Tafas v. Dudas Et Al - Document No. 175
Tafas v. Dudas Et Al - Document No. 175
Tafas v. Dudas Et Al - Document No. 175
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TRIANTAFYLLOS TAFAS, )
)
Plaintiff, )
)
v. ) Case No. 1:07cv846 (JCC/TRJ)
)
JON W. DUDAS, et al., )
)
Defendants. )
)
CONSOLIDATED WITH
SMITHKLINE BEECHAM )
CORPORATION, et al., )
)
Plaintiffs, )
)
v. ) Case No. 1:07cv1008 (JCC/TRJ)
)
JON W. DUDAS, et al., )
)
Defendants. )
)
I. Introduction
support of the plaintiffs’ motions for summary judgment in the above-captioned consolidated
cases. The final rules published by the Patent and Trademark Office (“PTO”) on August 21,
2007, significantly alter patent applicants’ ability to claim and protect their inventions. Changes
Indistinct Claims, and Examination of Claims in Patent Applications, 72 Fed. Reg. 46,716 (Aug.
Dockets.Justia.com
Case 1:07-cv-00846-JCC-TRJ Document 175 Filed 12/27/2007 Page 2 of 23
21, 2007) [“Final Rules”] (to be codified at 37 C.F.R. pt. 1). The adverse effects of the Final
Rules will nowhere be felt more strongly than in the biotechnology industry. This industry relies
heavily on patent law and the current, established PTO rules of practice to obtain adequate
protection for its inventions and to attract financing for products that often take more than a
decade to reach the market. BIO is deeply concerned about the irreversible loss of patent rights
and the disincentives to innovation that the Final Rules will cause.
Like the plaintiffs, BIO believes that the Final Rules violate the patent laws and the
Administrative Procedure Act. 5 U.S.C. § 706. Instead of repeating the arguments the plaintiffs
have ably made on these points, BIO’s brief will address the significant harm that the provisions
of the Final Rules that place severe limitations on continuations and on the number of patent
claims an applicant can make will cause to the biotechnology industry and the public at large if
II. Background
BIO is the largest trade association representing the biotechnology industry. BIO was
founded in 1993 to represent biotechnology companies at the local, state, federal, and
international levels. As of December 2006, BIO’s membership consisted of more than 1,100
biotechnology companies, academic centers, state and local associations, and related enterprises.
Although BIO members’ concerns with the Final Rules overlap with the plaintiffs’, BIO
that will be uniquely affected by the Final Rules. BIO’s members range from large Fortune 500
companies to the smallest start-ups and university spin-offs. They are involved in researching
and developing biotechnology products across a wide array of technology areas, including food
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the U.S. biotechnology industry raised over $20 billion in financing and spent $19.8 billion on
research and development of more than 400 investigational drug products and vaccines. BIO,
BiotechGuide.pdf. Many of the medicines that companies in this industry developed are now
being used to treat the most vexing of human diseases, such as various forms of cancer. Modern
crop science applies biotechnology to enhance productivity in corn, cotton, and soybean farming,
and to reduce their environmental impact. Bioethanol made from crop wastes using enzymes
developed by the biotechnology industry could meet a quarter of U.S. energy needs by 2025. Id.
The vast majority of BIO’s corporate members are development-stage companies that
have yet to achieve profitability and that may be years from bringing their technologies to
market. To such companies, patents are vital. The ability to obtain clear and comprehensive
patent protection attracts the capital and corporate partners necessary for the costly and lengthy
development, approval, and marketing process for biotechnology inventions. Sustaining the
develop comprehensive patent protection for investigational products. For this, and other,
reasons, start-up biotechnology companies must apply for patents early and often. 1
The Final Rules’ limitations on continuations practice and the number of permissible
claims will weaken the patent protection available to biotechnology companies for
investigational products, and will undermine their efforts to obtain financing and other support to
1
Forgoing patent protection and relying on trade secrets protection is generally not a realistic
option for early-stage biotechnology companies. Several factors may drive the early disclosure
of new discoveries, including (1) the need to publish in scientific journals, (2) regulatory review
processes that require disclosure, (3) securities regulations that may compel disclosure, and (4)
the need to attract investors or development partners during the early stages of development,
which are typically the most difficult to fund.
