[Ip-health] Biotech Transfer Week Article: "As India Mulls Bill Modeled on Bayh-Dole,Critics Claim It May Stifle Innovation"

[Ethan Guillen]

An article on the Indian Bayh-Dole bill and opposition to it.

<snip>

For instance, the UAEM suggests that both the Bayh-Dole Act and the propose=
d
Indian IP Act focus too narrowly on patenting and licensing at the expense
of other forms of =B3knowledge production=B2 such as scientific publishing;=
 and
that the proposed act would =B3encourage research institutions to obtain
patents on publicly funded research to the exclusion of other methods that
could in many situations be more beneficial to access and encouraging futur=
e
innovation,=B2 such as peer-reviewed publication.

UAEM also claims that the Indian IP Act contains only weak safeguards for
ensuring access to life-saving medicines for developing nations such as
India. =B3Critics of the original Bayh-Dole Act point out that the safeguar=
ds
the act contained to allow for public access in case a publicly funded
innovation was not made available on reasonable terms have never been
successfully used,=B2 the paper states, referring to Bayh-Dole=B9s governme=
nt
=B3march-in rights=B2 provision.

=B3Instead of fixing this problem, the Indian IP Act currently has fewer
safeguards aimed at preserving public access,=B2 the paper adds. =B3Under t=
he
Indian IP Act, the government [loses] its opportunity to preserve access to
publicly funded research just 90 days after learning of the new technology.=
=B2

http://www.biotechtransferweek.com/issues/2_44/features/150680-1.html

As India Mulls Bill Modeled on Bayh-Dole,
Critics Claim It May Stifle Innovation

[November 12, 2008]


By Ben Butkus

A controversial intellectual property-ownership bill modeled on the US
Bayh-Dole Act has been approved by India=B9s Union Cabinet, the nation=B9s
highest executive authority, and is currently being considered in Indian
Parliament, multiple news sources reported last week.

The bill would alter existing IP rules by allowing academic institutions,
not the federal government, to patent publicly funded research, and would
reward institutions and inventors with a share of royalties or licensing
fees from resulting commercial products.

However, it was approved by the Union cabinet without an official draft
having been released or publicly debated, according to reports, which
spurred heavy criticism by scholars both in India and in the US.

For instance, the US student-run watchdog group Universities Allied for
Essential Medicines last week warned that the legislation fails to provide
safeguards to guide the direction of publicly funded research, and that its
emphasis on commercialization may ultimately stifle innovation and impede
access to medicines in India and other developing nations.

Further details of the bill, entitled the =B3Protection and Utilisation of
Public Funded Intellectual Property Bill 2008,=B2 or the =B3Indian IP Bill,=
=B2 are
unavailable as the Indian government has not publicly released an official
version of it.

Shamnad Basheer, an associate at New Delhi=B9s Oxford Intellectual Property
Research Center who has been following the bill=B9s progression on his blog
SpicyIP, told BTW in an e-mail this week that the bill was likely first
prepared in 2005 by the Indian Department of Science and Technology with th=
e
assistance of an IP law firm.

Currently in India, the federal government controls the rights to IP
developed at academic or research institutions with the support of public
funds. The bill would require the inventing institution to be assigned thes=
e
rights, much like the Bayh-Dole Act does in the US.

In addition, the bill would require that any royalties generated from
licensing the IP or selling products based on the invention be split equall=
y
among the inventing scientist or scientists; the academic institution that
employs them; and Indian funding agencies, according to the reports.

Late last month, the Hindu Business Times reported that the bill was
approved at a meeting of the Union Cabinet chaired by Indian Prime Minister
Manmohan Singh, and is expected to be introduced into Indian Parliament
soon.

Basheer told BTW that the bill will need to clear both houses of India=B9s
Parliament, known as Rajya Sabha and Lok Sabha, before it becomes law. He
did not provide an estimated time frame for the bill=B9s consideration by
Parliament, but said that he believes it will pass =8B though not in its
current form. He did not elaborate.

Representatives from the Indian Union Cabinet or Parliament could not be
reached for comment.

An editorial published earlier this month by LiveMint.com, an online versio=
n
of the Indian business newspaper The Mint, also confirmed that the bill wil=
l
be reviewed by Parliament without an official draft having been released an=
d
publicly debated.

If the bill is significantly altered or shelved, it would be at the behest
of several academic groups and media outlets in India and the US that have
seen portions of the bill and claim that, as written, it could stifle
innovation and impede access to healthcare innovations in developing
nations.

