Lupin settles Schering-Plough patent dispute

According to the source, Indian drug developer Lupin Ltd. confirmed that it has settled a patent dispute with Schering-Plough Corp. over that company's allergy drug Desloratidine; Clarinex®.

Under the settlement, Lupin said it would be able to sell a generic version of the drug starting July 1, 2012. The company did not provide further detail on the settlement. The deal means that Lupin would be able to sell a generic version of the drug before the key patent (US 6100274) expires in January of 2020. Lupin had previously asked for regulatory approval of a generic version, triggering a lawsuit by Schering-Plough.

 

Nycomed filed Patent Litigation against Glenmark for fluticasone Propionate lotion

Source confirmed that Nycomed US has filed a patent infringement lawsuit on Dec 12, 2008, in the US District Court

, Eastern District Court of New York regarding Glenmark's abbreviated new drug application for its fluticasone propionate 0.05% lotion product; CUTIVATE^®. There is only one patent listed in OB i.e. US7300669 which expires on Oct 20, 2019; exclusivities for this product has already expired on Mar, 2008 and Sep, 2008

 

Claim of  US7300669

1. A topical lotion, comprising: about 0.005 to 1.0 wt. % fluticasone, or a pharmaceutically acceptable salt or ester thereof; about 4.0 to 6.0 wt. % of a C14-C20 fatty alcohol or mixtures thereof; about 1.0 to 5.0 wt. % of at least one first skin conditioning agent; about 5.0 to 15.0 wt. % propylene glycol; and the balance in water; wherein the lotion is free of mineral oil and white soft paraffin, and wherein the lotion causes more vasoconstriction when applied to living human skin than does application of a cream containing mineral oil or soft white paraffin, or both, the cream containing the same amount of the fluticasone or the pharmaceutically acceptable salt or ester thereof.

Glenmark filed its ANDA containing a paragraph IV certification for a generic version of fluticasone propionate lotion with the US Food and Drug Administration, and following receipt of the notice from the FDA that Glenmark's ANDA had been accepted for filing, Glenmark notified the new drug application holder and patent owner.

 

Nycomed's lawsuit is part of the patent challenge process under the Hatch-Waxman Act. Based on the information published by the FDA, Glenmark believes it may be the first applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Nycomed's patent, Glenmark will be entitled to a 180-day exclusivity period.

Cutivate (fluticasone propionate) 0.05% lotion had annual sales at $33 million in the US, based on IMS sales data ending September 2008. On successful patent challenges, Glenmark will be entitled for the 180 days exclusivity.

 

Patent Fight between Teva Vs Glenmark For Cardiac Drug, Carvedilol

Indian Drug maker Glenmark has  challenged the monopoly of global generic giant Teva Pharmaceutical Industries Ltd for the cardiac drug carvedilol  which has a sell of around $2 billion in US market, by  filing its counterclaims in the US district court of New Jersey, claiming Teva’s two patents for making the drug is invalid and unenforceable.

Carvedilol was originally patented by GlaxoSmithKline Plc. which is widely used for treating congestive heart failure, under the brand name Coreg.

The product patent on this drug has expired in 2007, the generic companies including three Indian firms—Dr Reddy’s Laboratories Ltd, USV Ltd and Glenmark—have got approvals for copies of Coreg from the US Food and Drug Administration (FDA).

Teva had patented two different processes of making the active pharma ingredient (API) of this drug, and blocked most of the other generic manufacturers from entering the market on the strength of this.

Teva sued all the generic companies who have received the FDA approval for the drug and most of them settled the case with Teva and some of them even agreed to supply the API to Teva exclusively.

Glenmark, which is fighting a patent infringement case on carvedilol filed by Teva in August, has accused the Israeli drug firm of engaging in fake litigations and violating anti-trust law. But Teva believes that its patents are valid and Glenmark infringes those patents,”

Though the product patent has expired in US, the market price has not come down significantly in the absence of competition. While Glaxo sells the product at $246 for 100 tablets, Teva’s price is $213.

