Girl peels biscuits from bananas

PUNE: They may seem as different as chalk and cheese but 20-year-old Rucha Joshi has made a delicious discovery - she makes biscuits from banana peels.

According to Rucha, her invention holds exclusivity as she herself has reviewed literature at the CFTRI from 1865 to 2007. Except for a jam made in European countries, so far, she has not come across any other product made from banana peels.

Bhagwat V Patil, president of the Banana Growers’ Association of India said that he had not come across any such product before. “My visit literally proved ‘fruitful’, and I decided to find out if one could make biscuits out of banana peel pulp,” she says. With encouragement from her family, she started work. She prepared three varieties of biscuits, one without banana peel pulp, the other with 10 per cent banana peel pulp and the third with 20 per banana peel pulp.

After conducting an analysis of the biscuits, she found that as she increased the amount of pulp, the calories in the biscuits decreased, while the fibre increased. Furthermore, after doing a fungal analysis, it was found that they had a good shelf life.

While she presented the first research paper on low-calorie biscuits from BPP in 2002, she kept improvising on the same. As a result, her paper was selected the fourth best in India at the ‘Council for Science and Industrial Research (CSIR) 2nd diamond jubilee invention awards for school children’ in 2003. CSIR has also filed a provisional patent for her invention in 2003. In 2007, after training at the Mysore-based Central Food Technological Research Institute, Rucha’s research paper was selected for the international conference on solid waste technology and management held in Philadelphia, US in 2007.

A third-year biotech engineering student at KIT college in Kolhapur, the commercial viability of the project has led some private food processing companies already showing interest in the product.

New Move For an Indian Patent Database

Two years after India’s implementation of international trade rules on intellectual property rights, a lawyers group is rekindling a decade-old push to organize India’s patent applications into an electronic database.

IP law blog ("blawg") Spicy IP has sent a petition to the India Patent Office (IPO). Citing India’s status as an information technology leader and its emerging role as a patent “trendsetter” for the developing world, the petition calls on the IPO to “create a comprehensive database” of patents, including full specifications and claims. It also asked that the IPO to “upload patent office decisions,” which are currently confidential, in order to foster transparency and public accountability.

 

 

Eli Lilly withdraws Forteo patent claim in Kolkata

Mumbai: US drug multinational Eli Lilly & Co. has voluntarily withdrawn its application at the Kolkata patent office for a crystal form of its osteoporosis drug, sold under the Forteo brand. Lilly, which lost an earlier patent claim for another form of the same drug following a pre-grant opposition from a local rival drug maker USV Ltd in August, had filed three patent applications in India for different forms of this biotech drug.

Eli Lilly’s application for a crystalline form of the drug teriparatide has been withdrawn by the applicant under section 11B (4) of the Indian Patent Act last fortnight, according the patent office. Teriparatide is the generic name of Forteo. The company has already launched this product in India anticipating patent protection.

In August, after hearings on a pre-grant opposition filed by USV that lasted a year, the Kolkata patent office had rejected Eli Lilly’s first patent application, on grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy. Forteo is the only biotech drug—medicines that are developed from living forms—available in India for osteoporosis treatment.

However, at least two companies, including USV, are now expected to launch the generic version of this drug in the local market soon.

Eli Lilly’s decision to withdraw its patent application in India follows a similar move by other two multinational giants Novartis AG and GlaxoSmithKline Plc. (GSK) in India early this year. While GSK had withdrawn its Indian patent applications for two of its antiretroviral combination drugs, combivir and trizivir, used to combat HIV/AIDS, Novartis’ filing for patenting its HIV/AIDS drug atazanavir in India lapsed earlier this year as the company did not pursue the application.

India is likely to see many such patent withdrawals amid fierce opposition for local companies and some patient activist groups.

Indian patent rules do not permit patent protection for drugs here if it has been patented elsewhere before 1995, and its claims of innovation are only incremental, under the provisions of Section 25(1)(b) and Section 3(e) of the Indian Patents Act. The drug also cannot be patented if its efficacy is not significantly superior to an already known molecule under Section 3(d) of the law.

India rebuffs Lilly patent claim on Cialis

Regulators in India have rejected a patent claim by Indianapolis-based Eli Lilly and Co. for its Cialis erectile dysfunction drug.

The drug's basic components were synthesized in 1970 by Indian scientists at a government body that researches pharmaceuticals, the Central Drug Research Institute, an Indian drugmaker contended. Moreover, drugmaker Ajanta Pharma argued, the Indian scientists obtained a U.S. patent on the development five years later.

If Lilly's appeal of the decision fails, Cialis will compete with less-expensive forms of the drug in one of the world's largest markets. Lilly's predicament was the subject of an article in the Business Standard, an Indian business newspaper.
The newspaper said 72 other countries have accepted that the drug, whose generic name is tadalafil, is novel. India is the only country to reject a patent.

Sanofi Sues Glenmark Alleging Hypertension Drug Patent Violated

A unit of Sanofi-Aventis SA, France's largest drugmaker, and Abbott Laboratories sued India's Glenmark Pharmaceuticals Ltd. alleging infringement of a U.S. patent for the hypertension drug Tarka.

