If the heck of the WTO intellectual property waiver is in the details, what are the details? | McDonnell Boehnen Hulbert & Berghoff LLP


While the details of the WTO patent waiver have not been determined (or more properly negotiated), it is important to consider the structure of the international trade regime in which the waiver will apply and the consequences of any agreement. defining exactly what will be forfeited.

The GATT / TRIPS agreement is a treaty, which (of course) is an agreement between countries, and disputes and accommodations are between their governments. The extent to which a private company’s patent or other intellectual property rights are protected under these agreements depends on the actions these governments take to enforce them on behalf of the company. Thus, for protections such as patents, a government may agree to “turn a blind eye” to infringements committed by companies in other countries (or other governments) by refusing to assert the rights holder ‘s cause before the law. WTO, to unilaterally pressure governments (as in the Watch List and Special Watch List of the US Trade Representative’s Special 301 Report), or otherwise support private actions of a private company using the system legal status of an offending country. These “passive” actions (that is to say., refusal to enforce rights in countries that violate or “flout” requires very little positive action from a government. These are the types of de facto exemptions which may be effective, for example, for patented drugs which may be produced by conventional drug production technology in which the description of an active pharmaceutical ingredient molecule.

Details of COVID vaccine production have been exposed in various new sources (see Neuberg et al., “Exploring the Pfizer / BioNTech and Moderna COVID-19 Vaccine Supply Chain”; Weiss et al., “Life cycle of a COVID-19 vaccine: from DNA to doses”, USA today, February 7, 2021; King, “Why making a large-scale Covid vaccine is difficult”, World of chemistry, March 23, 2021; Cott et al., “How Pfizer makes its Covid-19 vaccine”, New York Times, April 28, 2021). But these are certainly not disclosed in the details necessary for commercial production, and the complexities of production are illustrated in the charts of the Time article, in which DNA is prepared in Chesterfield, MO and shipped to Andover, MA for mRNA production; then the mRNA sent back to Chesterfield or Kalamazoo, MI to be packaged in the vaccine nanoparticles; then sent back to Andover for testing before publication. While some of this complexity may be company-specific, it also represents the different technological requirements to prepare an effective vaccine. Most of the waiver-friendly countries (except India and South Africa) are unlikely to have the technological infrastructure to produce the vaccine. And the company in India, the Serum Institute (“the world’s largest vaccine maker”), which has the highest probability of being able to replicate the vaccine if the waiver is put in place recently, has been forced to “hand over its vaccines. to the [Indian] government “, according to an article in New York Times (Schmall et al., “India and its vaccine maker stumble on pandemic promises,” May 9, 2021).

It is evident that, with the almost total absence of patents involved in the preparation of COVID vaccines, the disclosure necessary to reproduce these vaccines (however difficult it may be in practice) is protected by trade secrets. If the WTO imposes this waiver, the question will be whether the United States will require the disclosure of trade secrets belonging to US companies or have disclosed them to the extent that those secrets are part of regulatory filings. Either of these measures would constitute a “take” under the Fifth Amendment (“Private property shall also not be used for public use without fair compensation”); see Epstein et al., “The Fifth Amendment Levy Clause,” Interactive constitution: common interpretation. Seemingly simple and straightforward, almost all of the words in the clause are subject to interpretation, none perhaps more so than to determine what “fair compensation” entails. It is likely that, if the government acts peremptorily with regard to the taking of trade secrets justified by a WTO waiver clause, the effect on trade secrets will have the greatest consequences and will be the cause of the breach. most controversies. Indeed, the prospects that flow from it are probably among the biggest obstacles to implementing any waivers in a way that could have any chance of achieving the stated goal of facilitating the production of COVID vaccines.

This prospect also raises the question of how such a waiver will be implemented in US treaties. Treaties are not necessarily “self-executing” and must become enforceable through an act of Congress. The distinguishing feature of these treaties is that “ the provisions of international agreements which would oblige the United States to exercise the power that the Constitution vests exclusively in Congress are to be considered non-self-executing, and implementing legislation is necessary. to give these provisions internal legal effect. . ” See Mulligan, “International Law and Agreements: Their Effect on American Law,” Congress Research Service 7-5700, September 19, 2018. The need for Congress to act, although not having the heavy weight implied by the approval of treaties (that is to say., a two-thirds majority vote in the Senate) could nonetheless face significant opposition if it were interpreted as allowing the government to exercise some form of “eminent domain” over the trade secrets of pharmaceutical companies. In this regard, such an act could easily be characterized as a “forced transfer of technology” and even theft of intellectual property if, for example, these trade secrets could be used to militarize rather than to immunize against viral infections.

The public stance of the administration increases the likelihood of an unprecedented invasion of private property in the United States. It also has implications for other aspects of foreign policy; for example, at least some of the trade secrets belong to BioNTech, a German company. Germany did not agree to the waiver, and if the United States discloses BioNTech’s trade secrets, there is no doubt that Germany would have reason to seek redress against America. This is only one of the possible legal consequences that the recent surrender to the so-called global “kumbaya” of the WTO waiver is likely to create.

Further complications are likely to arise as the negotiations progress. Provided that the Administration is properly informed and the waiver is duly limited (for example., to patents), these and other harmful consequences can be avoided. Given the possibility of serious liability arising from unforeseen acquiescence to generally uninformed appeals for a blanket waiver, this may not be a bad idea for anyone involved in the process. innovation (universities, technology transfer offices, pharmaceutical companies, patent attorneys and economists) counter these opinions with facts and make their views known and their voices heard.

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