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Scope of this treatise

The purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas. While the vast majority of cases that this treatise discusses are in the chemical, pharmaceutical and biotech areas, it is fitting that this treatise also include a discussion of some cases in the mechanical and electrical arts, especially in the area of patent infringement, that also have ramifications which those in the chemical/pharmaceutical and biotech area ought not ignore.

Table of Contents

We have divided this treatise into three separate sections: the first focusing on patentability,
the second on infringement and the third on enforceability. In all three sections,
we endeavor to identify trends where we perceive them and to extrapolate some of
those trends in order to predict the direction in which the courts are heading.

I. Cases Relating to Patentability 2

A. The utility requirement of Section 101.......................................................................... 2
B. The novelty requirement of 35 U.S.C. §102.................................................................. 3
C. Obviousness under 35 U.S.C. §103............................................................................... 8
D. Written description under 35 U.S.C. §112, ¶1............................................................. 12
E. Enablement under 35 U.S.C. §112, ¶1......................................................................... 14
F. Indefiniteness under 35 U.S.C. §112, ¶2..................................................................... 15

II. Cases Relating to Infringement 16
A. Claim construction........................................................................................................ 16
Pre-Phillips claim construction cases...............................................................................17
Post-Phillips claim construction cases..............................................................................19
C. Declaratory Judgment jurisdiction.............................................................................. 27
D. The FDA exemption to infringement under 35 U.S.C. §271(e).................................. 29
E. Infringement under 35 U.S.C. §271(f).......................................................................... 30
F. Willfulness.................................................................................................................... 31

III. Cases Relating to Enforceability 32
IV. Conclusions 36
About the Author 38

I. Cases Relating to Patentability

A. The utility requirement of Section 101

The court had occasion to consider the question of whether Expressed Sequence Tags (“ESTs”) met the utility requirement of 35 U.S.C. §101 in In re Fisher, 421 F.3d 1365, 76 USPQ2d 122 5 (Fed. Cir. 2005). The Federal Circuit defined ESTs as “a short nucleotide sequence that represents a fragment of a cDNA clone,” which “is typically generated by isolating a cDNA clone and sequencing a small
number of nucleotides located at the end of one of the two cDNA strands.” The court further noted that “[w]hen an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction.” In re Fisher, 421 F.3d at 1367, 76 USPQ2d at 122 7.
The particular claim at issue in Fisher was: A substantially purified nucleic acid molecule that encodes
a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5 In re Fisher, 421 F.3d at 1367, 76 USPQ2d at 122 7. The sequences identified in the claims were ESTs. The court cited Brenner v. Manson, stating that the basic quid pro quo contemplated by the Constitution and by Congress for granting a patent
monopoly is the benefit derived by the public from an invention with substantial utility. Accordingly, unless and until a process is refined and developed to this point—where specific benefit exists in currently available form—there is insufficient justification for permitting an applicant to engross what may prove to be a broad field. The court held that the claimed ESTs did not provide specific benefit in currently available form. In so holding, the court endorsed the PTO’s 2001 Utility Guidelines (“the Guidelines”), which stated that utilities that require 383 U.S. 519, 148 USPQ 689 (1966) or constitute carrying out further research to identify or reasonably confirm a “real-world” context of use are not substantial utilities. The court pointed specifically to Example 9 of
the Guidelines where a cDNA fragment disclosed as being useful as a probe to obtain the full length gene corresponding to a cDNA was deemed to lack a specific and substantial utility. The court concluded that the claimed ESTs were no more than research intermediates that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation
on those genes. Accordingly, because the claimed ESTs “do not correlate to an underlying gene of
known function,” the Federal Circuit concluded that the claims lacked patentable utility. In re Fisher, 421F.3d at 1374, 76 USPQ2d at 1232.

The language of the case suggests that ESTs are not per se unpatentable. One open question is how well characterized the “underlying gene of known function” must be. It would appear that one must have a known gene of known function to patent an EST hybridizable to it. Otherwise, it is difficult to comprehend when an EST would not be patentable, as they are always associated with a cDNA, which itself is always associated with a particular function sought.

For more information, please visit the following link: http://www.hunton.com/files/tbl_s47Details/FileUpload265/1475/Biotech2005.pdf.

 

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