[Ip-health] Mashelkar Report Misstates India's Right to Define Scope of Patentability

[B.Baker@neu.edu]

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The analysis below was prepared after a consultation of US NGOs in early=0D
January and was written in solidarity with Indian activists who have=0D
roundly critiqued the shoddy Mashelkar Report issued on the eve of the=0D
dangerous Novartis lawsuit challenging section 3(d) of the India=0D
(Amendments) Patent Act, 2005.  Limiting the rights of Big Pharma to win=0D
20-year patent monopolies on trivial changes in the form of a chemical=0D
entity, on new uses of existing products, and on new formulations or=0D
delivery systems, including combinations, is crucial to preventing on-going=
=0D
20-year renewals of patents on trivial grounds and to guaranteeing that=0D
generic producers are not blocked from producing life-saving medicines for=
=0D
poor people in India and in the rest of the developing world.  Moreover,=0D
other countries, including the Philippines are beginning to emulate India's=
=0D
strict patent standards, a trend that should spread like wildfire in=0D
developing countries.=0D
=0D
The Mashelkar Report should be roundly critiqued for its transparent=0D
capitulation to U.S. pressure and to the interests of Big Pharma and a=0D
certain pro-IPR segment of Indian generic industry.  Similarly, the=0D
Novartis lawsuit challenging section 3(d) should be condemned in the=0D
strongest terms, as was Big Pharma's 1998-2001 lawsuit against South=0D
Africa.  After a temporary lull following its public humiliations in 2001,=
=0D
Big Pharma is once again stepping out from behind the screen and deploying=
=0D
an army of lawyers to try to intimidate developing countries and generic=0D
producers.  Once again, activists must act up and fight back.=0D
=0D
MASHELKAR REPORT MISSTATES INDIA=E2=80=99S RIGHT TO DEFINE SCOPE OF PATENTA=
BILITY=0D
AND THREATENS ACCESS TO MEDICINES=0D
Professor Brook K. Baker=0D
Northeastern U. School of Law, Program on Human Rights and the Global=0D
Economy;=0D
Health GAP (January 26, 2007)=0D
=0D
The Mashelkar Committee in India was tasked with determining =E2=80=9Cwheth=
er it=0D
would be TRIPS compatible to limit the grant of patent for pharmaceutical=
=0D
substances to new chemical entity or to new medical entity involving one or=
=0D
more inventive steps.=E2=80=9D  In its recently released report, =E2=80=9CR=
eport of the=0D
Technical Expert Group on Patent Law Issues (Dec. 2006)=E2=80=9D [Mashelkar=
=0D
Report], not only did the Expert Committee misinterpret India=E2=80=99s fle=
xibility=0D
under international law to limit patents of pharmaceutical products to new=
=0D
chemical entities, it exceeded its mandate to critique section 3(d) of the=
=0D
India Patents (Amendment) Bill, 2005.  The errors in the Report include:=0D
=0D
1.  The Mashekar Report asserts without argumentation that =E2=80=9C[g]rant=
ing=0D
patents to only NCEs or NMEs and thereby excluding other categories of=0D
pharmaceutical inventions is likely to contravene the mandate under Article=
=0D
27 to grant patents to all =E2=80=98inventions=E2=80=99.=E2=80=9D  (=C2=B6 =
5.6.)  In =C2=B65.7, it goes even=0D
further and concludes that such a limitation =E2=80=9Cis not consistent wit=
h the=0D
TRIPS Agreement.=E2=80=9D  In doing so, the Report erroneously concludes th=
at the=0D
definition of invention (newness, inventive step, and industrial capacity)=
=0D
contained in Article 27.1 has any particular and definite meaning within=0D
the WTO TRIPS Agreement.  In particular, the Report ignores (does not even=
=0D
address) the flexibility that countries like India have under Article 1.1=
=0D
of the TRIPS Agreement, which states that =E2=80=9CMembers shall be free to=
=0D
determine the appropriate method of implementing the provisions of this=0D
Agreement within their own legal system and practice.=E2=80=9D  (Emphasis a=
dded.)=0D
=0D
Although Members must =E2=80=9Cgive effect to the provisions of [the TRIPS]=
=0D
