Crispy Generic IP

Another Step of Indian Patent office

noreply@blogger.com (Neelam Satija) — Tue, 27 Aug 2013 04:24:00 +0000

Yesterday, IPO has published a list of FER issued in 2013. This list can be checked by Month from Jan, 2013 to till today. All this shows that patent office is working very hard to clean up the backlog of application in queue. I appreciate the patent office efforts.

The link for the FER status can be accessed from here.

New Notification by Indian Patent Office – Status of pending patent application

noreply@blogger.com (Neelam Satija) — Wed, 21 Aug 2013 06:43:00 +0000

Indian Patent office, recently (Aug 19, 2013), published dynamic status of patent applications, which are categorised under 23 categories (Classification based on respective filed of invention). Categories are:

Agrochemicals, Biotechnology, Chemical, Civil, Communication, Electrical, Electronics, Food, General Engineering, Mechanical Engineering, Pharmaceuticals, Textile, Computer Science, Physics, Bio-Chemistry, Polymer Technology, Micro Biology, Metallurgy, Bio-Medical Engineering, Agriculture Engineering, Traditional Knowledge Biotechnology, Traditional Knowledge Chemical, Traditional Knowledge Mechanical

The patent applications are listed under 5 headings:

ü In process

ü Granted

ü Refused u/s 15

ü Abandoned u/s 21 (1)

ü Withdrawn after 15 months

The above can be accessed here. However one needs to go through whole list after selecting the category and type of status, to look for the desired patent application. This is not in searchable format. One more important thing is that this is data after Jul 01, 2012.

New Drug for HIV patients:- Tivicay

noreply@blogger.com (Neelam Satija) — Wed, 14 Aug 2013 04:37:00 +0000

FDA recently (Aug 12, 2013) approved Tivicay (dolutegravir), a new antiretroviral agent for HIV-1 infection. Tivicay is approved to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. Dolutegravir is available as 50 mg tablets. Dolutegravir is taken orally without regard to meals.

For complete information, click here

Strict Procedural Requirement at Indian Patent Office

noreply@blogger.com (Neelam Satija) — Mon, 12 Aug 2013 07:06:00 +0000

Recently, Controller has given decision for the two divisional applications which are related to Herceptin, Drug for Breast Cancer developed by Genentech. Herceptin (Trastuzumab) is a monoclonal antibody that interferes with the HER2/neu receptor. Trastuzumab costs about US$70,000 for a full course of treatment and brought in $327 million in revenue for Genentech in the fourth quarter of 2007. A news (inEconomic times) regarding the compulsory license has also been there but still DIPP is under consideration for this drug. Below is shown patent situation for the Herceptin in India:

(i). IN 205534 (Main patent for Herceptin) – As per the e-register (Indian Patent office) of this patent has been ceased on 3 May, 2013. From the e-Register, it appears that Genentech has paid last maintaince fee in Mar, 2012 and this time perhaps they have missed the deadline.

(ii). 1638/KOLNP/2005 (divisional application) - This application is still under opposition by Glenmark Pharmaceutical Limited.

(iii). 3272/KOLNP/2008 & 3273/KOLNP/2008 (divisional application): Both applications are held abandoned by IPAB recently on Jul 17, 2013. The reason for the abandonment of the two applications is summarised below:

ü Missed out a day in Filing request for examination: Last date for Request for examination for these application was Feb 11, 2009 as per sec 24 B (iv) of Indian Patent Act, but Genentech has filed the examination request one day late i.e. Feb 12, 2009.

ü Not divisional as per Patent act: Applications was filed as divisional of 1638/KOLNP/2005 which is also divisional of Main patent. It was held that there is no scope in patent act for filing further divisional application of a divisional application. In spite of this, if a divisional is further divided, later application will be considered as divisional of first parent application. In this case, original parent application was granted in Apr, 2007 and divisional applications (3272 & 3273) were filed in Aug, 2008 i.e. after the grant of Main Patent.

ü Not a proper divisional on the basis of plurality of the invention.

Genentech is also provided with an opportunity to be heard for the above matter, but they did not appear for the hearing. So this is another mistake on part of Genentech.

Above situation indicate that patent office is having strict compliance requirements, which needs to be fulfilled. Even a delay of one day or a single mistake can cost a lot for the Patent applicant. Also, there is now only one application of Herceptin (1638) which if granted can block the generic players to enter in the market. Also need to check the step taken by the Genentech to save its Main Patent whether they will request for restoration?

Allergen Yesterday Lost Patent For Combigan Eye Drops

noreply@blogger.com (Neelam Satija) — Fri, 09 Aug 2013 11:05:00 +0000

Combigan, product of Allergen, was patented under the Indian patent no. IN 219504. This patent is related to “combination of brimonidine and timolol” for topical opthalmic use. Ajantha Pharma limited has filed petition for the revocation of this patent at IPAB and succeed yesterday in revoking the patent.

