Tafas v. Dudas et al

Filing 217

MOTION for Leave to File a Brief in Support of The Plaintiffs' Anticipated Motions for Summary Judgment by Federation Internationale Des Conseils En Proprit Industrielle. (Attachments: # 1 Proposed Order # 2 Proposed Amicus Brief# 3 Exhibit A# 4 Exhibit B)(rban, )

Tafas v. Dudas et al

Doc. 217 Att. 2

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IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF VIRGINIA Alexandria Division TRIANTAFYLLOS TAFAS
Plaintiff,
v.

Case No. 1:07cv846 (JCC/TRJ)

JON W. DUDAS, et al.,
Defendants.

CONSOLIDATED WITH SMITHKLINE BEECHAM CORPORATION, etal.,
Plaintiff,
v.

Case No. 1:07cvl008 (JCC/TRJ)

JON W. DUDAS, et al.,
Defendants.

BRIEF OF AMICUS CURIAE FEDERATION INTERNATIONALE DES CONSEILS EN PROPRIETE INDUSTRIELLE IN SUPPORT OF THE PLAINTIFFS' ANTICIPATED
MOTIONS FOR SUMMARY JUDGMENT

R. Danny Huntington (VSB 16407) BINGHAM MCCUTCHEN LLP
2020 K Street NW

Washington, DC 20006-1806
[phone]

Of Counsel Maxim H. Waldbaum
Julie Busch

Counsel for Amicus Curiae Federation Internationale des Conseils
en Propriete Industrielle

Henry L. Mann

SCHIFF HARDIN LLP
900 Third Avenue New York, NY 10022 [phone]

Dockets.Justia.com

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I.

INTEREST OF THE AMICUS CURIAE

Established in 1906, FICPI is a Switzerland-based international and non-political association of approximately 4,000 intellectual property attorneys from over eighty countries

(including the United States). FICPI's members represent individual inventors as well as large,
medium and small companies. One of the members' major roles is to advise inventors in

intellectual property matters and secure protection for industrial innovation.

FICPI supports

predictable, balanced global protection of patents, the global harmonization of substantive patent law, and the interests of inventors and the U.S. Patent and Trademark Office (the "PTO") for recognizing a fair scope of patent protection consistent with the claimed invention. FICPI's interest in a fair, non-arbitrary set of PTO procedures is made dramatically clear from the large and increasing patent filings from outside the United States, which account for approximately 45% of all patent filings and maintained patents. See USPTO Performance and Accountability

Report: Fiscal Year 2007, Nov. 15, 2007 (the "2007 Annual Report") at 109-120, available at

http://www.uspto.gov/web/offices/com/annual/2007/2007annualreport.pdf.
FICPI is one of only two major world organizations that advise the World

Intellectual Property Organization ("WIPO"), an intergovernmental organization dedicated to promoting and protecting intellectual property rights worldwide, on all intellectual property
matters. In this capacity, FICPI members have attended most Diplomatic Conferences

concerning international intellectual property treaties and practices. WIPO's 180 member states

(including the United States) comprise almost ninety percent of the world's countries. See About
WIPO, at http://www.wiDO.int/about-wipo/en/. As one of the sixteen specialized agencies of the

United Nations system of organizations, WIPO administers intellectual property matters
recognized by the U.N.'s member states and twenty-three international treaties concerning

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intellectual property, including the Paris Convention for the Protection of Industrial Property. Id.

The United States is a member of the WIPO Standing Committee on the Law of Patents ("SCP")

and works with WIPO in efforts to harmonize substantive patent law worldwide, including
pursuant to a Substantive Patent Law Treaty, which currently is in draft form. See Substantive

Patent Law Harmonization, at http://www.wipo.int/patent/law/en/harmonization.htm.
As FICPI is largely comprised of patent practitioners representing foreign

inventors and corporate entities, FICPI is poised to give the court the perspective of the
international patent community. Because the instant case may potentially significantly affect the way foreign companies operate vis-a-vis their patent filing strategies, FICPI would like to voice
concerns regarding the threats posed by the PTO's "Changes to Practice for Continued

Examination

Filings, Patent Applications

Containing Patentably

Indistinct

Claims and

Examination of claims in Patent Applications," 72 Fed. Reg. 161 at p. 46716 (Aug. 21, 2007) (to

be codified at 37 C.F.R. pt. 1) (the "Final Rules"), and, in particular, Final Rule 1.78 regarding
voluntary (not restricted by Examiner decision) and involuntary divisional practice.1 In

November 2007, in direct response to such Final Rules, FICPI, assembled at its Executive

are subject to a restriction requirement in the parent.