According to source “Teva is trying to monopolized the market for carvedilol API by enforcing a patent which is invalid and prosecuting generic manufacturers that do not purchase carvedilol API from Teva in order to secure contracts with those companies,”

 

According to an executive of an Indian drug marker involved in a similar case in the US, if there is a ruling in favour of Glenmark, “it will certainly trigger an anti trust investigation against Teva’s share in this generic cardiovascular drug market.”

 

 

 

 

Eli Lilly files suit against Lupin, Aurobindo in US

The Hindu reported that the US-based pharma giants Eli Lilly and company has filed a suit against two Indian drug companies, Lupin, and Aurobindo Pharma alleging infringement of patent (US 5023269) of its anti-depressant drug Cymbalta, generically known as duloxetine HCl.

Filing a petition on November 24, before US District Court for the Southern Districts of Indiana, Eli Lilly and company has alleged that Lupin and its US-based subsidiary Lupin Pharmaceuticals Inc has infringed its inetellcutual property rights granted for anti-depressant drug Cymbalta.

According to the source the US drug giant has also filed complaint against Aurobindo Pharma USA INC, the US arm of Hyderabad-based Indian drug major Aurobindo Pharma.

Cymbalta, an anti-depressant drug whose patent will expire on June, 2013, has a total global sales of around two billion dollars in Eli Lilly's portfolio.

Till now, Eli Lilly and company has filed suits alleging patent infringement against six companies in United States of which three are Indian firms including Wockhardt.

The other three firms against which Eli Lilly and company has alleged patent infringement for its anti-depressant drug Cymbalta in US are Sandoz, Cobalt Laboratories and Impax Laboratories. These six firms against whom Eli Lilly and company has filed suit have actually applied for marketing approval of copy version Cymbalta under an abbreviated new drug application.

 

Roche Vs Cipla: Valgancyclovir Case

This is the first time an Indian court is reviewing the decision of the patent office, the Madras High Court today called for re-examination of a patent granted to Swiss drug maker F Hoffman-La Roche's valgancyclovir, marketed under the brand name Valcyte in India. Valgancyclovir is a critical drug needed for patients suffering with life threatening illnesses such as AIDS to prevent them from infections.

"Source said that the court wants the patent granted on Valgancyclovir to be re-examined before January 31, 2009. The court's decision is in response to a petition filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai patent office' decision to grant patent for Valgancyclovir without hearing their pre-grant opposition.

The patent for the valgancyclovir  was granted to Roche in June 2007, without hearing the pre-grant opposition filed by the patient groups alleging that the drug lacks novelty and hence non-patentable. The patient groups has maintained that the drug was first patented in the US in 1994 and as Indian laws provide product patent protection only to those drugs that are patented after 1995, and hence, cannot be considered patentable.

Here patient group erroneously said that valgancyclovir is pre-1995 invention which is non-patentable as a product in India . It is not the case because the  application for valgancyclovir was not available to the public before Jan 01, 1995, it was available only after Jan 01, 1995 so the drug qualifies post 1995 invention which is patentable in India  as a product U/S 5(2) of Indian Patent Act 1970.

Please also note that valgancyclovir product is patented in crystalline form in US. In US, the application claiming basic product and its crystalline form was rejected twice, but due to non-disclosure of the crystalline  form of valgancyclovir in prior art reference, applicant was able to get the claim on crystalline form of valgancyclovir.  But in India it is patented as a basic product and its crystalline form as well. Therefore, In my personal opinion, Cipla/opposition party (ies) has to invalidate the patent on the ground of lack of novelty and obviousness  based on prior art references; not just by saying that the claimed drug is pre1995 invention; thus non-patentable in India. Secondly, Roche may not get the preliminary injunction because of the price difference between two branded drugs (one is by Roche and another is by Cipla); we are expecting this from the outcome of the earlier case between Roche and Cipla for lung cancer drug, Tarceva.

Sun Pharma loses $3-bn revenue potential from US Market followed by rejection of ANDA by USFDA

Sun Pharmaceutical Industries, India's largest drug maker has lost $3-billion revenue potential from the US market after a rival beat it to gain the US regulator’s approval to sell the world’s best-selling anti-depressant drug, Venlafaxine.

