c

c 

OSDD1 is a CSIR (Council of Scientific and Industrial Research) led consortium with global

partners. It has more than 1700 registered participants and has received around Rs. 46 crores

from the Government of India. The main objective of OSDD is to provide affordable

healthcare to developing world by providing an open platform to the people. OSDD aims at

discovering drugs for diseases neglected by the industry.

This is done by providing an online platform, where participants can exchange research and

donate Intellectual property, wholly or partly. The new drug which is likely to be discovered

will be made available in the form a µgeneric¶ molecule for the industry to manufacture.2 It is

believed that the competition will ensure low prices of the drugs since the research cost of the

pharmaceutical companies will be very low. Also, the companies will not be spending money

on protecting the Intellectual property (IP) and litigation.

The first target of OSDD is Tuberculosis (TB). There has been no considerable breakthrough

in this area and there is a long way to go before we can expect any New Chemical Entity

(NCEs). According to the OSDD website, their first phase will comprise of drug discovery

whereas the second phase will comprise of clinical tests. OSDD is planning to fund the

clinical tests so that the NCE so discovered will be freely available to the manufacturers.3

Even though this might seem like a novel idea, Open Source in biotechnology is being used

already in Cambia4 which was founded by Richard Jefferson. At this non-profit organisation,

BIOS initiative (Biological Innovation for Open Society) was used to create a ³protected
???????????????????????????????????????? ????????????????
1
www.osdd.net (Last visited on 31.03.2011)
2
Project Director OSDD, ³Ooen Source Drug Discovery´ An Open Collaborative Drug Discovery Model for
Tuberculosis, Submitted to: WHO Expert Working Group on R&D Financing
3
ibid
4
http://www.patentlens.net/daisy/cambia/home.html (Last visited on 31.03.2011)
commons´ with legal structure to allow users to access, improve, and modify technologies

without infringing proprietary rights.5

The OSDD is governed by a licensing agreement. This agreement is a µclick wrap¶6

agreement. Each contribution is time and login stamped. The author is going to analyse this

agreement in detail and will try to explain the legal concepts involved and the future

implications on Intellectual property that might be derived from such an agreement.

OSDD is providing incentives and rewards for more participants to come forth and

contribute. These incentives are regulated by using Micro-attribution system7 are expected to

bring out more students and researchers to bring in meaningful contributions.

vc c 
 


The OSDD license agreement8 is a µclick wrap¶9 agreement and is binding on all the

members10. This agreement is renewed on every log in and the users are deemed to be aware

???????????????????????????????????????? ????????????????
5
Hassan Masum, Karl Schroeder, Myra Khan and Abdallah Daar, Open Source Biotechnology for Global
Health: two case studies, Available at http://openict4d.wdfiles.com/local--
files/start/Open%20Source%20Biotechnology%20for%20Global%20Health%20-
%20two%20case%20studies.pdf (Last visited on 31.03.2011)
6
Click wrap agreements are generally internet agreements which allow users to read the terms and conditions
before accepting them. See ProCD v. Zeidenberg 86 F. 3d 1447 (7th Cir. 1996)

?

?
 ?Open Source and Neglected Disease Drug Discovery??


??
? ??
8
APPENDIX
9
Supra note 6
10
In clause 1.1 of the agreement, it is specified that the services are only offered to persons capably of entering
into a contract.
of any new terms and conditions that might have been introduced.11 Also a new agreement is

deemed to super cede any prior agreements between OSDD and the user.

The agreement starts with establishing the bona fide intentions of OSDD and lays down the

objective of the agreement as ³In formulating these Terms the OSDD programme addresses

the potential problem of other parties filing, and being awarded patents or other Intellectual

Property Rights based on the information, data, ideas or other materials available on its

website, either pre-existing or generated by the OSDD community.´

Clause 2 puts the responsibility of proper use of the information on the user. It also lay down

that the activities of the user must not be in contravention to the ³vision and purpose´ of

OSDD.

