[Ip-health] Communications between Gilead and USTR regarding Malaysia compulsory license on HCV patents, 2017 to May 2018

Thiru Balasubramaniam thiru at keionline.org
Wed Nov 28 06:54:34 PST 2018


Communications between Gilead and USTR regarding Malaysia compulsory
license on HCV patents, 2017 to May 2018https://www.keionline.org/29257

Posted on November 28, 2018 <https://www.keionline.org/29257> by James Love
<https://www.keionline.org/author/james-love>

The attached document is a 78 page PDF file obtained from USTR under the
Freedom of Information Act (copy here
<https://www.keionline.org/wp-content/uploads/2018/11/malaysia-FOIA-SOF-cl.pdf>),
regarding communications between Gilead and USTR, over Malaysia’s decision
to grant a compulsory license on patents for HCV treatments.

This includes several emails and documents, including but not limited to
the following:

*2017 January 17-20*
World Economic Forum Annual Meeting – Davos, Switzerland. There is a
meeting held between Malaysian Minister of Economic Affairs and Gregg
Alton, Executive Vice President, Corporate and Medical Affairs of Gilead
Sciences (referenced in June 23, 2017 email from Barry Featherman).

*2017 June 18-19*
Karl Ehlers of USTR writes to Daniel Lee and Barbara Weisel of USTR and
Barry Featherman and Gregg Alton of Gilead, regarding facilitating a
meeting between Featherman, Briana Baron (Gilead) and the Malaysian
Embassy, “per our discussion with Gregg Alton.”

*2017 June 22*
A meeting is held at the Embassy of Malaysia between Barry Featherman,
Senior Director, International Government Affairs, Briana Barron, Senior
Counsel, Intellectual Property, and Lorie Ann Morgan, VP for Intellectual
Property of Gilead and Hairil Yahri Yaacob, Minister Counselor, Ministry of
Economic Affairs and Mohd Firdaus Mohd Ali, Second Secretary, Ministry of
Economic Affairs of Malaysia.

Gilead discussed the decision by the Malaysian government to reject
Gilead’s claim of data exclusivity.

*2017 June 23*

Karl Ehlers (USTR) emails Barry Featherman (Gilead) to ask how June 22nd
meeting between Gilead and Malaysian Embassy went.

Barry Featherman (Gilead) sends report to Karl Ehler (USTR) of the June 22
meeting at the Malaysian embassy. Among other things, Gilead told USTR
that: “even in the absence of data exclusivity, our data should still be
protected under TRIPS.” Gilead reported the Malaysian officials from the
Ministry of Economics encouraged Gilead to meet directly with the officials
at the Ministry of Health. The Malaysian officials from the Ministry of
Economics said they would also ask their headquarters to weigh in with the
Ministry of Health and they asked Gilead to send them more information
about their Minister’s meeting with Gregg Alton at Davos in January 2017.
Meeting participants included Barry Featherman (Gilead), Briana Barron
(Gilead), Lori Ann Morgan (Gilead via teleconference), Hairil Yahri Yaacob
(Malaysian Minister Counselor of Economics), and Mohd Firdaus Mohd Aldi
(Malaysian Second Secretary of Economics).

*2017 August 22*

Gregg H. Alton (Gilead) letter to HE Datuk Seri KV Subramaniam (Malaysian
Minster of Health), re: “Request for meeting to discuss HIV and hepatitis C
proposal from Gilead Sciences, Inc.”

I hope this finds you well since we last met at the February 2015 Wilton
Park meeting in Singapore, “HIV co-infections with viral hepatitis:
implications for screening and treatment in Asia.” I am writing to request
a meeting with you to discuss how we can work together to address HIV/AIDS
and hepatitis C in Malaysia. We are committed to making our innovative
HIV/AIDS and hepatitis C treatments available to patients in Malaysia and
would like to propose adding Malaysia to the list of countries eligible to
receive licensed generic versions of our HIV and hepatitis C medicines. If
your schedule permits, I will be in Australia and can travel to Kuala
Lumpur to discuss this proposal with you on Friday September 1 or anytime
that is convenient for you.