1 Under Final Rule 1.78, "a divisional can be filed for non-examined claims that
1. Without justification: 2 continuations of the divisional and 1
RCE of the divisional are permitted.

2. With justification: an unlimited number of continuations of the divisional and RCEs of the divisional are permitted.
3. Note restrictions on the claim of priority in the continuation of the divisional.

4. No continuations-in-part of the divisional are permitted".

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Committee in Seville, Spain, adopted a Resolution regarding Divisional Patent Applications and
protection relating to those PTO rules. FICPI EXCO/ES07/RES/003 (Nov. 2007) (attached as

Exh. A). FICPI is of the opinion that the PTO's Final Rules, particularly Rule 1.78, are contrary
to well-established law.

II.

THE

PTO

FINAL

RULES

ARE

INCONSISTENT

WITH

LAW

AND

OTHERWISE UNSUPPORTABLE

The PTO's authority to regulate patent applications is granted by Congress and is
subject to several limitations. First and foremost, 35 U.S.C. § 2(b)(2) empowers the PTO to Thus, by implication, and as a matter of

"establish regulations not inconsistent with law".

common sense, the PTO may not promulgate rules that violate any law.

A.

The Paris Convention Limits The PTO'S Authority To Restrict Divisional
Patent Applications

The Paris Convention for the Protection of Industrial Property, as amended, has been ratified by 172 Contracting Parties, including the United States. 21 U.S.T. 1583, 828

U.N.T.S. 306. Article VI, Clause 2 of the United States Constitution provides that treaties, along with the Constitution and Federal laws, are the "supreme Law of the Land". Thus, the Paris Convention constitutes binding authority which the Final Rules may not contravene. Article 4G
of the Paris Convention provides that:

(1) If the examination reveals that an application for a patent

contains more than one invention, the applicant may divide the application into a certain number of divisional applications and
preserve as the date of each the date of the initial application and

the benefit of the right of priority, if any.

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(2) The applicant may also, on his own initiative, divide a patent

application and preserve as the date of each divisional application

the date of the initial application and the benefit of the right of
priority, if any. Each country of the Union shall have the right to determine the conditions under which such division shall be
authorized.

In accordance with both subsections of Article 4G, an applicant shall be entitled

to divide a patent application to preserve the benefit of the priority date of the initial filing, either

based on an examiner's finding or the applicant's own initiative. With respect to subsection (2), while the Convention permits signatory nations to "determine the conditions under which such division shall be authorized", it confers no express authority allowing signatories to restrict the number of such divisional applications that an applicant may seek to file. Cf. Board of Appeals of the European Patent Office case number J 0011/91, at para. 3.1.1 (Aug. 1992) (attached as

Exh. B) (holding that an EPC rule placing an arbitrary time limit on when a divisional patent
application could be voluntarily filed violated Article 4G of the Convention). B. The Patent Act Does Not Confer Substantive Rulemaking Authority Upon
The PTO

The Patent Act limits the PTO's authority regarding the nature and the scope of

action it is authorized to take.

According to the Patent Act, the PTO is entitled to establish

regulations in order to "govern the conduct of proceedings in the Office", with the goal to
"facilitate and expedite the processing of patent applications". 35 U.S.C. § 2(b)(2). The Patent

Act did not vest any general rulemaking power to PTO.

A review of recent Congressional

proposals makes it clear that any change to the way claims are prosecuted by the PTO are

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substantive and will not be allowed without Congressional approval.
Manbeck, Jr. of October 15,2007 ("Manbeck Decl."), at paras. 9-12.

