[Ip-health] Medicines Patent Pool comments on USPTO Initiative to Incentivize Humanitarian Technologies

Suerie Moon suerie_moon at yahoo.com
Thu Nov 25 01:05:23 PST 2010


Dear all,
Please find here (http://www.medicinespatentpool.org/) and below the comments submitted by the Medicines Patent Pool to the US Patent and Trademark Office on its Initiative to Incentivize Humanitarian Technologies. 

Best wishes,
Suerie Moon, Ph.D.
Advisor, Medicines Patent Pool
smoon at medicinespatentpool.org
www.medicinespatentpool.org




Comments of the
Medicines Patent Pool

 

In response to: 

 

Request for Comments on Incentivizing
Humanitarian Technologies 

and Licensing Through the Intellectual
Property System

Department of Commerce, United States
Patent and Trademark Office

[Docket No. PTO–P–2010–0066]

 

 

Introduction

The Medicines Patent Pool thanks the USPTO for the
opportunity to provide comments on its important initiative, “Incentivizing
Humanitarian Technologies and Licensing Through the Intellectual Property
System.”  If structured well, the
humanitarian fast-track ex parte reexamination
voucher (henceforth “the Voucher,” for brevity) could have an important effect
on the willingness of patent-holders to license their technology in a way that facilitates
availability and access in the developing world.  The proposed incentive raises a number of
issues and challenges, many of which are reflected in the detailed questions
contained in the USPTO’s Request for Comments. 
Before turning to these questions, we preface our comments with our general
conclusion:  



Many of the complex questions that arise regarding
the optimal design of the Voucher require different factors to be weighed
judiciously.  For example, early-stage
research-related technology could be of great potential public health benefit,
but there would likely be a great deal of uncertainty regarding its
on-the-ground impact – how could the potential benefit be weighed against the
uncertainty of the outcome?  In addition,
it is perhaps impossible to devise rules in advance to weigh the value of a
particular technology against the importance of the problem being addressed,
against who would benefit, against a range of other variables.  For example, technology A could make a small
impact against a serious problem affecting children, while technology B could
make a major impact against a relatively less pressing problem affecting
adults.  How should the two technologies be
weighed against each other?  Or, the
patent-holder for technology A could make modest provisions to improve access
and availability in a few developing countries, while the patent-holder for
technology B could make much more generous and effective arrangements – how
should each be evaluated?  After some
deliberation, we have concluded that the level of complexity and uncertainty
involved suggests that setting hard-and-fast rules for Voucher qualification in
advance is likely to be inappropriate and administratively burdensome.  


Rather, we suggest the USPTO consider convening an
expert committee with individual members from global and national bodies with relevant
expertise to weigh carefully the various possible factors that may determine
which patent-holder is awarded a Voucher.  The committee’s decisions would be governed by
the principles and criteria established by USPTO, but have considerable
flexibility to weigh the multiple relevant variables.  The following criteria could be considered:

1.      --Scope of
problem addressed by technology

2.       --Severity of
problem addressed by technology

3.       --Vulnerability
of population addressed (e.g. children, rural populations, those living in
extreme poverty)

4.      -- Significance
of contribution (i.e. importance of the technology and on-the-ground impact)

5.       --Scope of
activities enabled by the license 

6.       --Absence of
unduly restrictive provisions in the license that would undermine the overall
objectives 

7.       --Additional
efforts made by patent-holders to ensure widespread access to the technology (e.g.
technology transfer initiatives)

 

In order to achieve political legitimacy and earn
the public trust, such a committee should include a wide range of stakeholders
(including affected populations), avoid conflicts of interest, and operate in a
transparent fashion regarding the criteria, decision-making processes, and
conclusions of its deliberations.  Furthermore,
given the many areas of technology potentially encompassed by the Voucher
program and the vast range of expertise required to make sound judgments, the
committee is likely to benefit from “crowd-sourcing” by accepting written
comments and submissions from a wide range of actors on a given
patent/technology/license under consideration for the Voucher.  The committee could serve, furthermore, as an
incubator for creative thinking within the US government on ways to contribute
to innovation, and to expand access to knowledge and technologies in developing
countries.