IPAB revoked the patent on the basis of Obviousness and Non compliance of Sec. 8. However, opponent filed the application with several grounds viz. Patent was obtained on a false suggestion or representation, that it is not an invention that it is obvious, that it does not sufficiently disclose and that Section 8 of the Patents Act, 1970 was violated. The brief analysis of judgement is as follows:

Section 8: First of all, Hon'ble Smt. Justice Prabha Sridevan provided the importance & scope of section 8 of Indian Patent Act and this read as follows:

“The Inventors and the Challengers must remember that

- S 8 must be complied with.

- It must be pleaded and proved that the lapse was with regarding applications in respect of the same or substantially the same invention( vide ORA 17/2012/PT/KOl order no 162/2013)

- The documents to prove this must be filed at the earliest if they are filed belatedly, costs may be imposed.

- The law does not say that the failure to furnish the S.8 details must be deliberate and willful or that the failure must be in regard to material particulars.

- It has been introduced to facilitate examinations and therefore the patentee must be candid and fair.

- The Controller cannot deal with this ground casually. They must adhere to the law nor can they dilute it. .

- The Patentee has a statutory duty under S.8, he cannot say that the particulars are available on the website. Nor can the Examiner condone the non-disclosure by saying the details are on the website.( vide Sugen vs Cipla IPAB)

- It is not a penal provision and the object of the law is clear disclosure and there can be no dilution.

- Rule 12(3) is part of the statute and indicates why this provision has been introduced and reflects the sentiments of the Ayyangar Committee report.

- The article “a” in the law cannot be understood to mean only one. Once the S.8(1) detailed particulars are given, the Controller may ask for the details relating to ‘a’ country. This means any. The Controller May ask for the Rule 12(3) details regarding any application.

- It is repeated that S.8 must be complied with.”

IPAB held that the respondent withheld information that ought to have been furnish under Section 8. In this case, EPO has rejected the patent and after appeal USA has also rejected the patent. Respondent has only served the controller with Canadian granted patent, which is in favour of him. This was clear case of hiding out the material facts.

Sec 3(d)- This ground was rejected and also provides elaborate the term “combination” used in explanation part of sec 3(d) by stating that

“The combination mentioned in the Explanation can be only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other”.

Obviousness: Here Justice referred to the decision of European (rejected), USA (on appeal) and Canada (affirmed) counterpart. Justice, also referred the judgment of Justice Pumfrey in (2004 EWHC 477 (Ch) Cipla Limited Vs. Glaxo Group Limited and also provide a clear explanation with respect to each reference. The invention was held obvious. The obviousness of the invention by the judgment is read as follows:

“Ms. P. Sita already knows from D1 and D2 that the serial combination has an additive effect and therefore the closest prior art was this combination”.

“It held that when viewed under a proper standard the evidence establishes a motivation to combine since it was common at that time to provide Brimonidine and Timolol sequentially and DeSantis taught fixed combination”.

Section 3(e): As described earlier, patent is liable to be revoked on the basis of sec 8 and obviousness so IPAB has not taken sec 3 (e) in to consideration as they were not provided with any comparison test to show that improvement in the concerned invention is only additive or more

Final Judgment: Petition is allowed and IN 219504 is revoked.

The above judgement gives a clear warning to applicants regarding the importance of Sec. 8 and also provides an explanation for the term “combination” referred in “Explanation” part of “Sec 3(d)”. The whole judgement can be accessed here.

Appreciation to Indian Patent office

noreply@blogger.com (Neelam Satija) — Fri, 09 Aug 2013 06:15:00 +0000

Guidelines for examination of computer related invention were published on Indian Patent Office site in Jun, 2013 inviting for the comments. The feedback for the guidelines has been provided by 32 organisations/individuals. Today patent office has published the draft guidelines along with the feedback/suggestion by different organisations/individuals. I appreciate the patent office for providing public an opportunity to help in making the final guidelines. Also appreciate the organisations/individuals, who participated in providing feedback/suggestion.

Guidelines for examination of computer related invention & Feedback can be accessed from Patent office site.

ANNOUNCEMENT BY IPAB

noreply@blogger.com (Neelam Satija) — Tue, 06 Aug 2013 15:24:00 +0000

IPAB announced the launch of a vibrant, user-friendly new website with the url http://www.ipabindia.in/. This has been launched by the Hon’ble Chairman Smt. Justice Prabha Sridevan. The new-look website is packed with a lot of features including search string operations. In order to make the transition of the website smooth, IPAB will continue to host the existing website till the new website is fully loaded with the entire data available on the existing website. The new website will go a long way in fulfilling the expectations of the users with regard to finding the relevant information easily.

