Rejection of Tenofovir patent strengthens the pre-grant opposition in India

The USPTO has rejected four patents of Gilead Sciences on a key HIV drug Tenofovir, which ultimately strengthens the pre-grant opposition filed in 2006 by Indian Network for People Living with HIV/AIDS to several patent applications filed by Gilead on tenofovir disoproxil fumarate (TDF) in India, on the ground that they did not meet the country's patentability standards.

TDF is important for people suffering with AIDS as a first line treatment, and also for those who have developed resistance to first-line antiretroviral therapy. WHO treatment guidelines include TDF in first and second-line antiretroviral regimens.

For the domestic generic industry, the development encourages production of the drug in the country, and gives them opportunities to export to developing countries to provide affordable treatment for millions of people suffering from AIDS.

US public interest organization, Public Patent Foundation (PUBPAT) challenged the patents in the US patent office, saying that Gilead's patent on TDF did not fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent in India, and other developing countries. Legal experts say, Gilead will now have to share this information with the Indian patent office, which is in the process of examining patent applications on TDF by Gilead.

Continuation of Patent battle Between Cipla...

Erlotinib is a derivative of gefitinib which is a pre-1995 invention, published before 1995 (in AU, GB & other countries). Gefitinib’s product patent, claiming markush structure in which n number of derivatives disclosed including gefitinib, does not disclose the ethynyl group attach to the phenyl ring in dependent claims. So invalidity for the Erlotinib’s patent may be cumbersome task for Cipla to prove the existence of product before 1995.

 

updates from European Patent Convention

 

Croatia and Norway have signed up to the European Patent Convention taking the total number of European Patent Organisation member states to 34.

EPO members now include all 27 members of the European Union, plus Croatia, Iceland, Liechtenstein, Monaco, Norway, Switzerland and Turkey. Alison Brimelow, EPO President said, “We welcome Croatia and Norway as new members who can contribute to shaping the IP framework that will sustain and improve Europe's growth and competitive position.”

Albania, Bosnia and Herzegovina, Serbia and the Former Yugoslav Republic of Macedonia also recognise the EPO, meaning that European patents are valid in 38 countries and a market of around 570 million people.

 

Teva Announces Approval Of Generic KytrilR Injection And Tablets

 

The U.S. Food and Drug Administration (FDA) has granted final approval for the Teva Pharmaceutical Industries’s Abbreviated New Drug Applications (ANDA) to market its generic version of Roche's antinauseant and antiemetic agent Kytril® (Granisetron Hydrochloride) Injection, 1 mg (base)/mL in 1 mL single-dose vials and 1 mg (base) Tablets. Shipment of these products has commenced.

As the first company to file an ANDA with a Paragraph IV patent certification for Granisetron Hydrochloride Injection, 1 mg (base)/mL in 1 mL single-dose vials, Teva has been awarded 180 days marketing exclusivity for this product.

Kytril® Injection and Tablets had annual sales of approximately $34 million and $89 million, respectively in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Patent Battle between Cipla and Roche for cancer drug

Now cipla is ready for launching the copycat version of lung cancer drug, Tarceva in India which was first introduced by Roche, a global Pharma leader. Roche has got the patent for product in India by overcoming the pre-grant opposition filed by Hyderabad Based Company Natco Pharma. The patent had been granted after scrutinizing the relevant prior arts, Delhi patent office had denied for grant of this patent application, but later on Chennai patent office had granted.

Cipla has got the marketing approval for the product and said that they will challenge the patent claming “its original invention dates does not justify for patent here” and will file post-grant opposition. Erlotinib, a generic name for Torceva is a derivative of gefitinib which is a pre-1995 invention. Many patent experts speculate that the patent for erlotinib does not qualify definition of the patent according to the Act 2005.

Roche may file a litigation suit against Cipla for recovering her damages. If later on, patent for erlotinib gets invalidated on the basis of that the derivative of a drug which exists pre-1995 does not qualify for patent, then what would be the impact of this decision upon other MNCs? Does this mean that “MeToo” are not patentable in India? If the decision goes in favour of Cipla then it would be great success story for the Indian Pharma company

Bilcare patent infringement

 

The Controller of Patents has dismissed two petitions against a patent granted to Bilcare, a Pune-based pharmaceutical packaging company.

The patent was for metallised packaging films, an anti-counterfeit solution. According to the new Indian Patent Act, an awarded patent can be challenged within a year.

Bilcare, which filed its patent application in March 2004, was awarded a patent in December 2005 by the Mumbai patent office.

Bilcare sued two packaging companies, Amar Tara and Associated Capsules, for infringing its patent with imitations.

 

Orion Vs Sun Pharmaceutical Industries Ltd. for Stalevo in the United States

Orion Corporation has been informed that Sun Pharmaceutical Industries Ltd., India (Sun), has amended its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorization to produce and market generic versions of Stalevo(R: 47.01, -0.50, -1.05%) tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent No. 5,446,194. The ANDA review process has recently just begun and the realization of generic competition is neither certain nor imminent. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. Sun previously filed Paragraph IV certifications against Orion's U.S. Patents 6,500,867 and 6,797,732, and Orion subsequently sued Sun (November 2007) in the United States for patent infringement. Of the six Orion patents listed in the FDA's Orange Book, three have not received Paragraph IV certifications from Sun (U.S. Patent Nos. 4,963,590, 5,112,861, and 5,135,950), and the latest of these expires 31 October 2010. Paragraph IV certifications are not uncommon in the USA. Orion is, together with Novartis, currently evaluating its legal options to protect its rights. Under the U.S. system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favorable decision on all challenged patents in the lawsuit.