In order to keep the value of the Voucher
sufficiently high to influence patent-holder behavior, the USPTO could set a
fixed number of Vouchers to be awarded per year - in effect, as a prize - and
further be made specific to each area of technology (e.g., three for
pharmaceuticals, three for agriculture, five for clean energy, etc) as deemed
appropriate by the particularities of each field.  Establishing a small, fixed number of Vouchers
and the criteria by which they will be granted could create a ‘race to the top’
whereby potential recipients compete with each other to adapt their licensing
practices on as many of the criteria as possible in order to maximize their
chances of receiving the Voucher.  Such a
system would avoid the pitfall (envisaged in question 8) that patent-holders
may only do the minimum necessary to cross a particular threshold to qualify
for the Voucher.


In general, it will be important to avoid creating
perverse outcomes, such as the reinforcement of weak patents through hurried reexaminations
or encouraging more widespread patenting in developing countries.  


Finally, two key risks have been identified with
the analogous US FDA priority review voucher program that bear mentioning here[i]: first,
a priority review obligation may put additional burden on the agency and
thereby extend the waiting time for other applicants; second, the accelerated deadline
may negatively affect the quality of regulatory decisions.  In order to minimize the risk of these
consequences in the PTO initiative, a reasonable fee could be charged to
applicants to cover or defray the additional costs to PTO of administering the
program, the total number of Vouchers could be kept relatively small,[ii]
and all reexamination decisions made under the Voucher could be reviewed for
quality (as is current practice for a random sample of patent examiner
decisions on initial examination). 


Response
to Questions:   

1.      1.
The FDA awards priority review vouchers to entities that develop drugs which
treat a tropical disease under 21 U.S.C. 360n. Should recipients of this FDA
voucher automatically receive a humanitarian fast-track ex parte reexamination voucher from the USPTO?

 

The FDA PRV system currently does not require
voucher recipients to make their medicines available or affordable in
developing countries; rather, it rewards the development of the product.  (the grant of its first voucher, moreover,
has been criticized[iii]).  The USPTO Voucher should be used to
incentivize patent-holders to take additional
steps to make their technologies widely accessible (defined as available and
affordable) in developing countries. 
This is an area in which the US FDA PRV system falls short, and where
the PTO system could help to remedy a gap in the existing system.  Furthermore, the list of diseases included in
the US PRV is itself incomplete (for example, Chagas disease and pediatric HIV
infection are currently excluded[iv]) and likely
to be a small subset of the humanitarian problems to be targeted by the PTO.  Any special link between the FDA PRV and the
PTO program could inadvertently privilege the diseases included in the FDA list,
such that other conditions would potentially be disfavored in consideration for
the Voucher.  Therefore, we do not
recommend that a recipient of the PRV automatically receive a PTO Voucher.

 

2.      
2. FDA priority review vouchers are transferable on the open market.
Should USPTO fast-track ex parte reexamination vouchers
similarly be transferable on the open market?

 

Currently, FDA PRVs are transferable once, which is
likely to limit the value of the Voucher. While there is legislation that has
been proposed to allow unlimited transfers (sale and re-sale), Congress has not
yet passed this legislation (Creating Hope Act S.3697 (2010)).  The PTO Voucher should be transferable on the
open market an unlimited number of times in order to maximize its value.  Furthermore, although the USPTO's Request for
Comments appears to contemplate that the Vouchers may only be used by patent
owners requesting ex parte reexamination of their own patents, it may be
worth considering whether the value of the Vouchers could be further enhanced
if any party were eligible to purchase and/or use the Vouchers to request a
third party ex parte reexamination of a patent.  Given that, as the Request for Comments
indicates, the "patent owner would not be required to waive any current
statutory and procedural rights, and would have the same time periods for
filing responses and other communications as under the existing procedure,"
allowing the Vouchers to be used for third party reexamination requests may not
unduly prejudice the rights of patent owners. 


