[Ip-health] Merck, Pharmasset, Gilead

Kaplan, Warren wak at bu.edu
Thu Jun 9 13:11:58 PDT 2016


I assume this joker Durette can (or at least should) be disbarred for this.  Durette seems to be 'retired' so perhaps  he conveniently gave up his license to practice law as well as his PTO Registration number? 


Warren Kaplan, PhD, JD, MPH
WHO Collaborating Center for Pharmaceutical Policy
Center for Global Health & Development
Boston University School of Public Health
801 Massachusetts Avenue
Boston, MA 02118
617 414 1152 (office)
617 414  1261 (fax)
http://www.bu.edu/pharm/the-program/
Skype warren.kaplan

.......__o
.......\<,
....( )/ ( )
"Our deepest fear is that we are powerful beyond measure.
We ask ourselves, who am I to be brilliant, gorgeous, talented and fabulous?
Actually, who are you not to be? ...“
Marianne Williamson


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Today's Topics:

   1. Judge nukes Merck's HCV patent suit against Gilead (Jamie Love)
   2. Pharmalot: Gilead won't have to pay $200 million in patent
      case because Merck Laywer lied. (Jamie Love)
   3. Re: Judge nukes Merck's HCV patent suit against Gilead
      (Michael H Davis)
   4. Tomorrow(Fri): Side Event on Treatment Access at the HLM on
      Ending AIDS (Catherine Kirk)
   5. Text of Modi's speech to the U.S. Congress and text of
      India-US Joint Statement After PM Modi Meets President Obama
      (Thiru Balasubramaniam)
   6. CIVIL SOCIETY LETTER TO COUNTRIES NEGOTIATING REGIONAL
      COMPREHENSIVE ECONOMIC PARTNERSHIP (RCEP) BEFORE THE AUCKLAND
      ROUND OF NEGOTIATIONS (leena menghaney)


----------------------------------------------------------------------

Message: 1
Date: Wed, 8 Jun 2016 16:28:36 -0400
From: Jamie Love <james.love at keionline.org>
To: Ip-health <ip-health at lists.keionline.org>
Subject: [Ip-health] Judge nukes Merck's HCV patent suit against
        Gilead
Message-ID:
        <CA+aiKTQkwVbBR_y2NUgq7REORGYDwC8okALfCRTMwiOk=2o2FA at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

I suggest skipping down to "What did Merck do that so Incensed the Federal
Judge?"


Jamie


http://seekingalpha.com/article/3980827-gilead-slam-dunks-merck-federal-court-ruling

Gilead Slam Dunks Merck In Federal Court Ruling
Jun. 8, 2016

Randall Yavitz

Summary

Merck's patent claims against Gilead were thrown out of Court in a
blistering order issued Monday by the Federal Judge in the lawsuit.

The Court barred Merck from asserting its claims for Hep C patents based on
misconduct by Merck and its employees.

The effect of the ruling is to overturn the $200 million jury verdict from
March, 2016 and relieve Gilead of any continuing royalty payments.

On Monday, Federal District Judge Beth Labson Freeman issued a decisive
victory to Gilead (NASDAQ:GILD) and stunning defeat for Merck (NYSE:MRK) in
the huge fight over Hepatitis C drug patent rights. This is not some sort
of interim or preliminary ruling; it is a TKO-the fight is over. The Court
concluded:

"Candor and honesty define the contours of the legal system. When a company
allows and supports its own attorney to violate these principles, it shares
the consequences of those actions. Here, Merck's patent attorney,
responsible for prosecuting the patents-in-suit, was dishonest and
duplicitous in his actions with Pharmasset, with Gilead and with this
Court, thus crossing the line to egregious misconduct. Merck is guilty of
unclean hands and forfeits its right to prosecute this action against
Gilead."

The Court's Order is definitive:

"For the foregoing reasons, IT IS HEREBY ORDERED that Merck is barred from
asserting the '499 and '712 Patents against Gilead and Merck shall take
nothing by this suit."

Let's face it, federal judges have lifetime tenure and, once appointed,
need not placate anyone. For this reason, their opinions can and do tend to
be pointed and sometimes even dramatic. Although I've practiced before the
federal courts for 35 years, I have rarely encountered a more passionate
and persuasive opinion than that issued yesterday by Judge Freeman.