Clause 3 is the crux of the agreement as it lays down the rights of the user and OSDD (acting

through CSIR). This clause is aimed at dealing with the intellectual property related issues

and hence avoiding any future conflicts. This clause states that the website and the

data/research available on it form a ³Protected Commons´. This concept of µprotected

commons¶ has not been explained anywhere in the agreement. Further, it clarifies that such

data research information etc belongs à

 to the OSDD community. Clause 3.1 expressly

states that any misappropriation of the Protected Commons will be liable to legal action.

Also, any research, invention etc. submitted to OSDD or generated using OSDD website will

be held by OSDD (acting through CSIR in Trust). OSDD will have  
 à over

any IP generated out of the drug discovery process and such IP will be used in furtherance of

the ³vision and mission´ of OSDD only. Since it is a standardised contract, everyone will

have to give up all their rights over any discovery/invention that they might make using

OSDD database.

???????????????????????????????????????? ????????????????
11
Clause 1.4 of the agreement
Clause 3.5 starts as ³except as stated above´ which makes it subject to the previous

provisions. This clause states that ³contents created on OSDD shall be governed by Creative

Commons license.´ Again µCreative Commons license¶ is not defined anywhere in the

contract but a web link 12 is given to understand the terms of this license. This agreement also

makes provisions for donating certain IP rights. This is incorporated under clause 3.6 where a

user may submit their patented inventions while retaining all the rights ³except to the extent

to be used in the drug discovery process or for selling any product or process arising out of

your invention.´

The miscellaneous provision contains indemnity clause, disclaimer, no third party beneficiary

clause, limitation clause and jurisdiction clause etc. The indemnity clause puts the burden on

the user to indemnify OSDD from any third party actions that might arise due to the user¶s

actions. This seems to be a mere legal formality since in practice, legal suits take years to

resolve the dispute and in most of the cases, a user will not be in a financial position to

indemnify a patent infringement suit. The agreement also excludes third party beneficiaries at

many places. It is important to note that there is no saving clause and OSDD has not vested

itself with any wide discretionary powers except that of altering the terms as and when it

deems fit.

v





A protected commons provides a secure platform where discussion concerning an invention

or improvement can take place without the invalidation of future patent applications, or the

misappropriation of information by third parties.13 This is very different from the public

domain since it does not invalidate future patent applications. Any piece of knowledge in the
???????????????????????????????????????? ????????????????
12
http://creativecommons.org/ (Last visited on 31.03.2011)
13
http://www.patentlens.net/daisy/bios/404.html (Last visited on 31.03.2011)
public domain may be readily misappropriated but all the information in Protected Commons

is protected by a licensing agreement.

Protected Commons differs from the legal framework of patents. It is, in fact, termed as

antidote to patents since patents restrict free-flow of information.14 While in patents the

information is disclosed to the public domain, research in protected commons is only

disclosed to the members. The final outcome might be patented in the name of the whole

community. In some Protected Commons (such as BIOS initiative), the subsequent changes

to the information can be patented by the author.15 But this does not seem to be the case in

OSDD since Clause 3 gives all the rights to subsequent changes to the Protected Commons.

c
c  c 

The provisions of the agreement as discussed above are loosely drafted but seem to address

most of the IP-related issues. Emily Marden has raised several questions regarding the

viability of open source model in drug discovery.16 cnter alia she has raised the point that a

drug is generally made up of multiple compounds. What will the status of the IP so generated

if one compound is open source generated and the other is privately developed? Will the

newly constituted drug be in the public domain?

???????????????????????????????????????? ????????????????
14
Society for Scientific Values, (thics in Scientific Research Development and Management: News and Views,
Vol. 7, No. 1, Sept 2009
15
cbid
16
Emily Marden, Open Source Drug Development: A Path to More Accessible Drugs and Diagnostics?, MINN.
J. L. SCI & TECH. 2010;11 (1):217-266
Clause 3 vests all IP rights arising from drug discovery process into the Protected Commons.