Agreement,=E2=80=9D Article 1.1, they have considerable flexibility in doin=
g so,=0D
especially with regard to the Agreement=E2=80=99s under-determinate languag=
e,=0D
including that governing scope of patentability.  In essence Article 1.1 of=
=0D
TRIPS devolves interpretive authority and discretion to sovereign nations=
=0D
to balance national interests within a minimally constraining international=
=0D
intellectual property system.  Rather than seeking harmonization at any=0D
particular level of intellectual property protection, the GATT negotiators=
=0D
agreed to core of minimum standards only.  Moreover, even in setting=0D
minimum standards, the negotiators left some implementation flexibility.=0D
Especially, where governments elected to adopt more general rules rather=0D
than very specific rules, as they did with respect to the definition of=0D
=E2=80=9Cinvention,=E2=80=9D there is necessarily broader discretion left t=
o Members to=0D
determine the strictness of their definitions of newness, inventive step=0D
[1] and industrial applicability.  Although these terms are not infinitely=
=0D
elastic, they are flexible enough to accommodate India=E2=80=99s current ch=
oice in=0D
Section 3(d) and arguably even a more stringent standard limiting=0D
pharmaceutical patents to new chemical entities involving an inventive=0D
step.  The existence of this reservoir of flexibility is particularly=0D
apparent given the wide variability of patentability standards and=0D
exceptions among the many Member countries.[2]=0D
=0D
2.  The Mashelkar Report does not directly claim that limiting=0D
pharmaceutical patents to new chemical entities involving an inventive step=
=0D
would constitute prohibited discrimination against a field of technology=0D
and thus be prohibited by Article 27.  However, over-eager reading between=
=0D
the lines of the Report might infer to such a claim.  To the contrary, the=
=0D
TRIPS Agreement clearly permits differentiation between fields of=0D
technology, even though it does not permit out-and-out discriminatory=0D
exclusion of patents for a particular field of technology.  Such=0D
differentiation is implicit in the many diverse forms of Article 30-related=
=0D
exceptions to patent rights such as:  private and non-commercial use,=0D
experimental use, teaching, prior use, pharmacy preparations, foreign=0D
vessels, international civil aviation, regulatory review (Bolar), and=0D
exhaustion regimes.[3]  Additional, express exceptions to patentability are=
=0D
set forth in Article 27.2 (protection of ordre public) and in Article 27.3=
=0D
(diagnostic, therapeutic and surgical methods; and plants and animal).=0D
Moreover, courts and patent offices routinely come up with patent standards=
=0D
specific to particular fields of technology.  India has simply chosen to=0D
clarify standards of patentability for pharmaceutical products in section=
=0D
3(d) of it Patent (Amendment) Act of 2005, and in doing so has neither=0D
unfairly discriminated against a field of technology nor created an=0D
erroneous exception to patentability.=0D
=0D
3.  The Mashelkar Report asserts, without argument, that neither Articles 7=
=0D
and 8 of the TRIPS Agreement nor the Doha Declaration on the TRIPS=0D
Agreement and Public Health can be used to derogate from the specific=0D
mandates of Article 27.  (=C2=B6 5.6.)  To the contrary, the Doha Declarati=
on in=0D
particular was adopted as a specific clarification that the TRIPS Agreement=
=0D
=E2=80=9Ccan and should be interpreted and implemented in a manner supporti=
ve of=0D
WTO Members=E2=80=99 right to protect public health and, in particular, to =
promote=0D
access to medicines for all.=E2=80=9D  (=C2=B6 4, emphasis added.)  Further=
more, the=0D
Doha Declaration states that =E2=80=9Ceach provision of the TRIPS Agreement=
 shall=0D
be read in light of the object and purpose of the Agreement as expressed,=
=0D
in particular, in its objectives and principles.=E2=80=9D  (=C2=B6 5(a).)  =
Article 7 of=0D
the TRIPS Agreement is part of the basic principles of the Agreement, and=
