2005
International Law Update, Volume 11, Number 6 (June)
Legal Analyses published by Mike Meier,
Attorney at Law. Copyright 2017 Mike Meier. www.internationallawinfo.com.
ALIEN
TORT CLAIMS ACT
In
suit by Nigerian citizens against former dictator, Seventh Circuit rules that
Foreign Sovereign Immunities Act does not apply to individuals and that Torture
Victim Protection Act precludes plaintiffs’ Alien Tort Claims Act claims
The
plaintiffs in this case are surviving Nigerian victims of the military junta
that oppressed Nigeria from November 1993 until May 1999. They allege that
officially sanctioned government crimes took place ranging from torture to
murder.
The
Illinois federal court rejected General Abdulsalami Abubakar’s (defendant’s)
claim that he was immune from suit under the Foreign Sovereign Immunities Act
of 1976 (28 U.S.C. Section 1605) for official conduct taken while he was a
Nigerian public official. Defendant filed this interlocutory appeal. In a
divided vote, the U.S. Court of Appeals for the Seventh Circuit affirms and
remands.
The
Court first notes that “‘[t]he FSIA defines a foreign state to include a
political subdivision, agency or instrumentality of a foreign state but makes no
mention of heads of state.’ ... We noted that the FSIA did not seem to
subscribe to Louis XIV’s not-so-modest view that ‘L’etat, c’est moi.’” [Slip
op. 9] Under 28 U.S.C. Section 1603(a), a “foreign state” includes “a political
subdivision of a foreign state or an agency or instrumentality of a foreign
state.”
In
turn, an “agency or instrumentality of a foreign state” includes a “separate
legal person, corporate or otherwise.” 28 U.S.C. Section 1603(b). Spurning
defendant’s argument that “separate legal person” must include an individual,
the Court declares: “[I]f it was [sic] a natural person Congress intended to
refer to, it is hard to see why the phrase ‘separate legal person’ would be
used, having as it does the ring of the familiar legal concept that
corporations are persons.” [Slip op. 10-11]
Acknowledging
a conflict with the Ninth Circuit on this point, the Seventh Circuit writes,
“We are troubled by this approach – that is, by saying Congress did not exclude
individuals; therefore they are included. Not only does it seem upside down as
a matter of logic, but it ignores the traditional burden of proof on immunity
issues under the FSIA.
“The
party claiming FSIA immunity bears the initial burden of proof of establishing
a prima facie case that it satisfies the FSIA’s definition of a foreign state.”
[Slip op. 12] The Court does concede, however, that some courts have applied
the FSIA to individuals when they are acting in their official capacity.
While
the Seventh Circuit’s interpretation of the FSIA as not affording immunity to
defendant favors the plaintiffs here, the Court’s conclusions about the
relationship between the Alien Tort Claims Act (ATCA) [28 U.S.C. Section 1350]
and the TVPA has the opposite effect. The majority holds that the 1991 Torture
Victim Protection Act (TVPA) [Pub.L. No. 102-256, 106 Stat. 72, 28 U.S.C.
Section 1350 note] precludes the bringing of torture claims under the ATCA.
Congress
intended the TVPA to occupy the field of civil remedies against torture and extrajudicial
killing. “If it did not, it would be meaningless. No one would plead a cause of
action under the Act and subject himself to its requirements if he could simply
plead under international law.” [Slip op. 20]
The
majority also finds some support in Sosa v. Alvarez-Machain, 124 S. Ct. 2739
(2004), See 2004 International Law Update 98. The Circuit Court writes:
“[w]hile there is no explicit statement to this effect in Sosa, the
implications are that the cause of action Congress provided in the Torture
Victim Protection Act is the one which plaintiffs alleging torture or
extrajudicial killing must plead.” [Slip op. 20]
Noting
the Supreme Court’s emphasis that courts should exercise “great caution” when
asked to adapt international law to private rights of action, the Seventh
Circuit reasons that “[i]t is hard to imagine that the Sosa Court would approve
of common law claims based on torture and extrajudicial killing when Congress
has specifically provided a cause of action for those violations and has set
out how those claims must proceed.” [Slip op. 22]
The
Court’s reading of Sosa specifically weakens the plaintiffs’ case because,
unlike the ATCA, the TVPA, contains a preliminary procedural demand that the
claimant has to have “[exhausted] adequate and available remedies in the place
in which the conduct giving rise to the claim occurred.” 28 U.S.C. Section
2(b).
This
might be problematic here because the Nigerian government had persecuted the
plaintiffs or their relatives as political enemies, arguably impeding their
access to justice. The Seventh Circuit remands the case to the district court
to determine whether it should let the plaintiffs file an amended complaint
under the TVPA, and if so, whether they have exhausted “all adequate and
available remedies” within Nigeria.
Citation:
Enahoro v. Abubakar, 2005 WL 1243178; No. 03-3089 (7th Cir. May 23, 2005); news
report by Laolu Akande “Abubakar floored at U.S. Appeal Court: Judges Say Human
Rights Case Against Ex Ruler Can Proceed,” available at www.africanews.com.
AMERICANS
WITH DISABILITIES ACT
In
class action by disabled U.S. citizens against Norwegian Cruise Line, Ltd.,
majority of U.S. Supreme Court narrowly construes “clear statement rule” as to
applicability of Americans with Disabilities Act to foreign ships that ply U.S.
ports so that main principles of Act may apply subject to its own internal
limitations and exceptions as well as to demands of international law
The
respondent (defendant below) is the Norwegian Cruise Line Ltd. (NCL), a Bermuda
Corporation with its principal place of business in Miami, Florida. It operates
cruise ships that regularly set sail for foreign ports from, and return to,
U.S. ports. Basically sea-going resorts, the ships supply passengers with
staterooms or cabins, food, and entertainment. Most of NCL’s passengers are
U.S. residents. As stated on the tickets, U.S. law applies to any controversies
arising between passengers and NCL. NCL also depends upon far-reaching
advertising in the U.S. to publicize its cruises and to enlarge its revenues.
