[Ip-health] Lawyers Collective Response to Testimony of Mr. Roy F Waldron, Pfizer Inc.

Ramya Sheshadri ramyasheshadri8 at gmail.com
Tue Sep 17 00:33:53 PDT 2013


Recently, several multinational pharmaceutical companies along with the US
Chamber of Commerce have been instrumental in mounting pressure on India to
decry the alleged state of Intellectual Property (IP) regime in India. On
June 27, 2013 a hearing, ‘A tangle of trade barriers’ before the US Energy
and Commerce Committee saw witness testimonies including that of Chief
Intellectual Property Officer, Pfizer Inc., Mr. Roy Waldron. The testimony
by Mr. Waldron makes certain assertions about the recent developments in
the Intellectual property regime of India.

These allegations arise from the recent developments that have taken place
in the Indian Intellectual Property regime, particularly patents. To
outline a few of these developments, firstly, the first ever compulsory
license was granted for a
cancer<http://www.lawyerscollective.org/tag/cancer> drug,
Nexavar, which was upheld by the Intellectual Property Appellate body.
Secondly, a landmark Supreme
Court<http://www.lawyerscollective.org/tag/supreme-court> Novartis
decision rejected the interpretation of section
3(d)<http://www.lawyerscollective.org/tag/section-3d> of
the Indian Patents Act, 1970 presented by Novartis. Thirdly, a
patent<http://www.lawyerscollective.org/tag/patent> on
Sutent, which did not satisfy patentability criteria, was revoked by the
Patent <http://www.lawyerscollective.org/tag/patent>Controller’s Office.

Mr. Roy Waldron’s
testimony[1]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn1>
hereinafter
‘the testimony’, in particular alleges that these recent decisions in India
threaten to undermine Pfizer’s and the multinational Companies’ ability to
innovate, create jobs and provide faster access to life saving medicine.
Mr. Waldron stresses that the value of intellectual property protection is
crucial for successful creation of new medicines.

He admits that India is crucial for Pfizer’s growth and Pfizer has
purportedly made efforts to provide access to medicine through ‘Patient
Access Programmes’. However, according to him, India’s environment is not
conducive to innovation and investment. He claims that since early 2012,
India’s policies and actions have undermined patent rights.

He alleges that India is rolling back protections for US innovators and
warns that this approach is going to do more harm than benefit to Indian
patients by resulting into reduced foreign investment. He is also
apprehensive that these decisions may be followed as a precedent by other
emerging economies which often see India as a leader to set the right tone
to promote innovation. In conclusion, he asserts that these discriminatory
decisions are a blow to the US economy and calls for a priority action
against India’s policies which, according to him, exploit US Intellectual
Property to benefit its own industry.

We now deal with specific issues in a detailed manner and address them
individually:

   1. *1.      **On R&D in drug development**- The testimony asserts that
   it takes more than $1 billion and 10-15 years of research to develop a new
   medicine.* Drug companies claim that since they spend billions of
   dollars per drug in research, they are entitled to whatever amount of
   returns they can recoup within the monopoly period and more. These claims
   are based on extrapolation from certain industry sponsored studies which
   are frequently cited by the pharmaceutical companies to justify these
   multi- billion dollar claims. The first study on pharmaceutical R&D claims
   the cost per drug to be $231 million (1987
dollar)[2]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn2>.
   This study was sponsored by major pharmaceutical companies such as Merck,
   Pfizer and Bayer which is based on confidential data submitted by these
   companies which cannot be independently verified. The results of this study
   were then exaggerated to multi-million dollar figures. For instance, on Jan
   2, 2001, then PhRMA President Alan Holmer announced that it takes about 500
   million USD just to get one drug into market. Public Citizen, a non-
   profit, critiques this figure on the grounds that the 1993 Di Masi study
   does not represent what companies actually spend on drugs to discover and
   develop new molecular entities. Rather, it includes the cost of all failed
   drugs and the expense of using money for drug research than other
   investments. It also does not account for tax deductions that companies get
   for R&D. Therefore it substantially overestimates the expenditures on R&D.
   According to the Public Citizen’s calculations after accounting for tax
   deductions and discounting the opportunity cost of capital, the 231 million
   USD figures is reduced to 56 million USD in 1990 dollars which in 110
   million USD in 2000 dollars.

