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.