See Decl. of Harry F.

The Final Rules that PTO wishes to implement, are consequently ultra vires, as substantive changes which severely impact the processing system. Indeed, the significant
While

changes in rights proposed by PTO amount to a modification of the substantive law.

referring to the processing of patent applications, the changes operated by the Final Rules limit the number of continuing patent applications, divisional patent applications, independent and dependent claims, all inventor/invention limiting without any studied justification. See, e.g.

Board of Appeals of the European Patent Office case number J 0011/91, Exh. B at para. 2.3.4

(Aug. 1992) (holding that the imposition of a cutoff time for the filing of divisional applications

to be "a substantial limitation" of an "essential right of the applicant which ... is not justified"). The consequence of such changes leads to a limited protection which an inventor's quid pro quo of giving up effective trade secret protection is vastly compromised. See 35 U.S.C. § 122(a).

Additionally, some previous unsuccessful attempts by Congress to enlarge the PTO's rulemaking power evidence the reality of the PTO's current limited scope of authority.
Indeed, as Mr. Manbeck mentioned in his declaration:

on June 8, 2005, the House of Representatives introduced the Patent Reform Act of 2005, H.R. 2795, which would have granted

the Director the power to promulgate regulations concerning
continuation practice. See H.R. 2795 §8. More broadly, the Patent

Reform Act of 2006, S. 3818, introduced on August 3, 2006 in the
United States Senate, contained a provision that would have

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allowed the PTO the authority to issue rulemakings to "carry out"
the Patent Act.

Manbeck Decl. at paras. 11-12.

Similarly, the Final Rules place improper restrictions on 35 U.S.C. § 132 provides that applicants may

requests for continued examination ("RCEs").

request a reexamination of any patent claim rejected or subjected to an objection or requirement by the PTO. As is the case with continuation and divisional applications, the statute makes no provision for the PTO to limit a patentee's right to do so, merely providing in subsection (b) that

the PTO may "prescribe regulations to provide for the continued examination of applications at the request of the applicant." 35 U.S.C. § 132(b) (emphasis added). This language is consistent with the notion that the PTO may determine the procedural rules and determine the appropriate fee to be charged for RCEs, so long as the rules "provide for", rather than restrict the procedure.

RCEs serve an important role in the patent prosecution process, representing a form of

finality with clarity: dialogue between examiner and applicant to determine the proper scope of
claims. If the PTO places restrictions on the Applicant that curtail the examination process, the PTO should provide for alternative procedures to preserve this dialogue, such as additional

interviews, informal submissions of proposed claims for review, etc. By simply restricting RCE
practice, the PTO impermissibly closes an important communications channel that will adversely

affect the quality of patents and create results directly contrary to the intent of the Final Rules.

The rigidity and capriciousness of the limitations that the Final Rules bring into
the processing system have extreme consequences and unfairly affect major research industries

at the university and corporate levels. Mere procedural changes could not accomplish this. The
Final Rules clearly detract from inventors' legal rights to define their inventions.

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C.

The PTO Is Without Authority To Make The Final Rules Retroactively
Applicable

FICPI shares plaintiffs' position that the PTO's Final Rules are to be considered

retroactive. Indeed, the Final Rules would apply to patent applications filed even before the date

of the Final Rules' entry into force. Motion For A

As stated in the Memorandum In Support of Plaintiffs' Order And Preliminary Injunction (the "GSK

Temporary Restraining

Memorandum") (dkt. no. 14), the Final Rules "retroactively change the legal consequences of
already filed continuing applications and patent prosecutions strategies."

A modification of the processing system should not be imposed on applications

already filed, in particular when this modification implies more duties to fulfill by the applicant, who, at the time of the application, was unaware of such duties. Indeed, the requirement of filing
a petition and showing to justify more than two continuing applications qualifies as an

imposition of new duties with respect to already filed, i.e. pending, applications. The retroactive impact of the Final Rules would cause significant injury (without noticeable benefit) to patent
application owners, as discussed in the GSK Memorandum.