Then came the second Di Masi study, in 2002, which inflated the 231 million
USD figure (1987 dollar) to almost 900 million USD (2000 dollar) after they
factored in the costs of post approval R&D. The second Di Masi study was
criticized by the US Congressional Budget Study in October, 2006 stating
that these figures are highly inflated  since about two thirds of what
makes R&D expenditure is just towards coming out with minor improvements
(“me- too drugs”).[3]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn3>

Recently, a new record seems to have been set for the “staggering cost” of
developing new drugs according to a recent article published in February,
2012 in the Forbes Magazine, according to which R&D costs average between
$4-11 billion per new drug which is 3-5 times more than the Di Masi studies.
[4]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn4>
However,
according to Light and Warburton, firstly, what companies count as “R&D” is
broader than just drug development. It includes cost of land,
infrastructure, equipment, general administrative overhead expenditure,
technical upgrades including software, etc. Companies also include the
legal expenses for filing, litigating and defending patents. This estimate
further includes the large fees paid to doctors to participate in clinical
trials and promote drugs. Secondly, to estimate the cost per drug, this
entire expenditure is divided by the number of “new drugs”, resulting into
huge numbers because the drug companies only consider New Molecular
Entities (New Molecular Entities) or new active ingredients as “new drugs”.
In reality, companies file numerous applications for minor variations of
these “new drugs” which according to the US Congressional Budget Study,
account for about 60% of United States Drug Budget. These minor variations
are less risky and involve substantial costs since the trials need to be
conducted on a much wider population in order to detect a sizable “minor
variation” in order for it to get approved. Thirdly, a significant portion
of these costs are born by public funded organizations and the Government.
For example the early research of
Glivec<http://www.lawyerscollective.org/tag/glivec> was
jointly conducted by Novartis, National Cancer Institute, Leukemia and
Lymphoma Society and Oregon Health and Science
University.[5]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn5>
Moreover,
the orphan drug status for Glivec entitled Novartis to claim a 50 percent
tax credit. Fourthly, there is no credible evidence to support that the
failure rate for drug development is as high as it is claimed; on the
contrary, the success rate for a drug increases as the drug proceeds in its
developmental stage. Lastly, the so called industry’s average cost per drug
is not the real out of pocket expenditure, but a highly inflated estimate
of the capital cost including profits forgone, had they invested it in an
index fund, instead of developing “new drugs”. In sum, according to Light
and Warburton calculations, the median, net corporate cost, excluding the
profits forgone for a new drug, based on the DiMasi study is $56 million in
2011. Therefore, the billion dollar claims for R&D are completely
fallacious.

   1. *On Section 3(d)-** According to the testimony, in another recent
   erosion of IP rights, India denied a patent under section 3(d) of its
   Patents Act for Gleevec, Novartis’ anti cancer therapy that has been
   patented in 40 other countries around the world. According to him, in that
   case, the Indian Supreme Court interpreted an
“enhancedefficacy<http://www.lawyerscollective.org/tag/efficacy>”
   requirement for patentability in a way that led to denial of the patent. He
   alleges that this decision is inconsistent with India’s obligations under
   the World Trade Organization’s (WTO)Agreement on Trade- related Aspects of
   Intellectual Property Rights(TRIPS) ** -* To understand the rationale
   behind section 3(d), it is important to understand the history of Indian
   patents. In post independence India, it was observed that foreign
   Multinational Companies (MNCs) held product and process patents over drugs
   and they instituted infringement suits against
domestic<http://www.lawyerscollective.org/tag/domestic> generic
   firms. These multinational companies dominated the pharmaceutical industry
   and would import the patented drugs. This resulted in high prices of drugs
   resulting in Indian prices being amongst the highest in the world. Aware of
   the consequence of product patents, ultimately in 1970, based on the
   recommendations made in Justice Ayyangar Committee Report, namely, that
   India treat chemical substances, food and medicines differently and only
   provide process patent protection for inventions in these fields. It also
   recommended codification of universally accepted principles of what are not
   patentable.[6]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn6>
Parliament
   then enacted the Patents Act, 1970 which treated inventions relating to
   food and medicines differently from other inventions and did not provide
   for product patents for these. As a result of there being no absolute
   monopoly and increased competition, the domestic Indian generic industry
   flourished, which led to early introduction of new drugs in Indian market;
   domestic production of bulk drugs while bringing prices down and enabling
   export of these drugs. Indian generic industry was able to supply high
   quality life saving medicine at an affordable cost not only for the people
   in India but also throughout the developing world and India became the
   “pharmacy to the developing world”.