Barry Featherman (Gilead) emails Karl Ehlers (USTR), Barbara Weisel (USTR),
and Daniel Lee (USTR) asking if they have time to speak today.

*2017 August 24*

Gregg Alton (Gilead) letter to HE Dato’ Sri Mustapa Mohamed (Malaysian
Minister of International Trade and Industry), re: “Request for meeting to
discuss HIV and hepatitis C partnership with Gilead Sciences, Inc.”

I hope this finds you well since we last met at the World Economic Forum in
January. As I mentioned then, Gilead is committed to making our innovative
HIV/AIDS and hepatitis C treatments available to patients in Malaysia. I am
pleased to share that we are expanding the reach of our HIV and hepatitis C
and HIV voluntary licensing program to include Malaysia, as well as
Belarus, Thailand and Ukraine. We would appreciate the opportunity to meet
with you to discuss this program expansion. Stanley Li, our General Manager
responsible for Malaysia, and Aaron Brinkworth, Senior Director of Access
Operations and Emerging Markets, will be in Kuala Lumpur the week of
September 4 if your schedule permits.

We decided to increase the scope of our voluntary licensing program
following a number of discussions with government officials,
non-governmental organizations (NGOs) and community groups regarding the
issues Malaysia and these three countries have experienced in expanding
access to HIV and hepatitis C therapies. We hope that the inclusion of
Malaysia in both our direct HIV and hepatitis C licenses, as well as in our
indirect license for our HIV medicines through the Medicines Patent Pool
(MPP), will help you and your government reach HIV and hepatitis C patients
in need of life-saving treatment…

*2017 August 28*

Karl Ehlers writes to Hairil Yahri Yaacob and Mohd Firdaus Mohd Ali
(Malaysia), introducing them to USTR’s Abigail Bacak, to schedule a meeting
between Malaysia trade minister Mustapa Mohamed and USTR Robert Lighthizer.

*2017 August 30*

Mohd Firdaus Mohd Ali writes to Karl Ehlers and Abigail Bacak of USTR, with
a letter requesting a meeting with Malaysia trade minister Mustapa Mohamed
and USTR Robert Lighthizer.

*2017 September 1*

Abigail Bacak of USTR writes Mohd Firdaus Mohd Ali of Malaysia and Karl
Ehlers of USTR with Barbara Weisel of USTR and Hairil Yahri Yaacob of
Malaysia copied, to say the meeting between Malaysia trade minister Mustapa
Mohamed and USTR Robert Lighthizer will be 45 minutes on September 11.

*2017 September 5*

Karl Ehler (USTR) email to Barry Featherman (Gilead) with Barbara Weisel
(USTR) and Daniel Lee (USTR) copied.

Barry,
We were wondering if you have heard back from MYS regarding the meeting
requests with Minister of Health or Minister of Trade?
Best, Karl

*2017 September 9*

Mohd Firdaus Mohd Ali (Malaysia) writes to Karl Ehlers of USTR, attaching a
tentative agenda for a meeting between E. Mustapa Mohamed, Minister of
International Trade and Industry, Malaysia and Ambassador Robert
Lighthizer, U.S. Trade Representative. The tentative agenda was for an
exchange of views on 7 topics plus “other areas of specific concern.”

*2017 September 11*

Meeting between E. Mustapa Mohamed, Minister of International Trade and
Industry, Malaysia and Ambassador Robert Lighthizer, U.S. Trade
Representative.

*2017 September 12*

Malaysian Prime Minister Najib has meeting with President Trump

*2017 September 14*

Barry Featherman of Gilead writes to Karl Ehlers of USTR.

“Dear Karl: I hope all is well. I send you warm greetings from Singapore.
We’re very concerned by a report in Malaysia’s The Star (the first article
below) that Malaysia’s cabinet approved issuing compulsory licenses to
import generic versions of sofosbuvir to treat patients in public health
facilities. Whilst we were aware of this, the concerning part is that
Malaysia’s Health Ministry said that it is preparing a statement on the
development. Additional coverage from Malay Mail Online is included, along
with a statement from the Malaysian AIDS Council that notes the government
decision was made August 4. I am curious if you have heard any news about
the government’s forthcoming statement on this development. Many thanks!
Barry”

Karl Ehlers (USTR) replies to above email from Barry Featherman (Gilead)
with Daniel Lee (USTR) and Barbara Weisel (USTR) copied.

