "problem-solution" approach employed in the EPO and JPO.
L. BIO supports the more liberal multiple dependent claiming practice followed in the EPO and JPO.
M. BIO reserves comment on the issue of claim construction, which BIO believes is not ripe for discussion.
N. BIO reserves comment on the issue of the doctrine of equivalents.
O. BIO supports conferring on assignees the right to file patent applications owned by those entities.
Comments