The argument that once the resulting product is out in the market, it being generic in nature,

can be easily developed upon and patented by any pharmaceutical company holds no ground

in the case of OSDD. Also E. Marden17 pointed out that if the compound generated by open

source is licensed to a pharmaceutical company, it can develop the compound into a new drug

which might be patentable free from open source constraints. This argument also does not

hold water since Clause 3 vests all IP rights in the protected commons of the information

available on the website as well as of the inventions that might be made as a result of this

information.

But the provisions of this agreement are drafted in such a way that it is highly unlikely for

any pharmaceutical company to donate their IP or money. The agreement takes away all

rights of the donor to appropriate their own IP after donating a part of it. Also if a drug is

invented by combining the compound of the open source and the compound of private nature,

the proprietary rights of such a compound will again be vested in the protected commons.

Such strict and one-sided provision will defeat the very objective on which the OSDD model

is based. Most of the drugs now a day are made of a combination of many compounds.

Unless OSDD comes up with a more compromising agreement, no pharmaceutical company

will be willing to work in collaboration with them.

Also, the cost of research and IP protection is very high. It is highly unlikely that OSDD will

be able to suffice solely on the funding of the Government of India.18 The research facilities

and the talent pool of OSDD might not be sufficient to discover drugs for diseases such as

TB. The incentive structure of OSDD also will not be able to attract the best talent in the

???????????????????????????????????????? ????????????????
17
cbid
18
Even though Corporates such as Infosys and SUN Microsystems are contributing monetarily, no
pharmaceutical company has come forth to help this initiative.
world. Only some students and researchers will be willing to contribute their research to the

public domain without patent incentives.

Another problem with this agreement is that it is trying to establish a viral agreement19 (till

now used in open source software for copyrights) in patent protection. Open Source involving

patents is completely different from open source in copyright (as is the case in software open

source).20 An inventor may feel cheated if his donation to the public domain earns money for

someone else. 21 Miss. Arti Kaur Rai22 believes that such viral agreements are not required at

all since public domain will suffice (acting as a huge pool of Protected Commons). This

unique situation has been discussed by Maurer23 in detail. He believes that such agreements

in case of drug discovery are unstable.24 But while looking at this agreement, I see no legal

reason why OSDD licensing agreement should falter but in order to block out all the legal

loopholes, OSDD might have pushed away all the pharmaceutical companies from

exchanging knowledge. Maurer also believes that maybe each scientist could do better

individually patenting his/her own inventions. But then that would defeat the whole purpose

of Open Source since individual patents will encourage monopolies.

???????????????????????????????????????? ????????????????
19
Stephen M. Maurer, Open Source Drug Discovery: Finding a Niche (or maybe several), 2 UMKC LAW
REVIEW [Vol. 75:000 2007]

?

?

?!?pan open-source R&D reinvigorate drug research?, " 
??
#$%%&&&'
'(%
%) %%%* %
+,+'( ? (Last visited on 31.03.2011)?
+
?Supra note 18?
22
Arti Kaur Rai, ³Open and Collaborative´ Research: A New Model for Biomedicine, in
cntellectual Property Rights in Frontier cndustries, 2005
23
Supra note 18
24
cbid while discussing the Cambian model
   c 

By this agreement OSDD is aiming to address any future infringements or IPR claims. Even

though the noble and innovative idea of CSIR is credit-worthy, the licensing agreement could

have been drafted in a more detail. Looking at the magnitude of the operations and the

potential breakthroughs OSDD might accomplish, it is highly unlikely that they will be able

to ward off infringers and subsequent litigation.

A plain reading of the agreement will reveal that different meanings can be attributed to its

provisions. Phrases such as, µprotected commons¶, µcreative commons license¶ and µweb

crawlers¶ have been used without giving a definite meaning to them. Such a loosely drafted

agreement could see a lot of litigation in future.

Another problem that OSDD might face is when the pool of members becomes too large, the

purpose of Protected Commons will perish since it will be no different from public domain.

