[Ip-health] TPP, TRIPS and compulsory licenses: raising the bar or confusing limited exceptions and compulsory licenses

Jamie Love james.love at keionline.org
Mon Jun 22 19:02:34 PDT 2015


​In the end, the plain language of the TPP on exceptions will be tested by
drug companies in ISDS, and maybe by governments in state to state
litigation.   I've been involved in more compulsory licenses cases than
anyone I know, and I don't see how anyone can advise anyone that the
current text in the TPP is anything short of a disaster for compulsory
licenses. ​  Articles 30 and 31 of the TRIPS each have very different
purposes and standards, and neither depends on the other.   If compulsory
licenses are subject to the 3 step test, the space for compulsory licenses
is much narrower.   The TPP needs to protect the Article 31 type compulsory
licenses.

When Brook says, "The danger of misapplication of QQ.E.4 to compulsory
licenses and government use in the future is minuscule," I could not
disagree more, and it is unfortunate that he gives comfort to the
incompetent negotiators who have created this mess.    If you can't get a
clarification in the text, it is because the PhRMA advisers to USTR won't
let it happen.

Jamie



On Mon, Jun 22, 2015 at 6:30 PM, Baker, Brook <b.baker at neu.edu> wrote:

> TPP, TRIPS and compulsory licenses:  raising the bar or confusing limited
> exceptions and compulsory licenses
>
> Although I agree with Jamie Love and the authors of this article that it
> would be better if the TPP directly acknowledged countries' freedom to
> provide for and use TRIPS-compliant compulsory license and government use
> flexibilities as set forth in Article 31 of the TRIPS Agreement, I
> disagree with an analysis that Article QQ.E.4 of the leaked 2014 version
> of the TPP applies on its face to Article 31 involuntary use (compulsory
> licenses and public, non-commercial use).
>
> The language of Article QQ.E.4 is limited to "limited exceptions:"  "Each
> party may provide limited exceptions to the exclusive rights conferred by
> a patent ..."  Article 30 of the TRIPS Agreement is the only
> patent-related section of TRIPS that directly uses the language "limited
> exceptions."  Article 31, in contrast, discusses "other use without the
> authorization of the right holder," a phrase of art universally understood
> to include compulsory licenses and government use.  Any doubt on this
> issue should be assuaged by footnote 7 to Article 31 that "Other use"
> refers to use other than that allowed under Article 30."  Moreover, the
> lineage of limited exceptions and compulsory licenses/government use is
> quite distinct and the two are typically provided for quite differently in
> separate sections in national legislation.  Finally, the Canada
> Pharmaceutical case also seems to clearly acknowledge the "difference"
> between the two sections, see, e.g., paragraphs 7.19, 7.91.
>
> It certainly is possible that crafty industry lawyers might disingenuously
> argue in the future that Article QQ.E.4, if adopted, applies to Article 31
> compulsory licenses and government use and well as Article 30 limited
> exceptions.  That doesn't mean that these lawyers would be correct or that
> they would win before a dispute panel.  These same crafty lawyers have
> been trying to argue that Article 39.3 requires many years of data
> exclusivity rather than minimum degrees of data protection. Even when
> advocates point to the dangers of legal-outlier interpretations, we should
> not overestimate the likelihood of their success.
>
> What does this mean for the TPP negotiations?  In my mind, it means that
> the danger of misapplication of QQ.E.4 to compulsory licenses and
> government use in the future is minuscule, but that direct clarification
> of its non-application to Article 31 compliant licenses might still be
> useful.
>
> Professor Brook K. Baker
> Northeastern U. School of Law
> Affiliate, Program on Human Rights and the Global Economy
> 416 Huntington Ave.
> Boston, MA 02115 USA
> Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
> Senior Policy Analyst Health GAP (Global Access Project)
> NGOs Board Member UNITAID
> (w) 617-373-3217
> (cell) 617-259-0760
> (fax) 617-373-5056
> skype: brook_baker
> b.baker at neu.edu
>
>
>
>
>
> On 6/22/15 9:14 AM, "Elizabeth Rajasingh"
> <elizabeth.rajasingh at keionline.org> wrote:
>
> >TRIPS and compulsory licences: raising the bar
> >​
> http://www.lifesciencesipreview.com/contributed-article/trips-and-compuls
> >ory-licences-raising-the-bar​
> >
> >​​
> >Sandra Kuzmich and Russell Garman
> >16-06-2015
> >
> >The proposed Trans-Pacific Partnership seemingly contains a bid by the US
> >to increase standards for compulsory licences above those already in place
> >internationally, say Sandra Kuzmich and Russell Garman of Frommer Lawrence
> >& Haug.
> >
> >The US is approaching the final stages of establishing a trade agreement
> >with 11 Pacific Rim nations. This pact, known as the Trans-Pacific
> >Partnership (TPP), aims not only to promote trade and improve economies in
> >the Asia-Pacific region, but also to address various other issues,
> >notably,
> >intellectual property. Of particular interest to the pharmaceutical
> >industry is a proposal by the US to increase standards for compulsory
> >licences above the requirements that the international community already