In the late 1980s, the developed countries, at the instance of their
corporate sector, sought increased protection for Intellectual Property
Rights (IPRs) at the Uruguay Round of multilateral trade negotiations under
the auspices of the General Agreement on Tariffs and Trade (GATT). The US,
through trade pressures and other unilateral measures, particularly the
repeated threats of use of §301 and §301 Special, as well as other
developed countries were able to pressure developing countries to yield.
India was the last to yield into these threats and agreed to become a
signatory to the Agreement on Trade Related aspects of Intellectual
Property Rights (the TRIPS Agreement), mainly because India felt it allowed
for flexibilities.

The TRIPS Agreement lays down minimum standards of intellectual property
protection and enforcements that countries must provide. It also provided
for certain flexibilities which include transition periods to developing
countries to comply with various requirements under TRIPS. The
flexibilities also include* *freedom to member countries to determine the
patentability standards and exclude certain types of patenting. The TRIPS
Agreement which deals with private rights does not detract from India’s
existing international obligations  under International Covenant on
Economic, Social and Cultural Rights (ICESCR) and International Covenant on
Civil and Political Rights (ICCPR) which deal with Fundamental Human Rights
with public interest element which includes a right to life, right to food,
right to health.

In 2002, in order to comply with the TRIPS Agreement, Indian parliament
amended the patent law to re- define “invention” and introduce a 20- year
patent term. During the transition period available to India under the
TRIPS Agreement, developments relating to lack of access to medicines due
to patent barriers globally, especially for
HIV<http://www.lawyerscollective.org/tag/hiv> and
cancer drugs, came to fore. Data regarding patenting activity and research
efforts in developed countries during this period also indicated a trend of
“evergreening”. By that time, it had also been noted by various authors and
reports that in developed countries patents were being granted increasingly
not for new molecules but largely for new forms of already known active
moiety, without enhancement in efficacy, i.e. allowing evergreening. This
holds good even today as it is evidenced by the findings of the European
Commission Pharmaceutical Sector Inquiry Report showing that for 219 INNs
between 2000 and 2007, nearly 40,000 patents had been granted or patent
applications were still pending, of which 87% were secondary patents
(primary v. secondary patent ratio was 1:7). In addition to that, it was
also known that, in the United States, pharmaceutical patents were delaying
the entry of generic medicines and patents were being invalidated on a
challenge in patent infringement
suits.[7]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn7>
The
challenge for Parliament, therefore, was to amend India’s law to make it
TRIPS- compliant and provide product patent protection to pharmaceuticals
while preserving the capacity of the domestic generic industry to produce
high quality drugs at affordable prices by preventing patenting new forms
of already known molecules. Parliament, therefore, further amended section
3(d) to prevent patenting of new forms of known substances which do not
demonstrate enhanced efficacy. The purpose of section 3(d) was to restrict
the grant of patents on new forms of known substances, particularly patents
on medicines which did not exhibit significant enhancement of efficacy
thereby preserving maximum competition in the Indian pharmaceutical
industry with a view to keeping prices of medicines low.

In 1997, Novartis AG, had filed a patent application for a polymorph of
imatinib mesylate (Novartis Application) which was examined in 2005 after
India amended its patent laws.  The Patent Controller rejected the Novartis
application based on grounds, including that it was hit by section 3(d). In
2006, Novartis challenged the decision of refusal of grant of patent and
the validity of section 3(d) before the Madras High Court. The Madras High
Court upheld the validity of section 3(d). In June 2009, the Intellectual
Property Appellate Body (IPAB) overturned the Patent Controller’s decision
on grounds of novelty and inventive step but upheld the non- grant of
patent on grounds of section 3(d) as Novartis failed to show that the
ß-crystalline form of imatinib mesylate exhibited significantly enhanced
therapeutic efficacy over imatinib mesylate, the known substance.
 Challenging the IPAB order directly before the Supreme Court, Novartis
tried to argue that the physico-chemical properties of the polymorph had
better flow properties, better thermodynamic stability and lower
hygroscopicity which resulted in improved efficacy. The Supreme Court
rejected this contention holding that in the case of medicines, improvement
in ‘therapeutic effect’ must be shown. While, improvement in physico-
chemical properties does not mean improvement in efficacy, bioavailability
may or may not lead to improvement in efficacy. They also held that
efficacy will be determined strictly on a case-by-case basis. In any case,
to fulfill the requirement of section 3(d), data has to be supplied proving
the efficacy requirements. The rejection of the Novartis Application was
also justified because in 1993 Novartis had already obtained a patent in
the United States and other jurisdictions for the active molecule,
imatinib, which disclosed its salts and that the present application only
concerned a polymorph of that salt. Therefore, the Novartis application was
rightly rejected. If Mr. Waldren feels that this decision is inconsistent
with India’s obligations under TRIPS, he should follow the Dispute
Settlement Procedure and request for consultations.