Despite
these close ties to the U.S., NCL registers almost all of its cruise ships in
other countries, flying so‑called “flags of convenience.” The respondent, for
instance, has registered the two NCL cruise ships involved in the present
litigation, the Norwegian Sea (Sea) and the Norwegian Star (Star), in the
Bahamas.
The
petitioners are disabled individuals and their companions who bought tickets in
1998 or 1999 for round‑trip cruises on the Sea or the Star, operating out of
Houston, Texas. Naming NCL as the defendant, the petitioners filed a class
action in a Texas federal court on behalf of all persons similarly situated.
They asked for declaratory and injunctive relief under Title III of the
Americans with Disabilities Act of 1990 (ADA), 42 U.S.C. Section 12181 et seq.
The
petitioners alleged that cruise ships come within both Title III’s ban on
discrimination in places of “public accommodation,” Section 12182(a), and its
bar to discrimination in “specified public transportation services,” Section
12184(a). Both sections demand that covered entities (1) make “reasonable modifications
in policies, practices, or procedures” adaptable to disabled individuals, and
(2) remove “architectural barriers, and communication barriers that are
structural in nature” where such removal is “readily achievable.”
Though
the district court found Title III generally applicable, it concluded that the
petitioners’ claims dealing with physical barriers to access could not go
forward because the federal departments that develop ADA architectural and
structural guidelines had not done so for cruise ships. The court dismissed the
barrier‑removal claims, but denied NCL’s motion to dismiss the petitioners’
other claims.
The
Fifth Circuit held that Title III does not apply to foreign‑flag cruise ships
in U.S. waters. The presumption is that, absent clear indications of
congressional intent to the contrary, generally-worded regulatory statutes do
not apply to foreign‑flag ships. Stressing that Title III contains no specific
provision mandating its application to such vessels, the Circuit Court upheld
the dismissal of the petitioners’ barrier‑removal claims and reversed on their
remaining claims.
The
Fifth and Eleventh Circuits having reached conflicting results as to the
applicability of Title III to foreign cruise ships operating in U.S. waters,
the U.S. Supreme Court granted certiorari to resolve the issue. In a set of
conflicting and concurring opinions on various issues and subissues, a bare
majority of the Court reverses and remands.
Justice
Kennedy announced the Court’s judgment and delivered the opinion of the Court
with respect to Part I (the history of the litigation as summarized above);
Part II‑A‑1, and Part II‑B‑2, in which Justices Stevens, Souter, Ginsburg, and
Breyer joined.
The
majority opinion first points out that Title III of the ADA bars discrimination
against the disabled in the full and equal enjoyment of “public
accommodations,” 42 U.S.C. Section 12182(a), and in “public transportation
services,” Section 12184(a). Various, more specific requirements supplement the
general prohibitions.
Thus,
entities that provide public accommodations or public transportation: (1) may
not impose “eligibility criteria” that tend to screen out disabled individuals;
(2) must make “reasonable modifications in policies, practices, or procedures,
when such modifications are necessary” to provide disabled individuals full and
equal enjoyment; (3) must provide auxiliary aids and services to disabled
individuals; and (4) must remove architectural and structural barriers, or if
barrier removal is not readily achievable, must ensure equal access for the
disabled through alternative methods.
The
majority in Part II-A-1, notes that important exceptions and limitations do
modify the above statutory criteria. “Eligibility criteria that screen out
disabled individuals are permitted when ‘necessary for the provision’ of the
services or facilities being offered.[Cite]. Policies, practices, and
procedures need not be modified, and auxiliary aids need not be provided, if
doing so would ‘fundamentally alter’ the services or accommodations being
offered. [Cite]. Auxiliary aids are also unnecessary when they would ‘result in
an undue burden.’ [Cite].”
“Additionally,
Title III does not impose nondiscrimination or accommodation requirements if,
as a result, disabled individuals would pose ‘a significant risk to the health
or safety of others that cannot be eliminated by a modification of policies,
practices, or procedures or by the provision of auxiliary aids or
services.[Cite].”
“Although
the statutory definitions ... do not expressly mention cruise ships, there can
be no serious doubt that the NCL cruise ships in question fall within both
definitions under conventional principles of interpretation. [Cite] The ...
Fifth Circuit, nevertheless, held that Title III does not apply to foreign‑flag
cruise ships in United States waters because the statute has no clear statement
or explicit text mandating coverage for these ships.”
“This
Court’s cases do hold, ... in some circumstances, that a general statute will
not apply to certain aspects of the internal operations of foreign vessels
temporarily in United States waters, absent a clear statement. The broad clear
statement rule (CSR) adopted by the Court of Appeals, however, would apply to
every facet of the business and operations of foreign‑flag ships. That
formulation is inconsistent with the Court’s case law and with sound principles
of statutory interpretation.” [2176-77]
In
Part II-B-2, Justice Kennedy’s majority opinion also points to Title III as
demanding barrier removal only if it is “readily achievable”. [Cite] The
statute defines that term as “easily accomplishable and able to be carried out
without much difficulty or expense”.[Cite]. Moreover, Title III directs that
the “readily achievable” determination take into account “the impact ... upon
the operation of the facility”. [Cite]
The
opinion then continues. “Surely a barrier removal requirement under Title III
that would bring a vessel into noncompliance with the International Convention
for the Safety of Life at Sea (SOLAS), Nov. 1, 1974, [1979‑1980], [32 U.S.T.
47, T.I.A.S. No. 9700], or any other international legal obligation, would
create serious difficulties for the vessel and would have a substantial impact
on its operation, and thus would not be ‘readily achievable.’ This
understanding of the statute, urged by the United States, is eminently
reasonable.”
“If,
moreover, Title III’s ‘readily achievable’ exemption were not to take conflicts
with international law into account, it would lead to the anomalous result that
American cruise ships are obligated to comply with Title III even if doing so
brings them into noncompliance with SOLAS, whereas foreign ships ‑‑ which
unlike American ships have the benefit of the internal affairs [CSR]‑‑ would
not be so obligated. Congress could not have intended this result.”