Effect of Ruling

After an eight-day trial, the jury rendered its verdict on March 20, 2016.
It determined that Merck's patents were valid and that Gilead had infringed
on the patents. It awarded Merck $200 million from Gilead for patent
royalties through 2015 and set the stage for phase 2 of the proceeding, in
which the Court was to award future royalties starting with 2016. Had the
judge subscribed to the 4% royalty that the jury awarded, that could have
been almost a billion dollars each year based on the mammoth sales that
Gilead has achieved with its Hepatitis C miracle drugs, Solvaldi and
Harvoni. Had the judge subscribed to Merck's demand for a 12% royalty, the
royalty payments could have been 3 times higher.

The Court did not submit equitable defenses to the jury, but instead held
its own bench trial on March 30, 2016. The order issued Monday resolves the
two equitable defenses raised by Gilead: waiver and unclean hands. The
Court's 65-page decision dissects the evidence and arguments and concludes
that there was not a showing of waiver, but there was a "clear and
convincing" showing of unclean hands by Merck. The result of this ruling is
to overturn the jury's verdict of $200 million and to moot phase 2 of the
proceeding, meaning that the Court will not consider granting future
royalties to Merck in any percentage.

What did Merck do that so Incensed the Federal Judge?

In 2004, Merck was having discussions with Pharmasset about a possible
collaboration on Hepatitis C drugs. According to a Non-Disclosure
Agreement, Merck was to "firewall" any individual who participated in
Merck's existing Hepatitis C program. Merck expressed great interest in
Pharmasset's leading compound, a nucleoside designated PSI-6130. Merck
pressed for information regarding the exact structure. Pharmasset was
willing to convey this information if Merck respected the firewall. Enter
the lead protagonist in the ensuing tragedy for Merck: Philippe Durette.
Dr. Durrette was a scientist who had worked on Merck's Hepatitis C program
for years; he was also a patent lawyer who was the lead prosecutor for
Merck's Hepatitis C patent portfolio. In short, he was the last person to
whom Pharmasset wanted to reveal the structure of its "crown jewel"
compound. Yet, in violation of the firewall, Dr. Durette was exactly the
person Merck sent to hear Pharmasset reveal the structure of its compound.
Disturbingly, Dr. Durette then used the information he had obtained to
prosecute Merck's HCV patent applications and to write new claims targeting
Pharmasset's work. All this was, of course, unknown to Gilead when it spent
$11 billion to acquire Pharmasset in 2011.

Having pirated Pharmasset's work, Dr. Durette's next assignment was to
effectuate a cover-up. Merck appointed him as its designated representative
to answer deposition questions about Merck's patent prosecution. He
testified that (NYSE:A) he had never been on the call with Pharmasset and
(NYSE:B) he had not learned about the structure of PSI-6130.

At trial, Dr. Durette recanted his testimony and suddenly remembered vivid
details about the call with Pharmasset, while denying that he had learned
about the structure or used it to Merck's advantage. But the judge pointed
out that Durette's patent amendments covered Pharmasset discoveries that
Merck had never researched or tested. Repeatedly, Judge Freeman states that
Dr. Durette's testimony at trial was not credible. Concluding that the
doctrine of unclean hands invalidated Merck's HCV patents, the Opinion
states:

"In this case, numerous unconscionable acts lead the Court to conclude that
the doctrine of unclean hands bars Merck's recovery against Gilead for
infringement of the '499 and '712 Patents. Merck's misconduct includes
lying to Pharmasset, misusing Pharmasset's confidential information,
breaching confidentiality and firewall agreements, and lying under oath at
deposition and trial. Any one of these acts-lying, unethical business
conduct, or litigation misconduct-would be sufficient to invoke the
doctrine of unclean hands; but together, these acts unmistakably constitute
egregious misconduct that equals or exceeds the misconduct previously found
by other courts to constitute unclean hands. Merck's acts are even more
egregious because the main perpetuator of its misconduct was its attorney."

Dim Prospects for an Appeal

Merck has indicated that it will appeal the ruling. This is apparently to
save face. Any appeal would be considered de novo on legal issues, but
deference would be shown to Judge Freeman on factual determinations. Since
the law cited seems unobjectionable and the facts are delineated with
exquisite detail, this opinion would seem pretty much unassailable.
Certainly this judge has sent a shot across the bow to Merck and other
pharmaceutical companies (e.g., Abbvie) who file patent claims for products
they have not worked on for the purpose of blocking or claiming royalties
from the true inventors.