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continue research. This in turn will harm the public, which may never receive the benefits of
patents than those in other areas of technology, such as electronic and mechanical patents. By
one measure, the percentage of first Office actions on the merits taken from continuing
applications is highest with respect to patents in the life sciences and biotechnology area by a
wide margin (approximately 42%, compared to about 24% to 28% in all other technologies). See
James Toupin, General Counsel, PTO, Presentation at the Los Angeles Intellectual Property Law
Association “Washington and the West” Conference: The State of the Patent System 8 (Jan. 25,
Final Rules will affect biotechnology more than other technology areas because biotechnology
applications and the associated patentability issues are often more complex, which results in a
longer and more involved examination process requiring more continuing applications and
Thus, the Final Rules are likely to have a disparate impact on BIO’s members. These
effects have important implications for the public’s access to the benefits of advances in
biotechnology. In particular, the Final Rules may prevent biotechnology companies from
III. If Implemented, the Final Rules Will Harm the Biotechnology Industry and the
Public Interest
Because of the diversity of BIO’s membership and the wide-ranging scope of the
technologies its members work with, it would not be possible to touch on all of the ways the
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Final Rules will adversely affect the biotechnology industry. Rather, in the sections that follow,
BIO focuses on several effects of the Final Rules, including some examples.
The first section discusses what are perhaps two of the most critical aspects in the lives of
biotechnology companies: (a) the decision as to which products to invest often limited
resources; and (b) the ability to secure financing for research and development of these products.
The second section discusses how biotechnology inventions benefit both from fully-developed
claims sets, which would be limited by the Final Rules to five independent and twenty-five total
claims, and from the ability to file multiple continuations and RCEs beyond the Final Rules’ de
facto limit of two continuations and one RCE. The final section highlights how these adverse
effects will harm the public good by suppressing the number of new biotechnology
advancements that reach the market and the number of biotechnology inventions publicly
disclosed.
Biotechnology companies often must choose to pursue a limited number of new products
or technologies from among several viable ideas. In some instances, these decisions have to be
made early in the development process because of the high up-front costs and capital
this decision-making process are the ultimate scope and robustness of patent protection. Absent
well-developed and robust patent protection, a biotechnology company is less likely to invest in
promising new technologies and will find it more difficult to obtain the financing necessary to
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For example, biotechnology companies developing large molecule biologics2 often have
to make large investment decisions early in the development process. Biologics are produced
using cell culture facilities that, on average, take three to five years to construct, cost between
$250 million and $450 million, and must often be constructed during clinical testing. See Henry
Grabowski et al., The Market for Follow-On Biologics: How Will it Evolve?, 25 HEALTH
AFFAIRS 1291, 1294 (2006). To make such investments, the company must have a clear prospect
of adequately protecting all aspects of the invention, including those aspects that become
important during the development process and are amenable to protection through continuation
or continuation-in-part (“CIP”) applications. Because the limitations in the Final Rules related to
continuations, CIPs, and claims sets will lead to more limited patent protection, biotechnology
companies are less likely to make these significant investments, thereby depriving the public of
research and development efforts. Unlike large biotechnology companies that may be able to
rely on their established portfolio of corporate assets and revenue streams to produce capital and
markets based on the commercial attractiveness of their inventions. Patents play a unique role in
the business models of such companies, for whom business risks are unusually high. For
example, of all compounds entering clinical testing, approximately 70% fail to reach Food and
Drug Administration (“FDA”) review. See Joseph A. DiMasi & Henry G. Grabowski, The Cost
2
Large molecule biologics include proteins, such as antibodies, growth factors, and hormones, as
opposed to small molecular entities derived from chemical synthesis.
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472 (2007). Biotechnology businesses must raise large amounts of capital in the face of such
failure rates. A recent study estimates the total capitalized cost of developing a biotechnology
drug at $1.2 billion—money that, in large part, must be raised by convincing investors. Id. at
475. If such high failure rates were not enough of a disincentive to investing such large amounts
of money, investors must also consider the time they have to wait before, if ever, getting a return.
It takes, on average, over eight years to advance a biotechnology drug through the required
clinical testing and the FDA approval process—time during which those investment dollars
could bring a safer, and quicker, return if invested elsewhere. Id. at 473.
biotechnology investment, and therefore is critical to the biotechnology industry. Patents ensure
against all odds, can provide investors a reasonable return and at the same time allow the public
to benefit from use of the product.3 Comprehensive patent protection, including that afforded by
continuations and fully-developed claims sets, mitigates business risk in the biotechnology
industry. The imposition of a de facto limit on the number of continuations and claims, however,
raises the likelihood that not all commercially important aspects of an invention can be protected.
