Patent Column

Takeda Sues Torrent Pharma for Diabaetic drug, pioglitazone

2009-07-06T20:19:00.000-07:00

Source reports that Takeda Pharmaceutical Co., a Japan based company sued India’s Torrent Pharmaceuticals Ltd. to prevent it from selling a copy of the Actos diabetes pill in the U.S. until 2016.

Torrent, based in Ahmedabad, India, is seeking U.S. Food and Drug Administration approval to sell a copy of the medicine. Takeda, Asia’s biggest drugmaker, contends the versions would infringe six patents on the medicine and wants a court to block approval until they expire in 2016.

Actos is the world’s best-selling diabetes drug, responsible for 387 billion yen ($4 billion), or 25 percent, of Takeda’s sales for the year ended March 31. Last month, Takeda failed to gain FDA approval for another drug, called alogliptin, that the company is counting on to replace Actos revenue when generic competition begins as early as January 2011, when a patent on the drug expires.

The six patents in the complaint relate to ways to use the compound pioglitazone, the active ingredient in Actos, in combination with other medicines. Torrent’s proposed label wouldn’t restrict use of the generic drug, so “Torrent will be marketing pioglitazon with specific intent” to infringe the patents, Osaka-based Takeda said in the complaint, filed July 2 in federal court in New York.

In its FDA application, Torrent maintained that it would not infringe any valid and enforceable patent by selling a generic version of Actos. Under federal law, Takeda’s suit triggers an automatic 30-month period in which the FDA can’t approve Torrent’s application unless a judge rules in the generic-drug maker’s favor before then.

Finally, Novartis loses battle for cancer drug patent

2009-07-05T20:46:00.000-07:00

Business Standard reports that the Novartis’s famed cancer drug, Glivec, will not get patent protection in India. The apex body on patent and trademark disputes, the Intellectual Property Appellate Board (IPAB), has ruled that the drug “lacks innovation” and the high price tag of Rs 1,20,000 per month per patient would be too high for the common man. “Any patent granted to support such a high monopoly price would be against ‘public order’,” the ruling said. This brings the curtains down on a high profile three-year legal battle over patent rights between the Swiss multinational drug major and the Indian government.

The IPAB panel, comprising Chairman ZS Negi and Technical Member PC Chakraborti, ruled that the beta crystalline version of the drug was not patentable under section 3(d) of the Indian Patent Act and lacked “significant enhanced efficacy” over and above the prior known molecule. The panel, in its decision on June 26, also ruled that the patents granted for the drug in about 40 countries may not be applicable to India.

RANBAXY FILED A POST GRANT OPPOSITION FOR OLANZAPINE PAMOATE SALT

2009-06-12T20:54:00.000-07:00

An opposition under section 25 (2) has been filed by M/s Ranbaxy Limited, India on May 21, 2009 for the Patent No. 220287 (IN/PCT/2001/338/KOL) entitled “AN OLANZAPINE PAMOATE SALT LAND PHARMACEUTICALLY ACCEPTABLE FOLVATE THEREOF” in the name of M/s Eli Lilly and company.

Medicis Sued Ranbaxy for Solodyn

2009-06-12T21:07:00.000-07:00

Medicis Pharmaceutical Corp. filed a suit against Ranbaxy Laboratories Ltd. India for allegedly trying to market a generic version of Medicis’ Solodyn, a extended release tablet of minocycline HCl.

Medicis alleges Ranbaxy infringed on one or more claims under Medicis’ U.S. Patent 5,908,838 when it submitted an abbreviated new drug application for a generic version of Solodyn to the U.S. Food and Drug Administration.

In its suit, Medicis is requesting a permanent injunction preventing Ranbaxy from infringing its patent by selling the generic version.

Last year, Ranbaxy entered in to agreement with Pfizer to settle the worldwide patent dispute involving cholesterol lowering drug Atorvastatin. LIPITOR, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity in the U.S.

Ranbaxy Laboratories Ltd., India’s largest pharmaceutical company, settled a patent infringement lawsuit with AstraZeneca in April 2008. AstraZeneca had filed a patent infringement lawsuit against Ranbaxy for trying to market a generic version of AstraZeneca’s Esomeprazole magnesium capsules, Omeprazole tablets and Felodipine capsules in the United States. Ranbaxy will be allowed to exclusively sell its generic version of Nexium (generic name Esomeprazole magessium) under a license from AstraZeneca on May 27, 2014. During the 180-day period following that date, Ranbaxy will distribute the only generic Esomeprazole magnesium product in the U.S.