As this Court correctly noted in its Memorandum Opinion, "because retroactivity

is not favored in the law", it is very unlikely that Congress intended to grant the PTO the power
to promulgate retroactive rules without stating such intention explicitly, (dkt. no. 64, at 27). The

Patent Act, however, does not give mention of the PTO's authority to make rules retroactively

applicable. Accordingly, the PTO was not vested with any right to promulgate retroactive rules.
Courts should be particularly wary of inferring retroactivity where the negative impact is of such profound magnitude, as is the case here with respect to the Final Rules.

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D.

The PTO Final Rules Place Arbitrary and Capricious Limitations On The Number Of Continuations, Divisionals, And RCEs

As further discussed in the Court's Memorandum Opinion, the PTO refers to

organizational problems as a justification to amend its former rules, "on the ground that the growing number of continuing applications and increasing number and complexity of claims in

applications had crippled the PTO's ability to examine newly-filed applications". Id. at 4. This
is not supportable.

First of all, the statement directly contradicts the language of the recently released

Annual Report, which parades the PTO's latest outstanding results.

Indeed, the message

presented therein by defendant Dudas is that the PTO achieved "another record-breaking year in

performance". Annual Report at 3. Detailing the PTO's outstanding performance, Mr. Dudas affirmed that "last year, Patents achieved its highest examination compliance rate in a quarter of
a century, at 96.5 percent. This year, Patents matched that with 96.5 percent compliance again."

Id. Mr. Dudas also added that "beyond achieving higher compliance and in-process review rates, [the PTO's] patent examiners' decisions are also increasingly being affirmed by our Board of
Patent Appeals and Interferences. This is the first time in recent history that the Board approved

outright the majority of decisions." Id. at 4. Accordingly, it is clear that even from the PTO's
own perspective, the system is not broken.

Given that the PTO's own public statements regarding its ability to perform its

delegated functions without the Final Rules are at such great odds with what it has alleged in this
suit, the Court should disregard such a claim as meritless. If there is some other unstated

purpose such as making the PTO's workload easier to handle, the PTO should be required to
evidence the necessary positive impact of the Final Rules.

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In addition to the obvious inconsistencies of the PTO's stated reasons for

modifying the current rules, the issue of organizational problems does not provide sufficient
grounds to amend well accepted and implemented rules. The balance of hardships between the protection offered to patent applicants and administrative simplicity without study favors the

former. In an article recently published in the Federal Circuit Bar Journal, it has been established that the limitation placed on continuing applications are taking up only 30% of the PTO's patent
examining resources, but that only 20% of all continuations are second or more continuations.

Ayal Sharon and Yifan Liu, Improving Patent Examination Efficiency and Quality: An
Operations Research Analysis of the USPTO, Using Queuing Theory, 17 Fed. Cir. Bar J. 2,

(2007). Thus, the net result of the initially proposed reform eliminates a mere 6% of pending

applications. Id. Thus, the justifications above for dramatic limitations in claims coverage are
belied by the PTO's own statistics which show only 6% of aH patent applications would be affected by Final Rules. As the authors state, "the rationale behind this reform does not make
sense." Id.

Another concern voiced by the PTO to justify the Final Rules is the issue of

submarine patents.

However, as discussed by Mr. Manbeck, Congress has already acted to

curtail this form of abuse by changing the exclusivity period from 17 years from the date of issuance to 20 years from the filing date from which the patent claims priority. Manbeck Decl.
at para. 36.

Finally, an analysis of the proposed changes made by the PTO reveals that such modifications would lead to an additional administrative burden on both sides. Indeed, the

evidentiary justification requirement stated, for example, under Final Rule 1.78(G) imposes additional and heavy burdens to the applicant who submits a divisional, with substantial

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additional paperwork while adding administrative work on the side of the PTO in charge of its
review, assuming the PTO does its job.

E.