It has been said that comedy is when something bad happens to someone else;
tragedy is when it happens to you. Merck's comedy has indeed turned tragic.
It is time for Merck to re-examine its corporate ethics.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to
initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not
receiving compensation for it. I have no business relationship with any
company whose stock is mentioned in this article.


--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love


------------------------------

Message: 2
Date: Wed, 8 Jun 2016 16:37:50 -0400
From: Jamie Love <james.love at keionline.org>
To: Ip-health <ip-health at lists.keionline.org>
Subject: [Ip-health] Pharmalot: Gilead won't have to pay $200 million
        in patent case because Merck Laywer lied.
Message-ID:
        <CA+aiKTTSdG-GXpNd2_UUmpgZxJhyPb=fy72Qz-1CgpEwePQk+Q at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

Ed provides a link to the option.

https://www.statnews.com/pharmalot/2016/06/07/gilead-merck-hepatitis-c-patent/

Gilead won't have to pay $200 million in patent case because Merck Laywer
lied.

By ED SILVERMAN @Pharmalot
JUNE 7, 2016

In an embarrassing blow to Merck, a federal court judge on Monday decided
that Gilead Sciences does not have to pay $200 million in damages that was
recently awarded in a patent dispute because Merck displayed a ?pervasive
pattern of misconduct.?

At issue was testimony from a retired Merck patent attorney, who was found
to have ?lied? repeatedly when recounting events that took place more than
a decade ago concerning patents for hepatitis C compounds, according to the
65-page opinion by US District Court Judge Beth Labson Freeman. At the
time, Merck held exploratory talks with another company, Pharmasset, about
a collaboration.

The judge concluded that the Merck lawyer, Philippe Durette, intentionally
gave false testimony during a deposition and a recent trial about his role
in those talks. His testimony helped a jury to decide that Merck was
responsible for the early discovery work that later led to the development
of the Sovaldi and Harvoni pills that are sold by Gilead. And she chided
Durette for claiming to have a faulty memory.

Moreover, Freeman decided Merck supported his ?bad faith conduct? by
directing him to continue work on Merck hepatitis C patents at the same
time he was allowed to participate in due diligence meetings with
Pharmasset employees. Freeman found that Merck?s misconduct was ?egregious?
and included lying to Pharmasset, misusing Pharmasset?s confidential
information, and breaching confidentiality.

The issue was raised after a jury trial in March and Gilead was allowed to
provide new evidence. (The 65-page opinion is dense, but rich with
interesting details).

Link to opinion here:  http://freepdfhosting.com/bbfe6ba5b0.pdf


--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love


------------------------------

Message: 3
Date: Wed, 8 Jun 2016 22:20:02 +0000
From: Michael H Davis <m.davis at csuohio.edu>
To: Jamie Love <james.love at keionline.org>, Ip-health
        <ip-health at lists.keionline.org>
Subject: Re: [Ip-health] Judge nukes Merck's HCV patent suit against
        Gilead
Message-ID: <kh9d8bkrufhtfa1gnbhlxod0.1465424393044 at email.android.com>
Content-Type: text/plain; charset="us-ascii"

I would suggest this is not an exceptional patent case.  This is the stereotypical patent pharmaceutical case  these are the people who give tufts the data they assert is reliable



Sent from my T-Mobile 4G LTE Device


-------- Original message --------
From: Jamie Love <james.love at keionline.org>
Date: 06/08/2016 4:29 PM (GMT-05:00)
To: Ip-health <ip-health at lists.keionline.org>
Subject: [Ip-health] Judge nukes Merck's HCV patent suit against Gilead

I suggest skipping down to "What did Merck do that so Incensed the Federal
Judge?"


Jamie


http://seekingalpha.com/article/3980827-gilead-slam-dunks-merck-federal-court-ruling

Gilead Slam Dunks Merck In Federal Court Ruling
Jun. 8, 2016

Randall Yavitz

Summary

Merck's patent claims against Gilead were thrown out of Court in a
blistering order issued Monday by the Federal Judge in the lawsuit.

The Court barred Merck from asserting its claims for Hep C patents based on
misconduct by Merck and its employees.

The effect of the ruling is to overturn the $200 million jury verdict from
March, 2016 and relieve Gilead of any continuing royalty payments.

