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					COMMITTEE NO. 1004            Chris Steinhardt, Chair

CHEMICAL PRACTICE

Scope of the Committee: Monitors, considers and reports on and makes recommendations
concerning matters relating to the intellectual property protection of chemical inventions
involving compositions of matter and processes for making and using them. Included are
consideration of proposed changes to statutes that affect chemical inventions and patents relating
to chemical subject matter. In addition, problems arising out of the rules of practice and
procedures in the United States Patent and Trademark Office relating to chemical inventions are
considered. The committee also studies and makes recommendations with respect to
international protection for chemical inventions.

Subject 1.     RESTRICTION PRACTICE IN TC1600 OF THE USPTO.

PROPOSED JOINT RESOLUTION 1001-1; 1002-1; 1003-1; 1004-1.

RESOLVED, that the Section of Intellectual Property Law of the American Bar Association

endorses the TC1600 Restriction Practice Plan of the United States Patent and Trademark Office

and urges the Office to adhere to the Guidelines for Restriction Practice for inventions relating to

genetic sequences, protein sequences, and Markush groups of chemical structures as the policy

for patent examinations as outlined in Chapter 800 of the Manual for Patent Examining

Procedure and in the Office's guidelines set forth in Examination of Patent Applications

Containing Nucleotide Sequences, 1192 O.G. 68 (November 19, 1996).


Past Action. None.


Discussion. The resolution is the result of a conference in Division X regarding the current state
of affairs relating to the way applications encompassing subject matter within the scope of the
four member committees of the Division are subject to restriction practice by USPTO examiners.
The Committees of the Division note that it is not uncommon for biotechnology and chemical
inventions to receive multiple restriction requirements before substantive examination is
undertaken by the Office. Furthermore, the number of separate inventions into which many such
applications are being restricted does not follow the guidelines and the supporting statutes set
forth in the relevant chapter of the MPEP and amounts to an intolerable burden on applicants
regardless of their financial means.

On October 6, 2003, the U.S. Patent and Trademark Office announced an "action plan" aimed at
improving patent quality and responding to concerns by applicants and the patent bar as related
to the rampant use by examiners of restriction practice and requiring excessive restriction. While

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the Committees believe that, although the plan contains no specific, positive steps forward,
instructing the examiners to abide by applicable laws and regulations, it is a welcome move by
TC1600. This move by the Office is at least a recognition of an existing problem. The
Committees are pleased that when this issue was raised at the Section's Mid-Winter Meeting in
January, 2003, it found a receptive audience in the USPTO leadership present at the Meeting.

As summarized by the Office and the press, the highlights of the five-point action plan are
described below:

       1.     Examples will be published of claim sets that currently do not place a serious
              burden on PTO examiners so that applicants can prepare applications to avoid
              restriction requirements.

       2.     Applicants and examiners will be encouraged to focus on rejoinder practice, an
              alternative to filing a new application for certain claim sets that have been
              restricted.

       3.     Training will be provided to TC1600 examiners to analyze and recognize claims
              sets that should be examined together, and to apply restriction practice in
              accordance with applicable law.

       4.     A "second pair of eyes" will be provided to review restriction decisions made by
              examiners to promote consistency.

       5.     The action plan will be continuously reassessed to ensure that it meets the needs
              of customers and PTO.

It is of note that, in announcing the action plan, USPTO officials emphasized that restriction is
discretionary with the examiners - pointing to an ongoing need of vigilance by patent applicants
and their representatives. The Committees will continue to monitor restriction practice in the
USPTO.

Subject 2.    SURVEY OF RECENT DEVELOPMENTS.

SUBCOMMITTEE A Ryan E. Melnick, Ph.D., Subcommittee Chair

UNITED STATES PRACTICE

A summary of noteworthy Court of Appeals for the Federal Circuit decisions reported in 2003
and affecting Chemical Practice is set forth below.

1.     Apotex, Inc. v. Thompson, 347 F.3d 1335, 68 U.S.P.Q.2d (BNA) 1725 (Fed. Cir. 2003).

Generic drug manufacturer, Apotex, filed an abbreviated new drug application (ANDA) for a
bio-equivalent of the anti-depressant, Paxil in March 1998. SmithKline Beecham was the holder
of the approved new drug application (NDA) for Paxil. At the time of the ANDA filing, only
one SmithKline patent was listed in the Orange Book for Paxil. Apotex submitted a Paragraph
IV certification for the listed patent, indicating that Apotex‘s proposed generic drug would not

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infringe the listed patent. SmithKline filed an infringement suit against Apotex, triggering an
automatic 30-month stay against the FDA approving Apotex‘s ANDA. Subsequently,
SmithKline obtained two more patents, which it asserted to the FDA covered Paxil. The FDA
listed those patents in the Orange Book and required Apotex to submit additional certifications
for the patents. Apotex filed this suit against the FDA and SmithKline asserting that the newly
listed patents did not cover Paxil and should be de-listed.

Subsequent to the filing of this lawsuit, SmithKline obtained several additional patents that it
submitted to the FDA for listing in the Orange Book. One patent was submitted in connection
with an NDA supplement for Paxil. The FDA listed all of these patents in the Orange Book and
required Apotex to submit additional certifications. SmithKline sued on the additionally listed
patents, which resulted in additional 30-month stays. Apotex amended its complaint in this suit
to also request de-listing of the additional patents. The district court dismissed the claim against
the FDA for failure to state a claim upon which relief could be granted.

The Federal Circuit affirmed, holding that

       Because we find nothing in the Hatch-Waxman Act that supports Apotex‘s
       argument that the FDA has a duty to screen Orange Book submissions by NDA
       applicants and to refuse to list those that do not satisfy the statutory requirements
       for listing, we conclude that the agency‘s interpretation of the Act set forth in 21
       C.F.R. § 314.53(f) is a reasonable one: that the Act does not require it to police
       the listing process by analyzing whether the patents listed by NDA applicants
       actually claim the subject drugs or applicable methods of using those drugs.

The Federal Circuit also upheld the FDA‘s practice of requiring new certifications by an ANDA
filer when additional patents are listed in the Orange Book subsequent to filing of the ANDA.
The FDA‘s practice of listing patents in the Orange Book when filed under a supplemental NDA
was also upheld.

2.     Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 65 U.S.P.Q.2d (BNA) 1481 (Fed.
       Cir. 2003)

Apotex filed for ANDA approval of the drug gabapentin. Warner-Lambert held the NDA that
approved the use of gabapentin to treat epilepsy. Warner-Lambert‘s patents, directed to the
compound itself and its use to treat epilepsy, had expired. Warner-Lambert also held a non-
expired patent directed to the use of gabapentin to treat neurodegenerative diseases. Upon
Apotex‘s ANDA filing, Warner-Lambert sued for infringement of the neurodegenerative use
patent under 35 U.S.C. § 271(e)(2)(A) and 35 U.S.C. § 271(b).