Must Attend: Paragraph IV Disputes Master Symposium

noreply@blogger.com (Neelam Satija) — Mon, 05 Aug 2013 08:41:00 +0000

Book your diary for

Thursday, October 03 to Friday, October 04, 2013

Millennium Knickerbocker Hotel, Chicago, IL

ACI proudly brings the next installment in Hatch-Waxman Series — the Paragraph IV Disputes Master Symposium.

Discussion points:

Ø Paragraph IV assertions of invalidity and non infringement in view of the AIA

Ø PTO proceedings as a parallel or alternate path in a Paragraph IV challenge

Ø New obviousness challenges based on evolving case law and patent reform

Ø Pleading strategies and dispositive motion practice vis-à-vis local patent rules

Ø New safe harbor considerations relative to pre-market and post-market activities

Ø Provisions under FDASIA and GDUFA which may impact Hatch-Waxman litigation

Ø New challenges to regulatory and market exclusivities

Ø The latest on patent settlement agreement drafting in view of Watson

Ø Claim construction and Markman strategies in light of continuing intra-circuit discord

Ø Evolving theories of law in divided infringement and inducement that are influencing method of treatment claims

Ø Damages and at risk launches in view of Protonix

Ø Inequitable conduct challenges post-Therasense and post-AIA

Federal Jurists from the Districts of Northern Illinois, Eastern Texas, and New Jersey are also participating in the conference. Their presence will provide opportunity to learn firsthand how the bench analyzes the theories of the case.

Complete information available at http://www.americanconference.com/home

Register now by calling 1-888-224-2480, faxing your registration form to 1-888-927-1563 or logging onto www.AmericanConference/PIVDisputesChicago .

Another Victory For The Generic Manufacturers – Based on Exclusive Provision Sec 3 (d) of Indian Patent Act

noreply@blogger.com (Neelam Satija) — Sat, 03 Aug 2013 09:29:00 +0000

Intellectual Property Appellate Board revoked a GSK’s Patent related to Lapatinib Ditosylate on Jul 27^th, 2013. Revocation application for Patent No.IN221171 has been filed by Fresenius Kabi Oncology Limited. The petition was attacked on the grounds of 64(1)(f) and on the grounds of Sections 64(1)(k), 64(1)(d), 2(1)(ja), and 64(1)(h) of The Patents Act. But the arguments were focussed on obviousness, S.3(d) and S. 8

IPAB pronounced the judgment after having a clear analysis of the patent, grounds by the opponent (Fresenius Kabi oncology Limited) and also the reply of the Patentee (GSK). The Decision of the IPAB is based on the following Grounds:

Sec 3(d):

The reply of the patentee of the examination report has been taken in to account wherein he admitted the enhancement by using lapatinib ditosylate as compared to prior art salts is the moisture sorbtion property and the increase in stability. It was held by IPAB after considering the interpretation of efficacy in decision “ Novartis Ag vs Union of India” that

“In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy.” Physico-chemical properties have nothing to do with therapeutic efficacy.

Applying S.3(d) and the decision of the Supreme Court in the Novartis case, IPAB held that the patent deserves to be revoked.

Obviousness:

Firstly, IPAB states that is necessary to understand who is the person Skilled in the Art, what is the Common General Knowledge and so on for deciding obviousness. In earlier judgment F.Hoffman la Roche v Cipla, it was held that according to law, the obviousness test will be made against the Person Skilled In the Art (Ms.P.Sita) and not a Person with Ordinary Skill In The Art. This had earlier described this person in the IPAB Order No.250/2012 in OA/8/2009/PT/CH and M.P. NOs.85 & 111 of 2012 In OA/8/2009/PT/CH - Sankalp Rehabilitation Trust vs. F.HOFFMANN-LA ROCHE AG and Others.

IPAB held that there is no doubt that selecting a correct salt is not easy, if the choice could only have been made by testing each compound one after the other with no clue available. But references provided by the opponent provide a clue. It was reasonable to hope it might, it would not have been a blindman’s buff choice. So to the Person Skilled in The Art taught by references provided by opponent, the invention was obvious. According to our Act, the patent is revoked if the invention is obvious. So the secondary considerations cannot change that. It is true that the applicant has not filed any evidence by way of affidavit, but the prior arts have been filed and on the facts of this case this material is sufficient.

S.8 disclosure and non-compliance:- This particular section destroys a patent which is otherwise patentable on grounds which have nothing to do with the invention, but only with the Inventor’s failure to comply with foreign filing particulars during the grant proceedings.

IPAB explains the intent of the law makers. Further regarding this section, it has been stated that

“ It is unfortunate that the office has failed to understand the importance of the S.8 requirement and leaves it to the Patentee to decide what he will give. We earnestly hope that this practice has died a natural death. It is important that the Patentee furnishes details of those search reports where there are objections like obviousness objections and shall not suppress them. If one of the major Patent offices alone has raised an obviousness objection, it is ‘the duty of the Patentee to disclose it, considering the Object of the Act”.