The US Food and Drug Administration (FDA) recently approved the generic of the tablet form of Effexor XR (Venlafaxine) to the US-based Osmotica Pharmaceutical's marketing application. The approval makes Sun Pharma's marketing application (abbreviated new drug application or ANDA) invalid.

Now, Sun Pharma will have to conduct fresh bio-equivalence study comparing with Osmotica's tablets and resubmit their ANDA, which effectively prevents its plans of launching the drug in the US market.

Effexor XR extended release drug in capsule form had annual sales of $3 billion for the month ended September 2008 and is the largest selling drug of Wyeth. Osmotica has already launched its tablet version following the product patent expiry of the basic ingredient in June, this year.

Unlike normal patent challenges by generic companies, Osmotica and Sun Pharma both developed an improvised tablet form of the drug and challenged the patent on basic ingredient venlafaxine, and not the original capsule version of the drug. While the product patents on Effexor are expected to expire by 2017, the patent on key ingredient venlafaxine expired this year.

Osmotica's generic version of Venlafaxine extended release tablets was approved by US FDA in May 2008 before Sun Pharma could get approval. Following this, Osmotica filed a citizen petition with US FDA directing all subsequent ANDA filers to resubmit their ANDA for proving bio-equivalence to Osmotica's tablet version, and not Wyeth's capsule version.

Though Sun Pharma had challenged the patents on three strengths of Effexor in 37.5 mg, 75 mg and 150 mg, based on an innovative technology for extended release tablets, Wyeth Pharmaceuticals did not sue Sun Pharma for infringing its patent and had issued a ‘covenant not to sue’ (a legal term in which an aggrieved party agrees not to sue the party liable to such action).

US generic drug major Mylan Pharmaceuticals is believed to be the first to file ANDA for this drug on capsule form. Wyeth had also entered into an out-of-court settlement with Teva Pharmaceuticals of the US for the same product in capsule form. However, Wyeth chose to sue other challengers such as India's Lupin Pharmaceuticals, Impax Laboratories, Anchen Pharmaceuticals and Alsa Corporation (a subsidiary of Johnson & Johnson) in the case of Effexor XR capsules.

 

 

DRL Launches Authorized Generic Version of Imitrex(R)* Tablets- Sumatriptan succinate

Dr. Reddy's Laboratories announced that it has launched the authorized generic version of GlaxoSmithKline's Imitrex(R) (sumatriptan succinate) tablets 25mg, 50mg, and 100mg in the United States. Dr. Reddy's is the first company to launch an authorized generic version of Imitrex(R) tablets in the US market.  In October 2006, the Company announced that it had settled patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GlaxoSmithKline Imitrex(R) tablets.

 

 

 

Orion Sued Sun pharma for a key drug entacapone; a parkinson drug

Finnish drug firm Orion has filed a patent infringement lawsuit against Sun Pharma in the United States to protect its key drug Comtan, used for treatment of Parkinson's disease.

India's Sun Pharma Global is seeking to market a generic version of Comtan in the Unted States and has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking to sell the drug, Orion said.

"Comtan contains entacapone and is a product developed by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis," Orion said in a statement.

Orion said by suing to enforce its patent it is entitled to an automatic stay prohibiting FDA from approving Sun Pharma Global's application for 30 months, or until an earlier court decision adverse to Orion's patent in the patent infringement lawsuit.

 

 

 

Lupin is going to launch new generation cardiac drug- Ivabradine

Business Standard reports that Mumbai-based drug major Lupin will launch a new generation cardio-vascular drug in India, aiming to tap the Rs 3,600-crore cardiac drug market.

Normally, the pulse rate of a high risk heart patient is above normal and this in turn increases the risk of a heart attack. The drug to be introduced by Lupin will help reduce the heart beat, thereby reducing the probability of a heart attack.

The Drug Controller General of India (DCGI) has given marketing approval for the drug, Ivabrad (Ivabradine) in 5mg and 7.5mg tablets.

“The drug will offer a new and innovative approach for the treatment of symptomatic stable angina in heart patients. We will price the drug in such a manner that it is affordable for Indian patients,” said Kamal K Sharma, managing director, Lupin.