The Federal Circuit held that Warner-Lambert had no cause of action under 35 U.S.C. §
271(e)(2)(A) because the use for which the FDA granted approval in the NDA was no longer on
patent. Upon statutory construction of 35 U.S.C. § 271(e)(2)(A), the Court held that ―it is not an
act of infringement to submit an ANDA for approval to market a drug for a use when neither the
drug nor that use is covered by an existing patent, and the patent at issue is for a use not
approved under the NDA.‖



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The Federal Circuit also held that Apotex was not liable for inducing infringement under 35
U.S.C. § 271(b) by filing for its ANDA. Despite the fact that some gabapentin sold by Apotex
would likely be used to treat neurodegenerative diseases, the Court held that ―the request to make
and sell a drug labeled with a permissible (non-infringing) use cannot reasonably be interpreted
as an act of infringement (induced or otherwise) with respect to a patent on an unapproved use,
as the ANDA does not induce anyone to perform the unapproved acts required to infringe. That
a generic maker may someday induce someone to infringe can only be determined when that act
occurs, and § 271(e)(2) was not designed to cover such future acts.‖

3.     Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 66 U.S.P.Q.2d (BNA) 1225 (Fed. Cir.
       2003).

Allergan held an NDA for using the drug brimonidine to reduce intraocular pressure. There is no
patent coverage of brimonidine itself or its use to treat intraocular pressure. Brimonidine is
commonly used to treat open-angle glaucoma. For years, the accepted belief of the medical
profession was that open-angle glaucoma was caused by high intraocular pressure. It was later
discovered that open-angle glaucoma might actually be a neurodegenerative disease of the optic
nerve. After this discovery, Allergan obtained two patents for the use of brimonidine. One
patent was directed to protecting the optic nerve and the other was directed to neural protection.

Alcon filed for an ANDA in order to market generic brimonidine. Allergan then sued for
infringement under 35 U.S.C. § 271(e)(2), asserting that Alcon would induce infringement of its
patents by inducing doctors and patients to use brimonidine for the patented uses. The Federal
Circuit noted that generally, inducing infringement claims are permissible under § 271(e)(2).
They stated that ―a patent holder asserting infringement of a patent that claims a FDA-approved
method of use for which an ANDA seeks approval will, in many instances, have to prove
induced infringement.‖ They indicated, therefore, that summary judgment of non-infringement
under § 271(e)(2) is ―inappropriate where the plaintiff can demonstrate the existence of a
genuine issue of material fact with respect to the claim that the ANDA filer will induce
infringement of its patent upon approval of the ANDA.‖

However, in the instant case, the Court held that Allergan‘s action for induced infringement
under § 271(e)(2) was barred as a result of Warner-Lambert Co. v. Apotex Corp., which held that
a method of use patent holder may not sue an ANDA applicant for induced infringement of its
patent if the ANDA applicant is not seeking FDA approval for the use claimed in the patent and
if the use claimed in the patent is not FDA-approved.

4.     Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 67 U.S.P.Q.2d (BNA) 1664
       (Fed. Cir. 2003)

Schering had owned a patent covering the antihistamine loratadine, marketed under the name
Claritin®. Schering also owned a patent directed to a metabolite of loratidine called
descarboethoxyloratadine (DCL). DCL is always formed in the human body when a patient
consumes loratidine. The loratadine patent had expired and several generic drug manufacturers
sought ANDA approval to market loratadine. Schering had listed the DCL patent in the Orange
Book, causing the generic companies to submit a Paragraph IV certification claiming that the
DCL patent was invalid.


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The Federal Circuit found that the loratadine patent inherently anticipated the DCL patent
because DCL was always produced when a patient took loratadine. The Court held that inherent
anticipation ―does not require a skilled artisan to recognize the inherent characteristic in the prior
art that anticipates the claimed invention.‖ Rather, a later factual determination that the
characteristic in question is inherently present is sufficient. The Court further held that a prior
art reference can inherently anticipate a claim even where the prior art does not explicitly
disclose any limitation of the claim. Thus, although the loratadine patent did not disclose any
feature related to DCL, it nonetheless inherently anticipated the DCL patent. The Court stated,
―[i]n general, a limitation or the entire invention is inherent and in the public domain if it is the
‗natural result flowing from‘ the explicit disclosure of the prior art.‖ Finally, the Court held that
the loratadine patent was an enabling disclosure of DCL even though it did not describe how to
make DCL in its isolated form from loratadine. It was sufficient that the loratadine patent
disclosed administering loratadine to a patient, allowing one to practice the loratadine patent to
produce DCL in the human body without undue experimentation.

5.     Glaxo Wellcome, Inc. v. Andrx Pharms, Inc., 344 F.3d 1226, 68 U.S.P.Q.2d (BNA) 1302
       (Fed. Cir. 2003)

Glaxo held a patent to a controlled sustained release formulation of the drug bupropion
hydrochloride, which it marketed as the antidepressant Wellbutrin7SR® and the smoking-
cessation medicine Zyban7®. Andrx filed an ANDA to market generic versions of the drug and
filed a Paragraph IV certification, certifying that it did not infringe Glaxo‘s patent or that the
patent was invalid. Glaxo subsequently sued based on the filing of the ANDA. The claims of
Glaxo‘s patent required the use of hydroxypropyl methylcellulose (HPMC) to control the release
rate of bupropion hydrochloride. A specific range of release rate was also a claim limitation.
Andrx‘s proposed formulation used HPMC, however, they asserted that in their formulation a
polymeric membrane instead of HPMC controlled release rate. Andrx obtained its own patent
directed to its formulation.

Based on the expert testimony, the Federal Circuit found that HPMC affects the release of
materials when it swells in contact with water. There was no evidence that the HPMC in
Andrx‘s formulation did not swell in water. The Federal Circuit first held that proper claim
construction of Glaxo‘s patent did not require that the HPMC have a specific grade or molecular
weight. Next, the Court held that summary judgment of non-infringement was not appropriate
because, the separate patentability of Andrx‘s formulation did ―not automatically negate
infringement‖ and there was a dispute in material fact as to whether the release rate of Andrx‘s
formulation was different as claimed in the Glaxo patent. Thus, the case was remanded for
further proceedings.

6.     Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 347 F.3d 1367, 68 U.S.P.Q.2d
       (BNA) 1857 (Fed. Cir. 2003)

Merck acquired a patent directed to treating urolithiasis and inhibiting bone reabsorption by
administering 4-amino-1-hydroxybutane-1,1-biphosphonic acid. The patent‘s term had been
extended by 1,371 days under 35 U.S.C. § 156 to compensate for the time consumed by
regulatory review and approval by the FDA. Merck marketed the monosodium salt of the 4-
amino-1-hydroxybutane-1,1-biphosphonic acid as Fosamax® for the treatment of osteoporosis
and Paget‘s disease. Teva filed an ANDA and Merck subsequently sued under 35 U.S.C.

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§ 271(e)(2).

Based on intrinsic and extrinsic evidence, the Federal Circuit construed the claims to cover the
acid salt form of the drug as well as the acid, even though the claim language only recited ―acid.‖
Based on this construction, the Court ruled the patent infringed. However, Teva alternatively
challenged the validity of the original patent term extension, arguing that the claim was directed
to the acid while FDA approval was for the acid salt form of the drug. The Federal Circuit noted
that the patent term extension statute defines ―drug product‖ as ―including any salt or ester of the
active ingredient.‖ The court stated that ―[t]he Director of the Patent and Trademark Office is
charged with the decision of whether the patent is entitled to term extension. 35 U.S.C. § 156(d).
The Director determined that the ‗077 patent ‗does claim the active ingredient of the proposed
product,‘ and duly so notified the Secretary.‖ Thus, upon giving ―appropriate deference‖ to the
Director‘s decision, the Court upheld the grant of a patent term extension.