   1. *On Compulsory licenses** – Mr. Waldron states in the testimony that
   Compulsory licenses are used by competitors as a means to obtain
   authorization to use technology developed by others without having to pay
   the substantial costs associated with developing and testing the product.
   He further stated that, India sought to justify its 2012 compulsory
   license, in part, on the basis of “failure to work the patent” because the
   product was being imported rather than manufactured locally. He added that
   while Compulsory licenses should only be used in certain extraordinary
   circumstances, the local manufacturing requirement initially used to
   justify the compulsory license was clearly inconsistent with India’s
   international obligations.*

Firstly, The TRIPS Agreement does not prevent member governments from
taking measures to protect public health. The Doha Declaration reinforced
the fact that developing countries could use the TRIPS flexibilities to
take measures for public health. Compulsory Licenses are a recognised
flexibility under the TRIPS Agreement which may be used normally and not
merely in emergencies. Article 31(b) provides for use without authorization
of the right holder which may be done away with in situations of emergency.
This means Compulsory licenses may be used in normal circumstances as well
as in emergencies. In India, under normal circumstances a compulsory
license may be granted if three conditions are satisfied- firstly if the
patentee has failed to satisfy the reasonable requirements of the public,
secondly if the patentee has failed to provide the invention at a
reasonable price and lastly if the invention is not being worked in India.
[8]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn8>
In
addition to that, Section 92 is a special provision which provides for
issuing a compulsory license in emergencies. Section 92A further provides
for issuing a compulsory license for export of patented pharmaceutical
product to countries with insufficient manufacturing capabilities.
Secondly, the working requirement gains its rationale from Article 7&8 of
the TRIPS Agreement which specify that patents must be instrumental in
achieving technology transfer. The first and only compulsory license
granted so far by India fulfilled all three grounds of the above mentioned
requirements. Bayer had refused generic drug manufacturer NATCO’s attempt
to enter into a voluntary license and in the compulsory license proceedings
before the Controller, it was proven by the patentee’s own statement of
working that the quantity imported for Indian use was hardly commensurate
with the requirements of the Indian public. The demand and supply table
shown in the IPAB
order[9]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn9>
shows
the flagrant disparity between the demand and the supply.

The table is reproduced here as under:
Total patientsDemand for 80% of patientsBottles per month (required)Bottles
imported in 2008Bottles imported in 2008Bottles imported in 2010Liver Cancer
~20,000~16,000~16,000Nil~200 bottlesUnknownKidney cancer~8,900~7,120~7,120



Further, Nexavar is India’s first compulsory license as against Malaysia’s
three, Indonesia’s six, and four each by Italy and Canada. The grant of the
compulsory license was therefore justified.