In the present case we are rejecting the S.8 objection only because the applicant has not made out the grounds of attack by stating the facts. The facts have to be pleaded and the applicant must state how the particular undisclosed application was for the same or substantially the same invention. In any event, in the absence of pleading and proof of violation, we reject this ground of attack.

Final Judgement: the invention is obvious and is hit by S.3(d) and Patent No 221171 is revoked. The Petition is allowed with costs of Rs.50,000/-.

This judgment provides the generic companies an opportunity to manufacture/Launch lapatinib ditosylate after the expiry of substance patent of Lapatinib in India (2019). This provides two years earlier market entry for the generic companies as patent revoked has normal expiry of 2021, which is now not a concern. But still the GSK has a chance to file Appeal against this decision. Now we can wait for the further step of GSK.

Whole judgment can be read here

Good News for the Apple’s phone Lovers

noreply@blogger.com (Neelam Satija) — Thu, 18 Jul 2013 17:45:00 +0000

Today, a patent application is published on USPTO which describes finger sensor having pixel sensing circuitry for coupling electrodes and pixel sensing traces and related methods. This US patent application is filed by Apple Inc. in January 2013. This is another application in the list of Apple’s US application. There are already more than 3,000 patent application is the name of “ Apple Inc.” at USPTO.

The patent describes a technology in which a sensor is used to trace a person's finger and fingerprint and determine, based on that, if they have proper credentials. Apple's patent application doesn't go as far as including the security features that might come with it on the software side, but it's clear what the technology is designed to do.

So Apple’s Lover can wait.... May be they get this new feature in future in iphone

Apple's New US Patent Application

Indian Patent Database URL has been changed

noreply@blogger.com (Madhav Trivedi) — Wed, 05 Jan 2011 05:01:00 +0000

Indian Patent Database is now available on below URL:

http://www.ipindia.nic.in

Natco Pharma tightened the belt to fight against Teva's citizen petition for Glatiramer Acetate

noreply@blogger.com (Madhav Trivedi) — Sat, 28 Nov 2009 03:50:00 +0000

Pharmabiz reuter has informed the whole matter that Natco Pharma, a Rs 400 crore Hyderabad-based pharma company, is planning to suitably respond to Teva Pharma's Citizen Petition with the US FDA regarding Glatiramer Acetate product. Teva had alleged, that there is a significant difference between Natco's product and its Copaxone. According to Natco Pharma the petition is intended to prolong Teva's monopoly on Copaxone, used in the treatment of multiple sclerosis. This Citizen Petition is very similar to another petition which Teva had filed in 2008, which was rejected by US FDA earlier this year.

Natco and Mylan's abbreviated new drug application for Glatiramer Acetate has been accepted for review by the US FDA in September 2009 and the review is presently on going. This attempt of Teva is to delay the approval of the ANDA. This product is extremely important for Teva's sales (US$ 11.1 billion in 2008) and it is the largest product in their portfolio. For Natco, this product, on approval, represents a significant upside. Natco is the only generic producer in world of this product, involving complex peptide chemistry.

Natco press release said that the company stands firmly behind the safety and integrity of its marketed Glatiramer Acetate product and it will respond to Teva's unfounded claims.

India going harder : India may ask exporters to boycott KLM to deter EU for holding up drug cargo

noreply@blogger.com (Madhav Trivedi) — Wed, 28 Oct 2009 04:39:00 +0000

Even as the Indian government is planning to file a complaint with World Trade Organisation (WTO) against the European Union (EU) on the issue of seizure of Indian drug shipments at EU ports, the government is also exploring other options to pressurise the EU nations to change the patent laws, amended some time back, to make them more stringent.

According to pharmabiz sources, the Union Commerce Ministry is contemplating to motivate the pharmaceutical exporters in the country not to send their cargo through KLM Airlines of Netherlands as a retaliatory measure against that country. It may be noted that Netherlands has been one of the EU countries which has been seizing Indian drug shipments at its ports on charges of counterfeit/patent infringement. For instance, the customs authorities at Rotterdam in the Netherlands had some months back seized shipments of the generic drug losartan, which was manufactured in India and was in transit to Brazil. Losartan, indicated to treat high blood pressure, is not under patent protection either in India or Brazil.

Due to its competitive prices, most of the Indian pharmaceutical exporters have been using the services of KLM Airlines to send their cargo to Latin American and African countries. As the volume is quite large, if the Indian pharmaceutical exporters take the retaliatory measures in this regard, it will be a huge loss to the Netherlands company, sources said.

The Indian government's contemplation in this regard comes in the wake of near total collapse of all efforts at different international forums to find an amicable solution to the nagging issue. The entire issue was triggered last year when the EU countries began implementing local patent rules rigidly some months back. These EU rules stipulate that any product patent that has been granted in EU countries, if being transported through their countries, is also liable for confiscation under their patent law.