7.     Abbott Labs v. Baxter Pharmaceutical Prods, Inc., 334 F.3d 1274, 67 U.S.P.Q.2d (BNA)
       1191 (Fed. Cir. 2003)

Abbott owned a patent to compositions and methods for preventing the degradation of the
anesthetic sevoflurane by adding an effective amount of a Lewis acid inhibitor. Baxter filed an
ANDA to market generic sevoflurane, filing a Paragraph IV certification that it would not
infringe Abbott‘s patent. Abbott sued for infringement.

The Federal Circuit first held that the claim construction of the phrase ―an amount effective to
prevent degradation‖ was not limited by a prior art sale of sevoflurane containing Lewis acid
inhibitor amounts of up to 131 ppm. The court found that what constitutes an effective amount
of a Lewis acid inhibitor depends on many environmental considerations, including the container
used. Thus, the prior art sale did not limit the claim construction.

The Federal Circuit further held that ―only one Lewis acid inhibitor falls within the claim scope‖
of the claims at issue. Despite the fact that the claims used the transitional phrase ―comprising‖
and called for ―a Lewis acid inhibitor,‖ the court found that using a Markush group of Lewis acid
inhibitors limited the claim to only a single Lewis acid inhibitor. The Court noted that ―a proper
Markush group is limited by the closed language term ‗consisting of.‘‖ Thus, ―only one member
of a Markush group‖ is permitted in a Markush claim. The Court stated that ―[i]f a patentee
desires mixtures or combinations of the members of the Markush group, the patentee would need
to add qualifying language while drafting the claim.‖ However, the Court also stated that ―[t]o
prove literal infringement of these claims on remand, Abbott must show a species selected from
the members of the recited Markush group is present in Baxter‘s sevoflurane composition in an
amount effective to function as a Lewis acid inhibitor.‖ Thus, a possible interpretation of the
holding is that other Lewis acid inhibitors would be permitted as long as one of them is present
in amounts sufficient to be an effective Lewis acid inhibitor if used alone.

8.     Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 68 U.S.P.Q.2d (BNA) 1154 (Fed. Cir.
       2003)

Jansen is the sole inventor and owner of a patent directed to treating or preventing macrocytic-
megaloblastic anemia by administering a combination of folic acid and vitamin B12. Rexall
markets an over-the-counter dietary supplement known a Folic Acid XTRATM containing folic

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acid and vitamin B12 that is labeled and advertised for the maintenance of proper blood
homocysteine levels. The claims at issue indicated that the use of the treatment was for treating
or preventing macrocytic-megaloblastic anemia and called for administering the preparation to a
―human in need thereof.‖

The Federal Circuit held that the claims should be construed such that an infringer must
recognize the need to treat or prevent macrocytic-megaloblastic anemia when administering the
combination. Because there was not sufficient evidence that Rexall‘s customers took Rexall‘s
product in order to treat or prevent macrocytic-megaloblastic anemia, the Court affirmed the
district court‘s grant of summary judgment of non-infringement. The Court stated that ―[u]se of
an over-the-counter product like Rexall‘s is quite different from the use of a product pursuant to
a prescription from a medical doctor. In the latter case, a prescription is evidence of a diagnosis
and a knowing need to use the stated purpose.‖

9.     The Board of Education v. Am. Bioscience, Inc., 333 F.3d 1330, 67 U.S.P.Q.2d (BNA)
       1252 (Fed. Cir. 2003)

A Florida State University research group under the direction of Professor Robert Holden
conducted synthetic work on taxol derivatives. One particular research effort focused on
developing radiosensitizing taxanes by attaching nitro groups in a collaboration with Professor
Li-Xi Yang. Dr. Hossein Nadizadeh, a post-doctoral researcher in the Holden group, worked on
the project. Another group member, Dr. Chunlin Tao, who did not work on the collaborative
project but had exposure to it, eventually left the group to join American Bioscience. Drs.
Patrick Shoon-Shiong and Neil Desai of American Bioscience directed Tao to work on creating
radiosensitizing analogs of taxotere, a compound differing from taxol by having a 10-hydroxy
group in place of taxol‘s 10-acetoxy. Tao synthesized these analogs by adding nitro groups. A
patent covering the analogs issued naming Shoon-Shiong, Desai, Tao, and Dr. Paul Sandford,
another American Bioscience researcher, as inventors. The issue considered by the Federal
Circuit was whether inventorship of the patent should be changed under 35 U.S.C. § 256 to name
Holden, Yang, Nadizadeh, and Tao, removing the other American Bioscience personnel.

The Federal Circuit held that, aside from removing Sandford, which was not contested,
inventorship should not be changed. They noted that only Shoon-Shiong, Desai, and Tao
conceived of having both the taxotere derivative and a nitro group. The Court stated: ―Having in
mind specific portions of a claimed compound is not the same as conceiving the compound with
all of its components. One must have a conception of the specific compounds being claimed,
with all of their component substituents, and the record does not support a finding that Holton or
any of his co-workers conceived the three claimed compounds, all of which lack taxol‘s 10-
acetoxy group.‖ Thus, Holden, Yang, and Nadizadeh‘s contributions of adding a nitro group to
taxanes were not considered to be inventive conception of the claimed compounds.

10.    Chen v. Bouchard, 347 F.3d 1299, 68 U.S.P.Q.2d (BNA) 1705 (Fed. Cir. 2003)

Chen had filed an application directed to taxol derivatives having fluorine in place of taxol‘s 7-
hydroxy group. In the application, Chen described that mixtures of 7-alpha- and 7-beta-
fluorotaxols were produced by his disclosed synthesis. After issuance, Chen discovered that in
fact, his method produced mixtures of 7-alpha-fluorotaxols and 7,8-cyclopropataxols. He
subsequently withdrew his patent from issue and filed a continuation. He was only able to obtain

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claims directed to 7,8-cyclopropataxols after filing a continuation-in-part application. An
interference was declared with Bouchard‘s application, also directed to 7,8-cyclopropataxols.

The Federal Circuit held that Chen‘s original application did not provide written description of
7,8-cyclopropataxols and thus that he was not entitled to the earlier priority date. Despite the
fact that the earlier application disclosed the synthetic method that resulted in 7,8-
cyclopropataxols, the Court noted that Chen‘s original application ―not only [did] not disclose
the structural formulae of any cyclopropataxol derivatives, [it] apparently also [did] not disclose
any analytical data or other characteristics of such derivatives.‖ In distinguishing earlier case
law, the Court stated that ―Chen did not simply misname or incorrectly illustrate the structural
formula of the products that he later asserted were inherently produced; he also failed to disclose
any characteristics of those products that would evidence possession of the invention.‖ After
addressing other evidence related to conception and reduction to practice, the Court affirmed the
Board of Patent Appeals and Interferences decision to grant judgment in the interference to
Bouchard.