“It
is logical and proper to conclude, moreover, that whether a barrier
modification is ‘readily achievable’ under Title III must take into
consideration the modification’s effect on shipboard safety. ... This reference
is to a safety threat posed by a disabled individual, whereas here the question
would be whether the structural modification itself may pose the safety threat.”
“It
would be incongruous, nevertheless, to attribute to Congress an intent to
require modifications that threaten safety to others simply because the threat
comes not from the disabled person but from the accommodation itself. The
anomaly is avoided by concluding that a structural modification is not readily
achievable within the meaning of Section 12181(9) if it would pose a direct
threat to the health or safety of others.” [2180-81]
[In
a plurality opinion approving the language in Part III-A, Justices Stevens,
Souter, and Thomas join Justice Kennedy. This plurality concludes that, if
Title III set up a demand that disrupted a foreign‑flag cruise ship’s internal
affairs, the CSR would come into play. The result would be that the requirement
would continue to apply to U.S. flag ships. Moreover, Title III requirements
having nothing to do with internal affairs would continue to govern domestic
and foreign ships alike. This application‑by‑application approach squares with
how the federal courts have traditionally dealt with the CSR.]
“If
the Court has held that the [CSR] restricts some NLRA applications to foreign
ships (e.g., labor relations with foreign crews), but not others (e.g., labor
relations with American longshoremen), it follows that Title III of the ADA
also demands its case‑by‑case application. The CSR, if it is invoked, would
restrain some applications of Title III to foreign ships (e.g., certain
structural barrier modification requirements), but not others (e.g., the
statute’s ban on discriminatory ticket pricing).”
“The
[CSR] acts as an implied limitation on a statute’s otherwise unambiguous
general terms. It operates much like other implied limitation rules; they
eschew applications of otherwise unambiguous statutes that would trespass on
sensitive terrain in a way that Congress is unlikely to have intended had it
thought about the matter. See, e.g., EEOC v. Arabian American Oil Co., 499 U.S.
244, 260 (1991). An all‑or‑nothing approach would convert the [CSR] from a
principle of interpretive caution into a trap for an unwary Congress. It might
also lead to nullification of the entire statute, or of some arbitrary set of
applications larger than the domain the rule protects.” [2181‑2182]
Citation:
Spector v. Norwegian Cruise Lines, Ltd., 125 S. Ct. 2169 (U.S.S.C. 2005).
ENVIRONMENTAL
LAW
In
dispute over duty of U.S. to carry out environmental clean-up of its abandoned
U.S. bases in Philippines, Ninth Circuit holds that CERCLA generally does not apply
outside U.S. territory
During
1992, the United States vacated the Clark Air Force Base and the Subic Naval
Base in the Philippines. Eight years later, the present plaintiffs
unsuccessfully petitioned the U.S. Air Force and Navy to conduct an environmental
assessment of the bases. The plaintiffs then filed this lawsuit against these
branches, contending that they have been exposed, or are likely to be exposed
to, environmental contamination at the abandoned military bases.
Plaintiffs
alleged that the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), 42 U.S.C. Section 9601 required that the U.S.
investigate and possibly clean up its former military bases. CERCLA (42 U.S.C.
Section 9605(d)) provides that “[a]ny person who is, or may be, affected ...
may petition the President to conduct a preliminary assessment of the hazards
to public health and the environment which are associated ... If the President
has not previously conducted a preliminary assessment of such release, the
President shall ... complete such assessment ...”
The
District Court for the Northern District of California dismissed the complaint
for failure to state a CERCLA claim. The court relied on the canon of statutory
interpretation that legislation of Congress is presumed to apply only within
the territorial jurisdiction of the U.S., unless Congress has indicated
otherwise. The U.S. Court of Appeals for the Ninth Circuit affirms.
The
CERCLA does not generally provide for extraterritorial application. It does,
however, authorize a very limited class of foreign claimants to sue where U.S.
vessels or facilities have released hazardous substances into the navigable
waters, territorial sea or shoreline of the claimants’ country. 42 U.S.C.
Section 9611(l). This, of course, does not help the plaintiffs here.
The
Court then points out that CERCLA Section 9605(d) is silent as to the locations
it covers and who may petition for a preliminary assessment. The plaintiffs,
however, argued that Congress clearly intended to have CERCLA apply to former
military bases. CERCLA’s definition of the “United States” includes “the
several States ... and any other territory or possession over which the United
States has jurisdiction ...” 42 U.S.C. Section 9601(27). The Government
contended that “possession” refers to U.S. property that is not within the
territory of another sovereign nation.
Since
the plaintiffs still have to show that they could state a substantive claim at
the time of filing their action, however, the Court does not have to decide the
issue of scope. “The [plaintiffs] cannot state a claim under CERCLA due to the
... presumption against extraterritoriality. The Supreme Court and this court
have adhered to the longstanding principle of American law that legislation is
presumed to apply only within the territorial jurisdiction of the United States
unless the contrary affirmative intention of Congress is clearly expressed. ...
Courts must assume that Congress legislates with knowledge of the presumption that
a statute ‘is primarily concerned with domestic conditions.’ ...” [...]
“Applying
the presumption against extraterritoriality to the case at bar, we can find no
evidence that Congress expressly (or implicitly) intended to authorize suits
under CERCLA by foreign claimants allegedly affected by contamination occurring
on a U.S. military base located in a foreign country. ...”
“Even
if we were to accept that the language in CERCLA cited by the appellants may be
interpreted as bringing such sites within the geographic reach of the statute,
this would not overcome the statutory presumption against extra-territoriality,
which applies with force and counsels against interpreting CERCLA to provide a
cause of action to foreign claimants such as the appellants. ...” [Slip op.
12-14]
Furthermore,
the plaintiffs did not state a claim that existed when they filed their
lawsuit. After all, the military bases had been under Philippine control for
ten years. Having surrendered possession of the bases, the U.S. no longer has
the authority to do an environmental assessment or clean-up.
