EU Patent, Patent Court Could Finally Be Approved In Coming Weeks

A new proposal by European Union governments could signal the end of a years-long struggle for a unified European patent and patent court. The compromise, which has the support of the European Commission (EC), appears likely to make it through the European Parliament despite pockets of resistance.

The working group of the Council of the European Union agreed on the patent package on 19 November, the EC said. The package consists of a regulation creating a European unitary patent through enhanced cooperation of 25 of the 27 member states (Spain and Italy are not participating); a separate regulation establishing a language regime for the patent; and an international agreement involving 26 EU countries setting up a single, specialised jurisdiction to hear patent cases.

Under the compromise, there will be a one-stop-shop for unitary patents at the European Patent Office (EPO) in Munich, and the patent will be effective in 25 EU countries, the EC said. After a 12-year transitional period, there will be a language regime that works in 23 languages before and after a patent registration procedure at the EPO. Requests for registrations can be filed in all EU languages, and will be processed in one of the three working languages of the EPO – English, French and German. After registration, patent claims and descriptions will be translated into all languages. The agreement will cut the translation costs for obtaining a single EU patent by 80 percent, the EC said.
The compromise creates a specialised unitary patent court, eliminating the need to litigate the same patent in different territories, the EC said. All governments agreed that the court will be seated in Paris, with a satellite court in London to handle chemical and pharmaceutical patents, and another in Munich to deal with mechanical engineering patents. All companies, no matter where established, can obtain a unitary patent, the EC said.

Unitary Patent “Will Make a Difference”
An EC impact assessment shows that the total cost of obtaining patent protection in Europe now is €36,157 euros. A unitary patent in 25 member states will cost €6,425 during the 12-year transition period, and €4,725 after that period, it says. By comparison, the total cost of a patent in the United States is €1,850.

The Council is expected to adopt the proposed compromise on 10 December, and Parliament may debate and vote on it the same week, JURI said. If the package clears the legislature, the two regulations could be adopted by 21 December, with an agreement for the patent court signed by governments on 18 February, the EC said. The package won’t become effective until EU countries ratify the international accord, it said. If that happens before 1 November 2013, the first unitary patent could be granted in April 2014, it said.

The original EC proposal is here [pdf].

Hearing in controversial Glivec case between Novartis & Union of India enters crucial stage

Saturday, November 17, 2012

Hearing in the controversial imatinib mesylate (Glivec) case between the Swiss pharma major Novartis AG and the Union of India & Others is continuing in the Supreme Court of India which is expected to conclude by the end of this month.

After several adjournments during the last more than couple of years, the final argument in the case was commenced on September 11, 2012, with representatives for Novartis being the first to present their arguments before the apex court. The court then also heard the arguments from generic companies like Cipla, Natco, Ranbaxy and Hetero, Indian government and Cancer Patients Aid Association.

According to sources, the court will now hear the responses and rebuttals from the representatives from both sides on the case. The hearing is expected to be concluded by the end of November. The two judges hearing the case may then reserve their decision, with the verdict to be announced sometime thereafter, sources said.

The Supreme Court case, between Novartis and the government of India, is the final act in a legal battle that stretches back to seven years over India's future capacity to produce low-cost generic medicines for its people, and for patients in other developing countries. In this long pending case, Novartis is challenging Section 3(d) of India's Patents Act which prohibits 'evergreening' - the practice of multinational pharma companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.

Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office in Chennai. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d), an important health safeguard that does not allow companies to get patents on new forms of old medicines.

With the Chennai Patent Office's rejection of patent after 2005, Novartis approached the Madras High Court challenging the decision of Patent Office along with questioning the relevance of section 3(d) of Indian Patent Act.

In 2007, the Madras High Court rejected Novartis' challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. In determining the issue of constitutional validity, the court held that the word "efficacy" used in section 3(d) had a definite meaning in the pharmaceutical field. The case was then transferred from the Madras High Court to the Intellectual Property Appellate Board (IPAB), which in turn rejected the application.

Novartis appealed again, this time to the Indian Supreme Court in 2009 after the IPAB rejected its appeal for a patent on the beta-crystalline form of imatinib mesylate, an anti-cancer drug.

IPO Guidelines for processing of patent applications relating to Traditional Knowledge (TK) and biological materials

The Controller General of Patents has issued guidelines for processing of patent applications relating to Traditional Knowledge (TK) and biological materials.
The same can be accessed here.

CGPDTM publishes draft Guidelines for processing of patent applications relating to traditional knowledge and biological material for comments/suggestions | Public Notice