Sanofi-Aventis Germany said in a complaint filed Dec. 7 in federal court in Newark, New Jersey, that Glenmark has applied to the U.S. Food and Drug Administration to market a copy of the medicine, used to treat high blood pressure. The two companies are seeking a court order blocking Mumbai-based Glenmark from selling the drug until the patent expires in 2015. Sanofi in 2004 granted Abbott Park, Illinois-based Abbott an exclusive license for U.S. sales of the combination of the compounds trandolapril and verapamil hydrochloride.

Pfizer first MNC to get HIV drug patent in India

Global drug major Pfizer's new HIV/AIDS drug Celzentry (generic name: Maraviroc) has become the first known HIV/AIDS treatment drug to get a patent in India, in a significant development against the backdrop of the patent battle between multinational drug companies and patient groups in India.

Maraviroc, the first in a new class of oral HIV medicines developed in the last ten years and expected to become a major blockbuster HIV/AIDS drug globally, was granted a patent in India under the Patent Number 204132, based on the patent application 885/BOM/1999 filed with the Bombay patent office.

Discovered and developed by Pfizer scientists since 1997, Maraviroc, which works by blocking the entry of the virus into human cells, received approval from the US Food and Drug Administration (FDA) only in August 2007, through an accelerated regulatory approval process. One month later, the European Commission gave marketing approval for Maraviroc in Europe. Interestingly, the European Patent Office (EPO) is yet to grant a patent for Maraviroc, citing insufficient data.

Nicholas wins patent for anti-cancer drug

US Patent and Trademark office has granted it a product patent that covers new compounds used as therapeutic agents in the treatment of cancer. This includes a company's clinical candidate P-276-00, and processes for its preparation.

New data and studies done on the compound P-276-00 would also be presented at the 49th Annual Meeting and Exposition of American Society of Hematology (ASH) which is being held at Atlanta, Georgia. The presentation of data on pre-clinical studies at annual conference of American Society of Hematology marks an important milestone for development of NPIL's oncology compound.

Nicholas Piramal had also entered into a drug discovery collaboration or two cancer molecules with MSD Pharmaceuticals, the Indian arm of global drug major Merck & Company. Earlier the company had been granted a patent in South Africa for its Cyclin-Dependent Kinase (CDK) inhibitors, another agent helpful in cancer treatment drugs. The company has related national phase applications in 14 other countries. It has filed five other patent applications covering different aspects of its CDK inhibitors.

FW: GSK pulls out patent applications for 2 anti-AIDS drugs in India

GlaxosmithKline (GSK) has withdrawn the patent applications of two anti-AIDS medicines in India.

It is believed that the company formally withdrew the application of Abacavir, however, the other drug of the company, namely, Trizivir, is believed to be withdrawn after it made a request of not examining its case to the patent office. The company had filed the patent application in the Kolkata patent office last year.

A second-line anti-retroviral (ARV) drug, Abacavir, is used to treat patients who have developed resistance to first-line medications. Trizivir is a blend of three ARV drugs, which are used for first and second-line treatments. These drugs are however included in the list of drugs that the Centre and WHO recommend for HIV treatment.

Companies like Cipla, Ranbaxy and Hetero, etc, are already marketing one or both these drugs in the country. However, if GSK had received the patent, these companies would have had to pay a royalty to the company. As a result, this would increase the cost of HIV treatment.

It is believed that the company`s drugs were salt forms of the existing drugs and it considered to be cautious to pull out the application rather than being rejected. The company felt that a rejection could diminish its chances of getting patent in other developing countries.

Sun settles patent row with Novartis

Sun Pharmaceutical Industries has reached an out-of-court settlement with Novartis in the United States with regard to a patent dispute over the Swiss drug major’s Alzheimer’s drug Exelon.
“Under the terms of the settlement, Sun Pharma will not market generic Exelon in the US until sometime prior to the expiration of the patents covering Exelon.
The US Food and Drug Administration (FDA) had granted final approval for Sun Pharma’s generic version of Exelon, chemically known as rivastigmine tartrate, on October 22, 2007. The approval had come after the completion of the 30-month stay triggered by Novartis’ complaint for patent infringement. However, the litigation between the two companies was still ongoing. At the time of the announcement, Sun Pharma had said that the company would “evaluate all its launch options.” Sun Pharma, being one of the first to file an abbreviated new drug application to sell generic Exelon in the US, was eligible to share a 180-day marketing exclusivity on the drug. However, had Sun Pharma launched its generic version of Exelon before reaching an agreement with Novartis or the court’s ruling, it would have done so at risk of damages claim from the Swiss company. US-based Watson Pharma and India’s Dr Reddy’s Lab were also first-to-file on this product. The Hyderabad-based company has also received final approval to market rivastigmine tablets in the US on October 31st, 2007. Ranbaxy Laboratories is also seeking approval to market a generic version of Novartis’ drug in the US.

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.