On Monday, Federal District Judge Beth Labson Freeman issued a decisive
victory to Gilead (NASDAQ:GILD) and stunning defeat for Merck (NYSE:MRK) in
the huge fight over Hepatitis C drug patent rights. This is not some sort
of interim or preliminary ruling; it is a TKO-the fight is over. The Court
concluded:

"Candor and honesty define the contours of the legal system. When a company
allows and supports its own attorney to violate these principles, it shares
the consequences of those actions. Here, Merck's patent attorney,
responsible for prosecuting the patents-in-suit, was dishonest and
duplicitous in his actions with Pharmasset, with Gilead and with this
Court, thus crossing the line to egregious misconduct. Merck is guilty of
unclean hands and forfeits its right to prosecute this action against
Gilead."

The Court's Order is definitive:

"For the foregoing reasons, IT IS HEREBY ORDERED that Merck is barred from
asserting the '499 and '712 Patents against Gilead and Merck shall take
nothing by this suit."

Let's face it, federal judges have lifetime tenure and, once appointed,
need not placate anyone. For this reason, their opinions can and do tend to
be pointed and sometimes even dramatic. Although I've practiced before the
federal courts for 35 years, I have rarely encountered a more passionate
and persuasive opinion than that issued yesterday by Judge Freeman.

Effect of Ruling

After an eight-day trial, the jury rendered its verdict on March 20, 2016.
It determined that Merck's patents were valid and that Gilead had infringed
on the patents. It awarded Merck $200 million from Gilead for patent
royalties through 2015 and set the stage for phase 2 of the proceeding, in
which the Court was to award future royalties starting with 2016. Had the
judge subscribed to the 4% royalty that the jury awarded, that could have
been almost a billion dollars each year based on the mammoth sales that
Gilead has achieved with its Hepatitis C miracle drugs, Solvaldi and
Harvoni. Had the judge subscribed to Merck's demand for a 12% royalty, the
royalty payments could have been 3 times higher.

The Court did not submit equitable defenses to the jury, but instead held
its own bench trial on March 30, 2016. The order issued Monday resolves the
two equitable defenses raised by Gilead: waiver and unclean hands. The
Court's 65-page decision dissects the evidence and arguments and concludes
that there was not a showing of waiver, but there was a "clear and
convincing" showing of unclean hands by Merck. The result of this ruling is
to overturn the jury's verdict of $200 million and to moot phase 2 of the
proceeding, meaning that the Court will not consider granting future
royalties to Merck in any percentage.

What did Merck do that so Incensed the Federal Judge?

In 2004, Merck was having discussions with Pharmasset about a possible
collaboration on Hepatitis C drugs. According to a Non-Disclosure
Agreement, Merck was to "firewall" any individual who participated in
Merck's existing Hepatitis C program. Merck expressed great interest in
Pharmasset's leading compound, a nucleoside designated PSI-6130. Merck
pressed for information regarding the exact structure. Pharmasset was
willing to convey this information if Merck respected the firewall. Enter
the lead protagonist in the ensuing tragedy for Merck: Philippe Durette.
Dr. Durrette was a scientist who had worked on Merck's Hepatitis C program
for years; he was also a patent lawyer who was the lead prosecutor for
Merck's Hepatitis C patent portfolio. In short, he was the last person to
whom Pharmasset wanted to reveal the structure of its "crown jewel"
compound. Yet, in violation of the firewall, Dr. Durette was exactly the
person Merck sent to hear Pharmasset reveal the structure of its compound.
Disturbingly, Dr. Durette then used the information he had obtained to
prosecute Merck's HCV patent applications and to write new claims targeting
Pharmasset's work. All this was, of course, unknown to Gilead when it spent
$11 billion to acquire Pharmasset in 2011.

Having pirated Pharmasset's work, Dr. Durette's next assignment was to
effectuate a cover-up. Merck appointed him as its designated representative
to answer deposition questions about Merck's patent prosecution. He
testified that (NYSE:A) he had never been on the call with Pharmasset and
(NYSE:B) he had not learned about the structure of PSI-6130.