India, which has over 60 million people suffering with heart diseases, has a cardiac drug market valued at Rs 3,600 crore, growing at a rate of 15 per cent every year.

Lupin is hoping to increase its current market share of 5.03 per cent (or revenue of Rs 175 crore) in this market. By 2010, over 100 million Indians are expected to be heart patients. The drug was originally developed by the France-based Servier Laboratories and was launched in February 2006 in the global markets. Lupin will launch the drug in India, with an exclusive arrangement with Servier.

 

Indian Drug Manufacturer Wockhardt has filed ANDA for Stalevo, a Parkinson's disease treating drug

Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.

Wockhardt has filed an abbreviated new drug-marketing application(ANDA) with the US Food and Drug Administration (FDA), seeking authorization to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, said Orion Corporation. Approximately 6.5 million people worldwide suffer from Parkinson's disease, a disabling neurological condition. Stalevo simplifies the treatment process by combining levodopa, the most widely-used agent for treating Parkinson's disease, with enzyme inhibitors carbidopa and entacapone.

 

 

Auxin developed hearing aid

Indian Express reports that Surat-based Auxin Life Science company has developed a Titanium middle ear prosthesis after extensive research and development of seven years. Till now, this product was imported from different companies in South America and Germany.

Auxin Life Science is the first Asian company to develop the titanium middle ear prosthesis. The company has got the patent certificate from the Government of India. Auxin managing director Jai Diwan said their product is priced at Rs 5,000, which is Rs 7,000 less than the imported ones.

Solar Taxi

 

The Press Release of the Ministry of New and Renewal energy published on Monday  Oct 20, 2008 discloses  that Five patent applications have been filed in India for solar based vehicles. This has been informed by the patent office. Out of these, one patent has been granted, another abandoned, one withdrawn and the rest are under their examination.

This was stated by the Minister of State for New and Renewable Energy, Shri Vilas Muttemwar in a reply to a question by Shri Rajkumar Dhoot in Lok Sabha.

As per the available information from the internet, Mr. Louis Palmer, a resident of Switzerland is using high energy ZEBRA batteries made from common salt, ceramics and nickel, for running a solar powered vehicle – the solar taxi in his world tour for promoting awareness about conserving energy resources and the environment.

Ranbaxy-GSK Alliance: Key for the Success

Ranbaxy Laboratories Limited and GSK have submitted a joint investigational new drug (IND) application for respiratory inflammation candidate to the Drug Controller General of India for permission to initiate Phase-I human clinical trials.

Earlier this year, GlaxoSmithKline approved further development of the respiratory drug by Ranbaxy under a research and development collaboration pact between the two companies, signed in April 2007. The two companies are collaborating on two research programmes - one in chronic obstructive pulmonary disease (COPD) and the other in anti-infectives.

Ranbaxy plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials, after it has successfully completed the necessary regulatory safety and toxicity studies on the drug candidate in India.

As per the multi-year R&D collaboration agreement, Ranbaxy will be conducting Phase I and Phase II clinical studies through Proof of Concept while GSK will have the option to conduct further development through final registration and commercialisation.

Ranbaxy expects to receive over $100 milion in potential milestone payments for the product developed by Ranbaxy and subsequently launched by GSK in multiple indications. It expects a double-digit royalty on worldwide net sales.

The GSK-Ranbaxy R&D collaboration was initiated in 2003, and further expanded in February 2007. The new milestone payments and royalties will be per the revised agreement and will also apply to this current development program and to future discovery programmes.

In July 2007 the two companies reached an agreement to settle their dispute over a US patent covering GSK's herpes pill Valtrex (valacyclovir hydrochloride tablets), under which Ranbaxy will introduce its generic copies of Valtrex in the US in the latter part of 2009 and will have 180 days of exclusivity to sell the product there, highlighting a trend where top multinational patent holders have started collaborating with their generic rivals, while simultaneously competing in the same markets.

