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American Intellectual Property Law Association
Biotechnology Committee
Biotechnology in the Courts Subcommittee
Report
Summaries of Recent Decisions of Interest to the Biotechnology Community
Prepared for the AIPLA Biotechnology Committee
May 15, 2011
Edited By:
Melanie Szweras
Subcommittee Chair
Bereskin & Parr LLP
E-mail: [email protected]
CONTRIBUTORS
Lynn C. Tyler
Jennifer L. Schuster
The AIPLA Biotechnology in the Courts Subcommittee Report is a forum for members of the
subcommittee to present summaries and commentary on recent judicial decisions of interest to
the biotechnology community. Any view of a contributor expressed in a summary should be
understood to reflect only the present consideration and views of the contributor, and should not
be attributed to the AIPLA or any of its committees, the contributor’s firm, employer, or past or
present clients, to other contributors, or to the editor. To request an electronic copy of the
Report, or if you are interested in summarizing a case for a future edition, please contact Melanie
Szweras at [email protected].
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CONTRIBUTORS:
Lynn C. Tyler is a partner and registered patent lawyer in the Intellectual Property
Department of Barnes & Thornburg LLP in Indianapolis. He concentrates his practice in
litigation of intellectual property matters, representing clients at all stages of the process.
Mr. Tyler is listed in Best Lawyers in America® and Indiana Super Lawyers®. He is the
author of several published articles on issues of intellectual property or federal procedure
in a variety of peer-reviewed publications. In 2010, one of his articles won the prestigious
Burton Award for Legal Achievement. The first of his two articles on inequitable conduct
has been cited by two Federal Circuit Judges in published opinions.
Mr. Tyler graduated summa cum laude in 1981 from the University of Notre Dame and in
1984 received his J.D. magna cum laude from the University of Michigan Law School. In
2007, he received a M.S. in Biology from Purdue University (Indianapolis campus).
Mr. Tyler’s civic activities include being a co-founder, past president, and volunteer for
the Neighborhood Christian Legal Clinic. For his work on behalf of the Clinic, he
received the Indianapolis Bar Association's Pro Bono Award in 2002 and was a corecipient of the firm's inaugural Joseph A. Maley Pro Bono Award in 2009.
Jennifer L. Schuster is an associate in Barnes & Thornburg LLP’s Indianapolis, Indiana
office, where she is a member of the firm’s Intellectual Property and Litigation
Departments.
Ms. Schuster completed her undergraduate and graduate work at Purdue University,
where she was a recipient of the Steven C. Beering Scholarship and Fellowship. She
received her B.S. in molecular biology with honors in research and B.A. in creative
writing in 2004, both with highest distinction, and her M.S. in genetics in 2005. While at
Purdue, she was selected as an outstanding senior in the School of Science and was a
member of Phi Beta Kappa.
Ms. Schuster received her J.D. magna cum laude from Indiana University School of Law
– Bloomington in 2008, where she was awarded the Chancellor’s Fellowship. She was an
Executive Competition Coordinator for the Sherman Minton Moot Court Board and a
Notes and Comments Editor for the Indiana Law Journal. Upon graduation, she was
elected to the Order of the Barristers and Order of the Coif.
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TABLE OF CONTENTS
I.
Billups-Rothenberg, Inc. v. Assoc. Regional and Univ. Pathologists, Inc., Appeal No.
2010-1401, slip op. (Fed. Cir. Apr. 29, 2011)………4
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Case Summaries
I.
Billups-Rothenberg, Inc. v. Assoc. Regional and Univ. Pathologists, Inc.,
Appeal No. 2010-1401, slip op. (Fed. Cir. Apr. 29, 2011).