This Committee will also look at developments in other major markets of the world regarding
chemical patent practice, as addressed by the following subcommittees:

SUBCOMMITTEE B Gail A. Dalickas, Subcommittee Chair

EUROPEAN PATENT OFFICE PRACTICE

In 2004, the European Union will expand from 15 to 25 members, and by 2007 will add Bulgaria
and Romania. While it is readily apparent this growth has many implications for Europe and the
world, in economic, social and political terms, patent practitioners must also prepare for the
ramifications of this growth for intellectual property laws and enforcement.

New EU member states will be members of the European Patent Convention. Although
European Community trademarks and design protection will automatically extend into new EU
member states, European patents will not. Moreover, members of the EPC are not necessarily
members of the EU; Switzerland, Liechtenstein, Monaco, Turkey, Bulgaria, Romania, Albania,
and the Former Yugoslav Republic of Macedonia are EPC members that are not EU member
states. One country that does not show signs of imminently joining the EPC is Malta, which is of
interest for reasons discussed below.

Of relevance to patent practitioners in the chemical and pharmaceutical arts is the doctrine of
patent exhaustion. In contrast to the doctrine of patent exhaustion in the United States, patent
exhaustion in the EU is regional, rather than national. Simply stated, once a patentee, or
someone authorized by the patentee, has marketed a patented product anywhere in the region
comprising the EU the EFTA states (Iceland, Norway and Liechtenstein), the patent rights in that
product have been exhausted everywhere in the region, regardless of whether or not the state in
which the product was marketed is one in which the patentee has patent protection.

Regional patent exhaustion is a direct consequence of the common European market. Because
provisions of the EC treaty prohibit quantitative restrictions on imports between member states
other than for specific purposes including the ―protection of industrial and commercial property,‖
the European Court of Justice has concluded that although patent rights can be exerted in such a

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way as to impose quantitative restrictions on imports, such restrictions can only be imposed
based on what the Court called the specific nature of the patent right. The nature of the patent
right, the Court said, is the exclusive right of the patentee to manufacture and sell a patented
product, either directly or through a licensee, and to take action against infringers. A stated
objective of the limitation on the exertion of patent rights is to avoid restricting trade among
member states.

Exceptions and modifications to patent exhaustion have been created, for example, when new
member states have joined the EU. One provision (Act of Accession, Article 22, Annex IV, Title
I) provides that a holder of a patent for a pharmaceutical product in a member state, for which an
application was filed at a time when such protection was not available in the Czech Republic,
Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, may rely on patent protection
in the member state, even if such patent holder has already placed the patented product on the
market in one of the listed states by the patentee or with the consent of the patentee. Thus, there
is a loophole to patent exhaustion upon joining of the EU for certain new member states.
Whether a patentee from a particular state on the list can enjoy that loophole depends, of course,
on when and whether parent protection for pharmaceutical products will or has become available
in the particular state. A person intending to import or sell a pharmaceutical product covered by
this provision must give the patent holder one month notice prior to such sale or importation.
The motivation for this provision is unclear, since it amounts to giving notice of one‘s intent to
infringe a patent. There is no indication whether the failure of a patentee to act in response to
such notice constitutes a forfeiture of any later rights of enforcement.

Patent activity in Malta is essentially limited to pharmaceuticals, and 90 percent of Maltese
pharmaceutical patents are owned by Pfizer. While there is no domestic manufacturing in Malta
to speak of, there is pharmaceutical trade.

Malta and Cyprus are not in the list of states to which the above exception to patent exhaustion
for pharmaceutical products applies. Thus, previous sales in Malta or pharmaceutical products,
which sales were carried out or authorized by a patentee, will exhaust patent rights in the
products. One can envision that Malta might serve as a point of import for generic
pharmaceutical products for later importation into other EU states where patent rights will have
been exhausted by prior sales in Malta. It is notable that the exception, and thus the exception to
the exception, applies only to patents for pharmaceutical products.

What exactly is a pharmaceutical product is somewhat open to interpretation on a case-by-case
basis, and it is apparent that the definition of ―pharmaceutical‖ in the EPO is not entirely clear-
cut. While the term may be broadly applied in a regulatory sense, it appears the EPO defines
pharmaceutical products with respect to their effects on disease states. It is also unclear what is a
―patent for a pharmaceutical product.‖ For example, a patent for a process for making a
pharmaceutical product may, or may not, be a patent for a pharmaceutical product.

Unfortunately, this summary of patent exhaustion and some of the nuances associated with EU
expansion provides few answers, as do the relevant EU regulations. At the very least, holders of
patents to pharmaceutical products—defining the term broadly until a court addresses the issue—
would be prudent not to sell in Cyprus or Malta (or at least not to sell below a price that could be
commanded in a country where the products are covered by patent protection). It would also be
advisable, if one is intending to sell a pharmaceutical product in one of the Czech Republic,

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Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, to negotiate agreements
whereby the product is not to be exported into other EU member states, to provide evidence that
such sales, if conducted, are not with the patentee‘s consent. The outcome of eventual litigation
of issues such as those raised here is likely to be interesting as well, since under the provisions of
the European Council Regulations, cases can be litigated in courts in any member state.

SUBCOMMITTEE C John C. Todaro, Subcommittee Chair

JAPANESE PRACTICE

This is an update on recent patent law developments in Japan, which are of special concern to
chemical patent practitioners.

New Japanese Unity of Invention Rules

Effective January 1, 2004, Japan has changed its unity of invention law (Section 37 of the
Japanese Patent Law) to harmonize with PCT practice. Under the law in effect in Japan prior to
January 1, 2004, unity of invention required that there be a relationship between the main
independent claim and each of the remaining claims. A single general inventive concept was not
required, and application of the unity of invention law was complex.

The new unity of invention law requires that unity of invention be judged by examining whether
all claims have common ―technical features that define a contribution that each of the inventions
makes over the prior art.‖ The new law will permit examination of more than one invention in a
single application, if the inventions ―are so linked as to form a single general inventive concept.‖

In examination guidelines issued under the new law, the Japanese Patent Office (JPO) stated that
the new law will permit prosecution of a product and a method of using it (e.g., ―substance A‖
and ―a method of killing insects with substance A‖) in a single application. The guidelines also
stated that claims to an intermediate and a final product may be examined in a single application,
provided that the intermediate and final product ―have the same or technically closely related
structural element,‖ and ―the chemical structures of both products are technically closely related
to each other.‖

Employee Inventor Suits

Since the 1980‘s, there have been a growing number of lawsuits in Japan brought by inventors
against their employers, alleging that employers have failed to adequately indemnify employees
for the full scope of the invention. These lawsuits are supported by Japanese statutes, which
state that inventions are owned by the inventor, and that employees who are inventors have the
right to ―adequate remuneration from their employers.‖ (Japanese Patent Law § 35(3)) The
Japanese law provides that factors used to calculate the adequate remuneration include ―the
amount of profit that the employers will receive from said invention,‖ and ―the degree of
contribution from the employers in creating the invention.‖ (Japanese Patent Law § 35(4))

In some of these lawsuits, Japanese courts have awarded large amounts of damages to inventors.
The awards are based on the theory that inventors have not been adequately remunerated (as


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required by the statute), based on salaries and other compensation, for commercially successful
inventions.

Many in the intellectual property community have asserted that these lawsuits upset the
intellectual property rights of employers, and thus are harmful to the Japanese IP system.