Finally,
the plaintiffs contended that the Court should interpret CERCLA to apply
extraterritorially to make it conform to international law. “Perhaps
recognizing the tenuous nature of their claims under domestic law, the
[plaintiffs] suggest that we should interpret CERCLA to apply
extraterritorially so as not to run afoul of international law. The
[plaintiffs] rely on international principles espousing the view that activities
within a country’s jurisdiction or control should not cause significant injury
to the environment of another country. The Restatement ... appears to support
this view. ... RESTATEMENT (THIRD) OF FOREIGN RELATIONS LAW OF THE UNITED
STATES Sections 601-602 (1987).”
“Even
if we were to accept the [plaintiff’s] gloss on international law -- that one
nation should not injure another nation’s environment -- it does not follow
that denying the [plaintiffs] a cause of action as of 2002 violates
international law. The [plaintiffs] offer no authority for the proposition that
international law recognizes a current claim for a preliminary assessment or
cleanup of Philippine territory based on actions taken over a decade ago.”
“Furthermore,
assuming that the United States ‘injured’ the Philippines during its operation
of Clark and Subic, compensation presumably was, or should have been,
negotiated between the two nations when the United States turned the bases over
to the Philippines. Thus, we do not find that the [plaintiffs] have presented
an actual conflict between domestic and international law.” [Slip op. 25-27]
Citation:
ARC Ecology v. U.S. Department of Air Force, 2005 WL 1398736; No. 04-15031 (9th
Cir. June 15, 2005); background on this case is available on website of ARC
Ecology at www.arcecology.org.
EXECUTIVE
AGREEMENTS
In
dispute over attorneys’ fees in Holocaust litigation, Ninth Circuit reverses
lower court’s finding that plaintiffs were not “prevailing parties” while it
discusses, without deciding, whether executive agreements with Germany, Austria
and France created judicially enforceable private rights within meaning of 42
U.S.C. Section 1983
The
plaintiffs are insurance carriers in California that sought injunctive relief
in a California federal court against John Garamendi, the state insurance
commissioner, to prevent him from enforcing California’s Holocaust Victim
Insurance Relief Act of 1999 (HVIRA) [Cal. Ins. Code Ann. Sections 13800‑13807
(West Cum. Supp. 2003)]. It required insurance companies, inter alia, to
disclose information about insurance policies pending in Europe at the time of
the Holocaust. Ultimately, the U.S. Supreme Court held that Executive Branch
authority over foreign policy preempted HVIRA. See American Insurance
Association v. Garamendi, 123 S.Ct.2374, 71 U.S.L.W. 4524 (U.S.S.C. June 23,
2003), 2003 International Law Update 98.
Later,
the plaintiffs, deeming themselves victorious, sought attorney’s fees under 42
U.S.C. Section 1983. The Ninth Circuit remanded the issue of attorney’s fees to
the District Court and it turned down the request. The Court held that the
foreign affairs powers of the executive branch did not create a right or
privilege to obtain attorney’s fees under a 42 U.S.C. Section 1983 claim. The
plaintiffs then appealed.
The
U.S. Court of Appeals for the Ninth Circuit reverses. It holds that the
district court had read 42 U.S.C.Section 1988 [Fees in proceedings in
vindication of civil rights] too narrowly as depriving it of discretion to
award plaintiff insurance companies reasonable attorneys’ fees.
“The
district court concluded that the foreign affairs power did not ‘implicate a
right, privilege or immunity secured by the Constitution or laws of the United
States’ and therefore did not constitute a 42 U.S.C. Section 1983 claim. That
conclusion may have been correct as an abstract proposition, but it did not support
the further conclusion that plaintiffs were not prevailing parties. Because we
reverse the district court on the prevailing party point, we need not reach the
question whether the foreign affairs power independently confers private
rights. The fact that plaintiffs’ Due Process Clause and Commerce Clause claims
are properly cognizable claims under Section 1983 satisfies our inquiry and
should result in a fee award to plaintiffs. [810-811]
A
concurring opinion, however, does address this issue. It declares that: “[t]he
claim of preemption by the foreign affairs power is not a fee-generating claim,
for the reasons ably explained by the district court. In short, the foreign
affairs power, like the Supremacy Clause, creates no individual rights
enforceable under 28 U.S.C. Section 1983. Cf. Golden State Transit Corp. v.
City of Los Angeles, 493 U.S. 103, 107 ... (1989) (‘[T]he Supremacy Clause, of
its own force, does not create rights enforceable under Section 1983.’).” [811]
Citation:
Gerling Global Reinsurance Corp. of America el al. v. Garamendi, 400 F.3d
803 (9th Cir. 2005).
PATENTS
In
patent action by U.S. drug company, Supreme Court of Canada decides whether to
allow appeal of Canadian drug company from order issued under recent patent
regulations (which sought to conform to Agreement on Trade‑Related Aspects of
Intellectual Property Rights and North American Free Trade Agreement) imposing
freeze period on defendant’s new drug based mainly on presence of same public
domain substance in both plaintiff’s and defendant’s anticancer drugs
During
the 1970s, the National Cancer Institute, a U.S. government‑funded organization
learned that the bark of the Pacific yew (taxus brevifolia) contained
paclitaxel, an anticarcinogenic substance, and put this data into the public
domain. Since the yew bushes died when stripped of their bark, however, doubts
arose on whether drug companies could turn out enough quantities for
pharmaceutical production.
The
respondents here include Bristol-Meyers Squibb headquartered in New York City
plus its Canadian subsidiary (collectively BMS). In the following decade, BMS
produced a drug containing paclitaxel, later marketed as Taxol. In the course
of that work, it secured several Canadian patents which involved new
formulations and new methods of administering the medicine. None of these
patents applied to paclitaxel as such.
Working
independently of BMS, the appellant, Biolyse Pharma Corporation (BPC) found out
that it could extract paclitaxel from a different species of yew (taxus
canadensis) without killing the trees. It applied to the Minister of Health for
a notice of compliance (NOC) in order to put its product on the market. The
Minister required BPC to submit a New Drug Submission (NDS) rather than an
Abbreviated New Drug Submission (ANDS), contending that its different botanical
source and its claims for new and different uses for the medicine prevented any
reliance on BMS’s Taxol as a Canadian reference product.