Reported by: Lynn C. Tyler and Jennifer L. Schuster
Summary
“Another [two] bite the dust.” A panel of the Federal Circuit affirmed summary
judgment that two patents directed to genetic tests for detecting Type I hereditary
hemochromatosis were invalid. The asserted claims of U.S. Patent No. 5,674,681 (the
‘681 patent) were invalid for lack of written description. Id. at 2. At best, the ‘681 patent
narrowed the location of the relevant mutations to a 300 bp region on a particular
chromosome, but did not provide the sequences of any relevant mutations. Id. at 10-11
and 12. The asserted claims of U.S. Patent No. 6,355,425 (the ‘425 patent) were invalid
as anticipated under 35 U.S.C. § 102(b) by U.S. Patent No. 6,025,130 (the ‘130 patent).
Id. at 2. The ‘130 patent disclosed the relevant mutation and thus anticipated the ‘425
patent, even though the ‘130 patent suggested the mutation may just have been a
polymorphic variant. Id. at 14-15.
Procedure
Billups-Rothenberg (“Billups”) sued Associated Regional and University
Pathologists (ARUP) and Bio-Rad Laboratories (“Bio-Rad”) for infringement of the ‘681
and ‘425 patents. Id. at 2. The parties filed cross-motions for summary judgment. The
district court denied Billups’s motion for summary judgment of infringement, and
granted ARUP’s motion for summary judgment of invalidity. Id. at 2. The Federal Circuit
affirmed the district court’s judgment. Id.
Decision
Factual summary
Hereditary hemochromatosis (HH) is a disorder associated with excessive iron
absorption by the body. Id. at 3. HH is caused by specific mutations in genes that regulate
iron absorption. Id. The gene in question, High Fe (“HFE”) is located on the short arm of
chromosome six in humans. Id. HH is an autosomal recessive condition. Id. The claims of
the patents-in-suit are directed to the detection of one or both of two distinct mutations in
the HFE gene, known as C282Y and S65C. The prior art ’130 patent described three
mutations in the HFE gene: C282Y, S65C, and H63D. Id. at 4. The asserted claims of the
‘681 patent covered only the C282Y mutation (without mentioning it). Id. at 4-5.
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Billups filed the application that led to the ‘681 patent in 1994. The ‘681 patent
describes that HH is a disease caused by a gene linked to the major histocompatibility
complex (“MHC”), and identified chromosome six as the location of the gene responsible
for HH. The ‘681 patent identified known techniques for detecting mutations. The ‘681
patent did not disclose any HH-causing mutations, as the inventors had yet to identify
any. Id. at 5.
In 1996, Dr. John N. Feder and colleagues, none of whom were associated with
Billups, sequenced the hemochromatosis gene and published their results. Id. The
research led to numerous U.S. and foreign patents, including the ‘130 patent, that
disclosed the exact sequences of the three mutations at issue in the case. Id. at 6. The ‘130
patent also described genetic tests for diagnosing HH based on the disclosed mutations.
In March, 1999, nearly three years after Dr. Feder’s team published their work,
Billups researchers filed the application for the ‘425 patent. Id. The Billups team had
used the genetic sequences identified by Dr. Feder to develop its tests. Id.
Court’s analysis
With respect to the ‘681 patent, the Court began its analysis by reviewing some of
the standards for the written description requirement from the recent en banc decision in
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) and other leading
cases. The Court noted that the inventor must disclose the claimed invention to “allow
persons of ordinary skill in the art to recognize that the inventor invented what is
claimed.” Id. at 1351. The written description requirement “limits patent protection to
those who actually perform the difficult work of ‘invention’ – that is, conceive of and
complete the final invention.” Id. The “level of detail required to satisfy the written
description requirement varies depending on the nature and scope of the claims and on
the complexity and predictability of the relevant technology.” Ariad, 598 F.3d at 1351
(citing Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005)). “[A]n adequate
description of a DNA requires more than a mere statement that it is part of the invention
and reference to a potential method for isolating it; what is required is a description of the
DNA itself.” Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-67
(Fed. Cir. 1997) (internal quotations omitted).