But it is strongly felt by the author that no matter the contents of the agreement, OSDD will

be facing a lot of infringements once it comes out with NCEs.

 vv c



   
Open Source Drug Discovery platform hereafter referred to as OSDD to include OSDD
members, OSDD foundation, CSIR, its partners, sponsors and agents.
OSDD is a CSIR- led, Team India consortium with a vision to provide affordable healthcare
through collaborative drug discovery to reduce the cost involved in drug discovery process.
The OSDD program covers the entire spectrum of processes in drug discovery. This includes
the identification of drug-able non-toxic targets, in vitro and in vivo validation, in silico
screening of molecules, lead optimization, pre-clinical toxicity and clinical trials.
OSDD welcomes all those who share its vision and are committed to the cause. This website
enables sharing of ideas, information, articles, papers and other literary work, data, reagents,
notes, etc., among the users of OSDD for furtherance of the OSDD vision.
In formulating these Terms the OSDD programme addresses the potential problem of other
parties filing, and being awarded patents or other Intellectual Property Rights based on the
information, data, ideas or other materials available on its website, either pre-existing or
generated by the OSDD community.
OSDD recognizes that to protect the legal rights of the OSDD, the contributors and the results
of the collaborative research, it is necessary that it take legal action against those
misappropriating the Intellectual Property available and which has arisen from the
collaborative research.
Towards this end, all participants are required to partially assign their right(s) pertaining to
whatever they contribute, to CSIR acting on behalf of OSDD,for the sole purpose of taking
action against any potential infringement. Such an assignment is partial and only for the
purpose of protecting the Intellectual Property generated by OSDD. This step will prevent the
IPR based on the information, ideas and Intellectual Property generated by the OSDD users
from being misappropriated. Thus OSDD/CSIR holds the Intellectual Property over the
content generated as Protected Commons.
We offer the services of OSDD and the OSDD website/portal for all those who are
committed to the OSDD vision. To use the OSDD portal, its contents, software, web-based
and other services you agree to the following terms and conditions and any policies,
guidelines or amendments thereto that may be presented to you from time to time including,
but not limited to, the terms and conditions (Terms) listed below. These Terms may be
updated in future and you will be able to find the most current version of this Agreement on
the website www.osdd.org.
 
à    à
à  
à
<!--[if supportLists]-->1.1 <!--[endif]-->OSDD offers the services available on its website to
you, provided that you are of legal age to form a binding contract and are not a person barred
from participating in OSDD by the laws of India or any other applicable jurisdiction. Use of
this site constitutes your acceptance of these terms and conditions, which take effect
immediately on your first use of the site. OSDD acting through CSIR (India) reserves the
right to change these terms and conditions at any time by posting changes online.
<!--[if supportLists]-->1.2 <!--[endif]-->In order to access the information and services
available on OSDD website you are required to provide current and accurate identification
for contact as well as other information as part of the registration process. You may be
required to fill out online form(s) available on the website.
<!--[if supportLists]-->1.3 <!--[endif]-->You are responsible for maintaining the
confidentiality of your password. You will be held responsible for all the activities from your
account.
<!--[if supportLists]-->1.4 <!--[endif]--> You are responsible for regularly reviewing
information posted online to keep abreast of any changes. OSDD or CSIR India does not
accept any responsibility to keep you informed about any changes in the terms of use. Your
continued use of the site after changes are posted constitutes your acceptance of the
agreement as modified by the posted changes.
<!--[if supportLists]-->  <!--[endif]-->  