BPC
then submitted independent clinical studies. The Minister approved the safety
and efficacy of the BPC product as a new drug and issued it an NOC in 2001. BMS
sought to quash this NOC, however, claiming that its issuance had turned on a
finding of bioequivalence to the BMS product.
In a
reversal of policy, Parliament in 1993 repealed the compulsory licence
provisions of the Patent Act and canceled all compulsory licences issued on or
after December 20, 1991. In part, these changes flowed from international duties
accepted by Canada under the Agreement on Trade‑Related Aspects of Intellectual
Property Rights, 1869 W.N.T.S. 299 (TRIPS). Some may have thought that Canada’s
compulsory licensing system might also clash with Canada’s obligations under
the North American Free Trade Agreement, Can. T.S. 1994/02, in particular Art.
1709(10), signed at the end of 1992.
The
new statute abrogated the usual regulatory lag of two years before a generic
manufacturer could obtain an NOC. To prevent the generic companies from abusing
these “early working” and “stockpiling” exceptions, however, the government
also laid down the Patented Medicines (Notice of Compliance) Regulations (PMR).
These allowed a patent owner to submit a patent list of any drug that includes
a “medicine.”
If
another manufacturer later asks for a NOC for the same drug this “second
person” may serve a Notice of Allegation (NOA) that the “first person’s” patent
list is not a proper bar. It may contend, for instance, that the first person
is not in fact the owner or exclusive licensee in Canada of the drug, or that
the patent(s) have expired, or are invalid, or that the applicant would not
infringe any claim for the medicine itself and no claim for the use of the
medicine.
After
being served with an NOA, the innovator may ask for an order barring the
Minister from issuing a NOC until all of the listed patents have expired. This
application activates a 24‑month statutory freeze on the issuance of a NOC.
On
an application for judicial review, the motions judge found that BPC had
neither applied for, nor obtained, regulatory approval on the basis of
bioequivalence. He ruled that, even though neither BMS nor BPC had any patent
claim to paclitaxel, Section 5(1.1) of the NOC Regulations caught BPC because
paclitaxel was present in both the BPC and the BMS products. The motions judge
quashed the NOC and the Federal Court of Appeal upheld that decision. In a
six-to-three decision, the Supreme Court of Canada allows BPC’s appeal.
In
the majority’s view, the Minister was entitled to issue the NOC to BPC on the
basis of its NDS without making it subject to the statutory freeze. Reading the
NOC Regulations to grant BMS a monopoly merely by showing the presence of a
public domain medicine like paclitaxel in its product would provide no value to
the public in return for the monopoly BMS seeks. When we interpret the NOC
Regulations in their proper context, and especially in light of the wording of
the statutory power that authorized them, the NOC Regulations do not have the
broad effects claimed by BMS.
Parliament
enacted the reform legislation in question to protect the rights of patentees
to the extent of barring generic manufacturers from marketing “copy‑cat drugs”
until the expiry of all relevant patents. Under the NOC Regulations, the court
hearing the prohibition application has no discretion to lift the stay even if
it thinks the innovator’s case for interim relief is weak. Nor does the court
have a discretion to leave the contending parties to their remedies under the
Patent Act. The “second person’s” application for a NOC simply goes into a
“deep‑freeze” until the statutory procedures have played themselves out.
Moreover,
Section 5(1.1) of the NOC Regulations does not apply to innovative drugs. The
courts should limit it to applications for generic copies of patented drugs in
the circumstances had in mind by the regulator.
Furthermore,
since Biolyse did not rely on bioequivalence, its product did not fall within
the scope of Section 5(1) of the NOC Regulations either. The product was
properly treated as an innovator drug, rather than a “copy‑cat drug,” and
neither Sections 5(1) nor 5(1.1) had any application.
Applying
the modern approach to statutory interpretation, a court cannot take the word
“submission” in Section 5(1.1) out of this context. It also has to look to the
scope of the regulation-making power in Section 55.2(4) of the Patent Act; it
permits a generic manufacturer to work the patented invention within the 20‑year
period (“the early working exception”) to the extent necessary to obtain a NOC
at the time the patent(s) expired and to “stockpile” generic product towards
the end of the 20‑year period to await lawful market entry. Thus, the judge
must consider the grammatical and ordinary sense of the words and give the
precise scope of the word “submission” in Section 5(1.1) a purposive
interpretation within this context.
Secondly,
in analyzing the more specific schemes of the Patent Act and the Minister’s
regulation‑making power, it is apparent that the NOC Regulations are directed
to persons who are making use of the “patented invention” which is not
necessarily co‑extensive with the patented drug or the patented claims. BMS has
no patent on paclitaxel and the mere fact that paclitaxel is found in the
Biolyse product does not mean that Biolyse took advantage of BMS inventions for
the purpose of “early working” a generic copy or “stockpiling” looking toward
the expiration of the BMS patents.
Moreover,
the limiting words of Section 55.2(4) do not disturb the usual requirement that
regulations must fall within the regulation making power. The “plain meaning”
adopted by the Federal Court of Appeal in this case would suggest that Section
5(1.1) is ultra vires the very specific authority granted by Section 55.2(4).
Finally,
the internal structure of the NOC Regulations supports a narrower
interpretation. The word “submission” also appears in Section 4(1), which
provides the template upon which the drafters modeled Section 5(1.1).
Moreover,
the courts have ruled that Section 4(1) does not apply to all submissions. Any
other interpretation of Section 4(1) would allow innovator companies to
sidestep the time limits applicable to patent lists by simply making corporate
or technical changes to their filing by way of a supplementary NDS. In this
context, the courts have found that an unqualified and unrestricted
interpretation of the word “submission” would be destructive of regulatory
intent.
The
majority further explains. “The broad interpretation urged by BMS would lead to
an absurd result. The ‘medicine’ in the drug to which the patent list relates
need not itself be patented, or indeed owe anything to the ingenuity of the
‘first’ person. It could be a ‘medicine’ whose usefulness was discovered by
somebody else (as in the case of paclitaxel) or something in the public domain
as common as penicillin.”