> >has in place.
> >
> >A compulsory licence to use a patent is a legal provision that allows a
> >government to license the use of a patented invention to itself or a third
> >party without the consent of the patent owner. The use of compulsory
> >licences has been agreed upon by members of the World Trade Organization
> >(WTO) through the 1995 TRIPS Agreement. In the negotiations leading up to
> >TRIPS, compulsory licensing was an area of intense discussion, as
> >developing countries wanted the agreement to provide easier access to
> >technology, while developed countries sought stronger protection for
> >patented technologies. The result of those discussions is article 31 of
> >TRIPS, which offers countries broad discretion in the use of compulsory
> >licensing, but under certain conditions.
> >
> >The requirements governing compulsory licensing among WTO members were
> >revisited by the 2001 Doha Declaration on the TRIPS Agreement and Public
> >Health, which was adopted to address the issue of patents preventing
> >access
> >to medicines for those in need. The Doha Declaration established that
> >TRIPS
> >does not restrict WTO members from taking measures to protect public
> >health, affirming the freedom of each member to determine what constitutes
> >a national emergency and the grounds on which the compulsory licences are
> >granted.
> >
> >To further expand the rights of governments to address public health
> >needs,
> >in 2005 WTO members adopted an amendment to article 31 of TRIPS, known as
> >article 31bis. The amendment addressed the needs of countries that do not
> >have the capacity or resources to manufacture generic versions of patented
> >medicines by permitting the countries to import generic substitutes
> >without
> >interference from the patent owners.
> >
> >Challenges
> >
> >Despite attempts by WTO members to assist countries with public health
> >needs through compulsory licences, there are challenges and obstacles in
> >the way of doing so.
> >
> >First, countries are often reluctant to use compulsory licences out of
> >fear
> >of retaliation, which may be founded in instances of patent owners and/or
> >their home countries responding aggressively to the use of compulsory
> >licences to their patents. For instance, in response to Thailand’s use of
> >compulsory licences to produce antiretroviral drugs that included pharma
> >company Abbott’s lopinavir/ritonavir combination, Abbott accused Thailand
> >of ignoring the patent system and elected not to launch any new medicines
> >in Thailand as a protest. Further, in April 2007 the US Trade
> >Representative (USTR) placed Thailand on its Special 301 Report, a watch
> >list of countries that allegedly fail to provide adequate protection or
> >enforcement of IP rights.
> >
> >As another example, non-governmental organisations such as Doctors Without
> >Borders suspect that increased measures to seize pharma products at the
> >borders of countries in Europe were in retaliation to developing countries
> >with compulsory licences that use Europe to transit drugs from India.
> >
> >Second, the use of compulsory licensing is restricted or limited by
> >commitments in bilateral agreements. The USTR often pursues trade
> >agreements that require greater protection of IP rights than that afforded
> >under TRIPS, referred to as ‘TRIPS-plus’ provisions.
> >
> >The US has entered into 20 free trade agreements and many of these
> >require,
> >for example, specific restrictions or conditions on compulsory licences
> >(eg, only as a remedy to anti-competitive practices, for public
> >non-commercial use, for cases of national urgency, etc).
> >
> >Third, the process of obtaining a compulsory licence under TRIPS is
> >inefficient. For example, the single instance of a compulsory licence
> >under
> >article 31bis involved Canada authorising a compulsory licence to drug
> >company Apotex to manufacture generic AIDS medicines for exportation to
> >Rwanda. Canada (the exporter) and Rwanda (the importer) found the
> >procedure
> >to be complicated and cumbersome.
> >
> >Apotex also had little incentive to participate in the process due to
> >difficult negotiations with the patent owners and concerns that the term
> >of
> >the compulsory licence was too short to recover the costs of manufacturing
> >the AIDS medicines.
> >
> >The TPP and waiving TRIPS
> >
> >The USTR has indicated that in the TPP the US is seeking to establish more
> >flexible pharma IP rights protections for developing countries than exist
> >in developed countries. However, it is questionable whether the provisions
> >that the US is proposing will actually assist developing countries to meet
> >their public health needs.
> >
> >"THE US MUST BALANCE ITS ECONOMIC RESPONSIBILITY TO PROTECT THE IP OF ITS
> >DOMESTIC INDUSTRIES AND ITS MORAL RESPONSIBILITY TO AID THOSE NATIONS IN A
> >HEALTH CRISIS."
> >
> >While the negotiations surrounding the TPP are closed to the public and
> >details of the agreement have been kept secret (which is itself a source
> >of
> >controversy and debate), drafts of the TPP have been leaked. Most recent
> >is
> >a May 16, 2014 version of the TPP released by WikiLeaks. In this version,
> >article Q.Q.E.4 requires that compulsory licences (1) are “limited”; (2)
> >“do not unreasonably conflict with a normal exploitation of the patent”;