Though the country had engaged in hectic negotiations at different international forums during the last several months to find an amicable solution to this vexed issue, there have been no desired results with no abatement in the seizure of Indian drug shipments at different EU ports. There were several instances of seizures by EU/US Custom authorities of the Indian generic medicines in transit to various developing countries in Latin America and Africa on the grounds of counterfeit/patent infringement, patent litigations in US courts, etc.

The government so far failed to cut much ice with the EU authorities in relaxing regulations on patent and trade mark issues so that at least the drug shipments on transit cannot be seized at the EU ports on charges of counterfeiting and patents infringement. Though the government had provided data of Indian drug shipments which were seized at EU ports, the EU authorities have so far defended their action.

Forest, Glenmark drug fails against smoker's cough (oglemilast)

noreply@blogger.com (Abhishek) — Wed, 19 Aug 2009 14:18:00 +0000

Glenmark Pharmaceuticals and U.S. partner Forest Laboratories said a drug they were developing to treat smoker's cough failed in a mid-stage trial, knocking Glenmark shares down more than 17 percent on Wednesday.

The Indian firm had been banking heavily on the drug's success, and its breakdown means it will miss out on a potentially lucrative multi-billion dollar market, analysts said.

The drug was to treat chronic obstructive pulmonary disease (COPD), a persistent blockage of airways caused by emphysema or chronic bronchitis that affects an estimated 14 million Americans and is the fourth most common cause of death.

Glenmark and Forest said a Phase IIb study meant to determine the best appropriate dosing for the medicine, called oglemilast, did not show statistically significant results.

"Everybody had built in some kind of an upside because of commercialisation of this molecule," said Sarabjit Kour Nangra, analyst with Angel Broking.

"So, once there is no visibility or lesser visibility in terms of those coming through, the stock is taking a knock. The shares depend on how the R&D unfolds from here."

PIPELINE LOSES SHINE

Glenmark has two other drugs in mid-stage trials: one to treat Type II diabetes, and one for osteoarthritic pain, incontinence and neuropathic pain, according to the company's website.
It also has several other molecules, including those to treat rheumatoid arthritis, obesity and cardiovascular disorders that are in earlier-stage trials.

"Big multinationals may think twice about partnering with Glenmark because of this failure," said Verma, noting pharmaceutical giants were looking to keep their costs in check and would not want to risk spending on drug development only to see the compound fail in later-stage trials.

"We need to re-evaluate whether the trial was designed appropriately, what were the shortcomings ... we need to internally analyse all that," Glenmark Managing Director Glen Saldanha told a conference call.

Oglemilast did not show a statistically meaningful benefit, compared with a dummy drug, in a 12-week study that evaluated three doses of the medicine in patients with moderate to very severe forms of the ailment, Forest and Glenmark said.

Pharmaceutical Companies's Net Dips and Ups (2)

noreply@blogger.com (Madhav Trivedi) — Tue, 04 Aug 2009 06:00:00 +0000

The results declared by the individual companies are derived from the reliable sources likewise Pharmabiz, economic times, india profit etc.

Indoco Remedies net profit dips by 31%, net sales by 10

Indoco Remedies hit by lower domestic sales during the quarter ended June 2009 and its net profit declined sharply by 31.4 per cent to Rs 16.88 crore from Rs 24.60 crore in the similar period of last year. Despite higher exports its net sales declined by 10.2 per cent to Rs 98.34 crore from Rs 109.49 crore. The fall in profit impacted earning per share, which nosedived to Rs 13.74 from Rs 20.02 in the last period.

The company's exports increased by 16.1 per cent, but its domestic formulation sales declined by 17.5 per cent. The sales declined due to it introduction certain credit control measures in the current and previous quarters. However, the de-growth in domestic sales was much lower as compared to earlier quarters. The products like Cyclopam, Tuspel Plus, MCBM-69, Clokit, Febrex Plus Drops, etc., achieved positive trend during the quarter under review.

Exports to regulated market registered a growth of 15 per cent to Rs 22.47 crore from Rs 19.54 crore. Its Baddi facility received UK MHRA approval. The AOK (Germany) tender dispatches are in full swing and its API plant at Patalganga received approval for supply of metformin API for the OAK tender. The exports to emerging markets increased by 24.09 per cent to Rs 4.48 crore from Rs 3.61 crore.

Sanofi-aventis net profit moves up by 29% to €2.3 bn in Q2

Sanofi-aventis, the third largest pharma giant in the World, has clocked impressive performance during the second quarter ended June 2009 on account of better performance by its products like Lantus, Lovenox and Taxotere. Its net profit increased by 29.4 per cent to €2,268 million from €1,753 million in the corresponding period of last year. Its net sales increased by 11.2 per cent to €7,438 million from €6,689 million. The earning per share improved to €1.74 during the quarter from €1.34.