This will lead to higher perceived business risk, reduced levels of investment, and hence a lower
3
It is for this reason that capital markets are extremely sensitive to the impact of patent law
changes on the biotechnology industry. For example, on March 14, 2000, when President
Clinton and Prime Minister Blair made a joint statement raising doubts about patent protection
for newly decoded human gene sequences (a statement that was subsequently clarified),
biotechnology stocks went into a tailspin. In a single day, the NASDAQ biotechnology index
dropped by about 13%, Alex Berenson & Nicholas Wade, A Call for Sharing of Research
Causes Gene Stocks to Plunge, N.Y. TIMES, Mar. 15, 2000, at A1, with some companies losing
as much as 20% of their market value within a few hours, Eliot Marshall, How a Bland
Statement Sent Stocks Sprawling, 287 SCI. 2127, 2127 (2000).
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likelihood that research is begun, continued, or brought to fruition in the form of new products or
These adverse consequences of the Final Rules also will affect university-based research.
Unlike many other industries, much of the biotechnology industry’s pipeline of products is
universities and research institutions often lead to multi-faceted inventions, which are frequently
patented and licensed to start-up biotechnology companies for further development and
commercialization. This process of patenting and licensing promotes the interests of research
institutions in seeing their discoveries translated into real-world products that benefit patients and
consumers, and funnels billions of dollars from the commercial marketplace back into basic
research and higher education. 4 But, because the limitations on continuations, CIPs, and claims
sets in the Final Rules will limit the patent protection for these discoveries, the flow of funds to
universities for basic research will be reduced, because private industry will not risk making
Many of BIO’s member companies are small companies that demonstrate the relationship
between university-based research and the private marketplace. The initial technology for these
often seek their initial round of investment from venture capital firms. It was important to these
venture capital firms that the patents protecting the biotechnology companies’ technology have
4
For 2006 alone, U.S. academic institutions organized in the Association of University
Technology Managers (“AUTM”) reported receiving research funding from industry licensees
under more than 12,600 active licenses. See AUTM U.S. LICENSING ACTIVITY SURVEY: FY
2006, SURVEY SUMMARY 5 (2007), available at http://www.autm.org/events/file/
AUTM_06_US%20LSS_FNL.pdf. At approximately $3.18 billion, industry-provided research
funding constituted the second-largest source of research funding for U.S. universities, hospitals,
and research institutions during that year. See id. at 20. Of almost 5,000 new licenses granted
under university patents, two-thirds went to small companies and start-ups. See id. at 31.
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enough longevity to support the research and development cycle necessary to make the
biotechnology companies can be successful in securing initial and on-going investments if they
are able to develop a patent strategy using a series of continuations and fully-developed claims
Without the flexibility to protect all aspects of any one of their inventions through
continuations and full claims sets, universities, through spin-off companies, may not be able to
attract the investments necessary to bring the inventions to commercial fruition—all due to the
The PTO justifies the new restrictions on continuations practice, in part, on what it views
as unfocused and abusive practices. See 72 Fed. Reg. at 46,719-46,720. The PTO also claims
that the new limits on the number of claims and the examination support document (“ESD”)
requirement will assist patent examiners in their examination and evaluation of patent
applications. See id. at 46,721. But the PTO already has the authority to regulate and punish
those rare instances of actual abuse of the patent process. See 37 C.F.R. § 10.18; Manual of Pat.
5
Prior to June 8, 1995, the term of protection of a U.S. patent, including a patent issued on a
continuation application, was seventeen years measured from the grant of the patent. Since June
8, 1995, however, the term of protection begins on the date of grant and ends twenty years from
the filing date of the application for the patent. If priority of an earlier application or applications
is claimed under sections 120, 121, or 365(c) of Title 35, the twenty-year period is measured
from the filing date of the earliest of such earlier applications. The patent term provisions of
Section 154, applicable to virtually all currently pending patent applications, thus provide a
significant disincentive to dilatory prosecution tactics since successive continuation filings “eat
up” patent term of any patent issued on such applications. Applicants’ incentive therefore is to
obtain allowance as quickly as possible to have the greatest amount of term remaining after the
patent issues.