Barry,
We hadn’t heard about this. As your team gathers information and confirms
the current status, please keep us posted.
Best,
Karl

*2017 September 18*
The Malaysia government issued an Exercise of Government’s Rights Under
Section 84 Patents Act 1983 [Act 291) to authorize Pharmaniaga Logistics
Sdn Bhd, Malaysia to exploit the patented invention for Sofosbuvir.

*2017 September 19*

Email from Karl Ehlers (USTR) to Barry Featherman (Gilead) with subject
line “Any updates on your requested meeting with Ministry of Health?”

I was just speaking with the Malaysia Embassy, and they were wondering too.
Best, Karl

*2017 September 21*

Call between Barry Featherman (Gilead) and Daniel Lee (USTR), Karl Ehlers
(USTR), and Shannon Nestor (USTR), Marc Knox (Gilead) copied.

*2017 September 26*

Meeting between Karl Ehlers (USTR), Barry Featherman (Gilead), Gregg Alton
(Gilead), Daniel Lee (USTR, by phone from Ottawa) as well as Shannon Nestor
(USTR), Christina Olson (USTR), Marc Knox (Gilead) copied.

*2017 October 2*

Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs of
Gilead Sciences, meets with then Malaysian Minister of Health Subramaniam
Sathasivam.

*2017 October 2*

Gregg H. Alton (Gilead) letter sending additional information to
then-Malaysian Minister of Health Subramaniam Sathasivam regarding the
addition of Malaysia to the Gilead voluntary license of HIV and hepatitis C
drugs.

Gregg H. Alton (Gilead) sent a letter to Prime Minister of Malaysia the
Honourable Dato’ Sri Mohd Najib bin Tun Abdul Razak regarding “Gilead
Sciences voluntary licensing of HIV and hepatitis C medicines in Malaysia.”

I write regarding the recent addition of Malaysia to the list of countries
eligible to receive licensed generic versions of Gilead Sciences’ HIV and
hepatitis C medicines. I would like to take this opportunity to share the
full benefits of our voluntary licensing program, and explain the specific
ways in which our voluntary licensing program can help expedite and expand
access to generic versions of our medicines.

…

In summary, we believe that it is unnecessary and counterproductive for the
Government of Malaysia to exercise its rights pursuant to Section 84(1)(a)
of the Patents Act 1983 [Act 291], as our direct licensing agreements could
help Malaysia reach more patients sooner. We have expressed these
sentiments during our conversations in the United States…

*2017 October 4*

Meeting between PhRMA and USTR, regarding “SE pharmaceutical issues.” USTR
says it “ would like to start with Vietnam and Malaysia.” PhRMA said its
group would include Chris Kuzmuk (PhRMA), Chris Moore (PhRMA), Ruben Duran
(PhRMA), Amey Sutkowski (PhRMA, likely), Megan Falken (GSK), Doug Goudie
(Pfizer), Laurel Vogelsang (Merck). The USTR people in the email thread are
Daniel Lee, Christine Brown, Karl Ehlers, Marta Prado, Christina Olsen.
Email chain organizing meeting spans Sept 10-Oct 3, begins with request
from Daniel Lee of USTR to Chris Kuzmuk of PhRMA to discuss SE Asia
pharmaceutical issues.

*2017 October 5*

Following Oct 4th meeting, Chris Kuzmuk (PhRMA) emailed Daniel Lee (USTR
and Karl Ehlers (USTR) with Amey Sutkowski (PhRMA) and Ruben Duran (PhRMA)
CC’d for “a good contact at the Malaysian Embassy, as they’ve been a bit
unresponsive to us at this point!”

Karl Ehlers (USTR) promptly responds with card file and direct email of
Hairil Yahri Yaacob and card file of Mohd Firdaus Mohd Ali of Malaysian
Embassy. Mentions that they’ll likely hear back from Firdaus but if not to
let USTR know and they will contact Malaysians.