Its consolidated pharmaceutical sales increased to €6,726 million during the second quarter ended June 2009 from €6032 million, representing a growth of 11.5 per cent and consolidated sales of vaccines increased by 8.4 per cent to €712 million from €657 million. The company's sales in Europe improved by 4.6 per cent to €3,079 million. US sales increased by 5.4 per cent to €2,438 million, driven by fine performances from Lantus (up by 28.7 per cent), Taxotere (up by 9.6 per cent) and Eloxatin (up by 10 per cent).

Christopher A Viehbacher, CEO, said, "The group delivered very strong results in the second quarter, driven by solid growth of key pharmaceutical brands and vaccines, strong sales in emerging markets and recent acquisitions. Multaq has just been launched in the US in July. The strong progression of our earnings has led us to raise our guidance for 2009 to EPS growth of around 10 per cent. Since the beginning of the year, we have launched a new R&D approach to increase innovation, we have strengthened our growth platforms through acquisitions, and we are moving forward with the transformation of our company. Those achievements constitute another step toward our vision of becoming a leading diversified global healthcare company with a sustainable growth profile by 2013."

During the first half of 2009, sanofi recorded net sales growth of 6.7 per cent to €14,545 million from €13,626 million in the corresponding period of last year mainly due to appreciation of US Dollar against Euro. Its net profit increased by 22.3 per cent to €4,446 million from €3,636 million. Its R&D expenditure moved up by 3.7 per cent to €2,260 million from €2,180 million.

Dishman Pharma consolidated net surges by 41% in Q1

Dishman Pharmaceutical and Chemicals, a Rs 1062 crore pharma from Ahmedabad, has reported strong growth in profitability during the first quarter ended June 2009 and its consolidated net profit moved up by 41.4 per cent to Rs 39.20 crore from Rs 27.73 crore in the corresponding period of last year. However, its net sales declined by 3.5 per cent to Rs 227.71 crore from Rs 235.87 crore. Its other operating income increased to Rs 15.48 crore from Rs 0.33 crore. With strong growth in profits, its earning per share during the quarter went up to Rs 4.85 from Rs 3.44.

The income from CRAMS activities declined to Rs 168.35 crore from Rs 182.48 crore in the similar period of last year. Its income from marketable molecules went up by 11.2 per cent to Rs 59.36 crore from Rs 53.39 crore.

Orchid Chemicals' net loss at Rs 29.76 cr in Q1

Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has suffered a setback during the first quarter on account of interest burden, foreign exchange loss and lower operating income. It posted slightly lower net loss for the first quarter ended June 2009 to Rs 29.76 crore as against Rs 31.65 crore in the corresponding period of last year. However, its net sales moved up by 8.2 per cent to Rs 305.82 crore from Rs 282.55 crore.

The profit before interest, depreciation and taxation also moved down by 26.6 per cent to Rs 64.92 crore from Rs 88.33 crore The company provided Rs 29.98 for foreign exchange loss during the quarter under review as against a gain of Rs 3.50 crore. Further its interest burden jumped by 70.8 per cent to Rs 51.66 crore from Rs 30.24 crore. Orchid's other operating income declined to Rs 3.01 crore from Rs 23.77 crore.

The business performance of Orchid during the first quarter of this fiscal remained steady in terms of volumes and revenues. The US generics business gained from an increased demand for Orchid's oral cephalosporin products which has served to counteract the impact of competition in certain injectable products. Orchid's EU generics business has taken off well with the company dispatching key cephalosporin products based on additional approvals secured by the partner, and with Tazobactam-Piperacillin, the key penicillin injection continuing to increase its market share at a steady pace.

During the first quarter of this fiscal, Orchid received its final ANDA approvals for amlodipine besylate tablets and levetiracetam tablets. With this, the cumulative count of Orchid's final ANDA approvals moved to 32, out of which 26 are in the cephalosporin segment and 6 are in the NPNC segment.

Orchid's cumulative ANDA filings in the US market total to 58. The break-up of the total ANDA filings is 29 in the cephalosporins space, 5 in the betalactams space, 21 in NPNC (includes 7 Para IV, First-to-File filings) segment and 3 in the carbapenems segments.
Additional ANDAs which are in the advanced stages of development and analysis will be filed progressively in the ensuing quarters.

The cumulative filing count of applications of Marketing Authorizations in Europe is 29 of which 4 have received approval. The break-up of the total MA filings is 23 in the cephalosporin segment, one in the betalactam segment, two in the carbapenem segment and three in the NPNC segment. In the API (Active Pharmaceutical Ingredients) segment Orchid's cumulative US DMF count is 72. The break-up of the total filings is 26 in the cephalosporin segment, 33 in the NPNC segment, two in the betalactam segment and 11 in the carbapenems segment. In the European market space the cumulative filings of CoS (Certificate of Suitability) count remained at 20 which includes 12 in cephalosporin segment, seven in NPNC segment and one in the betalactam segment. Orchid's Japanese DMF filings remained at three.