“So
long as such ‘medicine’ shows up as a component, however minor, in the chemical
composition of the drug to which the patent list relates, the ‘second person’
(including an innovator who is seeking to manufacture a new and useful drug) is
barred from proceeding to market by the automatic statutory freeze, and this
‘bar’ will continue for so long as the patent list holder can ‘evergreen’ its
product by resorting to patentable improvements or other components or
additions, be they ever so minor. This would stifle competition and innovation
in the pharmaceutical industry and produce a result at odds with what the
regulator was trying to achieve.” [¶ 66]
“In
my view, Section 5(1.1) does not apply to innovative drugs. It should be
confined to applications for generic copies of patented drugs in the circumstances
contemplated by the regulator, i.e., where a manufacturer makes a submission
for a NOC for a drug which contains a medicine that it purports to copy from
another generic but in fact copies from the innovator company that has filed
the patent list.”
“That
is not this case. Where an applicant relies on bioequivalence, it will be
caught by Section 5(1). On the facts here, neither Section 5(1) nor Section
5(1.1) applies. Accordingly, I conclude that the Minister was entitled to issue
the NOC to the appellant Biolyse on the basis of its NDS without subjecting
Biolyse to the statutory freeze.” [¶ 69]
“If
BMS believes that the Biolyse product infringes its patent(s), it has recourse
to the usual remedies under the Patent Act. The NOC ought not to have been
quashed, and the appeal should be allowed. [¶¶ 70-71]
Citation:
Bristol‑Myers Squibb Co. v. Canada, 2005 S.C.C. 26; [2005] S.C.J. No. 26 (Sup.
Ct. Canada, May 19).
TERRITORIAL
WATERS
U.S.
Supreme Court rejects State of Alaska’s claim of title to certain submerged
lands underlying waters located in southeastern Alaska finding insufficient
evidence to support historic inland waters status
Invoking
the U.S. Supreme Court’s original jurisdiction, the State of Alaska sued the
United States in 2000 over title to certain submerged lands located in
southeastern Alaska. One of the submerged lands consists of pockets and
enclaves underlying waters between the southeastern Alaska islands known as the
Alexander Archipelago.
All
points within the pockets and enclaves are more than three sea miles from the
mainland and from any individual island of the Archipelago. Alaska alleged that
the waters of the Alexander Archipelago are “historical inland waters,” and
therefore U.S. territory.
The
Court holds that the waters at issue were not historically inland waters. Where
a U.S. State wishes to claim submerged lands based on an area’s status as
historic inland waters, it has to show that the U.S. : (1) exercises authority
over the area; (2) has done so continuously; and (3) has done so with the
acquiescence of foreign nations. The U.S. must somehow have asserted the right
to exclude innocent passage of vessels, even if it has never actually exercised
the right. See 1958 Convention on the Territorial Sea and Contiguous Zone, Art.
14, subds. 1,4.[15 U.S.T. 1606; T.I.A.S. 5639; 516 U.N.T.S. 205].
As
it often does in original suits, the Court appointed a Special Master to
develop the facts. After making a thorough examination, the Master recommended
that the Court grant summary judgment to the U.S. The Master found that Alaska
had at best presented “questionable evidence” that the U.S. has exercised the
kind of authority over the waters needed to prove an historic waters claim.
Challenging
the Master’s recommendation, Alaska identified four historical events as
supporting its position that the Alexander Archipelago’s waters qualify as
historic inland waters. The State first pointed to incidents during the period
of Russian sovereignty.
“In
1824, the United States and Russia entered into a treaty that, inter alia,
granted United States vessels the right, over the next 10 years, to ‘frequent,
without any hindrance whatever, the interior seas, gulphs, harbours, and creeks
[of the Alexander Archipelago], for the purpose of fishing and trading with the
natives of the country.’” [2146] (see Convention Between the United States of
America and Russia, Art. 4, 8 Stat. 304 (1825). In Alaska’s view, the Treaty
shows that the Russian claim had extended to the entire Archipelago.
The
Court, however, is unpersuaded. “The principal problem with Alaska’s assertion
is that the 1824 Treaty by its terms did not address navigation for the purpose
of innocent passage.’[¼]
Yet evidence of the assertion of this right -- not a lesser right -- must be
provided to support an historic inland waters claim.” [2146-2147]
The
Treaty of 1824 also provided for Russia to station a brig [two-masted sailing
ship], the Chichagoff, at the southern border of Russian America. Alaska urged
that this provision implied that Russia’s purpose in stationing the brig there
was to keep any foreign vessels from entering the Alexander Archipelago’s
waters. The Court rejects this reading holding that “the Chichagoff reminded
American mariners that they were no longer free to trade with the natives, or
to approach within cannon shot of the Russian lands ‘without any hindrance
whatever.’” See 1824 Treaty, Art. 4, (8 Stat. 304). [2147]
The
second historical event cited by Alaska is the period of early U.S. sovereignty
between 1867 and 1903. However, “Alaska cites not a single incident
demonstrating that the United States acted in a manner consistent with an
understanding that the Alexander Archipelago waters were inland.” Id. at 21-22.
In
an 1886 letter from then Secretary of State Thomas F. Bayard to the Secretary
of the Treasury, Bayard declared that the U.S. did not claim the Archipelago as
U.S. territory. Alaska, however, posited that Secretary Bayard’s letter was
merely internal correspondence and did not announce to any foreign nation that
the U.S. had abandoned a claim to the Archipelago.
“It
may be true that no foreign nation ever became aware of Secretary Bayard’s
letter [...] Regardless, Secretary Bayard’s letter still provides strong
evidence that the United States, as of 1886, did not claim a right to exclude
all foreign vessels from Alexander Archipelago waters and had no intention of doing
so. We do not need to parse the letter to see whether it ‘announced to any
foreign nation that the United States had abandoned a claim to the
Archipelago,’ for Alaska can muster no proof that the United States as of 1886
had made any such claim in the first place.” [2148-2149]
The
third historical event is a litigating position taken by the U.S. during a 1903
arbitration proceeding. Before the Alaska Boundary Tribunal, the U.S. had
stated that the “political coast” of Alaska consisted of all of the Alexander
Archipelago waters. Before the Special Master, the U.S. sought to discount its
century-old submissions “as mere hypothetical statements”. [2149]
“The
Special Master rejected this view and instead agreed with Alaska that in its
submissions to the tribunal the United States ‘was expressing a considered
analysis of the [Alexander Archipelago] area.’ Ultimately, however, the Special
Master still concluded that the United States’ submissions to the tribunal were
‘not an adequate assertion of authority over the waters of the Alexander
Archipelago.’”