At trial, Dr. Durette recanted his testimony and suddenly remembered vivid
details about the call with Pharmasset, while denying that he had learned
about the structure or used it to Merck's advantage. But the judge pointed
out that Durette's patent amendments covered Pharmasset discoveries that
Merck had never researched or tested. Repeatedly, Judge Freeman states that
Dr. Durette's testimony at trial was not credible. Concluding that the
doctrine of unclean hands invalidated Merck's HCV patents, the Opinion
states:

"In this case, numerous unconscionable acts lead the Court to conclude that
the doctrine of unclean hands bars Merck's recovery against Gilead for
infringement of the '499 and '712 Patents. Merck's misconduct includes
lying to Pharmasset, misusing Pharmasset's confidential information,
breaching confidentiality and firewall agreements, and lying under oath at
deposition and trial. Any one of these acts-lying, unethical business
conduct, or litigation misconduct-would be sufficient to invoke the
doctrine of unclean hands; but together, these acts unmistakably constitute
egregious misconduct that equals or exceeds the misconduct previously found
by other courts to constitute unclean hands. Merck's acts are even more
egregious because the main perpetuator of its misconduct was its attorney."

Dim Prospects for an Appeal

Merck has indicated that it will appeal the ruling. This is apparently to
save face. Any appeal would be considered de novo on legal issues, but
deference would be shown to Judge Freeman on factual determinations. Since
the law cited seems unobjectionable and the facts are delineated with
exquisite detail, this opinion would seem pretty much unassailable.
Certainly this judge has sent a shot across the bow to Merck and other
pharmaceutical companies (e.g., Abbvie) who file patent claims for products
they have not worked on for the purpose of blocking or claiming royalties
from the true inventors.

It has been said that comedy is when something bad happens to someone else;
tragedy is when it happens to you. Merck's comedy has indeed turned tragic.
It is time for Merck to re-examine its corporate ethics.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to
initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not
receiving compensation for it. I have no business relationship with any
company whose stock is mentioned in this article.


--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love
_______________________________________________
Ip-health mailing list
Ip-health at lists.keionline.org
http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org


------------------------------

Message: 4
Date: Thu, 9 Jun 2016 03:49:42 +0000
From: Catherine Kirk <catherine.kirk at undp.org>
To: "'ip-health at lists.keionline.org'" <ip-health at lists.keionline.org>
Subject: [Ip-health] Tomorrow(Fri): Side Event on Treatment Access at
        the HLM on Ending AIDS
Message-ID:
        <AM4PR01MB18116F747708F1D997783120FF5F0 at AM4PR01MB1811.eurprd01.prod.exchangelabs.com>

Content-Type: text/plain; charset="us-ascii"

Event alert: SIDE EVENT on Increasing Access to Treatment to Achieve Sustainable Development Goal 3

2016 HIGH-LEVEL MEETING ON ENDING AIDS



When: Friday 10 June 2016, 13:15 - 14:30 EST

Where: UN Conference Room 1, UN Secretariat Building, New York

Organized by: UNDP & UNAIDS


Speakers: Celso Amorim, former Minister of Foreign Affairs, Brazil * Malebona Precious Matsoso, Director-General, Department of Health, South Africa * Andrew Witty, CEO GSK * Judit Rius, Legal Policy Advisor, Access Campaign, MSF * Mandeep Dhaliwal, Director, HIV, Health and Development Group, UNDP * Simon Bland, Director, New York Office, UNAIDS * Javier Hourcade Bellocq, Latin America and Caribbean representative, International HIV/AIDS Alliance *


The side event examines the how the lessons learnt from increasing access to HIV treatment, can be applied to improve the health and wellbeing of all people, irrespective of disease, or country, as envisaged by SDG 3. While great progress has been made in placing people on ART, millions are still being left behind. The gap in treatment is amplified by the ambitious commitments UN Member States made in 2015 when they adopted the 2030 Agenda for Sustainable Development and the Sustainable Development Goals (SDGs). In doing so, they committed themselves to ensuring the health and well-being of all people (SDG3) and a range of targets, including ending the epidemics of AIDS, TB, malaria and neglected tropical diseases as a public health threat and to combat hepatitis, water-borne diseases and other communicable diseases.