=0D
it provides for =E2=80=9Cthe mutual advantage of producers and users=E2=80=
=9D and for =E2=80=9C=0D
social and economic welfare=E2=80=9D broadly construed.  (Emphasis added.) =
 Article=0D
8 is also part of the basic principles of the Agreement, and it provides=0D
that =E2=80=9CMembers may, in formulating or amending their laws and regula=
tions,=0D
adopt measures necessary to protect public health ... provided such=0D
measures are consistent with the provisions of this Agreement.=E2=80=9D  Th=
e Doha=0D
Declaration and Articles 7 and 8 of the TRIPS Agreement tilt the balance in=
=0D
favor of defining scope of patentability to maximize access to medicines.=
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This maximization would support both the existing provisions of section=0D
3(d) of the Patents (Amendments) Bill, 2005, but also the adoption of the=
=0D
more stringent NCE-only standard.=0D
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4.   The  Mashelkar  went  far  beyond its terms of reference to indirectly=
=0D
challenge  the  legality  of Section 3(d) of the Patents (Amendments) Bill,=
=0D
2005:   =E2=80=9CThere  is  a  perception  that  even the current provision=
s in the=0D
Patents Act could be held to be TRIPS non-compliant.=E2=80=9D  (=C2=B65.11.=
)  The Expert=0D
Committee  was not asked to assess the legality of the Patents Bill nor has=
=0D
it  provided  any analysis whatsoever of alleged defects.  This unwarranted=
=0D
and  unprofessional excursion into areas beyond its mandate is particularly=
=0D
unfortunate  given the pending lawsuit in India by Novartis challenging the=
=0D
TRIPS compliance of Section 3(d).=0D
=0D
5.  The Mashelkar Report makes no mention whatsoever of India=E2=80=99s obl=
igations=0D
under  binding human rights law.  The Universal Declaration of Human Rights=
=0D
(UDHR),[4]  the founding document of the international human rights regime,=
=0D
recognizes  that  every person has a right to a standard of living adequate=
=0D
for  his or her health and medical care (Article 25), the right to share in=
=0D
scientific  achievements  (Article  27),  and  the  right  to  a social and=
=0D
international order in which the Declaration=E2=80=99s rights can be fully =
realized=0D
(Article  28).   The  skeletal  framework  of  a  human  right  to  health,=
=0D
articulated  in  the  UDHR, has been further specified in the International=
=0D
Covenant  on  Economic,  Social  &  Cultural  Rights (ICESCR),[5] a legally=
=0D
binding treaty signed by India.=0D
=0D
In  Article  12,  the  ICESCR guarantees the right of everyone worldwide to=
=0D
"the  highest  attainable  standard  of  physical  and  mental  health" and=
=0D
requires  State  Parties  to  take  steps  necessary  for  =E2=80=9Cthe pre=
vention,=0D
treatment   and  control  of  epidemic,  endemic,  occupational  and  other=
=0D
diseases=E2=80=9D  and  to  provide  =E2=80=9Cconditions  which would assur=
e to all medical=0D
services  and  medical  attention  in the case of sickness.=E2=80=9D  This =
skeletal=0D
right to health provision received further clarification when the Committee=
=0D
on  Economic, Social and Cultural Rights (CESCR) issued General Comment No.=
=0D
14  which concluded that there is a basic obligation to ensure a sufficient=
=0D
quantity  of essential medicines (=C2=B6 12(a)) and that these medicines mu=
st be=0D
affordable (=C2=B6=C2=B6 12(b), 17).  In sum, universal access to essential=
 medicines=0D
is  a  core,  non-derogable  duty  of  all  member States as is preventing,=
=0D
treating,  and  controlling  epidemic  and endemic diseases. (=C2=B6 43(d) =
and =C2=B6=0D
44(c)).=0D
=0D
6.  The Mashelkar Report creates a legally incoherent differentiation=0D
between what it calls =E2=80=9Cincremental innovation,=E2=80=9D meaning =E2=
=80=9Csequential=0D
developments,=E2=80=9D and =E2=80=9Cever-greening,=E2=80=9D meaning trivial=
 and inconsequential=0D
changes to an existing patented product.  In doing so, it provides no=0D