“The
Special Master noted that the issue before the 1903 tribunal was not ‘[t]he
status of the water of the Alexander Archipelago,’ but rather the land boundary
between southeast Alaska and Canada [...]. [I]t would be unrealistic to
conclude that counsel’s assertions at the tribunal should have made them (sic)
foreign nations (other than Britain) aware that the United States was asserting
a right to exclude them.” [2149]
The
fourth historical event is the 1924 seizure by the U.S. Coast Guard of the
Canadian vessel Marguerite pursuant to the 1906 Alien Fishing Act, which barred
foreign commercial fishing in Alaskan waters. In the Court’s view, however,
“[even were the seizure of the Marguerite taken as evidence of a right asserted
by the United States, the official correspondence cited by the Special Master
establishes that by 1934 the United States had reverted to the position taken
in Secretary Bayard’s 1886 letter.” [2150]
Citation:
State of Alaska v. United States, 125 S. Ct. 2137 (U.S.S.C. June 6, 2005).
TRADEMARKS
Under
Cuba trade embargo provisions, Cuban cigar maker did not acquire U.S. trademark
protection because it had failed to register it in U.S. and because it could
not rely on “famous marks” doctrine under applicable statutes and treaties
In
1963, the United States imposed an embargo on trade with Cuba. The Cuban Asset
Control Regulations (CAR)), 31 C.F.R. Section 515.201 etc. based on Section
5(b) of the Trading with the Enemy Act of 1917, codified as amended at 12
U.S.C. Section 95a (2000), set forth the ban. Thirty-three years later,
Congress codified the Regulations in the Cuban Liberty and Democratic
Solidarity Act of 1996 (LIBERTAD Act), codified at 22 U.S.C. Section 6032(h)).
The Secretary of the Treasury has delegated its administration to the Office of
Foreign Assets Control (OFAC).
The
Embargo Regulations ban Cuban companies such as Empresa Cubana del Tabaco,
d.b.a. Cubatabaco (plaintiff) from marketing cigars in the U.S. Plaintiff
nevertheless claims that it owns the U.S. COHIBA mark and that the sale by
Culbro Corp., and General Cigar Co. (defendants), U.S. companies, of COHIBA
cigars in the U.S. unlawfully infringes its mark.
In 1969,
plaintiff registered the COHIBA mark within Cuba. By January 1978, plaintiff
set about to register the COHIBA mark in seventeen nations, including most
Western European countries, but not the U.S. In 1983, plaintiff thought about
registering its COHIBA mark in the U.S. until it found out that defendant had
already secured the U.S. registration.
In
February 1985, plaintiff applied to the U.S. Patent and Trademark Office (PTO)
to register its BEHIQUE mark with the same trade dress that it was using on its
COHIBA cigars elsewhere. Two years later, plaintiff pondered challenging
defendant’s 1981 COHIBA registration, but decided against it.
Defendant
first discovered the name “Cohiba” in the late 1970s. After seeing reports that
plaintiff was intending to sell its COHIBA cigars outside of Cuba, defendant
applied to register the COHIBA mark with the PTO in March 1978, with a claimed
first use date of February 13, 1978. Defendant obtained the unopposed
registration in February 1981. Defendant concedes that the Cuban COHIBA was
already well known to U.S. cigar consumers when defendant was selling COHIBA
cigars in the U.S. from 1978 until late 1987. In early 1997, defendant launched
a new cigar under the COHIBA name.
Plaintiff
sued defendant in a New York federal court in November 1997. The first six
claims alleged violations of various treaty provisions and asserted that
plaintiff was entitled to relief under Sections 44(b) and 44(h) of the Lanham
Act, 15 U.S.C. Section 1126(b), (h). Specifically, of the claims actually
passed on by the lower Court, plaintiff claimed, inter alia, that defendant had
violated: (1) the protection under Article 6bis of the Paris Convention for the
Protection of Industrial Property, Mar. 20, 1883, as revised at Stockholm, July
14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 305 (‘Paris Convention’), for famous
marks; (2) Section 10bis of the Paris Convention’s ban on unfair competition;
(3) Articles 7 and 8 of the General Inter‑American Convention for Trade Mark
and Commercial Protection, Feb. 20, 1929, 46 Stat. 2907 (IAC) by using and
registering COHIBA for cigars knowing about plaintiff’s use of the mark on
cigars; (4) Articles 20 and 21 of the IAC’s prohibition against unfair
competition.
In
November 2001, defendant moved for summary judgment based on estoppel,
acquiescence, and laches, due to plaintiff’s alleged delay in objecting to
defendant’s use of the COHIBA mark. On January 29, 2002, plaintiff moved to
dismiss defendant’s affirmative defenses. Plaintiff also moved for partial
summary judgment on its claim that defendant had abandoned its 1981
registration, as well as its claims that defendant violated Articles 7 and 8 of
the IAC, Article 6bis of the Paris Convention, New York common law, and the
Federal Trademark Dilution Act (FTDA), 15 U.S.C. Section 1125(c).
In
June 2002, the District Court granted plaintiff a partial summary judgment on
its claim that defendant had abandoned the COHIBA mark during its period of non‑use
from 1987 to 1992. The court also dismissed defendant’s affirmative defenses of
acquiescence, estoppel, and laches.
On
May 6, 2004, the District Court entered an order, judgment, and permanent
injunction. The court inter alia: (1) granted plaintiff a judgment against the
defendant on its claim for infringement of plaintiff’s COHIBA mark pursuant to
15 U.S.C. Section 1125(a) and granted judgment to plaintiff on its claim that,
prior to November 1992, defendant had abandoned the COHIBA mark. The court also
canceled defendant’s trademark registration for the COHIBA mark, and
permanently enjoined defendant from using it; and (3) ordered defendant to
deliver to plaintiff all goods and labels bearing the COHIBA mark, and to
recall from retail customers and distributors products bearing the mark.