Join us: Follow the webcast:  http://webtv.un.org or Join the discussion #accessmeds


Focal points: Josefin Wiklund, wiklundj at unaids.org<mailto:wiklundj at unaids.org> and Richard Delate Richard.delate at undp.org<mailto:Richard.delate at undp.org>

Link to other HLM side events:  http://www.unaids.org/sites/default/files/media_asset/2016_HLM_side_events_en.pdf


Katie Kirk
T: +1 347 295 9249 | Skype: katie.kirk.undp |


------------------------------

Message: 5
Date: Thu, 9 Jun 2016 07:13:25 +0200
From: Thiru Balasubramaniam <thiru at keionline.org>
To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org>
Subject: [Ip-health] Text of Modi's speech to the U.S. Congress and
        text of India-US Joint Statement After PM Modi Meets President Obama
Message-ID:
        <CANi=se+E2hDCbytH7J6oVLcQf6rx79XUky_o7jTCFpTRVwGkzA at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

http://www.dnaindia.com/india/report-modi-in-us-full-text-of-pm-modi-s-speech-in-us-congress-2221459


<SNIP>

Our people to people links are strong; and there is close cultural connect
between our societies. SIRI tells us that India's ancient heritage of Yoga
has over 30 million practitioners in the U.S. It is estimated that more
Americans bend for yoga than to throw a curve ball. And, no Mr. Speaker, we
have not yet claimed intellectual property right on Yoga.

http://www.ndtv.com/india-news/full-text-india-us-joint-statement-after-pm-modi-meets-president-obama-1416614


<SNIP>

33.    The leaders welcomed the enhanced engagement on intellectual
property rights under the High Level Working Group on Intellectual Property
and reaffirmed their commitment to use this dialogue to continue to make
concrete progress on IPR issues by working to enhance bilateral cooperation
among the drivers of innovation and creativity in both countries.

<SNIP>

37.    The leaders reaffirmed their commitment to the Global Health
Security Agenda and the timely implementation of its objectives. The Prime
Minister noted India's role on the Steering Group and its leadership in the
areas of anti-microbial resistance and immunization. The President noted
the United States' commitment to support, undergo, and share a Joint
External Evaluation in collaboration with the World Health Organization.

38.    The leaders recognized the global threat posed by
multi-drug-resistant tuberculosis (MDR-TB) and committed to continue
collaboration in the area of tuberculosis and to share respective best
practices.

39.    The leaders noted the growing threat of non-communicable diseases
and the urgent need to address the risk factors by, inter alia, promoting
healthy lifestyles, controlling sugar and salt intake, promoting physical
activity especially among children and youth and strengthening efforts to
curb tobacco use. The leaders also reiterated the importance of holistic
approaches to health and wellness, and of promoting the potential benefits
of holistic approaches by synergizing modern and traditional systems of
medicine, including Yoga.

40.    The leaders strongly endorsed expansion of the Indo-U.S. Vaccine
Action Program, which is fostering public-private research partnerships
focused on the development and evaluation of vaccines to prevent
tuberculosis, dengue, chikungunya and other globally important infectious
diseases.


------------------------------

Message: 6
Date: Thu, 9 Jun 2016 21:44:51 +0530
From: leena menghaney <leenamenghaney at gmail.com>
To: IP-health <ip-health at lists.keionline.org>,  Thiru Balasubramaniam
        <suryavamsha75 at gmail.com>,      Thiru Balasubramaniam <thiru at keionline.org>
Subject: [Ip-health] CIVIL SOCIETY LETTER TO COUNTRIES NEGOTIATING
        REGIONAL COMPREHENSIVE ECONOMIC PARTNERSHIP (RCEP) BEFORE THE AUCKLAND
        ROUND OF NEGOTIATIONS
Message-ID:
        <CAFDmTiJ_54+wMUkNOAP74t7i2RiOhvSs_fzmiQfRynrPzzsd2w at mail.gmail.com>
Content-Type: text/plain; charset=UTF-8

CIVIL SOCIETY LETTER TO COUNTRIES NEGOTIATING REGIONAL COMPREHENSIVE
ECONOMIC PARTNERSHIP (RCEP) BEFORE THE AUCKLAND ROUND OF NEGOTIATIONS

 Letter sent to India, Indonesia, Myanmar, Thailand, Malaysia, New Zealand,
Lao, Philippines, Vietnam, Australia, Brunei, Singapore, Cambodia, Japan,
South Korea




Re: Intellectual Property and Least Developed Countries (LDCs) - Protect
Transition Period for LDCs


As civil society organisations concerned with access to medicines, to
educational resources, to environmentally sound technologies (ESTs), and to
other public goods and cultural creations and further concerned with
farmers? rights, food security and industrial development, we call on
countries negotiating the RCEP agreement and to protect the flexibilities
available under the WTO TRIPS agreement for Least Developed Countries
(LDCs).