<!--[if supportLists]-->2.1 <!--[endif]-->You agree that you are responsible for any content
that you create, transmit or display while using the OSDD website. You agree to use these
services only for the purposes that are legal and proper, in accordance with the vision and
purpose of OSDD and in accordance with the Terms and any applicable policies or
guidelines.
<!--[if supportLists]-->2.2 <!--[endif]-->You agree that you will not act or indulge in any
activity that will disrupt the services of OSDD website or services provided therein or even
the network connected to this website.
<!--[if supportLists]-->  <!--[endif]--> v  à
<!--[if supportLists]-->3.1 <!--[endif]-->OSDD is a secure platform for drug discovery. The
OSDD website, its services, the content, ideas, information, data, research results and other
materials generated by users and any information available on its website form a Protected
Commons. Such information, data, research results and other material available on the
website belong solely to the OSDD community, to be used to further its vision and mission
thereby forming a Protected Commons. To this extent, the information available on this
website in any form is confidential information and the proprietary right of the OSDD. Any
appropriation of this information to use it to develop patent rights based on such information,
without an explicit license of OSDD acting through CSIR, shall be misappropriation of the
Protected Commons, liable to legal action under the applicable laws.
<!--[if supportLists]-->3.2 <!--[endif]-->By using this website and in consideration thereof
you agree that any information, ideas, data, content, research results, invention, etc submitted
by you or generated using the website shall be held by OSDD acting through CSIR in Trust
as Protected Commons and you authorize OSDD acting through CSIR to take any action in
furtherance of the vision of OSDD and to protect the rights of Protected Commons.
<!--[if supportLists]-->3.3 <!--[endif]-->In order to exercise action against infringement of
these Terms, particularly against those who appropriate the ideas, information, data, content,
etc available on the website as a basis for obtaining patent, you agree to assign partially, any
Intellectual Property Right held by you to OSDD, to be exercised by CSIR India on your
behalf in Trust as Protected Commons, for the sole and limited extent of protecting the rights
of Protected Commons.
<!--[if supportLists]-->3.4 <!--[endif]-->You assign to OSDD acting through CSIR the
worldwide royalty free rights over the Intellectual Property generated out of the drug
discovery process, for the sole purpose of furthering the vision and mission of OSDD and for
that purpose only. It is understood that if the Intellectual Property so generated is used for any
purpose contrary to its vision and mission, this assignment shall stand unconditionally
revoked.
<!--[if supportLists]-->3.5 <!--[endif]-->In furtherance of the above assignment you agree
that OSDD acting through CSIR may license any Intellectual Property generated out of
OSDD for the sole purpose of furthering the vision and mission of OSDD.
  à
<!--[if supportLists]-->3.6 <!--[endif]-->Except as stated above, OSDD contents created on
OSDD shall be governed by Creative Commons license. You are advised to read and
familiarize with the terms of the Creative Commons license available at
http://creativecommons.org/.
You may exercise the rights provided under that license with to any information, data or
content available on the site.
3.6 You may submit your patented inventions (product or process) for the use of OSDD. You
may retain the rights over the patents except to the extent to be used in the drug discovery
process or for selling any product or process arising out of your invention. By submitting
your patented invention for OSDD you agree not to place any encumbrances on the product
or process arising out of the use of your patented product or process.
 
à
1.? Users are not permitted to use "web crawlers" or other types of software or hardware
technology to automatically download large amounts of material from the site.
Elements of the site are also protected by trademark, copyright and other laws and
may not be imitated in whole or in part on other web sites.
2.? Attempts to destroy the website by any destructive means such as by introducing
viruses would entail legal consequences.
3.? You agree to indemnify OSDD and CSIR India against all legal fees, damages and
other expenses that may be incurred by a result of your breach of the above warranty.
4.? These Terms and Conditions shall be governed by and construed in accordance with
the laws of India. Disputes arising here from shall be exclusively subject to the
jurisdiction of the High Court of Delhi, India.
5.? c   c
 ±
1.? You agree to hold harmless and indemnify OSDD from and against any third
party claim arising from or in any way related to your use of OSDD services,
violation of the Terms or any other actions connected with use of OSDD
services, including any liability or expense arising from all claims, losses,
damages (actual and consequential), suits, judgments, litigation costs and
attorneys' fees, of every kind and nature.
2.? This website has been designed in good faith by OSDD CSIR, but no
representation is made or warranty given [either express or implied] as the
completeness or accuracy of the information contained therein. By accessing
this site you agree that OSDD CSIR will not be liable for any direct or indirect
loss arising from the use of the information and the material contained in this
website. The Protected Commons material contained in this website belongs to
and remains solely with OSDD CSIR.
 3.? You agree that you are solely responsible for all contents posted by you on the
website and indemnify OSDD CSIR from any 3 rd party claim relating to
Intellectual Property or any other rights.
6.? c c 