Applying these standards to the case before it, as already noted the Court found
that the written description in the ‘681 patent was insufficient to sustain the asserted
claims. Billups argued that the patent’s disclosure of the location of the mutation to
within a 300 bp region, combined with the knowledge in the art at the time, was sufficient
to show possession of the invention, but the Court disagreed. The Court wrote:
The ’681 patent claims a test for mutations, yet it is
undisputed that the specification and originally filed claims
of the ’681 patent disclose neither the hemochromatosis
gene sequence nor any specific mutations within that gene.
Although the ’681 patent states that the hemochromatosis
mutations are in a gene encoding the α3 domain of a
nonclassical MHC class I heavy chain located on the short
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arm of chromosome six, that does not disclose the exact
location or sequence of the mutation.
Billups, slip op. at 11. Using language that is always fatal, the Court concluded that the
‘681 patent discloses no more than Billups’s “research plan.” Id.
The Court continued its analysis by noting that the ‘681 patent included genus
claims to methods for identifying unknown genetic mutations. Id. The asserted claim
covered a genus because it covered two or more disclosed embodiments. Id. The Court
then wrote:
For genus claims, “an adequate written description of a
claimed genus requires more than a generic statement of an
invention’s boundaries.” Ariad, 598 F.3d at 1349 (citing
Regents, 119 F.3d at 1568). Under Ariad, a patent must set
forth “either a representative number of species falling
within the scope of the genus or structural features common
to the members of the genus.” Id. at 1350. The ’681 patent
does not identify even a single species that satisfies the
claims.
Slip op. at 12.
Finally as to the ‘681 patent, Billups tried to salvage the adequacy of the written
description requirement by arguing that the claim included functional language which can
be sufficient when the art has shown a correlation between function and structure. Id. The
Court rejected this argument as well, however, citing the district court’s finding that the
art had not established such a correlation. Id. Thus, the court concluded that the asserted
claim of the ‘681 patent was invalid for lack of written description.
Billups’s ‘425 patent fared no better. The prior art ‘130 patent disclosed the exact
sequence of one of the mutations (S65C) on which the ‘425 patent was based, as well as
using the S65C mutation as a diagnostic and a genetic assay for detecting that mutation
along with two others. Id. at 13. Billups’s primary argument on appeal rested on its
interpretation of “the ’130 patent as concluding that the S65C mutation was only a
clinically insignificant polymorphism unrelated to disease state.” Id. at 14. Although this
interpretation had some support in the specification of the ‘130 patent, the Court rejected
it, noting:
[W]e have held that a “reference is no less anticipatory if,
after disclosing the invention, the reference then disparages
it.” Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d
1354, 1361 (Fed. Cir. 1998). Indeed, in Celeritas, this court
explained that “whether a reference ‘teaches away’ from
the invention is inapplicable to an anticipation analysis.” Id.
(quoting Kalman v. Kimberly-Clark Corp., 713 F.2d 760,
772 (Fed. Cir. 1983)).
Slip op. at 15. The Court affirmed the district court’s summary judgment of invalidity of
the ‘425 patent as anticipated by the ‘130 patent.
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Commentary (By the Authors)
Billups adds to the growing list of biotech patents invalidated for an inadequate
written description, including recent cases such as Centocor Ortho Biotech v. Abbott and
Ariad v. Lilly, as well as older cases such as Univ. of Rochester v. Searle and Regents of
Univ. of Cal. v. Lilly. Written description is obviously a defense of choice in biotech
cases, and should receive a corresponding amount of attention during prosecution. This is
not a comment on the preparation of the ‘681 specification, as the attorneys may have
done the best job possible with the available information. If the available information
does not satisfy the case law standards, however, perhaps the filing strategy should be reevaluated.
On the litigation front, in several of these cases a party with a patent but
inadequate proof that it possessed the invention at the time its application was filed
appears to have sued the party who has proof of prior invention. Perhaps that result was
inevitable, but it also suggests that additional due diligence prior to suit could have
avoided an expensive and adverse result. Again, this is not intended as a criticism of any
particular case as we are not privy to all the relevant facts.
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