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More importantly, the PTO ignores that current practices regarding continuations and
claims sets, on the whole, have a beneficial effect on patent quality and validity. Biotechnology
inventions tend to be more complex than those in many other areas. They also frequently arise in
publications, vibrant scholarly discourse in public forums, and substantial amounts of prior art
that must be discovered over time and carefully analyzed. Existing continuations and RCE
practice affords applicants the several rounds of prosecution that may be necessary to fully
prosecute a complex biotechnology invention, gives examiners the opportunity to fully consider
the case, and permits both examiners and applicants to develop the prosecution history to a point
respect, the Final Rules cause greater harm to inventions from biotechnology and other highly
complex technologies that may legitimately require multiple rounds of prosecution, because they
force applicants to “use up” their available continuations rather than settle for premature appeals
or insufficient protection.
company often does not yet know which of several disclosed alternative embodiments of the
invention will ultimately be developed commercially. The company must fear that important
during the product development phase—will not receive adequate patent protection because all
available continuations have been “used up” during earlier rounds of prosecution. The
competition for investment dollars drives biotechnology companies to file patent applications
early in the development of the invention to generate interest or to satisfy milestones required by
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their investors. As a result, these companies properly file applications long before the
Frequently, an initial biotechnology patent application will describe several products, and
several uses for these products, based on the inventor’s laboratory experiments. For example, a
scientist may find a way to halt the abnormal growth of a number of different cancer cell lines in
cell culture, and corroborates this finding with a mouse study using experimental tumors from
several of these cancer cell lines. The patent application teaches that the invention is useful in
the diagnosis and treatment of solid tumors generally, and discloses specific methods for treating
a number of cancers. During prosecution of the patent application, however, the patent examiner
may allow only some of the specific cancer treatment claims—for example, those that are
supported by both mouse and cell culture data—and may finally reject claims related to treating
solid tumors generally, or treating specific types of cancer for which the applicant presented only
This common conundrum presents the patent applicant with a difficult choice: the
applicant does not yet know for which of the several disclosed embodiments—in this example
Should the applicant accept a patent with narrow claims, and run the risk that subsequent clinical
research confirms the medical and commercial value of the invention in another indication that
was disclosed in the application but not among the allowed claims? In biotechnology, the
development of the commercial product requires significant further testing in animals, and FDA
approval is needed to conduct the series of clinical trials necessary for final approval. As noted
above, because the lengthy animal and human clinical trials are extremely resource-intensive,
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applicants may pursue different products serially over time, using continuations and robust
For example, an antibody product initially pursued for one type of cancer was later
developed for other types of cancer—indications that were disclosed in the original patent
Similarly, other antibodies, initially claimed and developed through clinical trials for rheumatoid
arthritis, were subsequently pursued for other originally disclosed diseases such as Crohn’s
disease, psoriasis, and sarcoidosis, which have been the subject of continuation applications.
However, the Final Rules may not permit the biotechnology company to file continuations with
whose importance only becomes clear after investing in additional research—not only for the
initial embodiment whose prosecution may already have used up the available continuations. As
such, the vastly restricted continuations and claims practice under the Final Rules robs such
companies of much of the flexibility needed to protect their investigational products and bring
The small BIO member companies described above, which often develop technologies
first generated at a university, are able to implement a patent strategy that involves a series of
continuations with disclosures that are both broad and deep. The ability to plan for multiple
continuations allows these companies initially to make broad disclosures safely with limited
funding. This strategy plays an important role in a company’s ability to secure initial and on-
going investments, which are necessary for continued research and development. The ability to
satisfactorily capture all of the benefits of a broadly enabling technology also is important in
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technology.
As mentioned above, claims practice under the Final Rules will allow only five
independent and twenty-five total claims to be examined per application before an ESD is
required (the “5/25 Rule”). The 5/25 Rule will also extend across all copending, commonly
owned applications containing at least one patentably indistinct claim. If the sum of all the
claims in each commonly owned application containing at least one patentably indistinct claim is
greater than the limits of the 5/25 Rule, the applicant either must file an ESD before the first
Office action on the merits or must cancel claims in excess of the limit.