In December 2003, a Japanese government IP policy committee from the Japanese Ministry of
Economy, Trade and Industry, issued a report on the employee inventor lawsuits. In its report,
the Committee urged that the Japanese law be amended with the goal of leaving the matter of
remuneration for employees‘ inventions to an independent determination between the parties.
The Committee report focused in part on the concept of ―adequate remuneration.‖ The report
suggested amendments to the law that would have the effect of making the courts give greater
consideration to the contribution of employers after completion of the invention, including
―executing patent application procedure, developing technologies for exploitation of the
invention, conducting sales, advertising and undertaking license negotiations, as well as
contributions to creation.‖ The report cited employer contributions such as ―improvement
activities, sales expenses, advertising expenses, and other contributions after completion of the
invention,‖ which should be factored in the determination of whether the remuneration of the
inventor was adequate.

It is expected that a bill will be introduced in the Japanese Diet sometime in 2004, to enter the
Committee‘s proposed revisions into Japanese law.

Japanese Patent Office Fee Reductions

Japan has introduced a new law revising its fee structure for applications filed after April 1,
2004. Under the new law, the basic application fee is reduced from ¥21,000 to ¥16,000.
However, the basic request for examination fee is doubled, from ¥84,300 to ¥168,000, with
additional fees based on the number of claims.

Also, the annuity fees are significantly decreased under the new law. For example, the annuity
fees for the first through third year will be approximately one fifth of the present annuity fee.

The new law permits an applicant to obtain a partial refund of the examination fee, if the
application is withdrawn prior to examination.

New Patent Invalidation Appeal Procedure

Japan has instituted a new patent invalidation system, effective January 1, 2004. Under the
invalidation system in effect before 2004, Japanese patents could be subject to an opposition,
which was an ex parte procedure before the Japanese Patent Office filed within six months of the
issue date, and an invalidation trial system, which was an inter partes procedure, also before the
Japanese Patent Office.

Under the new invalidation appeal procedure, a third party appellant may bring an action to
invalidate a patent at any time. Under the new procedure, the appeal may be maintained on the
grounds of lack of novelty or inventive step, misappropriation of right, or various other grounds.


                                               11
In most cases, the appellant has the right to demand a trial. The appeal involves an oral
proceeding, and either party has the right to appeal to the Tokyo High Court.

The new law also provides that during an appeal, the Japanese Patent Office may provide a
statement to the Tokyo High Court concerning the appeal (provided that the statement is
requested by Tokyo High Court).

In connection with this new invalidation appeal, the law restricts the rights of patentees to file for
a ―correction of patent‖ (in which the patentee may amend the claims to reduce the scope of the
claims) to within 90 days of patent issue.

Duty of Disclosure in Japan

Japanese law was revised effective September 1, 2002, to introduce a duty of disclosure
requirement. Under the Japanese duty of disclosure rules, however, failure to disclose a
reference cannot be used as a reason for invalidation of a patent. More recent revisions, effective
January 1, 2004, have permitted the filing of relevant references by a third party after a patent
issues. The references may be submitted anonymously.

SUBCOMMITTEE D Peter R. Wilcox, Subcommittee Chair

CANADIAN PRACTICE

General Patent Practice Amendments

Amendments to the Canadian Manual of Patent Office Practice (MOPOP) were made in
September 2003. Chapter 19: Amendments to Patent Applications was amended to provide
further guidance to patent practitioners relating to the form and types of amendments that can be
made during prosecution of an application. The amendments also emphasize several Rules which
previously have not been strictly adhered to during prosecution but for which the penalty for lack
of response/completion can result in abandonment of a pending application.

Suggested templates for correspondence to the Patent Office were provided in the amendments.
For example, it is recommended that all correspondence outline in headings the nature of the
amendments being addressed.

The amendments to Chapter 19 included a list of reasons for which the Patent Office may
consider that an applicant has failed to reply in good faith to an examiner‘s requisition. Failure to
do so may result in abandonment of an application in accordance with Paragraph 73(1)(a) of the
Patent Act. The reasons include:

       (a)     failing to provide a response that corrects all the defects identified by the
               examiner, or failing to make satisfactory amendments to avoid the objections;

       (b)     reintroducing subject matter previously removed to overcome an Examiner‘s
               objection;

       (c)     adding informal or other obviously objectionable claims;


                                                 12
       (d)     failing to provide a response to a requisition for information, under section 29 of
               the Patent Rules, pertaining to the status of corresponding applications in foreign
               jurisdictions, including listing art cited in such prosecution;

       (e)     failing to provide a certified copy and proper certification of a previously
               regularly filed application following a requisition under section 89 of the Patent
               Rules; and

       (f)     failing to include in the description the date of the original deposit within the
               International Depositary Authority (IDA) following a requisition under subsection
               104.1 of the Patent Rules.

Case Summaries:

1.     GlaxoSmithKline Inc. v. Genpharm Inc. [2003] F.C.J. No. 1582 (Fed. T.D.)

The Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations") are
modeled on the U.S. Hatch-Waxman Act.

In this case under the PMNOC Regulations, GlaxoSmithKline ("GSK") sought an order
prohibiting the Minister of Health from issuing a Notice of Compliance ("NOC") to Genpharm
Inc. ("Genpharm") until the expiry of its Canadian Patent 1,287,060 (the "060 patent"). GSK's
060 patent related to paroxetine hydrochloride, a serotonin reuptake inhibitor used in the
treatment of depression and anxiety. Genpharm sought the issuance of an NOC in relation to its
tablets of paroxetine hydrochloride. Genpharm asserted that its compound did not infringe the
060 as the 060 Patent covered the hemihydrate form, and Genpharm's compound was in the
anhydrate form.

At issue was: 1) if the Notice of Allegation ("NOA" – similar to a "certification letter" under
Hatch-Waxman) filed by Genpharm was valid; 2) how the 060 patent claim in issue was to be
construed; 3) whether Genpharm's allegation that the 060 patent was invalid was justified; and 4)
whether Genpharm's allegation that its product would not infringe the 060 patent was justified.

With respect to the validity of the NOA, GSK argued that the NOA must set out the entire
factual basis to assert invalidity and non infringement. Since the evidence tendered by Genpharm
was not set out in the NOA, GSK argued that the NOA was deficient. Further, GSK argued that
the NOA was deficient since the NOA did not identify the specific sections of the Patent Act
Genpharm intended to rely on. Genpharm argued that the NOA contained sufficient detail for
GSK to know the real grounds of their allegations, and further that they should be allowed to file
evidence to reply to GSK's evidence and argument. The court held that the NOA set out
sufficient detail and was valid because a) it raised allegations of invalidity relating to anticipation
and obviousness, b) it raised the issue of non-infringement, and c) the substance of the relevant
section of the Patent Act was included, and failure to identify the section specifically was not
fatal.

With respect to how the 060 patent should be construed, only one patent claim was in issue. The
claim read as follows: "Crystalline paroxetine hydrochloride hemihydrate.‖ Applying the
"purposive approach" to construing patents, as outlined by the Supreme Court of Canada in
Whirlpool Corp. v. Camco Inc. [2002] 2 S.C.R. 1067 and Free World Trust v Electro Santé Inc.

