Tuesday, April 28, 2009

Compulsory License of Tamiflu (from Gilead Report of February 2009)


Compulsory Licenses

In a number of developing countries, government officials and other interested groups have suggested that pharmaceutical companies should make drugs for HIV infection available at low cost. Alternatively, governments in those developing countries could require that we grant compulsory licenses to allow competitors to manufacture and sell their own versions of our products, thereby reducing our product sales. For example, in the past, certain offices of the government of Brazil have expressed concern over the affordability of our HIV products and declared that they were considering issuing compulsory licenses to permit the manufacture of otherwise patented products for HIV infection, including Viread. As a result of discussions with the Brazilian government, we reached agreement with the Brazilian Health Ministry in May 2006 to reduce the price of Viread in Brazil by approximately 50%. In addition, concerns over the cost and availability of Tamiflu related to a potential avian flu pandemic have generated international discussions over compulsory licensing of our Tamiflu patents. For example, the Canadian government may allow Canadian manufacturers to manufacture and export the active ingredient in Tamiflu to eligible developing and least developed countries under Canada=92s Access to Medicines Regime. Furthermore, Roche has issued voluntary licenses to permit third party manufacturing of Tamiflu. For example, Roche has granted a sublicense to Shanghai Pharmaceutical (Group) Co., Ltd. for China and a sublicense to India=92s Hetero Drugs Limited for India and certain developing countries. Should one or more compulsory licenses be issued permitting generic manufacturing to override our Tamiflu patents, or should Roche issue additional voluntary licenses to permit third party manufacturing of Tamiflu, those developments could reduce royalties we receive from Roche's sales of Tamiflu. Certain countries do not permit enforcement of our patents, and manufacturers are able to sell generic versions of our products in those countries. Compulsory licenses or sales of generic versions of our products could significantly reduce our sales and adversely affect our results of operations, particularly if generic versions of our products are imported into territories where we have existing commercial sales.

Wednesday, April 22, 2009

US-Korea FTA Approved by Korean Parliamentary Committee


SEOUL (Reuters) - The South Korean parliament's foreign affairs committee approved on Wednesday a free trade deal with the United States signed two years ago, paving the way for the entire assembly to vote on the pact this month.

Amid a rowdy scene in which ruling conservative Grand National Party members physically fought off opposition lawmakers trying to stop the proceedings, the committee passed the deal, which some studies have said will boost the two countries' $78 billion annual bilateral trade by as much as a quarter.

But despite earlier expectations that the wider assembly vote would be held soon after the committee's approval, the GNP may not put the deal to a vote until June, its floor leader was quoted as saying by South Korea's Yonhap news agency.

The scene was reminiscent of a melee over the trade pact in parliament late last year, when sledgehammer-swinging opposition MPs tried to break through a barricade of office furniture and fire extinguisher-spraying ruling party legislative aides.

The agreement has broad support among members of South Korea's ruling conservative Grand National Party (GNP) and according to surveys is backed by a majority of the public.

But it could face fresh resistance from opposition MPs and the country's powerful farm lobby, who believe government compensation plans do not adequately address the losses that may hit farmers as protectionist measures are rolled back and competition intensifies.

South Korean officials have said an early passage of the bill could add pressure on the U.S. Congress to ratify the deal. Congress has yet to begin debate on the pact.

Two senior U.S. senators on Monday urged President Barack Obama to begin the process of passing the deal, which he opposed during last year's election campaign, saying approval of the pact was needed to help reinforce the United States' partnership with South Korea.

Obama called during last year's campaign for the South Korean agreement to be renegotiated to include more favorable provisions for U.S. automakers and other manufacturers.

(Reporting by Jack Kim; Editing by Jonathan Hopfner)



South Korea's parliamentary committee Wednesday passed a bill to ratify the government's free trade agreement with the United States, sending it to a plenary session for final approval, according to Yonhap News Agency.

The endorsement by the National Assembly's Foreign Affairs, Trade and Unification Committee came amid protests from opposition lawmakers who claim that the move is premature and that Seoul should wait until Washington becomes more favorable toward the agreement.

Seoul and Washington signed the free trade deal in June 2007, but its ratification has been delayed by opposition in both countries. It must be ratified by legislative bodies of both countries to take effect.

The FTA will knock down tariff and non-tariff barriers between the two economies whose two-way trade reached $84.7 billion in 2008, according to the Korea International Trade Association.

Tuesday, April 07, 2009

Patent Linkage in EU FTA


Parliamentary Questions
17 February 2009
WRITTEN QUESTION by David Martin (PSE) to the Commission

Subject: Patent linkage in the draft EU-Korea free trade agreement Answer

Article 9.9.5 of the draft EU-Korea free trade agreement (FTA) introduces patent linkage into the agreement. Patent linkage is both a TRIPs Plus provision and contrary to EC law. Patent linkage in the EU-Korea FTA may seriously hinder access to affordable medicines and indeed the Commission itself has acted against comparative provisions introduced in the EU. Can the Commission therefore elaborate on the implications of and reasons behind the incorporation of Article 9.9.5 into the draft agreement and clarify how patent linkage can be introduced into an FTA when the Commission itself does not believe it should exist in national EC law?


24 March 2009
Answer given by Baroness Ashton on behalf of the Commission

Negotiations of a Free Trade Agreement (FTA) with Korea are currently ongoing, including on a chapter with detailed provisions on Intellectual Property.

These negotiations on intellectual property have to be seen against the backdrop of other FTAs signed by the Parties, and in particular the FTA signed between Korea and the United States (US) of 30 June 2007 ('KorUS' -- of which the text is publicly available), which provides for detailed provisions related to pharmaceuticals products.

It follows from KorUS that Korea should in principle introduce 'patent linkage' in its legal system. The question of patent linkage being a topic of intellectual property, it has been raised in the discussions between the Commission and Korea, in line with the Commission's overall approach in FTA negotiations to ensure that our FTA partners do not discriminate our economic operators as compared to those of third countries. If and when Korea were to undertake commitments on this issue vis-=E0-vis another trading partner, as is the case with the US, EU companies should in principle also benefit from such commitments.

The Honourable Member is right in pointing out that EU rules do not provide for patent linkage. This is not the Commission's intention to introduce a change of EU rules or EU policy on patent linkage through the FTA with Korea.

The intellectual property aspects of the EU-Korea FTA negotiations are still underway, and the Commission can not, at this stage, prejudge the final outcome of these, which are conducted with the objective of reaching a balanced agreement, taking into account the diverse interests at stake.