日本経済新聞　2007/8/7

インド高裁、改良薬特許認めず　ノバルティスの請求棄却

　インドのチェンナイ高裁は6日、従来の医薬品を改良した新薬に特許を与えないインドの特許法は不当とするスイス製薬大手ノバルティスの訴えを棄却した。インドは世界中に価格の安い後発医薬品を供給する一大拠点。インドで特許が認められなければインド製の安い後発薬が各国に出回り、新薬の開発利益を奪われかねないとして世界の製薬会社に影響を与えそうだ。

　問題の薬は慢性骨髄性白血病などの治療に使う抗がん剤「グリベック」。ノバルティスは約40カ国で特許を得たが、インド特許庁は2006年1月、特許申請を却下。ノバルティスが06年5月、チェンナイ高裁に提訴していた。

　05年施行のインド特許法には既存の薬の成分を改良しただけでは新しい発明とは言えず、特許は与えないという条項がある。高裁は、この条項が世界貿易機関（ＷＴＯ）の貿易関連知的所有権協定（ＴＲＩＰＳ）に反するというノバルティスの訴えを退けた。

August 7, 2007　Bloomberg News

India rejects Novartis patent appeal

Novartis AG said its challenge to Indian patent law over that country's rejection of a patent on the best-selling cancer treatment Gleevec was turned down by a court.

The Basel, Switzerland-based company challenged India's legal basis for the rejection of a patent on Gleevec. The Indian government last year denied the application, saying the drug was insufficiently innovative. Novartis said it probably won't appeal yesterday's decision.

Novartis said strong patent laws would strengthen Indian research. The High Court in Chennai deferred to the World Trade Organization to settle whether India was meeting international trade rules. Doctors Without Borders and other groups contend a court victory by the drug maker would have dried up a major source of affordable medicines for people across the globe.

"This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India," Tido von

2007/8/7　www.kaisernetwork.org

Indian Court Rejects Novartis' Challenge to Country's Patent Law

An Indian court on Monday rejected Swiss pharmaceutical company Novartis' challenge to a section of the country's Patents Act that aims to restrict certain kinds of patents, Reuters India reports. India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy. Indian Health Minister Anbumani Ramadoss in April urged Novartis to withdraw its challenge over concern that it could disrupt the global supply of antiretroviral drugs. Novartis also brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug.

Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug. If Novartis wins the case, it potentially could set a precedent for other pharmaceutical companies seeking patent protection for drugs, including antiretrovirals, some HIV/AIDS advocates have said. Novartis in May said it would wait for the court's ruling in the case before deciding how to proceed.

The court in its ruling said that it does not have jurisdiction over whether Indian patent laws complied with the WTO's intellectual property laws. According to Reuters India, Novartis said that it likely will not appeal the decision. A Novartis spokesperson said the company does not agree with the ruling, adding that the company "await[s] the full decision to better understand the court's position." A Novartis statement said the ruling would "have long-term negative consequences for research and development into better medicines for patients in India and abroad." According to some critics of the Novartis case, changes to India's patent laws could have affected the supply of affordable antiretrovirals from India. "We absolutely welcome this court order," Leena Menghaney of Medecins Sans Frontieres in India said. She added, "It basically means fewer patents will be granted by the Indian patent office, and that means more affordable drugs can be produced by Indian manufacturers" .