> >and (3) “do not unreasonably prejudice the legitimate interests of the
> >patent owner, taking account of the legitimate interests of third
> >parties”.
> >
> >This proposal imposes restrictions on compulsory licences to which WTO
> >members are not currently held, since article 31 of TRIPS does not limit
> >the grounds or underlying reasons under which a compulsory licence may be
> >used. In contrast, the second TPP condition (that the compulsory licence
> >“do[es] not unreasonably conflict with a normal exploitation of the
> >patent”) may be interpreted as a bar against any compulsory licence
> >designed to expand access to a drug.
> >
> >In a leaked previous version of the TPP, dated August 30, 2013, there was
> >an additional provision that stated “[n]othing in this chapter shall limit
> >a party’s rights and obligations under article 31 of the TRIPS Agreement
> >or
> >any amendment thereto.” Such a provision would have permitted countries to
> >use compulsory licences as long as they met the conditions of article 31,
> >regardless of whether the conditions in article Q.Q.E.4 are met, but this
> >provision was removed in the subsequent May 16, 2014 version of the TPP.
> >
> >Australia, perhaps in recognition of the fact that the reference to
> >article
> >31 of TRIPS was omitted in the May 16, 2014 version of the TPP, recently
> >proposed to add a footnote to the TPP stating “[f]or greater certainty,
> >nothing in this chapter shall prevent a party from taking measures
> >pursuant
> >to article 31 of the TRIPS Agreement, including any waivers or amendments
> >thereto”.
> >
> >However, this footnote does not have the same impact as the TRIPS article
> >31 provision in the August 30, 2013 version of the TPP, because the
> >footnote can be interpreted to mean that countries seeking compulsory
> >licences can use the procedures set out in article 31 but would still have
> >to comply with the conditions in TPP article Q.Q.E.4.
> >
> >Proponents of the May 16, 2014 version of the TPP could also point to
> >article Q.Q.A.7(b) as a potential means to address a healthcare crisis via
> >a compulsory licence. This article states that the TPP “does not and
> >should
> >not prevent the effective utilisation of the TRIPS/health solution”.
> >
> >The TRIPS/health solution is a waiver of TRIPS obligations for a
> >developing
> >nation facing a public healthcare crisis and having insufficient drug
> >manufacturing capabilities. But using this type of compulsory licence is
> >burdensome and requires that various safeguards are met, including
> >information specifying the quantities of drug needed, evidence of an
> >inability to manufacture the drug, numerous notices from an exporting
> >country, and a guarantee that the drug will be used for public health
> >services. Implementation of a compulsory licence under article Q.Q.A.7(b),
> >therefore, is not a viable option for countries in urgent need of
> >healthcare.
> >
> >Therefore, while it is proclaimed that the TPP sets more flexible pharma
> >IP
> >rights protections for developing countries, the information leaked to the
> >public about the provisions governing compulsory licences indicates
> >otherwise.
> >
> >The US must balance its economic responsibility to protect the IP of its
> >domestic industries and its moral responsibility to aid those nations in a
> >health crisis. Perhaps that balance may be achieved with requirements for
> >using compulsory licensing that are less restrictive than those presently
> >proposed in the TPP, such as a condition that more strongly encourages
> >nations in need of a compulsory licence to work with the patent owner in
> >exchange for relaxing the requirement that the compulsory licence must
> >“not
> >unreasonably conflict with a normal exploitation of the patent”.
> >
> >Such a compromise may even prove to be financially beneficial to
> >developing
> >nations, as analyses such as the one conducted by Amir Attaran at the
> >University of Ottawa in Canada have shown that the prices of drugs
> >obtained
> >through international procurement are ultimately lower than the prices of
> >drugs obtained through compulsory licensing.
> >
> >The TPP is viewed as a template for future trade agreements between the US
> >and other nations. Consequently, it is essential that the US strikes the
> >right balance in relation to the provisions governing compulsory
> >licensing.
> >
> >Sandra Kuzmich heads the life sciences group at Frommer Lawrence & Haug.
> >Her practice focuses on strategic IP counselling and product life cycle
> >management in the areas of pharmaceuticals and biotechnology. She can be
> >contacted at: skuzmich at flhlaw.com
> >
> >Russell Garman is an associate at Frommer Lawrence & Haug. He focuses his
> >practice on developing and managing global patent portfolios and on
> >protecting life sciences technologies throughout their life cycle. He can
> >be contacted at: rgarman at flhlaw.com
> >
> >----
> >Elizabeth Rajasingh
> >Perls Research and Policy Fellow, Knowledge Ecology International
> >1621 Connecticut Ave. NW, Suite 500
> >Washington, DC 20009
> >*elizabeth.rajasingh at keionline.org <elizabeth.rajasingh at keionline.org>* |
> > 1-202-332-2670
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-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
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