Pharmaceutical Companies's Net Dips and Ups

noreply@blogger.com (Madhav Trivedi) — Wed, 29 Jul 2009 04:46:00 +0000

The results declared by the individual companies are derived from the reliable sources likewise Pharmabiz, economic times, india profit etc.

Cadila Healthcare consolidated net jumps by 39% inQ1

Pharma major Zydus Cadila on Monday reported a growth of 39 per cent in its consolidated net profit for the first quarter ended June 30 to Rs 124.79 crore, over the same period a year earlier.

Consolidated total income of the company also rose to Rs 907.76 crore during the April-June period of this fiscal from Rs 715.62 crore of the same period last year, Cadila Healthcare (Zydus Cadila) said in a filing to the Bombay Stock Exchange (BSE).

On a standalone basis, the drug maker posted a net profit of Rs 122.56 crore in the latest quarter of FY'10, whereas the same was at Rs 55.64 crore in the corresponding period a year ago. “The standalone figures for the current quarter are not comparable with the figures of the corresponding quarter of the previous year because of demerger of consumer products division, which got merged with Zydus Wellness, a subsidiary of Cadila Healthcare,” the filing said. Shares of Cadila Healthcare were trading at Rs 399.05, up 2.54 per cent in afternoon trade on the BSE.

GlaxoSmithKline's net profit moves up 8% in Q2

Glaxosmithkline (GSK) Pharmaceuticals has recorded a 8.2% growth in net profit for the second quarter ended June 30, propped up by a higher treasury income and launch of its new products.
The company’s net profit stood at Rs 124.4 crore this quarter compared with Rs 114.9 crore for the same period of the previous financial year. GSK Pharma’s revenues jumped 9.7% to Rs 457.4 crore from Rs 416.9 crore in the corresponding quarter last year.

GSK Pharma MD Hasit Joshipura told economic times: “Net profit was positively impacted by treasury income, while sales growth was on account of the launch of new products, ahead of schedule. Recent launches include Arixtra (antithrombotic agent), Rotarix (rotavirus diarrhoea vaccine) and Tykerb (refractory breast cancer drug).” GSK Pharma has seen sales doubling in the vaccines segment. Vaccines, which earlier comprised 6% of the sales, accounted for 12% for the most recent quarter. According to Mr Joshipura, future growth will be driven by new product launches from the stable of the parent company. On Tuesday, the GSK Pharma stock was up 0.28% to close at Rs 1351.15 on BSE.

GSK Pharma currently has $350 million (approximately Rs 1,685 crore) of cash on its books and is looking at utilising this money in two ways. “We are looking at acquiring brands for which some have already been shortlisted. We are looking for a strategic fit and if that exists, we will go out and buy them.”

Glenmark Q1 net profit dips 54% on forex loss

Drug maker Glenmark Pharmaceuticals today reported a decline of 54 per cent in its consolidated net profit to Rs 53.45 crore on account of forex losses and higher interest cost for the first quarter ended June 30, 2009 over the same period last year.

Total income rose to Rs 551.28 crore in the latest quarter, as against Rs 471.74 crore in the same period previous fiscal, Glenmark Pharmaceuticals said in a filing to the Bombay Stock Exchange.

"Sales growth across regions for the quarter has been encouraging. Even though the environment across markets remains subdued, we still managed to accelerate sales growth in the first quarter," Glenmark Pharmaceuticals CEO and MD Glenn Saldanha said.

On the standalone basis, the company has posted a decline of 90.79 per cent to Rs 5.22 crore for the quarter ended June, compared to same quarter last year.

Total income rose to Rs 221.97 crore in the quarter ended June 30, against Rs 194.41 crore in the same quarter last year.

Alembic net up to Rs 12.25 cr, sales at Rs 292 cr

Alembic Ltd, a Rs 1100 crore Vadodara-based pharma major, has announced strong bottom line during the first quarter ended June 2009 as against a net loss due to foreign exchange loss in the corresponding period of last year. The company earned a net profit of Rs 12.25 crore as compared a net loss of Rs 4.70 crore. Its net sales went up by 26.7 per cent to Rs 290.64 crore from Rs 229.34 crore

The company's export sales moved up to Rs 133.97 crore from Rs 114.13 crore, a growth of 17.4 per cent and its domestic sales increased by 29.6 per cent to Rs 158.52 crore from Rs 122.27 crore in the quarter ended June 2008. Total sales to regulated market increased by 33 per cent to Rs 109 crore from Rs 83 crore.
The profit before interest, depreciation and taxation also increased by 29.8 per cent to Rs 30.76 crore from Rs 23.70 crore. The company incurred R&D expenditure of Rs 9.23 crore during the quarter ended June 2009 as compared to Rs 8.52 crore in the corresponding period of last year. It has launched two ANDAs in US market during the quarter. It filed one ANDA and its cumulative total reached to 20 ANDAs and 32 DMFs till the end of first quarter of 2009-10.

