Microsoft loses patent appeal

Microsoft Corp must pay more than $140 million for infringing on software patents owned by a Michigan-based technology company, a federal appeals court has ruled. Z4 Technologies Inc sued Microsoft and Autodesk Inc, maker of drafting software, in 2004, claiming the technology they used to activate newly installed software and deter piracy infringed on patents created and owned by David Colvin, the owner of privately held z4. Commerce Township, Mich.-based z4 argued that Microsoft's Windows XP and Office 2003 suite of productivity software used its patented method of asking computer users to supply two passwords, or authorization codes, before they could fully use new software. The technology in question also can be used to deactivate software. In April 2006, a federal jury in East Texas ordered Microsoft to pay $115 million to z4, plus attorney fees and $25 million for willful patent infringement. Microsoft, which had argued that the patents were invalid, appealed the decision. The jury also ordered Autodesk to pay $18 million to z4. On November 16, the US Court of Appeals for the Federal Circuit, which considers all patent appeals, upheld the lower court's decision in its entirety.

Venus Remedies files patent for Meningitis formula

Pharmaceutical company Venus Remedies Ltd on Monday said it has filed for patent protection of its fourth research product - a formula for treating Meningitis - in 48 countries.
The patent is filed for "Parenteral Combination Therapy for infective conditions with Drug Resistant Bacterium", the only solution for the treatment of Meningitis, Venus Remedies said in a communique to the Bombay Stock Exchange.

This product was launched for the first time in India in October 2005 under strategic marketing tie-ups with leading MNCs after filing for patent in the country, the company informed.
The niche product has become a Rs 25 crore brand within two years of its launch, the company said. The company has selected 48 countries, including Australia, Brazil, Canada, China, EU, New Zealand and the US, with high marketing potential for this product. The global market size for the product is estimated to be worth $ 900 million.

Indian pharma companies grow beyond generics

The country's pharma industry is finally coming of age. After years of working on copy-cat (generic) versions of drugs innovated by global pharma companies, India's first originally researched molecule (drugs from new chemical entity, NCE) is expected to hit the market by 2010-2011. Leading companies who are developing new molecules include Ranbaxy, Glenmark and Dr Reddy's. Over last couple of years, Indian pharmaceutical companies have stepped up their R&D spends, following a patent product regime. At present, nearly 10-12 companies have molecules under various stages of development.

 

"India has made inroads in the global pharma environment through innovation and Indian R&D has proved its capabilities in becoming a dominant force in the global generics industry. This has been demonstrated by various out-licensing deals like the four done by Glenmark with Forest, Teijin, Merck & Eli Lilly; as well as the other collaborative agreements made with global players.

 

One of the key strategies that can work to deliver success in NCE research for India companies is a project-based approach in partnering with more experienced players. Also, huge potential of therapeutic categories worldover can provide a great opportunity for pharma companies engaged in original research.

 

Dr Reddy's is the first Indian company to take a molecule - DRF2593 (Balaglitazone) to Phase III clinical trials. "Trials for safety and efficacy of Balaglitazone, as an oral anti-diabetic drug, are progressing well. It could take anything from 3-4 years for commercializing the molecule

FDA admits Sun’s appeal

US drugs regulator food and drug administration (FDA) has accepted a generic challenge by India’s Sun Pharmaceuticals Industries Ltd against Glivec, a controversial mega-earner cancer drug of Novartis AG, potentially weakening the Swiss drug maker’s petition against an Indian ruling denying the drug a patent. The challenge in the US, if it invalidates Novartis’ patent, will not only significantly stre-ngthen the plea of local drug makers here, but also open up a huge generics market for them in the US for this drug, which, last year, grossed some $2.5 billion (Rs11,605 crore then), equivalent to more than one-10th of Novartis’ revenues.
Novartis’ patent on Glivec was challenged by Sun Pharma through what is called a Para IV filing with FDA. The filing initiates a process with which a generics firm can seek marketing approval for an already patented product either by invalidating the patent, by proving there is fundamentally nothing novel in the product or by proposing to introduce a variant without infringing the patent. The appeal was listed early this month by FDA after a six-month surveillance by the regulator. Under the rules, Novartis is expected to respond to this challenge within 45 days of the date of listing.

Earlier, Novartis has challenged the Indian patent office’s decision to turn down its patent application through an appeal filed early in 2006 in the Madras high court. The case has since shifted to the Intellectual Property Appellate Board, or IPAB, which hears such disputes in the country. In 2006, the Chennai patent office refused Novartis’ patent claim for Glivec—which is a beta crystal or polymorphic form of the known cancer drug Imatinib Mesylate—on the ground that it is not an innovation and the Indian patent law does not identify this as patentable. One of the newly amended provisions in the Indian patent law, Section 3D, specifies that no derivatives or modified forms of known drug substances are patentable unless it enhances the therapeutic efficacy substantially.