*2017 October 7*

Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs of
Gilead Sciences, sent a letter to Prime Minister of Malaysia the Honourable
Dato’ Sri Mohd Najib bin Tun Abdul Razak regarding the October 2 meeting
with Minister of Health Subramaniam Sathasivam. Gregg H. Alton notes that
the purpose of this meeting was to explain the Minister of Health “the
benefits of a voluntary license over the use of Section 84”. The October 7
letter states:

“In light of the availability of a voluntary license for not only our
hepatitis C medicines, but also our HIV and hepatitis B medicines, we would
be disappointed if your government decides to exercise its rights pursuant
to Section 84(1)(a) of the Patents Act 1983 [Act 291] on sofosbuvir. We
believe the use of Section 84 is unnecessary and may become
counterproductive in the development of a sustainable ecosystem of
voluntary licensing, which could ultimately help Malaysia reach more
patients sooner.”

Gregg Alton (Gilead) letter to HE Datuk Seri KV Sathasivam Subramaniam
(Malaysian Minister of Health) following up on their meeting.

…We hope you will consider the benefits of a voluntary licensing approach
as you endeavor to treat hepatitis C patients in Malaysia. In the meantime,
we intend to appeal the Section 84(1)(a) decision and have requested a
hearing before the Minister of Domestic Trade as soon as possible. Gilead
is concerned with the procedure by which we were informed of the decision,
our opportunity for appeal, and the reasons for the decision.

At our meeting we presented several new items for your consideration. We
are at your disposal at any time should you have questions regarding our
voluntary licensing program. I think that we would both agree that the 7-
day deadline to respond to your compulsory license decision should not
serve to unduly truncate your ability to fully review our proposal.
Although we made an official request for an extension via the Malaysian
Embassy in Washington, D.C., I hope that you will look favorably upon our
request given the fruitful discussions we have started.

As we discussed, a comprehensive voluntary licensing model approach would
better serve your public and private patients, show Malaysia’s willingness
to use public private partnerships to meet the needs of its citizens, and
serve as a strong multinational innovator model that other companies will
wish to emulate.

I look forward to further discussions as you consider our voluntary
licensing proposal and next steps. As a first step to addressing your
questions, I am attaching two lists per your request:
1) A list of our current Indian voluntary licensees; and
2) The contact information for our local representatives.

*2017 October 25*

Following October 5th email chain, Chris Kuzmuk (PhRMA) emails Karl Ehlers
(USTR) stating that they have not heard back from Hairil Yahri Yaacob
(Malaysia) after several emails, and requesting his phone number. Karl
responds promptly providing Mohd Firdaus Mohd Ali’s (Malaysia) cell phone
number and offering that Christine Brown (USTR) will get them them Hairil’s
contact information if not.

*2017 October 31*

Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs of
Gilead Sciences sends a letter to Datuk Dr Noor Hisham bin Abdullah,
Director General of Health at the Malaysia Ministry of Health. In this
letter, Gregg H. Alton acknowledges that he spoke with Dr Noor Hisham bin
Abdullah and then Malaysian Minister of Health Subramaniam Sathasivam on
October 2. In this letter Gregg H. Alton states that:

“Given the availability of a voluntary license for not only our hepatitis C
medicines, but also our HIV and hepatitis B medicines, we would be
disappointed if the Malaysian government decides to exercise its right
pursuant to Section 84(1)(a) of the Patents Act 1983 [Act 291] on
sofosbuvir. We believe the use of Section 84 is in violation of local and
international laws and treaties, unnecessary and may become
counterproductive in the development of a sustainable ecosystem of
voluntary licensing, which could ultimately help Malaysia reach more
patients sooner.”

*2017 November 3*

Letter (on letterhead) from Gregg Alton to G. Payne Griffin (USTR)
regarding “our recent issues in Malaysia.”

Dear Mr. Griffin:
Thank you for taking the time to meet last week to discuss our recent
issues in Malaysia.

As we discussed, Malaysia’s recent issuance of a compulsory license on our
hepatitis C medicine, sofosbuvir, represents a potential violation of TRIPS
and other international patent protection regimes.

The Malaysian government’s action directly harms Gilead’s business in
Malaysia. We believe the Malaysian government’s recent actions – both the
unnecessary and inappropriate use of government license and data
exclusivity rejections – warrant U.S. government engagement.

