[Ip-health] WIPO study on Anti-Competitive Enforcement of Intellectual Property Rights (Sham Litigation)

Thirukumaran Balasubramaniam thiru at keionline.org
Thu Dec 1 02:14:25 PST 2011


http://keionline.org/node/1329

WIPO study on Anti-Competitive Enforcement of Intellectual Property Rights (Sham Litigation)

Submitted by thiru on 1. December 2011 - 12:10

Lucia Helena Salgado, from Coordinator of Regulatory and Market Studies, institute of Research on Applied Economics (IPEA) is presenting her study on Anti-Competitive Enforcement of Intellectual Property Rights (Sham Litigation) at the 7th session of the WIPO Advisory Committee on Enforcement.

The report can be found here:

http://wipo.int/export/sites/www/meetings/en/2011/wipo_ip_ge_11/docs/stu...

The following jurisdictions were selected for this comparative study: South Africa, Germany, Saudi Arabia, Argentina, Australia, Brazil, Canada, Chile, China, South Korean, Egypt, Spain, USA, France, India, Italy, Japan, Mexico, Russian, Turkey, European Union, United Kingdom and Peru.

Here are some excerpts from the report.

"In re Buspirone Patent Litigation, the Southern District of New York considered whether submitting a patent for inclusion on the FDA’s list of approved drug products was shielded by the Noerr-Pennington doctrine. The court held that a pharmaceutical patent owner was not entitled to Noerr immunity for such a listing act because the FDA plays a passive role in the listing process and does not exercise discretion concerning the listing of patents. This decision suggests that only communications that call for the substantive analysis of the claim may be considered petitioning within the meaning of the Noerr-Pennington doctrine."

"The Mexican agency responding to the inquiry (COFEPRIS), even not confirming to the proposed grid, listed a series of procedures related to IP rights, which in its feeling would regard anti-competitive purposes. Suits directed to extend the term of pharmaceutical patents.

According to such agency, even though the Mexican law limited the duration of some patents granted under a transitory provision to the remaining term of the foreign patent, but not to exceed twenty from the Mexican filing, a number of patent holders started court actions to extend the Mexican patents to a further term of protection accorded to the related foreign patent.

This foreign extension was due, for instance, to a Special Protection Certificate, a legal device to compensate patent holders for the delay imposed by the administrative review of the sanitary licenses needed to commercialize the pharmaceutical products. In some cases, the court has issued preliminary orders to maintain the patent in force until the merits of the case is judged, and therefore the generic alternatives were delayed. In specific cases, the preliminary orders were confirmed by the final judgment.

The Mexican authority did not inform whether anti-competitive claims were raised in those cases. It would however be noted that the first prong of the Promedia test would not be possibly satisfied in the mentioned cases, considering that the right sought in court was duly recognized.

Linkage cases

A number of court actions were filed against COFEPRI, alleging that by granting licenses for commercialization to beneficiaries that are not the patent holders of the licensed products; the agency would be violating such patents.

Non active elements included in the listings

The same agency also gives notice of a series of writs of mandamus against it, where court orders were issued to include in the Official Listing of Patents in Force as published in the Official Gazette, even though the included patents were not active product inventions, but combination or formula ones. COFEPRIS mentions that the criterion of inclusion in the official listing was accepted by the Mexican Supreme Court, but the orders would contravene such understanding.

Finally the agency also reports that the innovating pharmaceutical companies have requested the change of some regulatory legislation in order to ensure a broader linkage between patents and sanitary licenses. All those episodes are classified by the agency as “monopolist practices” or “excessive exercise” of Intellectual Property rights."

"In the case Imatinib, the Chilean Competition Authority decided an alleged abuse of judicial and administrative procedures by Novartis in regard of the mentioned pharmaceutical. The majority vote found that the industry was adequately exercising its patent rights even though a subsequent technical study demonstrated that no infringement had in fact occurred.
Most cases filed in court regarding Imatinib were dismissed, and in consequence of such exercises, it was alleged that the competing firm suffered a delay of 14 months to enter the market. A dissident vote in the Authority decision found undue utilization of court and administrative means with anti-competitive purposes.

According to the literature, in other 1993, case, a vexatious use of preliminary orders in a patent issue caused considered competitive damage to the Chilean economy."


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org



Tel: +41 22 791 6727
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