=B3There is no =8Cone size fits all=B9 solution =8A [and] it is doubtful th=
at the
benefits of legislation closely modeled on Bayh-Dole would outweigh their
costs in developing countries.=B2
In an editorial published on Nov. 1, The Mint intoned the latter argument b=
y
writing that =B3the sad significance=B2 of the bill moving as far as it has
without public review stems from two factors: =B3First, it is all about
patenting output of research financed by public money. Second, it is
strictly geared to exclusive licensing for commercial use of what could be
crucial innovations for public health.=B2

According to Basheer, =B3the key advantage [of the bill] is that it provide=
s
more clarity on title and ownership to IP when government money is used. Th=
e
key disadvantage is that it doesn=B9t protect public interest as much as it
ought to have =8A and doesn=B9t vest enough discretion in the hands of the
inventor.=B2

Basheer did not elaborate, but on SpicyIP and in an article published on
SciDev.net, he noted that a laudable aspect of bill is that, unlike the
Bayh-Dole Act, which leaves royalty-sharing policies to the academic
institutions, the Indian IP Act would ensure that inventors receive at leas=
t
30 percent of any royalties stemming from licensing.

=B3But despite this guarantee of a share in the profits, individuals are le=
ft
with little option of determining how their invention can be used,=B2 Bashe=
er
wrote in the SciDev.net article. =B3For example, even if researchers wish t=
o
place their invention in the public domain or license it non-exclusively,
they cannot do so =8B rather, the bill puts this discretionary power in the
university's [tech-transfer office].=B2

The Mint editorial agreed, writing that =B3the scientist will have no say
here. So, [the Indian government] would not have the power to repeat past
decisions such as not patenting an antimalarial compound that could make a
low-priced drug available. As we=B9ve argued before, this bill needs to
encourage open source and non-exclusive licensing, too.=B2

Last week, UAEM echoed these concerns and introduced several more of its ow=
n
in a white paper that analyzes various provisions of the Indian bill and
raises questions about how the Bayh-Dole Act impacts university patenting i=
n
the US.

For instance, the UAEM suggests that both the Bayh-Dole Act and the propose=
d
Indian IP Act focus too narrowly on patenting and licensing at the expense
of other forms of =B3knowledge production=B2 such as scientific publishing;=
 and
that the proposed act would =B3encourage research institutions to obtain
patents on publicly funded research to the exclusion of other methods that
could in many situations be more beneficial to access and encouraging futur=
e
innovation,=B2 such as peer-reviewed publication.

UAEM also claims that the Indian IP Act contains only weak safeguards for
ensuring access to life-saving medicines for developing nations such as
India. =B3Critics of the original Bayh-Dole Act point out that the safeguar=
ds
the act contained to allow for public access in case a publicly funded
innovation was not made available on reasonable terms have never been
successfully used,=B2 the paper states, referring to Bayh-Dole=B9s governme=
nt
=B3march-in rights=B2 provision.

=B3Instead of fixing this problem, the Indian IP Act currently has fewer
safeguards aimed at preserving public access,=B2 the paper adds. =B3Under t=
he
Indian IP Act, the government [loses] its opportunity to preserve access to
publicly funded research just 90 days after learning of the new technology.=
=B2

The white paper concludes that the Indian IP Bill =B3has serious flaws whic=
h
need to be addressed in an open and public setting to determine whether any
legislation should be enacted and if so what kind.=B2

=B3Given the track record of Bayh-Dole in the United States, policy makers
need to seriously consider what they hope to accomplish by enacting similar
legislation, its suitability for a different country context, and whether
the measures adopted will accomplish the stated goals of the legislation
while protecting the public interest,=B2 the paper added.

UAEM=B9s white paper comes on the heels of another paper published last mon=
th
in PLoS Biology by a group of US-based academics examining the ongoing
debate of whether legislation based on the Bayh-Dole Act is appropriate for
developing nations.

The group, which was funded by the Open Society Institute, the Ford
Foundation, the Ewing Marion Kauffman Foundation, and various US government
agencies, claims that Bayh-Dole=B9s contributions to US innovation are ofte=
n
overstated, particularly in the biotechnology sector; and that the act may
be outdated even in the US because patent law and science have changed
considerably since the bill was enacted in 1980.

The authors assert that =B3countries seeking to enhance the contributions o=
f
universities and public-sector laboratories to social and economic
development have numerous policy options,=B2 including providing additional
funding for basic and applied research and education, and strengthening the
ability of companies to assimilate university research.

But these benefits are often reserved exclusively for developed countries,
the PLoS Bio paper suggests. =B3Even policies focused on [IP] management ne=
ed
not presume that patenting and exclusive licensing are the best options,=B2
the authors wrote. =B3There is no =8Cone size fits all=B9 solution =8A [and=
] we
believe it is doubtful that the benefits of legislation closely modeled on
Bayh-Dole would outweigh their costs in developing countries.=B2