Left unchecked, these decisions set a precedent and send a clear message to
other countries, particularly in the region, that disrespect for American
intellectual property will be tolerated by the U.S. government. We
understand others in the biotech and pharmaceutical industry are closely
following our issue due to their concern about the potential impact on
their interests in Malaysia and other global markets.

Since we met, we have been informed by the Malaysian government that they
have rejected our appeals on the rejection of data exclusivity for both our
HIV medicine, Genvoya, and our hepatitis C medicine, Harvoni. No
explanation was provided in the appeal rejection letter, which is attached.

We would appreciate USTR’s support on these matters and hope Ambassador
Lighthizer will communicate the U.S. government’s concerns to the
Government of Malaysia, preferably by sending a letter expressing the U.S.
government’s disappointment in these developments. We understand there
could also be an opportunity to discuss our issues with the Government of
Malaysia on the margins of the upcoming APEC Summit in Danang.

Thank you again for your time and consideration.

Best Regards,
Gregg Alton

CC:
Ambassador Robert Lighthizer, U.S. Trade Representative
Elizabeth Kendall, Acting Assistant U.S. Trade Representative for
Innovation and Intellectual Property
Karl Ehlers, Acting Assistant U.S. Trade Representative for Southeast Asia
and the Pacific
Daniel Lee, Deputy Assistant U.S. Trade Representative for Innovation and
Intellectual Property

Attachments:
Notification of data exclusivity appeal rejection
Summary of compulsory license issue
Summary of data exclusivity rejections
Correspondence to the Prime Minister
Correspondence to the Minister of Health
Correspondence to the Minister of International Trade
Correspondence to the Director General of the Ministry of Health

*2017 November 4*

Letter from Gregg Alton (Gilead) to Payne Griffin (USTR) with Elizabeth
Kendall (USTR), Karl Ehlers (USTR), and Daniel Lee (USTR) copied titled,
“Thank you letter to G. Payne Griffin USTR 11.3.17” stating, “Please find a
letter regarding our issues in Malaysia including updates regarding our
data exclusivity rejections, attached.” (Attachment is dated November 3rd,
noted above)

*2017 November 7*

Barry Featherman (Gilead) sends email to Karl Ehlers (USTR), Daniel Lee
(USTR), Elizabeth Kendall (USTR), titled “Fwd: Malaysian agreement to
import generic SOF”. Gilead is objecting to the agreement between DNDi and
Pharco regarding the supply of ravidasvir and sofosbuvir to Pharmaniaga, on
two grounds.

Please see below for recent press articles referring to Pharmaniaga’s
agreement with Pharco and DNDi on sofosbuvir. The stated date of the
agreement is July 26, 2017 for ten years. This seems problematic on two
fronts: 1) this agreement pre‐dates the Cabinet’s decision to authorize the
public use taking and 2) the public use taking is for a three‐year duration
yet the agreement is for ten years.

Best, Barry

Malaysian drugmaker Pharmaniaga announced it entered into a collaboration
with Pharco Pharmaceuticals and DNDi to promote access to affordable
ravidasvir and sofosbuvir in Malaysia. The announcement notes that generic
sofosbuvir importation is allowable under Section 84 of Malaysia’s Patents
Act 1983 and TRIPS. The agreement is a ten‐year deal, effective July 26,
2017. Coverage follows from The Sun Daily, The Star, The Edge Markets and
M2 Pharma.

*2017 December 9*

Email from Barry Featherman (Gilead) to Karl Ehlers (USTR) and Daniel Lee
(USTR).

Hi Karl and Daniel: Just a note that I am once again enroute to Kuala
Lumpur. The Minister of Domestic Trade has sent us a note offering to meet
with us on Monday. I’ll let you know how the meeting goes. Best, Barry

*2017 December 9*

Email from Karl Ehlers (USTR) to Barry Featherman (Gilead), cc to Daniel
Lee (USTR)

Barry
That is great news, thanks for letting us know. Are you also going to see
Nat Turner of the Embassy, and Catherine Spillman of FCS? Assuming you
will, but just checking as they have their meeting coming up with the Prime
Minister’s office and I am sure a conversation w you would be helpful to
them beforehand. K.