In terms of impact, RCEP will cover nearly 50% of the world?s population -
including the most vulnerable, marginalised and impoverished - such as
people living in Least Developed Countries (LDCs).

LDCs are given an extended transition period vis-a-vis intellectual
property (IP) under the WTO?s Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) during which period LDCs are under no
obligation to implement the provisions of the TRIPS Agreement. This is in
recognition of their special requirements, their economic, financial and
administrative constraints, and the need for flexibility so that they can
create a viable technological base and protect their capacity to make or
procure low cost generic medicines.

We would like to draw your attention to the current negotiating text of the
draft IP chapter, which proposes the premature adoption of intellectual
property obligations by LDCs.  (Please see Annex 1 for detailed analysis).

We request IP negotiators designated by your government in RCEP to
recognise specific concerns and needs of LDCs when it comes to IP and their
need to retain policy space in defining their domestic IP system.

Any attempt to weaken in any way LDCs? right to transition periods or the
utilization of the flexibilities vis-a-vis intellectual property will be
disastrous for LDCs Members and their citizens.  It would also damage the
credibility of ASEAN and it trading partners, revealing their total
disregard for the socio-economic constraints and needs of the poorest and
most vulnerable segment of the international community.

Please do not hesitate to contact Ms. Sangeeta Shashikant (
sangeeta at twnetwork.org) and/or Ms. Leena Menghaney (leena.menghaney at msf.org)
for any additional information.



SIGNATORIES



Global Networks & Organizations

LDC Watch

Third World Network

M?decins Sans Fronti?res - Access Campaign

International Treatment Preparedness Coalition -South Asia

International Trade Union Confederation (ITUC)

Electronic Frontier Foundation



Inter-regional and Regional Networks

Asia Pacific Network (APN+)

Asian Network of People who Use Drugs (ANPUD)

The South East Asia Regional Initiatives for Community Empowerment (SEARICE)

TREAT Asia/amfAR - The Foundation for AIDS Research



National Organizations and Networks

FTA Watch, Thailand

Indonesian AIDS Coalition, Indonesia

Positive Malaysian Treatment Access & Advocacy Group (MTAAG+), Malaysia

All India Drug Action Network (AIDAN), India

Initiative for Health & Equity in Society, India

Thai Treatment Action Group (TTAG), Thailand

S Srinivasan, LOCOST, India

Thai Network of People Living with HIV/AIDS (TNP+), Thailand

AIDS Access Foundation, Thailand

Education International, Belgium

Research Foundation for Science Technology & Ecology, India

UNION C, Nepal

Lawyers Collective, India

Shalini Bhutani, Legal Researcher & Policy Analyst, India

AIDS Care China, China

Indian Drug User?s Forum (IDUF), India

Public Health Association of Australia, Australia

Delhi Network of Positive People (DNP+), India

Vietnam network of people living with HIV (VNP+), Vietnam

National Association of People Living with HIV/AIDS in Nepal (NAP+N), Nepal

Italian Labour Union (UIL), Italy

Positive Women Network  (PWN+), Sri Lanka

Myanmar Positive Group (MPG), Myanmar

Lanka Plus Organization, Sri Lanka

Lhak-Sam (Bhutan Positive Network), Bhutan

Association of people living with HIV in Pakistan, Pakistan

Cambodian Network of People Living with HIV (CPN+), Cambodia

Professor Brook Baker, Health GAP, USA





Annexure 1 - LDCs AND INTELLECTUAL PROPERTY OBLIGATIONS IN COMPREHENSIVE
ECONOMIC PARTNERSHIP (RCEP) NEGOTIATIONS ? CRITIQUE



In terms of impact, RCEP will cover nearly 50% of the world?s population -
including the most vulnerable, marginalised and impoverished - such as
people living in Least Developed Countries (LDCs).

The negotiating text of the IP chapter was leaked online on 19 April 2016
and is now available http://keionline.org/node/2472. The leaked text
reveals that the draft IP chapter proposes the premature adoption of
intellectual property obligations by LDCs.