The
U.S. Court of Appeals for the Second Circuit affirms in part, reverses in part,
and remands. It reverses the District Court’s grant of judgment to Cubatabaco
on its claim of trademark infringement under Section 43(a) of the Lanham Act
and affirms the lower court’s dismissal of all other claims brought by
Cubatabaco.
“[A]bsent
a general or specific license, [Regulation] Section 515.201(b)(1) prohibits
transfers of trademarks to Cuban entities by persons subject to the
jurisdiction of the U.S.
The
District Court’s holding that plaintiff’s mark was sufficiently famous in 1992
for property rights to attach could be viewed as a transfer of [such] property
rights to plaintiff. “[W]e need not resolve it because plaintiff’s acquisition
of the mark through the famous marks doctrine is plainly barred by Section
515.201(b)(2).”
“Indeed,
plaintiff does not appear to be arguing that Section 515.527(a)(1) permits
acquisition through the famous marks doctrine. Instead, plaintiff argues that
(1) its acquisition of the mark is not prohibited by Section 515.201(b) because
that section does not cover transfers by operation of law and (2) its
acquisition of the mark is in any event permitted by the special license
granted to it by the OFAC.” [473]
The
Court rejects the applicability of a general license and sees no merit in the
special license argument. “...[The special license issued by OFAC to
Cubatabaco, which allows Cubatabaco to ‘pursue ... judicial remedies with
respect to claims to the COHIBA trademark,’ does not permit acquisition of the
mark via the famous marks doctrine. This license allows Cubatabaco to seek
relief in U.S. courts, but does not authorize transfers of property barred by
the Regulations.” [Id. at note 4]
The
government argued, the Court notes, that pursuant to Section 43(a), the Embargo
Regulations do not stand in the way of the lower court’s orders. “Section 43(a)
also ‘goes beyond trademark protection’ in the sense that the provision can be
used to protect trade dress or to protect against other forms of product
infringement.”
“But
this is not a case about trade dress. ... This is, rather, a case about which
entity owns the COHIBA trademark in the U.S., and ‑- principally because we
hold that the Regulations prohibit transfer of any property right in the COHIBA
mark to plaintiff ‑- we hold today that defendant, and not plaintiff, owns the
COHIBA trademark in the U.S. .”[478, note 9]
“[A
noted scholar] asserts that claims for protection of ‘famous’ marks should be
brought under Section 43(a). [That Section] gives a foreign national without a
federal registration of its mark standing to sue in a federal court, [to]
invoke the well‑known marks doctrine of the Paris Convention Article 6bis, and
[to] prevail if its mark is so well‑known in the U.S. that confusion is likely.
To the extent that a foreign entity attempts to utilize the famous marks
doctrine as basis for its right to a U.S. trademark and seeks to prevent
another entity from using the mark in the U.S., the claim should be brought
under Section 43(a).”
“Article
23 of the IAC, which appears under Chapter V of the IAC entitled ‘Repression of
False Indications of Geographical Origin or Sources,’ provides: ‘Every
indication of geographical origin or source which does not actually correspond
to the place in which the article, product or merchandise was fabricated,
manufactured, produced or harvested, shall be considered fraudulent and
illegal, and therefore prohibited.’ IAC, Article 23, 46 Stat. at 2934.”
“Article
20 of the IAC provides that ‘[e]very act or deed contrary to commercial good
faith or to the normal and honorable development of industrial or business
activities shall be considered as unfair competition and, therefore, unjust and
prohibited.’ IAC, Art. 20, 46 Stat. at 2930‑32.” [484 at note 12]
“Cubatabaco
does not claim that Article 21 prohibits a broader range of conduct than
Section 43(a) of the Lanham Act. Therefore, Cubatabaco cannot bring a claim
under Article 21 of the IAC pursuant to Sections 44(b) and (h). To the extent
Cubatabaco is attempting to raise claims under IAC Article 20, that provision
does not provide a separate basis for relief because it is implemented through
Section 43(a) of the Lanham Act.” [484]
Citation:
Empresa Cubana del Tabaco v. Culbro Corp., 399 F.3d 462 (2nd Cir. 2005).
Argentine
Supreme Court strikes down its amnesty laws. On June 14, 2005, the
Argentine Supreme Court struck down the laws of “final point” and “due
obedience,” which granted amnesty to members of the military dictatorship
(1976-1983) from prosecution for human rights violations. The Court finds that
the statutes [Laws 23.492 and 23.52] violated directly applicable treaties such
as the International Covenant on Civil and Political Rights [December 19, 1966,
999 U.N.T.S. 171] as well as customary international law. While the Court
acknowledges Congress’ constitutional power to grant amnesties, it cites
articles from the Inter-American Convention on Forced Disappearance of Persons
and the U.N. Convention Against Torture and Other Forms of Cruel, Inhuman or
Degrading Treatment or Punishment (G.A. Res. 39/46, 39 U.N. GAOR Supp. No. 51
at 197, U.N. Doc. A/RES/39/708 (1984)) to hold that such amnesty powers are not
absolute. The decision opens the door to prosecution of nearly 1500 military
officers – of which 10% remain on active duty – for disappearances, torture,
and other crimes against humanity. Finally, citing the Convention on the
Non-Applicability of Statutory Limitations to War Crimes and Crimes Against
Humanity, as well as other similar treaties, the Supreme Court affirms that
prosecution of military officers for their actions during the 1976-1983
dictatorship could proceed. Citation: Supreme Court of Argentina, Simon,
Julio Hector y otros s/ privacion ilegitima de la libertad, etc., causa No.
17.768, S. C. S. 1767; L. XXXVIII (June 14, 2005); St. Louis Post-Dispatch,
Buenos Aires, Wednesday, June 15, 2005, section A, page 12 (byline of Mayra
Pertossi, AP staff reporter).