*2017 December 10 to 13*

WTO 11th Ministerial meeting in Buenos Aires, Argentina.

*2017 December 10*

Email from Courtney Gillespie (Gilead) to Karl Ehlers (USTR), Daniel Lee
(USTR) with Gregg Alton (Gilead), Kacy Hutchison (Gilead), Chuck Clapton
(Gilead), Barry Featherman (Gilead), Michael Pascual (Gilead), Joseph
Damond (BIO), subject line “[EXTERNAL] Thank you and follow-up, Gilead
Sciences.”

Karl and Daniel,

Thank you for taking the time to meet with us last week. We appreciated the
opportunity
to discuss the compulsory license of sofosbuvir in Malaysia with you.
Please find an
updated summary and timeline of engagement with the Malaysian government
attached
for your background. Please let us know if you would like additional
information in
advance of this week’s MC11 meeting.

We would welcome the opportunity to provide a readout of our December 11
meeting
with the Ministry of Domestic Trade. Perhaps we can plan to reconnect on
Friday,
December 15 or the week of December 18.
Best,
Courtney

*2017 December 11*

Gilead meeting with Malaysia Ministry of Domestic Trade, in Kuala Lumpur.
Michael Pascual (Gilead), Barry Featherman (Gilead) and others.

*2017 December 12*

Email from Joseph Damond of BIO to Elizabeth Kendall, of USTR. Subject,
“Following up on Israel”

While I have you Elizabeth (know you are busy) two other quick things:

–Saw Daniel Lee on Thursday with Gilead about Malaysian CL — getting to be
a big deal to industry, given that Gilead has tried to do everything right
on pricing.
–Letting the TRIPS moratorium on non-violation nullification and impairment
cases expire would be a big deal for this industry — in the sense that we’d
greatly favor the expiration.

Hope all is well!

*2017 December 14.*

Subject line: “Thank you and follow-up, Gilead Sciences”
Michael Pascual (Gilead) wrote to Daniel Lee (USTR).
Hi Daniel, I am in DC tomorrow and was in the meeting with the Minister of
Domestic Trade this past Monday. I’d be happy to meet with you tomorrow to
give you a readout. Just let me know.

Best, Mike Michael Pascual | Director, Government Affairs, Asia | Gilead
Sciences Hong Kong

*2017 December 15*

Meeting at main USTR building to brief USTR on the Dec 11th meeting between
Gilead and the Malaysian Minister of Domestic Trade.

One of the emails concerning the meeting had the subject line “Re: Thank
you and follow‐up, Gilead Sciences,” and was send by Daniel Lee (USTR), to
Monica He (BIO) and Joseph Damond (BIO), with Cc: to Michael Pascual
(Gilead); Courtney Gillespie; Gregg Alton (Gilead); Kacy Hutchison
(Gilead); Chuck Clapton (Gilead); Barry Featherman (Gilead); Steward B.
Young (USTR) and Karl Ehlers (USTR).

*2017 December 15*

Email from Michael Pascual of Gilead (Director of Government Affairs, Asia)
to Karl Ehlers (USTR) and Nathaniel Turner (USTR), cc to Daniel Lee (USTR),
Barry Featherman (Gilead), Courtney Gillespie (Gilead) and Dean Thompson.
Subject is “Request to meet with PMO advisors.”

Karl,

It was a pleasure meeting you today and thanks for your offer to help
facilitate a meeting with the Prime Minister’s office. Would you and Na be
able to assist with requesting a meeting anytime January 4-8, 2018? Please
let me know if you need anything from me to start that process. I also
defer to you which advisor in the PM’s office would be most useful to
engage — Saiful, Efendi, or someone else.

*2017 December 16*

Email from Karl Ehlers (USTR) to Nathaniel Turner (State), Michael Pascual
(Gilead), cc to Courtney Gillespie (Gilead), Dean Thompson (State), Daniel
Lee (USTR), Barry Featherman (Gilead).

Mike,
It was great to chat – in particular, thanks for letting us know that you
have already responded to the Minister of Domestic Trade and made a
proposal per his request. Keep us posted on what you hear from his office.