Article 5.7 (Footnote 1) of the draft RCEP IP chapter undermines the
transition period LDCs are entitled to under the TRIPS Agreement, as the
exemption is limited only to patentable subject matter and electronic
registration regime and does not apply to all intellectual property.
Article 12.1 contains some elements supporting the LDCs? transition
periods, though a footnote suggests that LDCs may still be required to
implement some provisions in the draft RCEP IP Chapter.

Article 66.1 of the TRIPS Agreement guarantees (footnote 2) LDC Members of
the WTO a renewable exemption from TRIPS obligations (except for Articles
3, 4 and 5 of the TRIPS Agreement) in view of their special needs and
requirements (for e.g public health), economic, financial and
administrative constraints and their need for flexibility to create a
viable technological base. The TRIPS Agreement in its preamble also
recognizes the need for LDCs to enjoy ?maximum flexibility in the domestic
implementation of laws and regulations in order to enable them to create a
sound and viable technological base?.

In view of the above, we stress that countries negotiating RCEP should
recognize and uphold the current transition periods and waivers granted to
LDCs as well as any further extensions of the same by the WTO, and to adapt
below proposed amendments to RCEP text:

Article 5.7 should be amended to read:  ?The Parties agree that the
least-developed country parties will not be obligated to implement
intellectual property protections as provided for by TRIPS Council Decision
(IP/C/64) dated 11th June 2013 until 2021 or any further extension thereof,
whichever occurs later nor to implement intellectual property protections
on pharmaceutical products as provided in TRIPS Council Decision (IP/C/73)
dated 6th November 2015 and WTO General Council Decision WT/L/971 dated 2nd
December 2015 until 2033 or any further extension thereof, whichever occurs
later.?

Article 12.1 of the draft text should be amended accordingly and provisions
that undermine LDCs? flexibilities or that obligate or locks-in LDCs?
implementation of intellectual property should be deleted.

In accordance with Article 66.1 of the TRIPS Agreement, LDCs enjoy a number
of exemptions and waivers to the implementation of TRIPS Agreement which
are listed below for reference:

1. Pursuant to extension of transition period granted to LDCs in accordance
with Article 66.1 of the TRIPS Agreement, LDCs are exempted from applying
all TRIPS standards until 1 July 2021 (Footnote 3). This period must be
extended by the TRIPS Council on LDCs submitting a duly motivated request.
(Footnote 4) Thus far this transition period has been extended twice.

2. Further, LDCs have been granted a specific pharmaceutical transition
period wherein LDCs do not have to apply or enforce TRIPS provisions
concerning patents (footnote 5) as well as test data protection (footnote
6) in relation to pharmaceutical products until 1 January 2033(footnote 7).
This period must also be extended pursuant to a duly motivated requested.

3. In addition, the WTO General Council has granted LDCs waivers until 1
January 2033 from obligations to make available a mechanism for filing
patent applications for pharmaceutical products (mailbox) or to grant
exclusive marketing rights to such applications (Footnote 8)



In view of the above, we stress that countries and their negotiators should
recognize and uphold the current transition periods and waivers vis-a-vis
intellectual property granted to LDCs as well as any further extensions of
the same by the WTO. In fact, the text should encourage LDCs to fully
utilize these transition periods. In addition, countries negotiating RCEP
should not impose TRIPS-plus obligations on LDCs.

Footnotes:

1. [ASN/IN/NZ/CN propose: The Parties agree that the least-developed
country Parties will not be obliged, with respect to pharmaceutical
products, to implement or apply Paragraphs 1(a) of Article 4 (Patentable
Subject Matter) and Paragraph 4 of Article 4 (Electronic Registration
Regime) or to enforce rights provided for under these Paragraphs until 1
July 2021, without prejudice to the right of least-developed country
Parties to seek other extensions of the transition periods as provided for
in Article 66.1 of the TRIPS Agreement.]

 2. Pursuant to Article 66.1, such duly motivated requests ?shall? be
accorded.

 3. TRIPS Council Decision (IP/C/64) dated 11th June 2013. This exemption
has been extended twice so far upon LDCs submission of requests.

 4. Article 66.1 of the TRIPS Agreement

 5. Section 5 of the TRIPS Agreement

 6. Section 7 of the TRIPS Agreement

 7. TRIPS Council Decision (IP/C/73) dated 6th November 2015

 8. WTO General Council Decision WT/L/971







--
Leena Menghaney
Mobile: 9811365412


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