The PTO has included this provision ostensibly “to preclude an applicant from submitting
multiple applications with claims that are patentably indistinct . . . for the purposes of avoiding
However, the 5/25 Rule also effectively prevents applicants from prosecuting parallel CIPs or
continuations with any patentably indistinct claim for the purpose of capturing improvements or
other aspects of the invention. See id. at 46,725 Applicants and investors do not know whether a
continuation application contains a “patentably indistinct” claim until the PTO makes that
determination, making it necessary to delay filing of continuation applications until the parent
application is prosecuted to allowance. Such a result, however, will have a significant negative
impact on even well-meaning applicants who, far from engaging in “unfocused”’ or “abusive”
possible. A patent issued on such a serially filed continuation application is certain to lose part
of its effective protection, because much of its effective patent term (which is measured from the
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filing date of the earliest prior application) is consumed by the time it takes to sequentially
The 5/25 Rule will also prevent a biotechnology applicant from using so-called “genus”
and “species” claims to describe their inventions. Broad genus claims cover a wide breadth of
subject matter, often with few limitations. However, such claims are more vulnerable to
invalidity challenges on the basis of unidentified prior art or lack of enablement. Narrow species
claims describe different embodiments of the invention that fit within the scope of a genus claim.
Species claims are generally less vulnerable to invalidity challenges, but may allow a competitor
to successfully design around the claim limitations. Thus, during patent enforcement, it is
important to have both genus and species claims because the combination of these claims allows
The Final Rules effectively eliminate the ability of patent applicants to develop such
strategies of using multiple applications that are filed as research progresses. In addition to the
changes in claims and continuations practice, the PTO is requiring that applications containing
overlapping genus and species claims be prosecuted serially, rather than in parallel as is currently
allowed, and is requiring that a genus claim application be fully prosecuted before species claims
applications are even filed in an application with only patent distinct claims, called a
“divisional.” 72 Fed. Reg. at 46,727-46,728. As a practical matter, the second application would
not issue until about six years after filing under the best-case scenario, depriving applicants of
the full patent term to which they are entitled. In reality, the prosecution would likely require
Under current practice, genus and species claims could issue at the same time, typically
about three years after filing. By forcing applicants to prosecute continuations or divisionals
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serially, the PTO will reduce the effective period of exclusivity for the scope of the invention.
By reducing available patent term, the value of the patent, and thus the incentive to make the
Genus and species claims also are important for a discovery that can be licensed in more
than one market, an approach often used by universities and other research institutions. For
example, a basic genetic invention made in a research laboratory may eventually be of interest to
companies that develop very different products, such as laboratory reagents, veterinary
medicines for human use. Each of the various parties has its own specific patent-related needs:
a diagnostic company may have a need for claims specifically directed to test kits and diagnostic
methods; a drug company may need specific pharmaceutical composition claims; and a
manufacturing company may need specific biological process claims. With flexible use of
claims and continuations, specific aspects of the invention all can be protected separately,
allowing a research institution to license several small start-ups with different, specific
commercial applications, thereby promoting the dissemination and wider adaptation of new
technology in the marketplace. Under the Final Rules, however, both claims and continuations
become a precious commodity, confronting such licensors with hard choices between the
competing needs and interests of its licensees and, ultimately, quenching incentives for further
innovation.
This competition will occur, in part because the order in which subject matter is claimed
and examined can have significant effects. As explained above, the 5/25 Rule effectively
reduces the amount of time that a second or third patent is enforceable. Although the PTO
argues that the Final Rules will permit applicants a maximum of fifteen independent claims and
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seventy-five total claims through the use of two continuations or CIPs, those continuing
applications must be pursued serially to avoid exceeding the 5/25 limit across co-pending
applications. 72 Fed. Reg. at 46,725. Thus, should these subsequent claims issue in patents, the
applicant would have less enforceable patent term for second and third patents than afforded the
first patent. This necessarily harms applicants and particularly, applicants in biotechnology and
other high technology areas that require more claims to adequately cover the scope of the
invention.
Experience has shown that, in the case of complicated, evolving technologies such as
those in the biotechnology field, fully-developed claims sets and unrestricted continuations
practice actually improve patent quality and validity. 6 For example, more claims encompassing
specific embodiments of the invention will often allow patent examiners to better understand the
subject matter. While several continuations are pending, the patent examiner becomes intimately
familiar with the technology through prior art searches and the back-and-forth with the applicant
explaining the invention. During this period, applicants may also provide additional prior art,
possibly as a result of additional research or testing. Because of such extensive examination, the
quality of the examination and the quality of the claims are improved, and a much stronger
6
Conversely, there is no empirical evidence that continuation practice has resulted in higher
numbers of invalid patents. The finding of Lemley and Moore that continuations are more likely
to be litigated can be seen as an indicator of the commercial importance of continuations,
highlighting that continuation patents often are among a patent owner’s most valuable assets. (In
Lemley and Moore’s sample, continuations constituted 23% of all issued patents, but 52% of all
litigated patents. Mark A. Lemley & Kimberley A. Moore, Ending Abuse of Patent
Continuations 13 n.40 (Geo. Mason Univ. Sch. of Law, Law & Econ. Working Paper Series,
Paper No. 03-52, 2003; Univ. of Cal., Berkeley Sch. of Law, Pub. Law & Legal Theory Research
Paper Series, Paper No. 140, 2003), available at http://ssrn.com/abstract=462404.)