c - You expressly understand and agree that:
1.? Your use of OSDD services is at your sole risk. OSDD services are provided
on an "as is" and "as available" basis. To the maximum extent permitted by
law, OSDD expressly disclaim all warranties and conditions of any kind,
whether express or implied, including, but not limited to the implied
warranties and conditions of merchantability, fitness for a particular purpose
and non-infringement.
2.? OSDD do not warrant that (i) OSDD services will meet your requirements, (ii)
OSDD services will be uninterrupted, timely, secure, or error-free, (iii) the
results that may be obtained from the use of OSDD services will be accurate
or reliable, (iv) the quality of any products, services, information, or other
material purchased or obtained by you through OSDD services will meet your
expectations, and (v) any errors in the software will be corrected.
3.? Any material downloaded or otherwise obtained through the use of OSDD
services is done at your own discretion and risk and that you will be solely
responsible for any damage to your computer system or other device or loss of
data that results from the download of any such material.
4.? No advice or information, whether oral or written, obtained by you from
OSDD or through or from OSDD services shall create any warranty not
expressly stated in the terms.
7.? cc

c 
ccc
 - YOU EXPRESSLY UNDERSTAND AND
AGREE THAT OSDD SHALL NOT BE LIABLE TO YOU FOR ANY DIRECT,
INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR EXEMPLARY
DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF
PROFITS, GOODWILL, USE, DATA OR OTHER INTANGIBLE LOSSES (EVEN
IF OSDD HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES)
RESULTING FROM: (i) THE USE OR THE INABILITY TO USE OSDD
SERVICES; (ii) THE COST OF PROCUREMENT OF SUBSTITUTE GOODS AND
SERVICES RESULTING FROM ANY GOODS, DATA, INFORMATION OR
SERVICES PURCHASED OR OBTAINED OR MESSAGES RECEIVED OR
TRANSACTIONS ENTERED INTO THROUGH OR FROM OSDD SERVICES;
 (iii) UNAUTHORIZED ACCESS TO OR ALTERATION OF YOUR
TRANSMISSIONS OR DATA; (iv) STATEMENTS OR CONDUCT OF ANY
THIRD PARTY ON OSDD SERVICES; OR (v) ANY OTHER MATTER
RELATING TO OSDD SERVICES.
8.? 
cv

ccc - You agree that, except as otherwise
expressly provided in the Terms, there shall be no third party beneficiaries to the
Terms.
9.? 
c
You agree that OSDD may provide you with notices, including those regarding
changes to the Terms, by email, regular mail, or postings on OSDD services.
1.?  c

c
Entire Agreement. The Terms (including any policies, guidelines or amendments that may be
presented to your from time to time such as Program Policies and Legal Notices) constitute
the entire agreement between you and OSDD and govern your use of OSDD services,
superceding any prior agreements between you and OSDD for the use of OSDD services.
You also may be subject to additional terms and conditions that may apply when you use or
purchase certain other OSDD services, affiliate services, third-party content or third-party
software.
11. Waiver and Severability of Terms. The failure of OSDD to exercise or enforce any right
or provision of the Terms shall not constitute a waiver of such right or provision. If any
provision of the Terms is found by a court of competent jurisdiction to be invalid, the parties
nevertheless agree that the court should endeavour to give effect to the parties' intentions as
reflected in the provision, and the other provisions of the Terms remain in full force and
effect.
12. Statute of Limitations. You agree that regardless of any statute or law to the contrary, any
claim or cause of action arising out of or related to use of OSDD services or the Terms must
be filed within one (1) year after such claim or cause of action arose or be forever barred.
The section headings in the Terms are for convenience only and have no legal or contractual
effect.