 

PTO could also consider limiting the applicability
of Vouchers to the field of technology in which they have been granted.  Such a measure could help make the value of
the Voucher somewhat commensurate with the effort required to gain the
Voucher.  In other words, a Voucher earned
through the licensing of a pharmaceutical-related patent could only be used for
reexamination of another pharmaceutical-related patent.  The suggestion to limit transferability by
field of technology rests on the assumption that investments required to obtain
a patent are, in general, higher in some fields (e.g., pharmaceuticals) than
others (e.g., climate change technology, seed varieties), although there may be
important exceptions to this general assumption.  Such restrictions on transferability would
help to prevent a potential ‘flooding of the market,’ in which Vouchers
received from the licensing of lower-cost technologies would be traded on the
market and applied to higher-cost technologies, thereby reducing the incentive
of owners of higher-cost technologies to engage in the desired licensing
behavior.  In particular, the Medicines
Patent Pool believes it would be important to ensure that the Voucher created
an incentive for pharmaceutical
patent-holders to grant voluntary licenses through this program.  

 

It could be very useful for USPTO to commission a
study to model the value of the reexamination Voucher in various fields of
technology, as was done for the FDA PRV.[v]  In addition, further clarity on the period of
time reexamination proceedings currently take would be useful (from the request
for comments, it seems the USPTO currently takes on average 19-20 months to
respond to reexamination requests, but this figure does not seem to include the
average time that patent-owners or third-parties take to respond to the
proceedings); according to our calculations, such proceedings may take up to
18-20 months of time (for patent-owner or third-parties) and on average 19-20
months (for USPTO action), for a total of 37-40 months without the Voucher, and
24-26 months with the Voucher, or roughly a 1/3 reduction in duration.

 

3.      
3. What humanitarian issues should qualify for the voucher program? Neglected
diseases, debilitating health conditions in developing countries, chronic
hunger, widespread public health problems such as lack of sanitation or potable
water, and/or other issues predominantly affecting impoverished populations?
Can these be defined with reference to existing humanitarian aid organizations?

 

We restrict our comments here to the area of
pharmaceuticals and public health. 
Within this field, all public health conditions should be considered for
the Voucher; as health conditions and available technologies change
constantly.  Grant of the Voucher should
be based on the assessment of a number of criteria, including the severity and
scope of the public health problem, and the degree to which the patented
technology contributes to addressing it. 
Such judgments are complex and difficult to make based on a single
parameter; therefore, the expert committee (described above) should be given
the freedom to consider all public health problems that may arise, and to
render a reasoned judgment on why a particular set of patents/technologies
received the ‘prize’ Vouchers.

 

4.      
4. Other than actual use, how can a patent owner demonstrate that a patented
technology would be effective at addressing a particular humanitarian issue?
What kinds of expertise would be required to make those judgments?

 

It may be difficult to predict how a specific
technology will be used, particularly in the earlier stages of its development
or deployment.  In the area of
pharmaceuticals for HIV, for example, a promising drug may be approved by the
FDA but reach relatively few people in developing countries unless it is
recommended by the WHO in its treatment guidelines.  Or, the effectiveness of a product may only be
demonstrated after a significant time lag. Because of the difficulty of
assessing the concrete impact of a particular technology in advance, and the
potentially wide range of expertise required to make a reasonable assessment,
we recommend the use of an expert committee to make such judgments.  The committee could set higher standards for
evidence of effectiveness as a technology reaches maturity, for instance, while
relaxing such standards for earlier-stage technologies, provided that they hold
the potential for significant impact.

 

5.      
5. Should the USPTO consider statements from independent third parties
(particularly humanitarian organizations or researchers) on the effectiveness
or actual use of an invention to address humanitarian needs? Should such
submissions be required to qualify for a voucher?

 

Third party submissions should be welcomed as a
way of expanding the knowledge base available to the expert committee appointed
by PTO to award the reexamination Vouchers. 
This principle is especially important given the potentially wide-range
of relevant technologies, and the fast pace of innovation in a number of
fields.  In order to build trust in the
system and to avoid perceptions of undue influence, such submissions should be
made publicly available.

 

6.      
6. Should certain elements (e.g.,
neglected
diseases, tropical crops, developing countries) of qualifying humanitarian
criteria be defined with reference to lists or criteria provided by external
organizations experienced in such matters, such as the World Health Organization,
National Institutes of Health, Food and Drug Administration, United Nations, or
U.S. Agency for International Development? If so, which criteria of other
public or private organizations should be followed?