   1. *On Government list- **Mr. Waldron alleges that there have been
   reports circulating regarding the Indian Government preparing a list of
   medicines for which Compulsory license may be issued.* Secondly,
   according to the Indian Patent Act, 1970 the Central Government is
   empowered to use inventions for the purposes of the Government. Further if
   the Central Government is satisfied that a patent or should be acquired for
   the public purpose publish a notification to that effect, vesting the
   patent/ invention in the
Government.[10]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn10>
The
   government may also issue a compulsory license under section 84 of the
   Patents Act, if the abovementioned three grounds are not satisfied. It is
   the Governments prerogative as to how it plans to ensure its commitment to
   provide access to healthcare while staying TRIPS complaint. The means of
   issuing compulsory licenses by the Government should be well known to Mr.
   Waldron since United States has effectively used this remedy in numerous
   situations. In 2001, Department of Health and Human Services (DHHS)
   Secretary Mr. Tommy Thompson used a Compulsory license threat to authorize
   import of generic ciprofloxacin for stockpiles against a possible anthrax
   attack. Later, in 2005, the US Department of Justice defended its right to
   use compulsory licenses while defending itself against injunctive relief on
   patents relating to Blackberry email services. Then again, in November
   2005, the DHHS Secretary Michael Levitt testified before the US House of
   Representatives that he required the patent owners of Tamiflu to invest in
   US manufacturing facilities in case they have to confront avian flu
   pandemic. In 2007, when the US Supreme Court was petitioned to hear Zoltek
   Corp v. U.S. which concerned with the import of material from an
   unlicensed manufacturer used in F-22 jets for which Zoltek had a US process
   patent. The United States argues that it may, in effect, have a
   royalty-free compulsory license for government use of the product because
   the patented process is carried out in a foreign country, meaning that the
   patent holder is not entitled to “reasonable and entire compensation”.
   [11]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn11>
The
   Government list of drugs is therefore justified.
   2. *On Section 8 of the Indian Patents Act** –The testimony alleges that
   the Indian patent law is riddled with pitfalls for the pharmaceutical
   patent owner. For example, Section 8 of the Indian Patents Act, a provision
   with vaguely worded requirements on reporting of activity of other patent
   offices.* It is well known that the Patent Controller may not be in
   possession of all relevant information in order to examine the application,
   which is why Patent laws in most jurisdictions require patent applicant to
   furnish information material to the patent application. For instance, the
   US Manual of Patent Examining Procedure specifies that an applicant must
   file an Information Disclosure Statement which furnishes all prior
art<http://www.lawyerscollective.org/tag/art> or
   background information which typically includes other issued patents,
   published patent applications, scientific journal articles, books, magazine
   articles, or any other published material that is relevant to the patent
   application.[12]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn12>
This
   is to assist the Patent Office in prosecution. As regards material
   information, it includes foreign prosecution history.  In Therasense,
   Inc. v. Becton, Dickinson &
Co[13]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn13>.,
   the US federal circuit affirmed the District Court’s ruling that one of the
   patents at issue was unenforceable due to the applicant’s failure to
   disclose statements made to a foreign patent office during an
opposition<http://www.lawyerscollective.org/tag/opposition>
proceeding,
   which were inconsistent with the arguments made by the applicants before
   the United States Patent and Trademark Office (USPTO). Even before the
   European Patent Office, it is mandatory for an applicant to submit copies
   of search results received from the national patent office of the priority
   country under rule 141(1) of the
EPC.[14]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn14>
The
   rule stems from the understanding that the list of prior arts submitted by
   the Patentee is not sufficient. Similarly, in India, according to section
   8, an applicant for a patent in India who is prosecuting the same or
   substantially the same invention in a country outside India, shall file
   along with his application, a statement setting out detailed particulars of
   such application and an undertaking that he would keep the Controller
   informed of detailed particulars of such applications subsequent to filing
   of the statement within the prescribed time-period as the Controller may
   allow. The purpose behind this disclosure is to provide assistance to
   patent office in prosecution of the Indian patent application by providing
   information of other foreign patent offices as regards novelty,
   non-obvious, utility and other
observations.[15]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn15>
The
   spirit of the section is to make full disclosure regarding the application
   to the Controller in good faith. Therefore, section 8 requirements are
   neither new nor objectionable.
   3. *On Indian IP System’s fairness**- The testimony asserts that India’s
   protectionist and discriminatory policies exploit US IP to benefit its own
   industry.** *Indian patent system does not distinguish applications/
   examination procedure based on nationality of the applicant. Patents are
   granted by the Patent Controller’s office which is a quasi judicial body
   deriving its authority from the Patents Act 1970, which is TRIPS compliant.
   The litigation procedures are equally accessible to all and the judicial
   decisions are based on the Patents Act, 1970. There cannot be any
   interference by the government at all. India has firmly stood by its
   commitment to protecting intellectual property in compliance with TRIPS,