The Exception Of Final Rule 1.78 Is Illusory

Under the previous rules of the PTO, an applicant could file more than two

divisional applications as of right, i.e. as many as needed, and obtain the benefit of the priority
date of a parent application so long as the applicant complied with the formal requirements of Section 120. In order for an applicant to file more than two divisional applications, the Final
Rules add a justification requirement under Rule 1.78(G), requiring the applicant "to justify why the amendment, argument, or evidence sought to be entered could not have been previously submitted." (emphasis added). This is a standard which requires a proving of the negative,

already shown to be a heavy burden for patentees in prosecution history estoppel situations under
the Festo criteria. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd, 344 F. 3d 1359 (2003). The suggested layering of the Final Rules on patentees' rights is not healthy for the
patent system.

In fact, it appears by the Rules the PTO is attempting to address a problem not mentioned by them for justification, that is, not examiner overload but the abuse and misuse of

the PTO proceedings by applicants who wish to delay or submarine the proceedings for later economic advantage. But law already exists to take care of those miscreants: prosecution history laches, as created by the Federal Circuit in Symbol Technologies, Inc. v. Lemelson Medical,

Education and Research Foundation. 277 F.3d 1361 (2002). There is certainly no study or
support to extend those solutions by use of the proposed Final Rules.

10

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The proposed system of requiring a petition with supporting evidence is extremely vague and problematic to put into practice, not to mention expensive in both time and
cost to the applicant. How is an applicant supposed to show by proofs that he could not have

submitted his applications earlier? The PTO itself seemed to face issues explaining the concrete
application of the exception presented by the Final Rules.
Declaration pointed out:

Indeed, as Mr. Manbeck's

the PTO has indicated that the following reasons for filing continuation applications, which were all normal, customary,
sanctioned and accepted reasons for filing continuations prior to

the Final Rules, are no longer adequate to support a petition: (1) the
applicant attempts to submit newly discovered prior art; (2) the examiner's interpretation of the claims is unusual and only recently
understood by the applicant or the examiner changes his or her

interpretation of claim language; (3) the applicants have recently

discovered a commercially viable product, financial resources, useful subject matter, a competing product, or similar or parallel
technology on the market; (4) the applicant becomes disabled for a
lengthy time during the pendency of the application.

Manbeck Decl. at para. 40 (internal citations omitted).

Given the ambiguity as to how an

applicant can successfully justify additional filings and the broad discretion of the PTO, this
proposed "exception" is illusory in nature and does not alter the unnecessary rigidity of PTO's
Final Rules.

11

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III.

CONCLUSION

For the foregoing reasons, this Court should grant plaintiffs' motions for summary

judgment and end the attempt to unilaterally implement the Final Rules without proper studied
support and Congressional action.

Dated: January 2, 2007

Respectfully Submitted,

Federation Internationale Des Conseils
En Propriete Industrielle

R. Danny Huntingt|bn (VA BarW 16407) Bingham McCutchen LLP 2020 K Street NW

Washington, DC 20006-1806
[phone] Counsel for Amicus Curiae Of Counsel: Maxim H. Waldbaum
Julie Busch
Henry L. Mann

SchiffHardinLLP

900 Third Ave 23rd Floor
New York, NY 10022 [phone]

12

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TABLE OF CONTENTS

TABLE OF AUTHORITIES

»

I. INTEREST OF THE AMICUS CURIAE

l

II. THE PTO FINAL RULES ARE INCONSISTENT WITH LAW AND OTHERWISE
UNSUPPORTABLE

3

A. The Paris Convention Limits The PTO'S Authority To Restrict Divisional
Patent Applications

3

B. The Patent Act Does Not Confer Substantive Rulemaking Authority

Upon The PTO

'

4

C. The PTO Is Without Authority To Make The Final Rules Retroactively
Applicable

8

D. The PTO Final Rules Place Arbitrary and Capricious Limitations On The Number Of Continuations, Divisionals, And RCEs E. The Exception Of Final Rule 1.78 Is Illusory
III. CONCLUSION

9
11
12

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TABLE OF AUTHORITIES
Page

CASES

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd, 344 F 3d 1359
(2003)

10

Symbol Technologies, Inc. v. Lemelson Medical, Education and Research
Foundation. 277 F.3d 1361 (2002)
OTHER AUTHORITIES