 

While pre-defined lists offer the benefit of
clarity, they often lag behind evolving on-the-ground conditions.  The expert committee should be allowed to
make reference to lists generated by institutions with norm-setting mandates,
such as the WHO or CDC, but not be overly bound by such lists.  The PTO initiative has the potential to
influence and accelerate the
availability of technologies early in their development; doing so will require
that the expert committee have the freedom to be responsive and forward-looking
in their assessments of a technology and/or public health problem, which may
often mean going beyond pre-defined lists.

 

7.      
7. What actions should be considered to determine whether a patent holder has
made significant efforts to increase access to a patented technology? What types
of evidence of such actions can be submitted to minimize the burden on both
patent owners and the USPTO?

 

In the field of pharmaceuticals, the Medicines
Patent Pool has analyzed existing licensing practices and developed a set of
license terms and conditions that we believe would demonstrate significant
effort by patent-holders to increase access to a technology.  In most cases, medicines are made more
affordable through robust competition among multiple producers manufacturing at
acceptable levels of quality.  Based on
this principle, we suggest that licenses for pharmaceutical-related patents be
measured against the following yardstick: 

·        
Include wide geographical scope (e.g., licenses
available in all countries defined as low or middle-income by the World Bank)

·        
Enable follow-on research & innovation

·        
Include quality-assurance provisions

·        
Are licensed on a non-exclusive and non-discriminatory
basis

·        
Are licensed at reasonable royalty rates

·        
Are transparent on licensing conditions (e.g., licenses
made publicly available)

·        
Are transparent on patent rights (e.g., lists of
territories in which patent rights are held made publicly available)

·        
Facilitate technology transfer and development of
innovative capacity in developing countries

 

Evidence that the patent-holder had licensed the
relevant technology on humanitarian terms could be submitted to USPTO in the
form of the executed license agreement. 
Further evidence on availability and affordability of the product,
technology transferred, or other relevant concerns could be submitted by the
applicant, licensees, or credible third-parties.

 

8.      
8. How should a patented technology’s significance to a humanitarian
research project be determined? Should significance mean that the research
could or would not have occurred without the use of the patented technology?
Would considering economic or logistical factors suffice? Should qualifying research
efforts meet certain minimum thresholds (resources, number of researchers
involved, involvement from recognized humanitarian groups, etc.) to prevent abuse?

 

There
is tremendous variation between technologies, relevant humanitarian problems,
research approaches and needs.  As noted
above, the complexity of judging the significance of a given technology or
license suggests that an expert committee would be a better approach than
setting too many conditions a priori.  In order to prevent abuse, the committee
should be asked to consider input from the general global public, and to
operate in a transparent manner regarding the criteria, evidence, and rationale
used to reach its decisions.  

 

9.      
9. For the humanitarian research qualification, what factors should determine
whether terms of use are generous? Should it only focus on the cost of the
patented technology or consider other factors? What if the granting entity
retains any rights over the results of the humanitarian research?

 

A wide range of factors could be considered by the
expert committee in weighing the impact of a particular patent or technology on
a broader research agenda, including the importance of the technology, the
problem that is addressed, the scale of investments made, the degree of freedom
granted to carry out follow-on research, and the extent to which research data
and other relevant information is shared. 

 

The granting entity could retain rights over the
results of humanitarian research, provided that such rights did not impinge
unduly on further research and/or access to the end-product.  

 

10.  
10. How can the program encompass humanitarian issues affecting impoverished
populations in more developed countries in a way that is efficient to
administer and deters abuse? In particular, how should an applicant demonstrate
the existence of an impoverished group and that the product or treatment
primarily targets that group?

 

The definition of an impoverished or vulnerable
population and/or humanitarian issue is likely to change with time and
context.  Therefore, as noted above, we
encourage USPTO to give the expert committee a wide degree of latitude in
determining what comprises an appropriate problem or beneficiary population,
within a set of broad guidelines.  By
tasking the committee to select the best (three to five) licenses in a given
year, the USPTO can help to raise the bar for both the type of research carried
out to address humanitarian issues and the ways in which patents are managed to
ensure widespread access to the fruits of such research. 

 

11.  
11. Should vouchers to accelerate initial examination rather than reexamination
be offered for technologies addressing humanitarian needs? Are there other
pro-business strategies that the Department of Commerce or the USPTO should
pursue in future programs to incentivize humanitarian research and development and/or
best practices for intellectual property with humanitarian uses?

