Foreign NGO filed a opposition against Gilead`s AIDS drug patent application in India

 

The Brazilian Interdisciplinary AIDS Association (ABIA), a non-governmental organization (NGO) has joined Indian patient groups in opposing a patent application for Tenofovir (commonly known as Viread), a key AIDS drug marketed by Gilead Sciences in India.

This is the first time a foreign patient group has decided to oppose an Indian patent application on the grounds that an India patent would have a direct impact on Brazil's chances to produce and access affordable generic versions of the drug.

The Indian patent office will hear the oppositions filed by ABIA and an Indian NGO, Centre for Residential Care & Rehabilitation, next month. The NGOs said the drug consists of a previously-known compound, and should not be considered as an invention as per India's Patents Act.

Civil society groups have also filed an opposition to Gilead's patent application in Brazil.

"Though we are confident that patent will not be granted for tenofovir in Brazil, we must ensure the option of importing affordable generic versions from India remains open to our AIDS programme," stated Veriano Terto, ABIA's general coordinator. "This will contribute to the sustainability of our national AIDS programme's universal access policy, on which 180,000 Brazilians depend for their lives."

The WHO recommends tenofovir disoproxil fumarate (TDF) for use in first and second line drug regimens for people with HIV who suffer side effects from other drugs and those who have developed drug resistance.

Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 HIV people will receive the drug through the national treatment program. In April, the Brazilian government declared tenofovir to be of ‘public interest' in treating people with HIV.

As a result of patent oppositions filed in India previously in 2006, Gilead had offered voluntary licenses to several Indian generic manufacturers, even though no patent on the drug had been granted.

These agreements are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil. This allows Gilead to continue to charge high prices in these countries.

In Brazil, Gilead sells tenofovir for $1,387 (Rs 59,571) per patient a year, and in comparison, the cheapest available generic version manufactured in India costs only $158 (Rs 6770) per patient a year, the NGOs said.

Brazil will not be able to procure generic versions from India if tenovofir gets a patent in India. On the other hand, if the patent is rejected, Indian generic companies that did not sign the voluntary license agreement with Gilead would be able to supply tenofovir to Brazil and other middle-income countries. This would mean Brazil could purchase affordable generic versions of tenofovir from multiple producers competing against each other, helping them bring prices down.

The Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People (DNP+) had filed oppositions to the patent applications on tenofovir at the Delhi Patent Office in 2006.

Indian Patent office reject AIDS drug patent of Boehringer

The Indian Patent Office has rejected a patent application filed by multinational pharma company Boehringer Ingelheim on paediatric form of anti-AIDS drug nevirapine, which is a landmark judgment on patent which would definitely benefit HIV patients.
Nevirapine is an important anti-retroviral drug and invented in 1989, hence the drug was not patentable in India according to the Patent Act 1970. The Indian Patents Act contains some important safeguards designed to ensure that "frivolous patent applications are not granted at the cost of public health. These include section 3(d) of the Patents Act, which prevents "new forms, mere use, combination, complexes mixtures" of known substances from being patented unless there is a significant improvement in efficacy, and section 3(e) of the Act, which prevents "mere admixtures" of substances from being patented.

The company was trying to claim a patent on the syrup form of nevirapine, which is particularly important for children living with HIV who are unable to swallow tablets. This is the first decision from the Patent Office on the 13 patent oppositions filed by public health groups against AIDS drugs, and will set an important precedent for the pending patent applications, industry expert pointed out.

If the patent had been granted, price would have increased for children suffering from AIDS. In May 2006, the Indian Network of People Living with HIV/AIDS (INP+) and the Positive Women's Network (PWN) had filed a pre-grant opposition against the company's application.

RANBAXY-PFIZER GLOBAL SETTLEMENT

 

Pfizer and Ranbaxy both companies agreed to keep copies of  Lipitor off (an cholesterol drug) for an extra 20 month which would generate extra 20 $ billion for innovator company.  Under the agreement with Pfizer, Ranbaxy will introduce the copycat version of Lipitor and fixed dose combination of Atorvastatin -Amlodipine (Caduet in US) after Nov 2011. Earlier analyst had projected the entry of Ranbaxy’s generic product into the American Market after Mar 2010 when main patent expires, while Pfizer was seeking to delay the generic competition till 2016 (Crystalline form patent). Under the agreement, Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia prior to 2-4 month of the main patent expiry. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. Such kind of settlement will generate revenue about 2.5 $ billion for the Indian company.

 

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

 

 

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Daiichi Sankyo sued Mylan for patent infringement on AzorR

Japanese company Daiichi Sankyo filed a suit against Mylan for paten infringement on blood pressure product Azor^®. Mylan said Daiichi Sankyo filed the suit in a New Jersey federal court Tuesday against its India-based unit Matrix Laboratories Ltd., citing Matrix's application earlier this year with the Food and Drug Administration to sell a generic version of Azor^®. Azor^® is a new combination of Amlodipine Besylate and Olmesartan Medoxomil, which has got approval in 2007. Azor^® is having exclusivity till 2010 for its new combination. Innovator Company has listed only one patent (US 5,616,599) in Orange Book which covers Olmesartan Medoxomil as a product.

 

Patent Applications published in india

Following applications which are related to pharmaceutical field have been published on May 30, 2008.