10

Ayal Sharon and Yifan Liu, Improving Patent Examination Efficiency and Quality: An Operations Research Analysis of the USPTO, Using Queuing Theory, 17 Fed. Cir. Bar J. 2, (2007)
FICPIEXCO/ES07/RES/003 (Nov. 2007) Patent Reform Act of 2005, H.R. 2795
Patent Reform Act of 2006, S. 3818
Substantive Patent Law Treaty,

9
3 5
5

http://www. wipo. int/patent/law/en/harmonization. htm
USPTO Performance and Accountability Report: Fiscal Year 2007
USPTO Performance and Accountability

2
1
1

Report: Fiscal Year 2007, Nov. 15,2007
NYX50231930.4

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CERTIFICATE OF SERVICE

I hereby certify that on this 2nd day of January 2008,1 filed the foregoing BRIEF OF AMICUS CURIAE FEDERATION INTERNATIONALE DES CONSEILS EN PROPRIETE INDUSTRIELLE IN SUPPORT OF THE PLAINTIFFS' ANTICIPATED MOTIONS FOR SUMMARY JUDGMENT with the Clerk of the Court and served a true and correct copy to the
following by email:

Elizabeth M. Locke Kirkland & Ellis LLP
655 15th Street, NW Suite 1200

Washington, DC 20005

Email: [e-mail]
and

Craig C. Reilly

Richard McGettigan Reilly & West PC 1725 Duke Street Suite 600 Alexandria, VA 22314 Email: [e-mail]
Counsel for GSK Plaintiffs
Joseph Dale Wilson, III

Kelley Drye & Warren LLP Washington Harbour 3050 K Street NW Suite 400 Washington, DC 20007 Email: [e-mail]

Counsel for Plaintiff's Tafas
Lauren A. Wetzler

United States Attorney's Office
2100 Jamison Ave.

Alexandria, VA 22314 Email: [e-mail]
Counsel for the Defendants

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Thomas J. O'Brien
Morgan, Lewis & Bockius

1111 Pennsylvania Ave., NW Washington, DC 20004

Email: to'[e-mail]

Counsel for Amicus American Intellectual Property Lawyers Association
Dawn-Marie Bey

Kilpatrick Stockton, LLP
700 13th Street, NW, Suite 800 Washington, DC 20005 Email: [e-mail]

Counsel for Amicus Hexas, LLC, The Roskamp Institute, Tikvah Therapeutics, Inc.
James Murphy Dowd

Wilmcr Cutler Pickering Hale & Dorr LLP
1455 Pennsylvania Ave., NW Washington, DC 20004

Email: [e-mail]

Counsel for Amicus Pharmaceutical Research and Manufactures ofAmerica
Rebecca Malkin Carr

Pillsbury Winthrop Shaw Pittman LLP
2300 N St NW

Washington, DC 20037

Email: [e-mail]
and

Scott Jeffrey Pivnick

Pillsbury Winthrop Shaw Pittman LLP 1650 Tysons Blvd, Suite 400 McLean, VA 22102 Email: [e-mail]

Counselfor Amicus Elan Pharmaceuticals, Inc.

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Randal Karl Miller Arnold & Porter LLP

1600 Tysons Blvd., Suite 900 McLean, VA 22102 Email: [e-mail]

Counsel for Amicus Monsanto Company
Charles Gorenstein Michael K. Mutter

Birch, Stewart, Kolasch and Birch, LLP 8110 Gatehouse Rd., Suite 100 East
Falls Church, Virginia 22042 Email: [e-mail]

Counsel for Amicus Intellectual Property Institute of the William Mitchell College of Law
Robert E. Scully, Jr. Stites & Harbison PLLC

1199 North Fairfax Street, Suite 900 Alexandria, Virginia 22314 Email: [e-mail]

Counsel for Amicus Human Genome Sciences, Inc. Federation Internationale Des Conscils En
Propriete Industrielle

R. Danny Huntington (VA Bar# 16407) Bingham McCutchen LLP 2020 K Street NW Washington, DC 20006-1806
[phone]

Counsel for Amicus Curiae