Even as the two clashed over certain drugs, they continued their collboration in other areas and three months before settling the Valtrex dispute, in April 2007, Ranbaxy and GSK agreed to join hands on their anti-inflammatory drug research programme, under which Ranbaxy would also be responsible for conducting Phase I and Phase II clinical studies, while GSK would have the option to conduct further development through to final commercialization.

In January this year, Ranbaxy Laboratories Ltd announced the settlement of "all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate tablets", the generic version of GlaxoSmithKline's Imitrex tablets. The terms of the settlement, allowed Ranbaxy to distribute a generic version of Sumatriptan Succinate tablets in the 25mg, 50mg and 100mg strengths in the United States with an expected launch date in December 2008.

The Ranbaxy-GSK alliance envisages strong research workflow to emanate from a wide range of therapeutic areas of interest to Ranbaxy and GSK, including anti-infectives, respiratory, and oncology.

Ranbaxy also has a joint venture in the field of product development is Merck & Co., Inc, which was signed in May this year, for a drug discovery and clinical development collaboration for new products, in the anti-infective field. While Merck will identify the drug leads, potential molecules that can be developed into new drugs, Ranbaxy will develop the drug to the stage of human trials, with the right to co-commercialize the products in India in addition to royalties and milestone payments over product sales.

Compulsory license of docetaxel drug dispute

The Council of State will today consider the legitimacy of the compulsory licensing (CL) policy on cancer drugs implemented by the Public Health Ministry. The Commerce Ministry asked the government's legal advisory body to consider the policy's legality in June after the France-based pharmaceutical company Sanofi Aventis sent a letter to the chief of the Intellectual Property (IP) Department, Puangrat Asavapisit, asking for a review of the CL policy. The letter claimed the Public Health Ministry did not have the right to use CL to bypass the patent of its breast cancer drug Docetaxel.

The company cited articles 50 and 51 of the Patent Act, which stipulate that the Commerce Ministry had sole authority to announce the policy. Also, the company could take legal action against the Government Pharmaceutical Organisation (GPO) if its copycat version from India was imported to Thailand without permission.

The NGO also condemned the drug company for not respecting Thailand's rights under the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights, which allows a government to use CL. The group also lashed out at the Commerce Ministry for failing to protect public benefits through access to affordable life-saving drugs.

''Even the World Bank applauds the efficacy of the Thai policy on Aids drugs distribution,'' the group said in its statement released yesterday. ''Without compulsory licensing the government cannot afford to buy expensive drugs for HIV-positive people. Therefore it is the responsibility of every state agency to consciously protect public benefits.''

GPO board chairman Vichai Chokewiwat said he and officials from the National Health Security Office would testify to the Council of State today. He insisted the policy was legitimate under article 51 (2) of the Patent Act, which allows governmental bodies to exercise a compulsory licensing policy. The GPO's legal department and an IP law expert agreed, he said.

''Such a request is nonsense,'' Dr Vichai said. ''The IP Department has the authority only to finalise the royalty fee which the government has to pay to the drug patent owner only.''

Sanofi's Docetaxel is one of the four drugs named under the CL policy announced by former public health minister Mongkol Na Songkhla in January. The others are the breast cancer drug Letrozole and the leukaemia and gastrointestinal stromal tumour drug Imatinib, both produced by Novartis; and lung cancer drug Erlotinib, made by Roche.

 

Brajilian Patent office rejects patentof Gilead on HIV drug

The Brazilian Patent Office has rejected a patent application filed by Gilead Sciences for its Viread medication (Generic name tenofovir disoproxil fumarate [TDF]). This is the first time that a patent related to an antiretroviral (ARV) medicine has been rejected as a result of a pre-grant opposition in Brazil And Doctors Without Borders (DWB) is saying the move could increase access to a key AIDS drug across the developing world.

Tido von Schoen-Angier, executive director of DWB’s Access Campaign, says in a statement that Viread “is a cornerstone drug, recommended by the World Health Organization both for patients starting treatment and for those whose medications aren’t working anymore. In the past, Brazil’s production of anti-retroviral drugs has helped to bring down prices of ARVs globally. We hope this will happen again.”