Infringement Suit between Shire and Natoco for Fosrenol

2009-04-02T22:37:00.000-07:00

PHILADELPHIA, April 2/ Shire plc announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited ("Natco") for infringement of two of Shire's patents: U.S. Patent No. 5,968,976 ("'976 Patent"); and U.S. Patent No. 7,381,428 ("'428 Patent");

The lawsuit was filed in response to an ANDA (Abbreviated New Drug Application) filed by Natco seeking FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g FOSRENOL(R) (Lanthanum Carbonate) products. Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Natco's Paragraph IV notification letter, the FDA must refrain from approving Natco's ANDA for 30 months, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.

Shire has asserted the '976 and '428 patents based upon information provided to it by Natco. Shire will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible. Shire has a robust patent estate and is confident that it will protect the FOSRENOL franchise.

Abbott Laboratories sues Mylan for AIDS drug 'Kaletra' patent dispute

2009-03-17T02:21:00.000-07:00

Abbott Laboratories accused rival Mylan Inc. of infringing two U.S. patents for the AIDS drug Kaletra. Kaletra is a combination of two anti-HIV drugs Lopinavir and Ritonavir used for the treatment of HIV infectionm. Abbott contends that Mylan plans to sell low-cost generic copies of Kaletra tablets before the patents expire in 2021, according to complaints filed in federal courts in Delaware and Chicago.

"Abbott will be irreparably harmed" if generic versions of the drug aren't blocked by a judge, Abbott claimed in the Chicago suit.

The lawsuits were filed after Mylan announced that its India-based Matrix Laboratories Ltd. had received tentative U.S. Food and Drug Administration approval for the tablets under the president's Emergency Plan for AIDS Relief.

Natco Pharma Successfully opposes Indian patent application for Glatiramer Acetate

2009-03-16T00:53:00.000-07:00

NATCO Pharma Ltd has successfully opposed a patent application in India that covers the composition of Glatiramer Acetate, the generic version of Teva Pharmaceutical Industries' Copaxone. The patent application was submitted to the Indian Patent Office (New Delhi) by Yeda Research & Development Company, which licensed the Glatiramer Acetate product to Teva.

Glatiramer Acetate, marketed in pre-filled syringes, is used to treat multiple sclerosis (MS). NATCO has successfully commercialized its Glatiramer Acetate product in India and the Ukraine. NATCO challenged the Yeda patent application in the Indian Patent Office on several grounds including that it was obvious over the prior art. The Patent Office agreed with NATCO's arguments and refused to grant the application because of "obviousness and lack of inventiveness” over the prior art.

Oscient Sued Lupin for Antara, a Cholesterol Fighting Drug

2009-01-15T19:23:00.000-08:00

Oscient Pharmaceuticals Corp. have filed a patent-infringement suit in Maryland district court against Lupin Pharmaceuticals Limited, based in India, for the cholesterol-fighting drug Antara (Generically known as Fenofibrate).

Oscient based in Waltham, Mass., said it received a certification notice from Lupin on Dec. 3 advising the company that Lupin would seek FDA approval to market a generic version of Antara prior to the drug’s patent expiration (US7101574) in 2020. US7101574 claims a pharmaceutical composition in the form of granules, wherein each granule comprises a neutral micro-granule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization adjuvant, and wherein said fenofibrate is present in an amount greater than or equal to 60% by weight, relative to the weight of said pharmaceutical composition, and further wherein said binding cellulose derivative represents between 2 to 15% by weight, relative to the weight of said pharmaceutical composition.

A generic company needs to have either non-infringing composition of the claim or invalidate the claim to market the product in US.

Lupin settles Schering-Plough patent dispute

2008-12-17T19:36:00.000-08:00

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

2008-12-17T19:32:00.000-08:00

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

2008-12-04T19:52:00.000-08:00

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

2008-12-03T20:51:00.000-08:00

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

2008-12-02T20:43:00.000-08:00

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

2008-11-30T19:29:00.000-08:00

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

2008-11-24T20:58:00.000-08:00

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

2008-11-12T21:04:00.000-08:00

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

2008-11-10T23:42:00.000-08:00

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

2008-11-05T03:20:00.000-08:00

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

2008-10-22T20:18:00.000-07:00

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

2008-10-20T20:23:00.000-07:00

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

2008-10-13T20:54:00.000-07:00

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

2008-09-10T01:12:00.001-07:00

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

2008-09-03T20:59:00.001-07:00

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

2008-08-29T02:34:00.000-07:00

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

2008-08-28T22:10:00.000-07:00

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.