 

It would be useful to understand better the impact
of existing legislative provisions for accelerated initial examination in the
areas of HIV/AIDS, cancer, and green technology (i.e., 708.02
Petition to Make Special).[vi]  We would welcome further information from
USPTO on its assessment of such policies and their impact on R&D investment
and end-user access to technologies. 

 

Other pro-business strategies the USPTO could
engage in include improving the user-friendliness of the patent system as it
relates to humanitarian technologies. One of the difficulties in navigating the
patent system, particularly in developing countries, is the lack of reliable
and transparent data regarding patent status. 
In the field of pharmaceuticals, the Orange Book has contributed to
improving the transparency of the patent system in the US by listing the US patents relevant to a given
pharmaceutical product.  In an effort to
improve the usability and transparency of the patent system internationally,
the European Patent Office has mapped the landscape of patents relevant to
climate change-related technologies.  The
USPTO could carry out similar efforts on a range of technologies relevant for
improving human well-being in developing countries, including but not limited
to pharmaceuticals.  

 

 

12.  
12. Would non-monetary prizes or awards sponsored by the USPTO recognizing
humanitarian efforts encourage greater investment in the field? What criteria
should be used for selecting recipients?

 

If
the Voucher program is designed as a prize system, as suggested above, the
grant of a Voucher could be seen as an “award” in and of itself, which
recognizes the patent-holder’s licensing policy as one of the best in the
field.   In addition, USPTO could grant
other such awards to recognize patent-holders that make significant
contributions to improving human well-being and access to their
technologies.  The criteria for such
awards could be similar to those proposed on page 1 for receipt of the
Voucher.  

 

 

Conclusions

            The Medicines Patent Pool welcomes the initiative of the
USPTO to improve access to important technologies, such as pharmaceuticals, in
developing countries.  If designed well,
we believe the Voucher could have an important impact on the willingness of
patent-holders to generate innovation with potential benefits for populations
in low- and middle-income countries, and contribute to ensuring that the fruits
of scientific progress are accessible to those who need them.  We hope the Voucher initiative will encourage
pharmaceutical patent-holders to share their patents with the Medicines Patent
Pool.  We remain available to provide
further information or clarification of these comments, and to share our
experiences in developing pro-access licensing terms and conditions as our work
progresses. 

 

 

 

For
further information, please contact:

Suerie Moon, Ph.D.

Advisor, Medicines Patent Pool

smoon at medicinespatentpool.org

www.medicinespatentpool.org  

 










[i] See Kesselheim, A. S. (2008).
Drug Development for Neglected Diseases -- the Trouble with FDA Review
Vouchers. New England Journal of Medicine,
359(19), 1981-1983. doi:10.1056/NEJMp0806684 Available: http://dx.doi.org/10.1056/nejmp0806684;
and Moe, J., Grabowski, H., Ridley, D. (2009). FDA Review Vouchers.  New England
Journal of Medicine, 360(8), 837-838. 
Available: http://www.nejm.org/doi/pdf/10.1056/NEJMc086492





[ii] From 2005 to 2009, there were
roughly 500-700 determinations per year made on requests for reexamination.  Arguably, 5-10 reexamination requests given
priority review through the Voucher would not significantly impact waiting
times for other requests. 





[iii] See Anderson, T. (2009). Novartis Under Fire for
Accepting New Reward for Old Drug. The Lancet, 373(9673), 1414. doi:10.1016/S0140-6736(09)60804-7.
Available: http://dx.doi.org/10.1016/s0140-6736(09)60804-7 





[iv] The Creating
Hope Act S.3697 proposes to add Chagas disease and rare pediatric diseases to
the FDA list, but has not yet been passed by Congress.  





[v] See the estimates generated
for the FDA PRV in: Ridley, D. B., Grabowski, H. G., & Moe, J. L. (2006).
Developing Drugs for Developing Countries. Health Affairs (Project Hope), 25(2),
313-324. doi:10.1377/hlthaff.25.2.313





[vi] See “708.02 Petition to Make
Special [R-6] – 700 Examination of Applications.” Available at http://www.uspto.gov/web/offices/pac/mpep/documents/0700_708_02.htm.









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