PRAXAIR TECHNOLOGY, Inc.
`LAW DEPARTMENT 39 Old Ridgebury Road, Danbury, CT 06810/ Fax 203 837-2545
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`Internet: Bob_Hampsch@Praxair.com
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`Robert J. Hampsch
`Senior Intellectual Property Counsel
`203 837-2178
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`Jonathon N. Provoost
`Associate General Counsel
`Intellectual Property and Regulatory
`6 Route 173
`Clinton, NJ 08809
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` Date: November 25, 2009
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`Via E-mail: jonathan.provoost@ikaria.com
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`Dear Jonathan,
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`Thank you for your patience while Praxair investigates the issues surrounding our nitric
`oxide mix offering in México. As we discussed, Praxair has recently conducted an investigation of
`the regulatory and patent issues in México you raised in our telephone call of October 27, 2009.
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`Our investigation confirms that Praxair Mexico has the necessary authorizations from the
`Ministry of Health to produce nitric oxide as a medical grade gas. In addition, Praxair Mexico
`has made filings with the necessary authorities which allow it to sell nitric oxide mix in Mexico.
`Praxair Mexico expects to obtain the definitive permits and/or authorizations for the sale of nitric
`oxide mix in Mexico in the short term.
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` Specifically, in February 2005, Praxair México obtained the requisite authorization to
`produce nitric oxide as a Medical gas and currently has applications with the Ministry of Health
`seeking further regulatory approval for its’ nitric oxide offerings dating back to mid 2007. In late
`2007, the relevant authorities added a new requirement for the issuance of permits, the
`certification of Good Manufacturing Procedures (“GMP). Early in 2008 Praxair Mexico initiated
`the motions to obtain the GMP certification, however, up until July 2009, the relevant Mexican
`authorities has not appointed any entity which could issue the GMP certification. In July 2009,
`COFEPRIS became the only official recognized entity to issue the GMP compliance certification.
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`Based on these efforts and pending applications, Praxair México has the requisite
`authority to continue producing and selling nitric oxide mix. In addition Praxair Mexico shall
`continue its efforts to obtain the definitive permits from Ministry of Health and COFEPRIS on
`such applications.
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`With regard to the issues concerning México Patent No 206992, we can confirm that
`Praxair México does manufacture nitric oxide mix as a medical gas in cylinder form from their
`facilities. However, there are simply no valid claims in México Patent No 206992 that would
`prevent Praxair (or any other gas supplier) from making or selling nitric oxide mix or the
`associated equipment to our customers in México.
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`Ex. 2025-0001
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`As you know, claims 1-21 in México Patent No 206992 are directed to the use of nitric
`oxide as an inhalable medication. Such patent claims are contrary to Mexican law and are
`therefore subject to cancellation. We kindly draw your attention to Article 19, Paragraph VII of
`México Industrial Property Law which expressly prohibits patent protection of ‘ …methods for
`surgical, therapeutic or diagnostic treatment applicable to the human body or animals.’ The
`remaining claims 22-96 are directed to an inhalation device or apparatus to introduce nitric oxide
`in the airways of a mammal or patient. Because such patent claims are directed to an apparatus or
`inhalation device, such claims are not enforceable against Praxair for its making or selling nitric
`oxide mix in México.
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`The device used to provide the nitric oxide mix is referred to as the NOMIX system. The
`current NOMIX system is a collection of off-the-shelf components supplied by various vendors
`for use by hospitals. The NOMIX system simply comprises a mixed nitric oxide cylinder (500
`ppm nitric oxide gas with nitrogen gas balance) a pressure regulator, a flowmeter and PrinterNOx
`monitoring equipment. Our investigation also found that each of the independent apparatus
`claims in México Patent No. 206992 includes at least one element that is simply not present in the
`NOMIX system. Thus, enforcing México Patent No. 206992 against Praxair Mexico or the
`NOMIX system as presently configured is simply not a viable option.
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`We also understand that Ikaria has recently contacted the U.S. Embassy in Mexico asking
`for support to file actions against Praxair for patent infringement and alleged illegal sale of nitric
`oxide in Mexico. We believe this was an unwarranted action while Praxair was investigating the
`matter at your request. Therefore, we must insist that future discussions regarding this matter be
`directed only through our legal representative in Mexico or to me for any patent related concerns.
`The Praxair representative in México is Mr. Alejandro Fraga, our Legal Director who can be
`reached at +5281 8124 4800, e-mail alejandro_fraga@praxair.com.
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`Since there are no apparent Mexico regulatory issues or Mexican patent issues preventing
`Praxair Mexico from making and selling the nitric oxide mix, we consider this matter closed.
`Should you have any further questions or comments, please do not hesitate to contact me or Mr.
`Fraga directly.
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`Alejandro Fraga
`Salvador Urbina
`Jakob Janzen
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`Ex. 2025-0002