This April India’s Supreme Court oversaw a high profile case involving Novartis’ patent application for Glivec, a cancer-battling medication. Novartis led a 7 year battle in India, resulting in the rejection of the application. The court upheld that the application did not present a true invention, as defined by Indian law. As a result of international pressure, India passed a law in 2005 allowing patents on medications, but only for drugs and compounds discovered after 1995. Novartis patented a first version of the drug in 1993, which it later abandoned in development. The Indian Supreme Court found that the new application was not sufficiently different from the original published patent application and therefore does not merit patent protection. This precedent is a heavy blow to innovative companies such as Novartis, as it prevents them from “evergreening” a drug, a process by which pharmaceutical companies make minor changes to a known drug and then arguing for an extended patent. Such a procedure is widely accepted, not only in the United States, but other countries such as China and Russia, which also accepted the extended Novartis patent.
A recent case highlights another growing trend, that made headlines, when in March 2012 Indian generic drug manufacturer Natco Pharma Ltd. was granted a compulsory license for Bayer’s Nexavar. Shortly after this precedent, China announced in May of 2012 changes to patent law which would likewise allow for compulsory licenses, changes already planned for in 2008. Bayer’s attempt to appeal this decision was rejected in March 2013, following a government announcement in January to issue additional compulsory licenses for drugs such as Roche’s “Herceptin” and Bristol-Myers Squibbs “Ixempra” and “Sprycel”. This has led Roche to seek a partnership with Indian drug manufacturer Emcure Pharmaceuticals and to reduce prices in the local market by as much as 50%.
In 2005 Israel introduced an amendment to The Pharmacy Order aimed at improving the protection granted to privileged information disclosed for the purpose of drug registration. The change, prompted by growing US-pressure to enforce intellectual property rights, attempted to remove some of the barriers for Israel to enter the OECD.
The amendment is in line with global practices relating to regulatory organizations dealing with chemical compositions and molecules, in the pharmaceutics and agrochemical industries in particular. While the amendment may allow for protection of up to five years and six months by limiting the use of privileged information, in practice, this amendment does nothing to prohibit generic drug companies from applying for approval for use of the protected drug with the Ministry of Health and manufacturing commercial quantities. Further still, while the amendment is inspired by US regulations (which allow protection of five years), it is not possible to register an innovative drug in Israel prior to receiving market approval from one of the recognized countries (e.g., USA, EU). In practice, the registration process in Israel may be quite lengthy and in some cases was known to take even two years, were the result was an effectively shortening of the protection from five years and six months to roughly 3 years and six months.
Two additional issues arise with Israel’s patent law. The first is article 54a of The Patent Law, in effect since 1988. The article allows manufacture of generic drugs, including trials for regulatory approval, while a patent is still enforceable, without these actions being considered infringement. This allows immediate marketing of generic brand drugs after the patent expires. This article clearly favors generic drug manufacturers and presents them with a significant advantage over innovative companies. Similar laws and articles exist in developing countries, such as Brazil and India. Article 64 of The Patent Law deals specifically with extending the protection of a patent relating to a medication or medical device. Though the law was intended originally to grant the same protection afforded in the United States by the United States Patent and Trademark Office (USPTO), strong lobbying efforts have curtailed these effects. For example, it is required that similar extensions be granted in the US (Article 64d 6 and 7) and in another listed country. It is worthwhile to note in this context that in a memorandum of understating signed between Israel and the USA on Feb 18th 2010, Israel pledged to initiate and promote legislation to improve the article dealing with patent extension. Though bills have been proposed in the Knesset, Israel’s parliament, numerous times since, none have thus far received the required votes to pass. The changes and their effects are interesting to observe, as Israel attempts to balance between a strong local generic drug industry, and the steps it must take to advance towards being recognized as the innovative country affording and complying with international patent protection standards.