According to the non-profit, Viread can now be made by Brazilian generic companies or imported from abroad. Around 31,000 people currently receive Viread through Brazil’s universal AIDS treatment program, and an estimated 37,000 by the end of 2008, which would translate into considerable savings. Companies in India make a WHO-approved version for $158 for one patient’s yearly treatment, compared to the $1,387 charged by Gilead in Brazil.

A Gilead spokeswoman says that this patent has been issued in countries around the world, including most recently in China, and has been reissued in the United States following a thorough evaluation during the re-examination process that the U.S. Patent and Trademark Office concluded earlier this year. We remain confident in the strength of our intellectual property for Viread and plan to vigorously defend the patent and the scientific innovation on which it is based. If necessary, appealing a final decision will remain an option in Brazil.

The patent application filed by Gilead Sciences was opposed by a coalition of Brazilian NGOs and a government pharmaceutical laboratory. The patent office in Brazil rejected it on the grounds that it lacks inventiveness – one of the key requirements for a patent in Brazilian and international patent law.

 

 

J&J lost patent for drug galanthamine

Johnson & Johnson, the world's largest maker of health care products, lost a patent decision over its Alzheimer's treatment Razadyne, paving the way for sales of low-cost generic versions of the medicine by seven rivals.

In a ruling made public yesterday in federal court in Delaware, U.S. District Judge Sue Robinson said the patent is invalid because it doesn't adequately define how to use the drug, which has the chemical name galanthamine hydrobromide.

 

The decision will allow generic versions of Razadyne approved by the U.S. Food & Drug Administration to be sold in the United States, pending the appeal, the patent holders said in the statement. The patent, issued in 1987, expires in December 2008.

In 2005, the Johnson & Johnson subsidiaries sued units of Israel's Teva Pharmaceutical Industries, the world's biggest maker of generic drugs; Barr Pharmaceuticals, which Teva is buying; Mylan, the largest U.S. generic drugmaker; and Dr. Reddy's Laboratories, India's No. 2 drugmaker.

Also sued were the Purepac unit of Icelandic generic drugmaker Actavis Group HF; Alphapharm, part of Germany's Merck KGaA; and Par Pharmaceutical, according to Robinson's decision. She said the defendants admitted infringement and she held a 2007 non-jury trial on validity.

Following the ruling, Barr said it received final FDA approval to sell the generic version in 4-, 8- and 12-milligram tablets and plans to begin sales "immediately."

 

 

Marksans acquired Relonchem

 

Marksans Pharmaceutical Limited, one of India’s leading mid-size pharmaceutical company, announced the acquisition of Relonchem Limited, a leading UK based generic pharmaceutical company for an undisclosed sum. Relonchem Limited has clocked sales of US $ 32 million (approx.)

 

The recent acquisition will give Marksans Pharma an immediate sales and marketing front-end access to the highly regulated and lucrative generic medicines market in UK and Europe. The Company expects to derive significant cost benefits by transferring Relonchem Limited’s manufacturing operations to its state-of-the-art India manufacturing facilities.

 

Tapesh Gupta has sent you a hi5 Friend Request

Tapesh Gupta would like to be your friend on hi5! I set up a hi5 profile and I want to add you as a friend so we can share pictures and start building our network. First you need to join hi5! Once you join, you will have a chance to create a profile, share pictures, and find friends. Thanks, Tapesh Join hi5!» Tapesh Gupta 4 Friends

------------------------------------------------------ Copyright 2002-2008 Hi5 Networks, Inc. All rights reserved. 55 Second Street, Suite 300, San Francisco, CA 94105 Privacy Policy | Unsubscribe | Terms of Service

Pfizer agrees to settle Lipitor suit

Pfizer Inc announced that it has agreed to settle litigation related to its cholestrol drug Lipitor with Canadian generic drug maker Apotex Inc.

"In July 2008, we entered into an agreement with Apotex to settle that litigation, subject to certain conditions," Pfizer said in a quarterly report filed with the US Securities and Exchange Commission, the company did not provide details of the agreement.

Pfizer has been involved in patent litigation with Apotex to block the launch of generic Lipitor prior to the expiration of a patent that runs through July 2010.