   which is reflected in the fact that Pfizer has been granted 161 patents in
   India since 2005 alongside Sanofi SA getting 333 patents, followed by Swiss
   pharma companies F Hoffmann La
Roche<http://www.lawyerscollective.org/tag/roche> Ltd
   with 243 and Novartis AG with 200
patents.[16]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn16>Such
   numbers of patent grants would not have been possible had the Indian patent
   office been biased according to the nationality of the applicant.
   4. *On Pfizer market expansion in India**- The testimony asserts that
   Pfizer employs numerous individuals in India and has created more than
   15,000 jobs and has almost 70 ongoing trials.* It is well known that
   multinational pharmaceutical companies are hunting for cost- effective
   locations for conducting drug trials which is why India amongst other
   developing countries is a favourable market for Pfizer. Most of these
   trials involve phase 3&4 trials which involve minimal R&D. In addition to
   that, these trials conducted often involve a disregard for the consent
   norms.[17]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn17>
To
   note, Pfizer has conducted 3 trials in malaria in India and out of its 12
   trials for tuberculosis and 19 trials for diarrhea, none are being
   conducted in India. Therefore, Pfizer may be concerned about the diseases
   prevalent in India but the trials are not being conducted in
India.[18]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn18>
   5. *Questionable legal theories**- The testimony states that in the last
   year, Pfizer has struggled to defend its patent for compound sunitinib, the
   active ingredient in Sutent, against efforts to revoke it. The patent has
   now been revoked twice under questionable legal theories and is currently
   back in force pending new proceedings before the Indian Patent Office, an
   administrative body of the Ministry of Commerce and Trade. *Firstly,
   patents in India are granted by the Patent Controller’s Office which is a
   quasi- judicial body deriving its authority from the Patents Act, 1970
   which is TRIPS compliant. It is not an administrative body and the
   Government has no role to play. While it is factually correct that the
   patent for Sutent has been revoked twice, it was not certainly under
   questionable legal theories. In the first round of patent prosecution the
   report of the opposition board which may have been instrumental in the
   revocation was not made available to the patentee. The opposition procedure
   laid down in the Patents Act does not mandate that a copy of the report be
   supplied to the patentee. However this was held to be contrary to the
   principles of natural justice by the Supreme Court of India and remanded
   for fresh prosecution. In the second round, the Patent Controller failed to
   provide ‘further evidence’ submitted by the patentee to the opposition
   board. The ‘further evidence’ submitted by the applicant during prosecution
   is admissible subject to the discretion of the Patent Controller. It cannot
   be filed as a matter of right. However, this was held to be an irregularity
   of procedure and the decision of revocation was again sent for
   consideration afresh. India has a multi layered adjudicatory process, to
   eliminate this kind of error in decision making by an authority, which
   provides opportunity for recourse from an unfavourable decisions. Pfizer
   has sought recourse against the revocation twice though this very legal
   system during pending litigation and has been able to obtain orders based
   on principles of natural justice.
   6. *Infringing goods-** According to the testimony, during the back and
   forth revocation proceedings, one generic manufacturer (NATCO) launched its
   product in the Indian market as a result of which the market is now flooded
   with about two years’ worth supply from this manufacturer. According to
   him, in order for there to be effective patent protection, the system of IP
   enforcement ought to include mechanisms to recall infringing goods from the
   market.* Pfizer had sought to enforce its patent against NATCO based on
   an interim order by the Intellectual Property Appellate board (again a
   quasi judicial body) staying removal of the patent from the register after
   the controller had revoked the patent for the second time. NATCO was not a
   party to the consent based order according to which CIPLA had agreed to not
   market its product while the patentability of Sutent is decided. According
   to section 64 of the Patents Act, a manufacturer may file for revocation or
   assert it as a counterclaim in response to a suit for infringement, because
   the remedy for infringement once established can be obtained in the form of
   damages. NATCO may have infringed the patent, but it is within its right to
   invite a suit for infringement and contest the validity of the patent in
   the counterclaim. This is so in most patent jurisdictions.
   7. *On Pfizer Agenda-* Achieving low standards of intellectual property
   protection worldwide has been on the agenda of the pharmaceutical
   companies, since the beginning. Pfizer particularly, has been instrumental
   in putting the TRIPS Agreement on the table for negotiations; therefore, it
   is not surprising to see this statement furthering the same
agenda.[19]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn19>
However,
   the level of pharmaceutical companies’ influence over the US policymakers
   is disturbing. An example of Pfizer’s influence over the USPTO can be seen
   in a 2009 meeting in Mumbai which was jointly organized and co- sponsored
   by Pfizer and the
USPTO.[20]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn20>
The
   agenda of the meeting was to push for TRIPS-plus measures. The USPTO later
   admitted it as a
mistake[21]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftn21>.
   Is the USPTO meant to fill the coiffeurs of the MNC heads? The testimony
   makes it clear that Mr. Waldron is concerned only about the US interests
   and particularly that of Pfizer. We reject this twisted agenda which Mr.
   Waldron is trying to enforce at the cost of Indian interests.