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In sum, without the ability to protect all aspects of the inventions through continuations
and fully-developed claim sets, refinements made during the developmental testing process may
biotechnology invention are likely to unfold in a piecemeal fashion with continued research. As
the research identifies new improvements and aspects of the invention that are commercially
important, the biotechnology company properly will seek to patent them. If research is
application if it covers a workable product, since the biotechnology company will want to
maintain exclusivity around their invention. Without that patent protection, the disclosed
material is in the public domain and may be used by a competitor that has not invested in the
improvements. See Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054
(Fed. Cir. 2002). Thus, without patent protection, the biotechnology company is unlikely to
continue to invest in that improvement or aspect of the invention, and its importance or potential
may be lost. Moreover, because the effect of the Final Rules would have applicants file and
prosecute applications serially, a company may choose instead to pursue the aspects of the
invention that were claimed first, rather than those that provide the best result, creating an
As a result of the adverse effects discussed above, the public interest will be harmed in
two related ways if the Final Rules are allowed to go into effect. First, fewer new products and
technologies may be brought to market. Second, fewer products and technologies will be
disclosed to the public, contrary to the express purpose of patents to disseminate information in
order “to promote the Progress of Science and useful Arts.” U.S. C ONST. art. I, § 8.
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biotechnology companies will be less likely to attract investors to finance the development of
new products and technologies. Without these investments, these companies simply do not have
the resources to bring their new ideas to the market. Larger companies will also be unwilling to
invest substantial resources in developing new products and technologies without strong patents
that will protect their inventions from being copied once they are brought to market. In either
situation, the result is less investment in research and development and, ultimately, fewer new
intellectual property. As noted above, trade secrets protection is of less value to development-
stage biotechnology companies, because of their need to raise funds in the capital markets. But
any reliance on trade secrets protection will result in no public disclosure of these new
technologies, stifling innovation. This stifling effect will ultimately result in fewer new products
and technologies being developed. A similar effect may flow from patents filed and issued under
the Final Rules. Given the restrictions on claims and continuations, biotechnology companies
will have to limit what is claimed in a patent application. Accordingly, applicants will limit the
scope of the disclosure in their applications to avoid dedicating to the public potential
commercial embodiments. The effect, again, will be to stifle innovation because of the lack of
public disclosure.
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IV. Conclusion
In view of the foregoing harms to the biotechnology industry and the public that will be
caused by the PTO’s unlawful and unreasonable restrictions on patent practice, BIO, on behalf of
its members, respectfully requests that this Court grant the plaintiffs motions for summary
Respectfully submitted,
By: /s/
Randall K. Miller
VA Bar #70672
Counsel for Amicus Curiae
Biotechnology Industry Organization
ARNOLD & PORTER LLP
1600 Tysons Boulevard
Suite 900
McLean, VA 22102
Telephone: (703) 720-7030
Facsimile: (703) 720-7399
[email protected]
Ronald A. Schechter
David R. Marsh
Matthew M. Shultz
Kristan L. Lansbery
ARNOLD & PORTER LLP
555 12th Street, N.W.
Washington, D.C. 20004
Telephone: (202) 942-5000
Facsimile: (202) 942-5999
Vern Norviel
WILSON SONSINI GOODRICH &
ROSATI
650 Page Mill Road
Palo Alto, CA 94304
Telephone: (650) 320-4704
Facsimile: (650) 493-6811
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CERTIFICATE OF SERVICE
I hereby certify that on this 27th day of December 2007, I caused a copy of the foregoing
Brief of Amicus Curiae Biotechnology Industry Organization in Support of Plaintiffs’ Motions
for Summary Judgment to be electronically filed with the Clerk of the Court using the CM/ECF
system, which will send a notification of such filing to the following:
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Pro Se
/s/
Randall K. Miller
VA Bar #70672
Counsel for Amicus Curiae Biotechnology Industry
Organization
ARNOLD & PORTER LLP
1600 Tysons Boulevard
Suite 900
McLean, VA 22102
Telephone: (703) 720-7030
Facsimile: (703) 720-7399
[email protected]
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