                                                  13
[2000] 2 S.C.R. 1024, the court stated that it had to identify the essential elements of the claim.
To do so, the court held that it must look at the entirety of the patent, including the disclosure,
which identified the detection methods used by GSK in discovering the compound. Genpharm
argued that only the detection methods identified in the disclosure could be used in construing
the patent for to use any other methods would be to allow use of after-acquired knowledge which
would expand the scope of the monopoly granted by the patent. The court held that based on the
expert evidence, a worker skilled in the art would have knowledge of both the hemihydrate and
anhydrate form of the compound. Further, the court held that detection methods in addition to
those identified in the disclosure could be used in construing the claim. However, since the
purpose of granting the patent to GSK was that the hemihydrate form was more stable, it was
inappropriate to interpret the claim as covering "miniscule and minute amounts of crystalline
paroxetine hemihydrate.‖ The claim was held to mean "crystalline paroxetine hydrochloride
hemihydrate when it is found in a drug in sufficient quantity that it improves the handling
properties of such drug during manufacture.‖

Genpharm advanced two grounds of invalidity: a) obviousness, and b) anticipation. With respect
to both grounds, Genpharm introduced evidence relating to the prior art, specifically U.S. patent
4,007,196 disclosing a class of compounds that were 5-hydrotryptamine inhibitors, and two
academic articles describing paroxetine hydrochloride. Dealing with obviousness, the court
applied the test from Beloit Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.)
(whether a person of ordinary skill in the art would have come directly and without difficulty to
the solution taught by the patent) and held that based on the expert evidence, the prior art did not
indicate "the way in which to create, notice, and document the benefits of the hemihydrate
form.‖ Accordingly, the patent was not invalid on the basis of obviousness. Dealing with
anticipation, the court held that based on the expert evidence no single prior publication
disclosed the hemihydrate form. Accordingly, the patent was not found to be anticipated.

Finally, with respect to the issue of infringement, GSK argued that any evidence of hemihydrate
in Genpharm's product would constitute infringement. GSK conducted tests of Genpharm's
product, and supported its position by adducing expert evidence which suggested that
Genpharm's product contained varying degrees of hemihydrate. Genpharm attacked the testing
methodologies used by GSK's experts. The court held that doubt was cast on the validity of the
tests carried out by GSK, not only by Genpharm's experts but also by one of GSK's own experts
in cross-examination.

2.     GlaxoSmithKline Inc. v. Apotex Inc. [2003] F.C.J. No. 886 (Fed. T.D.)

In this case under the PMNOC Regulations, GlaxoSmithKline ("GSK") sought an order pursuant
to § 6(1) prohibiting the Minister of Health from issuing a Notice of Compliance ("NOC") to
Apotex Inc. ("Apotex") for the drug paroxetine hydrochloride until the expiry of its Canadian
Patent 2,214,575 (the "575 patent"). GSK's 575 patent relates to a dry granulation direct
compression formulation of paroxetine hydrochloride marketed as Paxil ®. In particular, the 575
patent related to a "pink hue" problem that developed on some tablets using the prior art
formulation. This new formulation of the drug, whereby microcrystalline cellulose (a commonly
known excipient) was absent from the formulation, solved the pink hue problem. Apotex alleged
in their Notice of Allegation ("NOA") that their product did not infringe the 575 patent, and that
the 575 patent was invalid.


                                                14
At issue was: 1) the proper construction of the claims of the 575 patent; 2) whether Apotex's
product infringed the 575 patent; and 3) whether the 575 patent was invalid on the grounds of
anticipation, obviousness, or on account of double patenting.

With respect to how the claims should be construed, the nexus of dispute related to the
appropriate meaning of the terms "paroxetine" and "paroxetine formulation.‖ GSK argued in
favor of a broad interpretation which would include not only hemihydrate forms, but also "any
salt or crystal form including paroxetine hydrochloride anhydrate.‖ Apotex argued in favor of a
narrow interpretation which would only include the hemihydrate form, and further, that the terms
were avoidably ambiguous. The court applied the "purposive approach" of claim construction
and determined that the proper construction of the claim would not include the anhydrate form of
paroxetine hydrochloride. This holding was based on three principle findings: first, that the
evidence adduced by GSK's experts was simply too general and did not address the meaning of
the terms in the context of the patent; second, that the purpose of the patent was to solve the
intermittent pink hue problem and the patent specification only identified this problem as
affecting the hemihydrate form; and third, that no skilled formulator wishing to produce tablets
containing the anhydrate form would utilize microcrystalline cellulose due to the inherent
instability and hydroscopic nature of the anhydrate form of paroxetine hydrochloride.
Accordingly the claims were construed to "be limited to formulations involving the free base and
hydrochloride hemihydrate forms of paroxetine.‖

With respect to Apotex's allegation of non-infringement, the court held that based on the
construction of the claims of the 575 patent, by shifting to an anhydrate form, Apotex had altered
the essential element of the invention, and therefore did not infringe the 575 patent.

Apotex advanced three grounds of invalidity: a) anticipation, b) obviousness, and c) double
patenting. With respect to anticipation, Apotex adduced evidence of the prior art, specifically
that GSK's 060 patent, disclosed "a paroxetine formulation made by 'conventional methods'
containing 'suitable carriers' utilized in a 'conventional manner'"; and that academic articles had
previously been published which disclosed "paroxetine compacts formulated in the absence of
water and utilizing excipients other than microcrystalline cellulose.‖ The court held that while
the prior art articles did not provide clear and unmistakable directions that would have led a
skilled formulator to the 575 patent, the prior art patents did.

Dealing with obviousness, the court relied on a prior decision in which the same parties had been
litigating substantially similar issues and held that using a dry formulation process to solve the
pink hue problem was not obvious.

Finally with respect to double patenting, GSK argued that since the 1989 amendments to the
Patent Act divisional applications should not be found invalid on account of double patenting. To
this end, GSK asserted that since protection now runs from the date of filing and not the date of
issue, no additional protection is gained from the existence of the second patent. The court
rejected this argument on the basis that the effect of the PMNOC Regulations was that a
mandatory injunction of 24 months is put in place, and that the existence of additional patents
allows the patent-holder to bring additional applications, thereby obtaining multiple injunctive
periods. This coupled with the fact that an inventor should not be able to receive additional
patents for the same invention, and the fact that the 575 patent was an "obvious variant" of the
060 patent led the court to hold that the 575 patent was invalid.

                                                15
3.     AB Hassle v. Genpharm Inc. [2003] F.C.J. No. 1910 (Fed. T.D.)

AB Hassle sought an order prohibiting the Minister of Health from issuing a Notice of
Compliance ("NOC") to Genpharm Inc. ("Genpharm") for the drug Omeprazole until the expiry
of its Canadian Patents 1,292,693 (the "693 patent"), 1,338,377 (the "377 patent"), 2,133,762
(the "762 patent"), and 2,025,668 (the "668 patent"). The 693 patent and the 377 patent are
formulation patents, while the 762 patent and the 668 patent are use patents. With respect to the
two formulation patents, Genpharm alleged invalidity, and with respect to the two use patents,
Genpharm alleged non-infringement.