In June, Pfizer settled most of its patent disputes with Ranbaxy Laboratories, allowing the Indian company to launch a generic version of Lipitor from Nov. 30, 2011. Pfizer could not immediately be reached for comment.

 

Venus emedies Launched Tobracef

Today, Venus Remedies has announced that the company has successfully launched its fourth research product, a fixed dose combination of cephalosporin with aminoglycoside under the brand name Tobracef in domestic market for the first time golbally. The Drug Controller General of India has accorded its approval to Venus Remedies for launch of the fourth innovative product developed by Venus Research Centre, after completion of its multi-centered Phase III clinical trials and all related studies in March 2008.

Tobracef, is a god send for APE/Cystic Fibrosis patients being the only solution for the treatment of life threatening infections caused by P Aeruginosa / MRSA in these patients. The PSD division is targeting to fast penetrate the Rs 2 billion domestic market and is expected to build this brand as a segment leader within 2 years of its launch. There are 50 patent applications in process in 50 countries across the globe for this wonderful product and the company is in talks for out-licencing of this product in US and other regulated markets of the world.

 

The New Highway for Generic Drug Companies

Indian Pharmaceutical giants like Ranbaxy, Dr Reddy's Lab, Wockhardt, Glenmark and Sun Pharma are now adopting a careful patent litigation path in the US market to expand their generic business instead of the aggressive patent challenges they pursued few years ago. This kind of adaptation has led to reduction of number of patent challenges by Indian companies in the US in the last few years.

Para IV applications (abbreviated new drug applications (ANDA) notifying to challenge innovator patents) filed by the domestic pharma firms with the US drug regulator have come down to 10-15 annually during the last two years from 20-30, said patent experts. Such kind of strategy of companies has declined the business for freelancer and Law firm specially working in Pharma Field. A source said that now a days many LPOs have shut down their pharma-specialized window and looking for another booming field.

According to source, Dr Reddy's Laboratories challenged 29 innovator patents out of 49 marketing applications by March, 2006-end. The company filed only 19 applications with 10 patent challenges with Para IV certifications in 2007-08, out of a cumulative 122 marketing applications in the US. Lupin, one of the fastest growing companies in the US generics prescription market, filed only 11 ANDAs, out of 62 cumulative ANDA applications till March 2008.However, the company has not revealed how many of these are Para IV certifications. Sun Pharma and its US subsidiary Caraco together have 53 approvals and about 90 products are waiting for approvals. The company filed about 29 applications last year.
Glenmark Generics, the generic arm of Glenmark Pharmaceuticals, has about 40-45 ANDAs pending for approval.

Experts said many companies were now adopting the strategy of not to challenge the patents, which they indicate as a Para III ANDA filing to the drug regulator.

Experts said that the foremost reasons for falling generic business by patent challenge are (i) the introduction of authorised generics (either innovators launch their own generics or allow others to launch drugs before patent expiry to ward off generic competition) (ii) more out-of-court settlements. Moreover there might be other reasons also like declining number of patented drugs going off-patent in future, tight competition, price erosion upon patent expiry and huge costs involved in the patent challenge and failure of domestic companies to win patent challenges to earn business.

"Patent litigation has become a risky game plan and now companies carefully evaluate the potential business benefits. The effort is not worthwhile unless you are sure of gaining at least a $10 million profit by the challenge," said Glen Saldanha, MD and chief executive of Glenmark.

Patent experts said very few of them were known to challenge innovator patents. Similarly, Wockhardt is also following a strategy of less patent challenges in the US market.

Although generic business is a substantial profitable business but since it includes huge cost and risk to win patent challenge, pharma companies need to change their vision to earn good business with minimum risk. These businesses may include developing a NDA (New Drug Application) product under 505(b) (2), to become authorized generics, looking for merging and acquisitions with platform technology based companies, developing innovative technology and license it out, in-licensing the technology patent and developing the product along with licensor. Although these alternative businesses incur a lot of investment and time but are worthwhile once you enter into market.