COMPOSITIONS AND METHODS OF USE

Application: 5766/CHENP/2007 A, Filing date: 2007-12-14, Publication date: 2008-05-30

NOVEL THIOPHENE DERIVATIVES AS SPHINGOSINE-1-PHOSPHATE-1 RECEPTOR AGONISTS

Application: 4717/CHENP/2007 A, Filing date: 2007-10-23, Publication date: 2008-05-30

POLYENE ANITIBIOTICS, COMPOSITIONS CONTAINING SAID ANTIBIOTICS, METHOD AND MICRO-ORGANISMS USED TO OBTAIN SAME AND APPLICATIONS THEREOF

Application: 3749/KOLNP/2007 A, Filing date: 2007-10-03, Publication date: 2008-05-30

HETEROCYCLIC COMPOUND

Application: 3907/KOLNP/2007 A, Filing date: 2007-10-12, Publication date: 2008-05-30

PROCESS FOR PREPARING MEMANTINE

Application: 5039/CHENP/2007 A, Filing date: 2007-11-09, Publication date: 2008-05-30

ABSORBABLE ALPHA - CYANOACRYLATE COMPOSITIONS

Application: 3906/KOLNP/2007 A, Filing date: 2007-10-12, Publication date: 2008-05-30

PROCESS FOR THE PRODUCTION OF METHYLCOBALAMIN

Application: 3750/KOLNP/2007 A, Filing date: 2007-10-03, Publication date: 2008-05-30

NOVEL COMPOSITION

Application: 3448/KOLNP/2007 A, Filing date: 2007-09-13, Publication date: 2008-05-30

PHOSPHATE SALTS OF 6-DIMETHYLAMINOMETHYL-1-

Application: 3608/KOLNP/2007 A, Filing date: 2007-09-24, Publication date: 2008-05-30

CRYSTALLINE FORMS OF

Application: 3609/KOLNP/2007 A, Filing date: 2007-09-24, Publication date: 2008-05-30

DRUG DELIVERY SYSTEMS FOR TREATMENT OF DISEASES OR CONDITIONS

Application: 3549/KOLNP/2007 A, Filing date: 2007-09-20, Publication date: 2008-05-30

INFLUENZA THERAPEUTIC

Application: 4010/KOLNP/2007 A, Filing date: 2007-10-17, Publication date: 2008-05-30

COMPOSITIONS WITH HYDROPHILIC DRUGS IN A HYDROPHOBIC MEDIUM

Application: 3647/KOLNP/2007 A, Filing date: 2007-09-27, Publication date: 2008-05-30
INC

THIENOPYRIDINE DERIVATIVES AND THE USE THEREOF AS HSP 90 MODULATORS

Application: 3649/KOLNP/2007 A, Filing date: 2007-09-27, Publication date: 2008-05-30

HYDROMORPHONE POLYMORPHS

Application: 3718/KOLNP/2007 A, Filing date: 2007-10-04, Publication date: 2008-05-30

BIODEGRADABLE ALIPHATIC-AROMATIC POLYESTER

Application: 4625/CHENP/2007 A, Filing date: 2007-10-17, Publication date: 2008-05-30

BIODEGRADABLE ALIPHATIC-AROMATIC POLYESTER

Application: 4632/CHENP/2007 A, Filing date: 2007-10-17, Publication date: 2008-05-30

PROTEASES FOR PHARMACEUTICAL USE

Application: 5915/CHENP/2007 A, Filing date: 2007-12-24, Publication date: 2008-05-30

2-AMINO-2-ALKYL-5 HEPTENOIC AND HEPTYNOIC ACID DERIVATIVES USEFUL AS NITRIC OXIDE SYNTHASE INHIBITORS

Application: 5754/CHENP/2007 A, Filing date: 2007-12-13, Publication date: 2008-05-30

PROCESS FOR ISOLATING GLYCOPROTEIN

Application: 429/KOL/2007 A, Filing date: 2007-03-21, Publication date: 2008-05-30

IMIDAZO[1,2-A]PYRIDINE DERIVATIVES: PREPATATION AND PHARMACEUTICAL APPLICATIONS

Application: 3709/KOLNP/2007 A, Filing date: 2007-10-01, Publication date: 2008-05-30

AN IMPROVED COMPOSITION

Application: 321/MUM/2008 A, Filing date: 2008-02-13, Publication date: 2008-05-30

PROCESS FOR PREPARATION OF PHENETHYLAMINE DERIVATIVES

Application: 3706/KOLNP/2007 A, Filing date: 2007-10-01, Publication date: 2008-05-30

DIHYDROBENZOFURAN DERIVATIVES AND USES THEREOF

Application: 4008/KOLNP/2007 A, Filing date: 2007-10-17, Publication date: 2008-05-30

DRUG DELIVERY DEVICES AND RELATED COMPONENTS, SYSTEMS AND METHODS

Application: 4049/KOLNP/2007 A, Filing date: 2007-10-22, Publication date: 2008-05-30

PURIFIED FORM OF TANAPROGET

Application: 4050/KOLNP/2007 A, Filing date: 2007-10-22, Publication date: 2008-05-30

MICRONIZED TANAPROGET, COMPOSITIONS, AND METHODS OF PREPARING THE SAME

Application: 4106/KOLNP/2007 A, Filing date: 2007-10-25, Publication date: 2008-05-30

POLYMORPH FORM II OF TANAPROGET

Application: 4107/KOLNP/2007 A, Filing date: 2007-10-25, Publication date: 2008-05-30

COMPOSITIONS CONTAINING MICRONIZED TANAPROGET

Application: 4108/KOLNP/2007 A, Filing date: 2007-10-25, Publication date: 2008-05-30

PROCESS FOR PREPARING 3,3-DISUBSTITUTED OXINDOLES AND THIO-OXINDOLES

Application: 4117/KOLNP/2007 A, Filing date: 2007-10-26, Publication date: 2008-05-30

MICRONIZED TANAPROGET AND COMPOSITIONS CONTAINING SAME

Application: 4119/KOLNP/2007 A, Filing date: 2007-10-26, Publication date: 2008-05-30

Source: Big patents