1. Asia Pacific Countries wish to copy Section 3(d)

The ET reports:

“More than 10 countries in the Asia-Pacific region are planning to adopt the much-debated provision which makes it difficult for drug makers to get patent protection for anything less than breakthroughs in pharmaceutical research. The provision describes what sort of pharmaceutical substance is worthy of a patent. The idea is to prevent companies from blocking the entry of cheaper rival products by passing off old medicines in new bottles as patent-worthy inventions.

Maldives, Pakistan, Sri Lanka, Vietnam, Indonesia, Malaysia and Bangladesh are actively considering adopting Section 3d of the Indian patent law. We get a lot of enquiries from a host of countries about the provision. The Philippines has already amended its law on similar lines, an official of the ministry of commerce & industries said. The nations that provided for patents for finished pharmaceutical products in 2005 now want greater flexibility in honouring their WTO commitments, Indian Pharmaceutical Alliance (IPA) secretary-general DG Shah said. “

One can’t help but be amused at the situation–the blind leading the blind!! While India is still figuring out what the term “efficacy” means, these brave countries have rushed in…..

Now we can all collectively engage with the various interpretative battles that loom around section 3(d)?

2. Novartis sues Ranbaxy in the US

Interestingly, as Ranbaxy fights Novartis in India in a litigation that is making international headlines, Novartis drags Ranbaxy to court in the US. This patent infringement suit follows a Para IV filing by Ranbaxy under the Hatch Waxman Act. The Business Standard Reports:

“Novartis, Europe’s third-biggest drugmaker, has sued Ranbaxy Laboratories to block sales of a generic version of the blood-pressure medicine, Diovan, in the US….

Ranbaxy, based in Gurgaon, originally agreed not to sell the drug until the patent expired. In June, it amended its application to say the patent is invalid, Novartis said in a complaint in the federal court in Newark, New Jersey. Novartis, based in Basel, Switzerland, said Ranbaxy “lacked a good faith basis’’ for its claim..”

ps: Many are surprised to hear that Ranbaxy is a party to the Novartis patent litigation in India. Not too surprising, since Ranbaxy was initially sued by Novartis , upon the grant of an exclusive marketing right (EMR) to Novartis in 2003. See post here.

3. “Pharma MNCs bullying govt with China sword?”

The Economic Times carries a condensed version of my earlier blog posting on the Novartis dispute and the need to move away from rhetoric towards a more constructive evaluation of section 3(d).

4. Recent article on Indian Patent Case (Bilcare) by American Law Professor:

Professor Sarnoff has recently posted an excellent article on SSRN dealing, in part, with an Indian patent case. Titled, “Bilcare, KSR, Presumptions of Validity, Preliminary Relief, and Obviousness in Patent Law”, the abstract is as below:

“In Bilcare Ltd. v. M/S The Supreme Industries Ltd., the Delhi High Court affirmed a lower court order vacating ex parte injunctions against an alleged infringer of a patent, rejecting arguments that the patent should be presumed valid even though the patent was the subject of opposition proceedings. In KSR International, Inc. v. Teleflex Co., the U.S. Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit’s long-standing interpretation of Section 103 of the Patent Act, i.e., that a challenger seeking to prove invalidity must demonstrate a teaching, suggestion, or motivation to combine prior art references. These cases reveal important insights (within varying procedural and substantive legal contexts) into statutory and judicial presumptions of validity that result from the grant of patents by administrative agencies. The article explains how such presumptions relate to evidence and proof rather than to the weight accorded to legal judgments. Using Bilcare as a reference, the article suggests that opportunities to present evidence challenging validity should be provided even in preliminary relief contexts, and discusses concerns that arise when validity is challenged in both administrative and judicial systems. The article then describes how the KSR decision adopted substantive legal rules for obviousness that supersede the statutory presumption of validity, shift the burdens of production and persuasion, and (for some inventions) limit the scope of relevant evidence that can be used by patent holders to prove non-obviousness. Finally, the article argues that the U.S. statutory presumption should not continue to be construed by the courts to impose heightened burdens of proving invalidity.

Isn’t it interesting that an American law professor is not only discussing an Indian patent case, but also suggesting that the law as endorsed in this case (that there is no “presumption of validity” under Indian Patent Law) might be the way forward for the US as well.

5 . “European Pharmaceutical Law Forum” Conference, Washington D.C., October 23-25

The Orange Book Blog, an excellent resource for those wanting to track Hatch-Waxman type cases, highlights an upcoming conference:

“Informa Life Sciences will be presenting a unique conference entitled “European Pharmaceutical Law Forum” in Washington, D.C., October 23-25. The conference will provide an invaluable introduction to the laws and regulations governing the pharmaceutical, biotech and generics industries in Europe.
At this premier global event you will be brought up-to-date with the key European cases shaping international pharmaceutical law and hear the latest regulatory and legal developments governing drug development, registration and commercialization in Europe. Leading European lawyers, in-house counsel and representatives of the European Commission and the Federal Trade Commission will present crucial information to help optimize your international legal strategy. Orange Book Blog is a media partner of this conference.”
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