 

Lupin Receives USFDA Approval for Divalproex Sodium Delayed-Release Tablets

Lupin Pharmaceuticals, Inc. (LPI), pune based Indian pharma company, announced that it has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U.S. Food and Drug Administration (USFDA). Lupin's Divalproex sodium delayed-release tablets are the AB-rated generic equivalent of Abbott Laboratories' Depakote(R) tablets, indicated for the treatment of certain types of seizures and convulsions. It may be prescribed alone or with other epilepsy medications. The delayed-release tablets are also used to control the manic episodes that occur in bipolar disorder. Depakote had annual sales of approximately $803 million for the twelve months ended March 2008, based on IMS Health sales data.

 

 

Ranbaxy launches generic anti-ulcer drug

Ranbaxy has launched generic versions of Astrazeneca’s anti-ulcer drug Prilosec 40 mg in the US. Following a settlement in April, Astrazeneca made Ranbaxy the authorized generics partner, which means that the Indian company can sell its generic drugs for 180 days before Prilosec’s patent expires.

However, the US-based company Watson Pharma, being the first generic company to successfully challenge Prilosec’s patent, will also have exclusive marketing rights during the 180 day period.

 

First Follow on Biologic by a US company

Insmed Inc., a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, has demonstrated the bioequivalence of INS-19, the company's recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen(R), an FDA-approved G-CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion.

Human bioequivalence studies utilize well-established, FDA-recognized methodology with rigorous standards. Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R). These human INS-19 and Neupogen(R) data complement Insmed's extensive analytical testing and comparative data from pre-clinical assessments.

"These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said Dr. Geoffrey Allan, President and CEO of Insmed. "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. Demonstration of bioequivalence is typically the sole clinical requirement to support FDA approval of generic drugs today. Thus, based on these data, Insmed intends to request a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19."

Insmed has one of the most robust follow-on biologics pipelines in the industry. Building upon the success of INS-19, the Company has also completed pre- clinical pharmacological and pharmacokinetic studies for its second follow-on biologic product, INS-20, which has demonstrated comparability to FDA-approved Neulasta(R). Based on these data, Insmed intends to initiate a Phase I bioequivalence study of INS-20 in humans in the fourth quarter of 2008. Insmed intends to seek approval of both products in the U.S. and launch the products on expiration of the relevant innovator patents.

 

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.

 

 

Tapesh Gupta has sent you a hi5 Friend Request

Tapesh Gupta would like to be your friend on hi5! I set up a hi5 profile and I want to add you as a friend so we can share pictures and start building our network. First you need to join hi5! Once you join, you will have a chance to create a profile, share pictures, and find friends. Thanks, Tapesh Join hi5!» Tapesh Gupta 1 Friends

------------------------------------------------------ Copyright 2002-2008 Hi5 Networks, Inc. All rights reserved. P.O. Box 31118, San Francisco, CA 94131, USA Privacy Policy | Unsubscribe | Terms of Service

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

Lupin gets tentative approval for TopiramateTablets

Indian based Company Lupin Pharmaceuticals Ltd. gets a tentative FDA approval for epileptic drug Topiramate. Topiramate (Topamax) is being sold by Ortho Mcneil, a subsidiary of Johnson & Johnson, used for the treatment of seizures.

 

Lupin said product will be introduce in the market once its patent expires in Sep 2008.  

 

 

Degree of Innovation in India

India-based Suven Life Sciences has got two granted product patents, one each in South Africa and China, for its new chemical treatments for disorders associated with neuro-degenerative diseases. The South African patent is valid until 2024 and the other until 2025.

Merck has received Patents in India for Obesity and Dyslipidemia Drugs

US-based Merck has received patent approval for two of its upcoming drugs for  dyslipidemia and obesity from the Indian Patent Office. The two newly patented drugs that are in the final stages of trial and are yet to receive the Drug Controller General of India’s (DCGI) approval.

 

Till now, Merck has only patent for its anti-diabetic drug called Januvia a 770 million product.

 

MSD Pharma is a wholly owned subsidiary of Merck & Co in India. Its director (marketing) Sanjiv Navangul said, “We have received patent approval for two more drugs in India which are in advanced Phase III trials. We soon expect to launch them here. However, we will have a competitive and right pricing for all our patented drugs based on comprehensive research.”