With respect to the 693 patent, there were 19 claims, all of which were dependant on the first
claim, which related to a pharmaceutical preparation containing: a) a core region (consisting of
inter alia omeprazole, plus an alkaline reacting compound), b) an inert subcoating, and c) an
outer layer comprising an enteric coating. Genpharm alleged invalidity on the grounds of
obviousness, insufficiency, ambiguity and anticipation.

Prior to engaging the invalidity analysis, the court considered the construction of the claims, and
referred to Apotex Inc. v. AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. and The
Minister of Health [2003] F.C.J. No. 1601; 2003 FCA 409 [Note: this case is summarized
below]. In that decision the Federal Court of Appeal had already considered the appropriate
manner in which to construe the 693 patent, and the court adopted that analysis. The court held
that "as a product claim it was not appropriate to look at the disclosure for the purpose of
construction, particularly to vary the scope or ambit of the claim.‖ Accordingly the claim was
construed so as to apply to a "pharmaceutical preparation which, in its finished product form,
contains a subcoating or separating layer between the core and enteric coating, however the
subcoating or separating layer is formed.‖

On the issue of invalidity, with respect to obviousness, the court held that on the evidence before
it, a person skilled in the art would not directly and without difficulty arrive at the invention.
Genpharm accordingly did not meet its burden of establishing that the patent was invalid on the
basis of obviousness. With respect to insufficiency and ambiguity, in applying § 34 of the Patent
Act the court held that the attack was not justified because the evidence showed that the
description was sufficient to enable a skilled person to make the invention. The patent was not
found to be invalid on the basis of insufficiency or ambiguity. Finally with respect to
anticipation, Genpharm relied on a previously issued EP patent. The court held that patent was
not invalidated on the basis of anticipation because a skilled person who read the EP patent
would not learn to apply an "inert" subcoating. The 693 patent was held to be valid.

With respect to the 377 patent, Genpharm alleged that the patent was obvious, and supported its
allegation on the basis of various prior art (two EP patents, a trade publication, and a U.S.
Patent). The court held that the evidence before it established that it was not known from the
prior art that instability existed in the enteric coated solid dosage forms, or that pH was a
causative factor of instability. Moreover, the prior art failed to disclose the use of an alkaline
compound to stabilize omeprazole in the solid state. Accordingly, the 377 patent was held to be
valid.

With respect to the 668 patent, there were 3 claims relating to the use of the drug in the treatment
of H.pylori. Genpharm argued that its drug would be used for the "old" purpose (inhibition of
gastric acid secretion) and thus their product did not infringe the 668 patent. Hassle argued that
                                                16
even if the product was labeled to indicate it should only be used for the "old" use, physicians
and pharmacists would prescribe and dispense the product for the "new" use. The court noted
that under the PMNOC Regulations, infringement of a use patent is not limited to the act of a
generic producer, but also includes infringement by patients. This could be made out where "the
second persons' actions and intentions would inevitably lead to the new use of the first person's
product.‖ With this principle in mind, and on the evidence before it, the court held that if the
NOC was issued, patients would infringe the 668 patent. Accordingly, Genpharm's allegation of
non-infringement was not justified.

Finally, with respect to the 762 patent, there were 77 claims relating to a combination of a
substance which inhibits gastric acid secretion and an acid-degradable antibacterial compound.
The claims for the most part related to either pharmaceutical compositions or synergistic
combinations of compounds such as omeprazole. Both parties relied on the same evidence that
they relied on regarding the 668 patent. The court held that Genpharm's allegation of non-
infringement was not justified.

4.     AB Hassle v. Apotex Inc. [2003] F.C.J. No. 1601 (F.C.A.)

This is an appeal from a decision of the Federal Court Trial Division, between AB Hassle and
AstraZeneca Canada Inc. (collectively "Hassle") and Apotex Inc. ("Apotex"), rendered under the
PMNOC Regulations. The trial judge granted the Application, prohibiting the Minister of Health
from issuing a Notice of Compliance ("NOC") for Apotex's product, Apo-Omeprazole. The trial
judge did not expressly make any finding with respect to the construction of the patent, but found
that the Notice of Allegation ("NOA") was deficient and non-compliant with the Regulations.
Accordingly, Hassle's application was granted, and the Minister was prohibited from granting an
NOC.

At issue on appeal was: 1) whether the trial judge erred by failing to construe the relevant patent,
Canadian Patent 1,292,692 (the "692 patent"); and 2) whether the trial judge erred in finding the
NOA deficient.

With respect to how the 692 patent should be construed, the Federal Court of Appeal noted that
claim construction is a matter of law, and therefore examined the correct construction of the
claims. Apotex argued that the portion of the claim describing the inert subcoating did not cover
"inert material formed between the core and enteric outer layer in situ from reaction between
certain components of the core and enteric outer layer.‖ It was Apotex's position that the claim
only covered subcoating "which is applied to the core and which is then covered by the enteric
outer layer.‖ In support of its position, Apotex relied on the wording of the patent disclosure.

The Court of Appeal held that given that this was a product claim, it was inappropriate to look at
the disclosure to construe the claim. The court noted that on its face, the claim did not purport to
place any limitations on the inert subcoating. For this reason the term "disposed on said core
region" was construed as describing the structure of the finished pharmaceutical product. Since
there was nothing in the claim that purported to place a process limitation on the finished product
preparation, the Court of Appeal construed the claim as meaning a "pharmaceutical preparation
which, in its finished product form, contains a subcoating or separating layer between the core
and enteric coating, however the subcoating or separating layer is formed.‖



                                                17
Since the court had construed the claim in the way that it did, the finding of the trial judge was
upheld (albeit on different grounds) and it was not necessary to decide the issue with respect to
the adequacy of the NOA. In any case, the court stated that that an NOA will be deficient where
the NOA fails to address the relevant patent claims.


Subject 3.     WELDON AMENDMENT.

In addition, this Committee assisted in preparing the report of the Ad Hoc Committee on the
Weldon Amendment to the FY 2004 appropriations bill for the USPTO (H.R. 2799). This report
is included in the report for Committee 1003 – Animals.




                                               18
                                                                              Not
                                                                             Heard     Info
                                                  For   Against   Abstain    From      Only
Joint Resolution 1001-1; 1002-1; 1003-1; 1004-1   34      0         0          6        87

Active Members Approving Report (34):

       Adamo, Kenneth R.                                Meilman, Edward A.
       Aisenberg, Irwin M.                              Ousterhout, Glenn A.
       Bremer, Howard W.                                Phan, Nhat D.
       Dalickas, Gail                                   Reece, Daniel B.
       DiPietro, Mark J.                                Ries, David F.
       Dorchak, Frederick Joseph                        Rumore, Martha M.
       Dziezak, Judie D.                                Schneider, John Edward
       Jacobs, David                                    Shelton, Dennis K.
       Jessum, Kim R.                                   Sorell, Louis Steven
       Kornbau, Anne Miller                             Srivastava, Sonali S.
       Lambert, Nancy M.                                Steinhardt, Paul Christopher
       Lindon, James                                    Todaro, John C.
       Linek, Ernest Vincent                            Tu, Peter
       Mason, Dwayne L.                                 Weilacher, Robert G.
       McDaniel, Terry Bruce                            Welch, Teresa Jean
       McGurk, Michael Robert                           Wilcox, Peter Robinson
       McLeland, Le-Nhung                               Wolfson, Jeffrey A.