Re: a contact at the PMO’s office when you are next in KL, as we discussed,
we think it would be a good idea to socialize your proposal if you can get
a meeting. We’ll confer with Dean and Nat and Catherine; they will be able
to advise on the best way to get a request in.

*2018 January 17*

Email from Gregg Alton of Gilead to Payne Griffin of USTR, requesting a
meeting with Ambassador Lighthizer at the World Economic Forum in Davos.
The request was for Robin Washington, the CFO of Gilead, and Alton.

Mr. Griffin,

I write to request a meeting with Ambassador Lightinzer at the upcoming
World Economic Forum in Davos, Switzerland. Robin Washington, our Chief
Financial Officer and Executive Vice President, and I will be in Davos and
would appreciate the opportunity to discuss Malaysia’s recent issuance of a
compulsory license on our hepatitis C medicine, sofosbuvir.

As we discussed last October, Malaysia’s compulsory license represents a
potential violation of TRIPS and other international patent protection
regimes. The Malaysian government’s action directly harmed Gilead’s
business in Malaysia. We believe the Malaysian government’s recent actions
warrant U.S. government engagement.

Left unchecked, these decisions set a precedent and send a clear message to
other countries, particularly in the region, that disrespect for American
intellectual property will be tolerated by the U.S. government. Since the
Malaysian compulsory license was announced, both the Chilean parliament and
Colombian Ministry of Health have made similar announcements regarding
hepatitis C medicines.

We understand others in the biotech and pharmaceutical industry are closely
following our issue due to their concern about the potential impact on
their interests in Malaysia and other global markets.

Emails arranging call between USTR and PhRMA regarding “recent developments
in Malaysia (email subject line: Malaysia), requested by USTR. Email chain
includes Daniel Lee (USTR), Karl Ehlers (USTR), Chris Moore (PhRMA), and
Chris Kuzmuk (PhRMA). Daniel Lee notes in his request for a call that he
and Karl “are planning to make a stop in Malaysia as part of a broader trip
to the region next week.”

*2018 January 18*

Call between Daniel Lee (USTR) and Chris Moore (PhRMA), possibly Karl
Ehlers (USTR) others, regarding updates on “recent developments” in
Malaysia.

*2018 January 19*

Email no body available from Daniel Lee (USTR) to Michael Pascual (Gilead),
subject line “Accepted: [EXTERNAL] Re: Thank you and follow-up, Gilead
Sciences”

*2018 February 8*

Email from Daniel Lee (USTR) to Chris Moore (PhRMA) and Chris Kuzmuk
(PhRMA), asking if PhRMA is “already planning to do a multi-hour briefing
for the Special 301 interagency sub-committee.”

*2018 February 22-23*

Emails arranging meeting on “ASEAN issues” specifically citing Indonesia
and Malaysia, between USTR and PhRMA, requested by Chris Kuzmuk of PhRMA.
Karl Ehlers (USTR), Daniel Lee (USTR), Christine Brown (USTR), and Chris
Kuzmuk (PhRMA) on the chain.

Daniel Lee (USTR) notes he will miss the meeting, but will be at “the PhRMA
Special 301 briefing” on March 7th.

*2018 February 28*

Meeting between PhRMA and USTR regarding ASEAN, touching bases on Indonesia
and Malaysia.

*2018 April 5*

Call between PhRMA and USTR regard ASEAN. Email chain discussing call began
with request from Chris Kuzmuk (PhRMA) to Marta Prado (USTR), Karl Ehlers
(USTR), and Daniel Lee (USTR) to discuss ASEAN markets, including Thai TIFA
meetings, Vietnam, Philippines, Indonesia, and “our quickly becoming
favorite Malaysia.”

Among those included in the email chain setting the call.
USTR
Karl Ehlers (USTR)
Marta Prado (USTR)
Ronald Baumgarten (USTR)
Bartholomew Thanhauser (USTR)
Daniel Lee (USTR)
PhRMA
Chris Kuzmuk (PhRMA),
Catherine Hinckley (Eli Lilly)
Matthew Lloyd Watkins (Pfizer)


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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