litmus test by which such categorization might be made.  How small a change=
=0D
must there be to be inconsequential instead of incremental?  Where minor=0D
modifications to existing molecular structures in now routine in=0D
low-standard countries, like the U.S., or where obvious new doses or new=0D
combinations of existing products are likewise patentable, how would Indian=
=0D
patent examiners make the alleged distinctions?=0D
=0D
7.  In addition to misapplying governing legal standards, the Mashelkar=0D
Report incorrectly assesses and references the national interests of India,=
=0D
of its medicines consumers, and even of its pharmaceutical industry by:=0D
=0D
      Ignoring public-health and access-to-medicines needs in their=0D
      entirety;=0D
      Confusing the practice of Indian producers in filing new use and new=
=0D
      form patents in low-standard, high-income countries with the issue of=
=0D
      setting proper TRIPS-compliant standards of patentability in India;=
=0D
      Failing to acknowledge that Indian pharmaceutical companies can=0D
      simultaneously earn high returns in U.S., European, and Japanese=0D
      markets for off-patent medicines and for medicines patented under=0D
      those countries=E2=80=99 lower patent standard, and still earn money =
and=0D
      serve the needs of much poorer Indian and developing country=0D
      consumers who rely on India for expanding and affordable access to=0D
      newer life-saving and life-enhancing medicines that are not=0D
      patentable under strict, but lawful, standards of patentability;=0D
      Misunderstanding India=E2=80=99s role as an international leader and =
defender=0D
      of developing-country interests and flexibilities on intellectual=0D
      property-related issues to advance public health and to ensure access=
=0D
      to medicines for all.=0D
=0D
8.  The Mashelkar Report fails to even acknowledge the input of civil=0D
society groups, including those from local and international intellectual=
=0D
property experts, that supported India=E2=80=99s flexibility to adopt a NCE=
=0D
standard of patentability for pharmaceutical products.  In contrast, it=0D
included summaries of submissions by multiple industry stakeholders and of=
=0D
patent-attorney stakeholders.=0D
=0D
The Mashelkar Report is a betrayal of the interests of people suffering=0D
   from life-threatening diseases worldwide, especially people living with=
=0D
   HIV/AIDS, and a capitulation to the interests of the multinational drug=
=0D
   companies and a narrow spectrum of India manufacturers that subverted=0D
   the process and stand to benefit from increased rights to charge=0D
   unconscionable prices and to extract monopoly profits at the cost of=0D
   denied access and millions of lives in India and abroad.=0D
=0D
Endnotes:=0D
=0D
1 Footnote 5 to the TRIPS Agreement gave Members flexibility to deem=0D
=E2=80=9Cinventive step=E2=80=9D as synonymous with =E2=80=9Cnon-obvious=E2=
=80=9D and =E2=80=9Ccapable of=0D
industrial application=E2=80=9D to be synonymous with =E2=80=9Cuseful.=E2=
=80=9D  However, the=0D
footnote does not restrict Members to that less strict standard, suggesting=
=0D
that they have flexibility to adopt much more rigorous tests.=0D
=0D
2 Different standards concerning patentability of computer programs is but=
=0D
one example of this variability.  Another testament to the degree of=0D
flexibility is efforts within WIPO to enact a new Substantive Patent Law=0D
Treaty.=0D
=0D
3 See, Christopher Garrison, Exceptions to Patent Rights in Developing=0D
Countries (UNCTAD-ICTSD 2006).=0D
=0D
4 U.N. Gen. Assembly Res. 217A, U.N. GAOR, 3d Sess., at 71, U.N. Doc. A/810=
=0D
(1948).=0D
=0D
5 International Covenant on Economic, Social and Cultural Rights, Dec. 16,=
=0D
1966, 993 U.N.T.S. 3, 6 I.L.M. 360 (1966) (entered into force Jan. 3,=0D
1976).  The ICESCR has been ratified by 152 U.N. Member states, and another=
=0D
seven, including the U.S., have signed, signaling their intent to become=0D
legally bound.