Active Members Disapproving Report (0):

       ……

Active Members Abstaining (0):

       ……

Active Members Not Heard From (6):

       Daignault, Ronald Arthur                         Morrison, Joyce L.
       Enin-Okut, Edu E.                                Spevack, David
       Marin, Mark
       Melethil, Sri




                                             19
Information Only Participants (87):

       Anand, Mona                         Muserlian, Charles A.
       Andrus, Alex                        Neth, Joann M.
       Bassler, Marc Benedict              Odar, Helen Ann
       Bauman, Mary P.                     Passe, James G.
       Biscardi, Cynthia L.                Pattumudi, Jay
       Bovee, Warren R.                    Patty, Randel Andrew
       Bovino, Scott Charles               Peev, Iordan Atanasov
       Brown, Anne Rachel                  Petraila, Heather C.
       Bucklin, Douglas                    Pitcher, Edmund R.
       Buratti, Jason R.                   Raber, Nancy K.
       Carmen, Michael E.                  Rabin, Frederick H.
       Cordray, Monique Leone              Renner, Edward H.
       Costanzo, Patricia Marie            Richards, Robert E.
       Curfman, Christopher Lee            Richardson, William H.
       Davis, Garrett V.                   Rigby, Russell J.
       Deleault, Robert R.                 Rufer, Raymond Thomas
       Duncan, Jeffery Maughan             Sarno, Maria Erlinda C.
       Eymard, Frank C.                    Schuler, Daretia M.
       Forstner, James A.                  Schwartz, Carl R.
       Gammill, Martha A.                  Shalloway, Edwin A.
       Gardner, Diane Leigh                Shapiro, Norman M.
       Golota, Mary Elizabeth              Sheehan, John M.
       Goodman, Kenneth D.                 Shetka, Debra Ann
       Graham, Mark Steven                 Shust, Nestor W.
       Guynn, John M.                      Simons, William Andrew
       Hauser, Robert                      Smith, Thomas Barton
       Horwitz, Lester                     Sokal, Allen Marcel
       Jeffers, Jerome L.                  Spector, Eric S.
       Jensen, Allen R.                    Steinkraus, Walter Jerome
       Karczewski, Lisa A.                 Thompson, Mark W.
       King, Kevin Willard                 Timoneda, Jesus Juanos I.
       LaFuze, William L.                  Tripp, Karen Bryant
       Lin, Spring                         Upham, John D.
       Marsh, James H.                     Van Eyl, Diderico
       McCallum, Jennifer Malvey           Vickstrom, Kristina
       McMahon, Eileen                     Walker, Timothy P.
       Meder, Martin G.                    Wendt, Jeffrey Lee
       Michel, Marianne Holland            Westby, Timothy S.
       Mooi, Leslie Ann                    Woodward, David Warren
       Morgan, Elio C.                     Woolley, Patrick C.
       Mosley-Goren, Molly D.              Yeager, Sally Stewart
       Moyer, Terry T.                     Young, Michele J.
       Mueller, Jerry K.                   Zallen, Joseph
       Mueting, Ann Marie



                                      20
Active Members Approving Resolution (34):

      Adamo, Kenneth R.                            Meilman, Edward A.
      Aisenberg, Irwin M.                          Ousterhout, Glenn A.
      Bremer, Howard W.                            Phan, Nhat D.
      Dalickas, Gail                               Reece, Daniel B.
      DiPietro, Mark J.                            Ries, David F.
      Dorchak, Frederick Joseph                    Rumore, Martha M.
      Dziezak, Judie D.                            Schneider, John Edward
      Jacobs, David                                Shelton, Dennis K.
      Jessum, Kim R.                               Sorell, Louis Steven
      Kornbau, Anne Miller                         Srivastava, Sonali S.
      Lambert, Nancy M.                            Steinhardt, Paul Christopher
      Lindon, James                                Todaro, John C.
      Linek, Ernest Vincent                        Tu, Peter
      Mason, Dwayne L.                             Weilacher, Robert G.
      McDaniel, Terry Bruce                        Welch, Teresa Jean
      McGurk, Michael Robert                       Wilcox, Peter Robinson
      McLeland, Le-Nhung                           Wolfson, Jeffrey A.


Active Members Disapproving Resolution (0):

      ……

Active Members Abstaining (0):

      ……

Active Members Not Heard From (6):

      Daignault, Ronald Arthur                     Morrison, Joyce L.
      Enin-Okut, Edu E.                            Spevack, David
      Marin, Mark
      Melethil, Sri




                                              21
Information Only Participants (87):

        Anand, Mona                              Muserlian, Charles A.
        Andrus, Alex                             Neth, Joann M.
        Bassler, Marc Benedict                   Odar, Helen Ann
        Bauman, Mary P.                          Passe, James G.
        Biscardi, Cynthia L.                     Pattumudi, Jay
        Bovee, Warren R.                         Patty, Randel Andrew
        Bovino, Scott Charles                    Peev, Iordan Atanasov
        Brown, Anne Rachel                       Petraila, Heather C.
        Bucklin, Douglas                         Pitcher, Edmund R.
        Buratti, Jason R.                        Raber, Nancy K.
        Carmen, Michael E.                       Rabin, Frederick H.
        Cordray, Monique Leone                   Renner, Edward H.
        Costanzo, Patricia Marie                 Richards, Robert E.
        Curfman, Christopher Lee                 Richardson, William H.
        Davis, Garrett V.                        Rigby, Russell J.
        Deleault, Robert R.                      Rufer, Raymond Thomas
        Duncan, Jeffery Maughan                  Sarno, Maria Erlinda C.
        Eymard, Frank C.                         Schuler, Daretia M.
        Forstner, James A.                       Schwartz, Carl R.
        Gammill, Martha A.                       Shalloway, Edwin A.
        Gardner, Diane Leigh                     Shapiro, Norman M.
        Golota, Mary Elizabeth                   Sheehan, John M.
        Goodman, Kenneth D.                      Shetka, Debra Ann
        Graham, Mark Steven                      Shust, Nestor W.
        Guynn, John M.                           Simons, William Andrew
        Hauser, Robert                           Smith, Thomas Barton
        Horwitz, Lester                          Sokal, Allen Marcel
        Jeffers, Jerome L.                       Spector, Eric S.
        Jensen, Allen R.                         Steinkraus, Walter Jerome
        Karczewski, Lisa A.                      Thompson, Mark W.
        King, Kevin Willard                      Timoneda, Jesus Juanos I.
        LaFuze, William L.                       Tripp, Karen Bryant
        Lin, Spring                              Upham, John D.
        Marsh, James H.                          Van Eyl, Diderico
        McCallum, Jennifer Malvey                Vickstrom, Kristina
        McMahon, Eileen                          Walker, Timothy P.
        Meder, Martin G.                         Wendt, Jeffrey Lee
        Michel, Marianne Holland                 Westby, Timothy S.
        Mooi, Leslie Ann                         Woodward, David Warren
        Morgan, Elio C.                          Woolley, Patrick C.
        Mosley-Goren, Molly D.                   Yeager, Sally Stewart
        Moyer, Terry T.                          Young, Michele J.
        Mueller, Jerry K.                        Zallen, Joseph
        Mueting, Ann Marie

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