[Ip-health] BMS / Mylan suit over sales of ATZ in Venezuela

leena menghaney leenamenghaney at gmail.com
Thu Apr 7 10:46:35 PDT 2016

yes I have been following for years and its even documented in MSF briefing

It relates to PAHO’s tender for procurement of the HIV medicine atazanavir
for Venezuela, from the the Indian subsidiary of the US generic company
Mylan in 2012 and 2014. Using a licensing agreement with Mylan that defines
patents as covering pending applications and pending appeals of rejected
applications, BMS sued Mylan in Indian and US courts to prevent export to
Venezuela (which was not included in the list of licensed territories),
despite the fact that there were and are no granted
product patents on the compound, pro-drug or salt form in India or
Venezuela. BMS does not have any granted patents in Venezuela but seeks to
bar Mylan Labs from supplying the drug based on claims of two pending
patent applications: VN 2005-000854 and VN 1999-000084. Supply in such
cases by generic companies falls foul of anti diversion provisions in VL
and can trigger such litigation which has a chilling effect on generic
companies that wish to supply in territories not included in the license.

There are blog posting on the case at this link:

The same problem is also in the sofosbuvir license from Gilead to generic
producers and a further scrutiny of all licenses (under the Pool and
bilateral) needs to happen.


On 6 April 2016 at 19:53, Amy Kapczynski <amy.kapczynski at gmail.com> wrote:

> Have people been following this case in the Second Circuit?  BMS is suing
> Mylan for selling atazanavir to Venezuela, under a licensing agreement that
> allegedly forbade sales to countries w/o patents.
> 2nd Circ. Eyes BMS $30M Suit Over Mylan's Sale Of AIDS Drug
> Share us on: By Pete Brush
> Law360, New York (April 5, 2016, 2:16 PM ET) -- The Second Circuit
> appeared poised Tuesday to revive Bristol-Myers Squibb Co.'s $30 million
> breach of contract suit against Mylan Laboratories Ltd. over Mylan's
> alleged unlawful sale of a patented Bristol-Myers AIDS drug in Venezuela,
> with one judge saying Mylan was "hell-bent" to skirt the companies' no-suit
> agreement.
> Mylan appeared to be pushing against headwinds before Judges Rosemary S.
> Pooler, Barrington D. Parker and Debra Ann Livingston in a case the Second
> Circuit already has revived once only to see it again thrown out in July by
> U.S. District Judge Paul A. Engelmayer on a motion to dismiss. Bristol
> Myers originally filed suit in 2013.
> Bristol-Myers says Mylan profited from distribution of atazanavir, a
> generic version of its patented drug Reyataz, in Venezuela despite a deal
> forbidding export to counties where its drug did not enjoy patent
> protection. Venezuela is one such country.
> The contract, charitable in nature and designed to give some developing
> nations access to a powerful antiretroviral medicine, gave Mylan access to
> drugmaking technology. It was geared primarily toward India and sub-Saharan
> Africa, Bristol-Myers says.
> Mylan counters that Bristol-Myers has not stated a claim for relief among
> other things because the letter of the no-suit agreement only forbids third
> parties from exporting the drug into forbidden territories.
> But Bristol-Myers says that is exactly what happened. Mylan sold
> atazanavir to the Pan American Health Organization while the drug was in
> India and the organization moved the drug to Venezuela, it says.
> While Judge Engelmayer twice been unimpressed with Bristol-Myers' claims,
> the Second Circuit, which revived the case for the first time in October
> 2014, appeared to take the opposite view again.
> Judge Parker appeared especially piqued by Mylan's argument sounding in
> the letter of the contract.
> “Your client was hell-bent on getting something that it hadn't bargained
> for and wasn't entitled to,” he told Mylan counsel Jessica L. Margolis of
> Wilson Sonsini Goodrich & Rosati PC.
> Judge Parker stated flatly that the case appeared to contain questions of
> fact that were not ripe for a motion to dismiss.
> And when Margolis asserted that Bristol-Myers — already on a third
> complaint in the trial court below — was simply “trying and trying to
> manufacture a breach of contract claim” related to the Venezuelan exports,
> it was Judge Pooler's turn to be unhappy.
> Mylan's conduct was “not in the spirit of the contract,” she said.
> If the case is reversed again, liability could hinge on whether the
> Washington, D.C.-based Pan American Health Organization was the exporter of
> the drug under Indian law.
> Bristol-Myers is represented before the Second Circuit by John W. Nields
> of Covington & Burling LLP.
> Matrix is represented by Jessica L. Margolis of Wilson Sonsini Goodrich &
> Rosati PC.
> The appeal is Bristol-Myers Squibb v. Matrix Laboratories, case number
> 15-1922, in the U.S. Court of Appeals for the Second Circuit.
> --Editing by Patricia K. Cole.
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Leena Menghaney
Mobile: 9811365412

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