In conclusion, the testimony asserts US interests in terms of US
leadership, US jobs, US companies, US turnover, etc., which indicates that
this statement is nothing but a propaganda driven by the US pharmaceutical
industry with little legal standing or significance. We urge the US
senators to reevaluate the irregularities plaguing the US Patent system
which seemingly has got slightly ahead of itself.


http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html
------------------------------

[1]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref1>
Available
at, (
http://democrats.energycommerce.house.gov/sites/default/files/documents/Testimony-Waldron-CMT-Trade-Barriers-India-US-2013-6-27.pdf
)

[2]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref2>
Joseph
DiMasi et al., “The Cost of Innovation in the Pharmaceutical Industry,”
Journal of Health Economics, 1991.

[3]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref3>
A
CBO study, Research and Development in the Pharmaceutical Industry, October
2006, Available at,
http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/76xx/doc7615/10-02-drugr-d.pdf

[4]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref4>
‘The
truly staggering cost of inventing new drugs’, Matthew Herper, February 10,
2012,(Available at,
http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/
)

[5]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref5>
‘Novartis
R&D on Glivec’, April 3, 2013, (Available at,
http://www.keionline.org/node/1697)



[7]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref7>
See
“Generic Drug Entry Prior to Patent Expiration: An FTC study”( US Federal
Trade Commission), July 2002

[8]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref8>
§84
of the Indian Patents Act, 1970 lays down these requirements.

[9]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref9>
Available
at,
https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&cad=rja&ved=0CC8QFjAB&url=http%3A%2F%2Fwww.elsevierbi.com%2F~%2Fmedia%2FSupporting%2520Documents%2FPharmasia%2520News%2F2013%2FMarch%2FIPAB%2520March%25202013%2520Nexavar%2520Order.doc&ei=wjw0UriBFsfarAfOzYCwBA&usg=AFQjCNHkfMmwMhZLw5mlqmRLhnRGUIrdmQ&bvm=bv.52164340,d.aGc

[10]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref10>
Section
100 and 102 of the Patents Act, 1970

[11]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref11>
KEIRN
2007:2 Recent examples of compulsory licensing of patents(Available at,
http://keionline.org/content/view/41/1)

[12]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref12>
Section
609, Chapter 0600, US Manual of Patent Examining Procedure, (Available at,
http://www.uspto.gov/web/offices/pac/mpep/s609.html)

[13]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref13>
US
Court of Appeals for the federal Circuit, May 25, 2011 (Available at
http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1511.pdf)

[14]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref14>
Rule
141, EPC, (Available at,
http://www.epo.org/law-practice/legal-texts/official-journal/information-epo/archive/20100803.html
)

[15]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref15>
 *Tata Chemicals v. Hindustan Unilever* [ORDER (No.166 of 2012)]

[16]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref16>
Pfizer’s
India patents, revenue grow despite adverse testimony, June 14, 2013,
(Available at
http://www.livemint.com/Industry/LUejZYnLgOwtdx7PJrHF4L/Pfizers-India-patents-revenue-grow-despite-adverse-testimo.html
)

[17]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref17>
Indian
drug trials fuel consent controversy, The Washington post, By Rama
Lakshmi,January 01, 2012, Available at,
http://articles.washingtonpost.com/2012-01-01/world/35440252_1_drug-trials-drug-companies-indian-patients

[18]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref18>
Based
on data obtained from US trial data as disclosed on the Government website,
http://www.clinicaltrials.gov/ct2/search/index

[19]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref19>
Peter
Drahos, ‘Expanding Intellectual Property’s Empire; Role of FTAs’ in
November 2003, Available at, http://ictsd.org/i/ip/24737/

[20]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref20>
‘Alert:
USPTO- Pfizer pushing for a TRIPS plus measures in India’ September 9,
2009, Available at,
http://aidsnews.blogspot.in/2009/09/alert-uspto-pfizer-pushing-for-trips.html

[21]<http://www.lawyerscollective.org/updates/lawyers-collective-response-testimony-mr-roy-waldron-pfizer.html#_ftnref21>
‘Tie
up with Pfizer in India a mistake, says USPTO’ March 22, 2010, Available at
http://keionline.org/node/813



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