Alembic has bought back 21,21,882 equity shares as at the end of June 2009, at an average price of Rs 35.28 for a total consideration of Rs 7.49 crore, which is about 22.69 per cent of the total buy-back size of Rs 33 crore.

Wanbury's net profit jumps to Rs 9.47 cr

Wanbury Ltd has posted strong growth in its net profit during the quarter ended June 2009 and its net profit went up sharply to Rs 9.47 crore from Rs 1.43 crore in the corresponding period of last year. Its net sales also moved up by 25.6 per cent to Rs 83.74 crore from Rs 66.66 crore. With smart improvement in profits, its earning per share reached at Rs 6.15 as against Rs 0.97 in the last period.

The profit before interest, depreciation, taxation and forex gains, improved by 155 per cent to Rs 18.13 crore from Rs 7.12 crore in the similar period of last year. The interest burden increased sharply by almost 75 per cent to Rs 6.15 crore from Rs 3.52 crore.

For the six months ended June 2009, Wanbury has shown a net loss of Rs 31.28 crore on sales of Rs 167.66 crore. The loss is basically due to provision of Rs 14.06 crore for the foreign exchange loss.

According to a company release, the merger scheme of The Pharmaceutical Products of India Ltd is still pending with BIFR.

In order to hedge its foreign currency earnings, when the Rupees was strengthening, Wanbury entered into derivative hedging structures protecting its dollar receivables. As at the end of June 2009, Mark to Market losses on thee derivatives amounted to Rs 29.07 crore. As an abundant caution, it had made a provision of Rs 35 crore as at the end of March 2009 to meet such anticipated forex losses and balance out of the same as at the end of June 2009 worked out to Rs 26.56 crore. The company has fully utilized Rs 85.28 crore raised from the proceeds of the FCCB issue.

Dabur India Q1 net up 15%

Dabur India Ltd reported a net profit of Rs 80.83 crore for the first quarter ended June 30, 2009 where as the same was at Rs 70.14 crore in the same quarter in 2008.

Total income for the quarter has increased to Rs 616.13 crore as compared with Rs 535.29 crore in the year-ago period.

Ranbaxy incurs net loss of Rs 363 cr before foreign exchange gains in Q2

Fortis Healthcare net zooms to Rs 7.6 cr in Q1

Aventis Pharma net up by 12.7% in Q2, interim dividend of 350%

Hikal net moves up by 25% in Q1

Wockhardt Ltd has sold its nutritional businesses to Abbott Laboratories

noreply@blogger.com (Abhishek) — Wed, 29 Jul 2009 04:25:00 +0000

Mumbai-based drug major Wockhardt Ltd which is battling a debt pile of over Rs 3,700 crore, has sold its nutritional businesses and a few facilities to Abbott Laboratories of the US for around $130 million (nearly Rs 626 crore) in cash.

Wockhardt has well-known products in the pediatric nutritional category such as Farex, Dexolac and Nusobee infant formulas. The transaction also includes nutrition manufacturing facilities in Lalru and Jagraon (in Punjab).

Earlier, Wockhardt had acquired nutritional supplement maker Dumex India Pvt Ltd, along with its products Protinex and Farex, in June 2006.

Abbott has confirmed it would acquire Wockhardt's nutrition businesses, Carol Info Services Ltd, and certain Wockhardt subsidiaries and group companies. The acquisition includes around 600 employees. Abbott expects the transactions to close in the second half of 2009, but they are not being conducted by its publicly traded subsidiary, Abbott India Ltd, it said.

Abbott offers Isomil, PediaSure, Ensure and Glucerna in India and plans to introduce additional products from its broad based nutritional portfolio to Indian consumers in the coming years, said the Abbott statement.

"This acquisition is an excellent strategic fit for Abbott to accelerate growth of its nutrition business in India, where the nutritional market is expected to experience strong growth in the coming years.

So from now onwards the new generation will see Abbott tag on Farex, Dexolac and Nusobee (infant formulas) instead of Wockhardt.

WIPO plans to implant "Global Patenting System" on developing nations through PCT II

noreply@blogger.com (Madhav Trivedi) — Wed, 29 Jul 2009 03:52:00 +0000

The new world patent order is being sought to be introduced through a comprehensive proposal drafted by the US by floating a new Patent Cooperation Treaty, PCT II, in the General Assembly of WIPO at Geneva. The trilaterals with the support of WIPO and World Health Organization are trying their best to get the proposal approved by the General Assembly by inducing some of developing nations.

The US, European Union and Japan are pushing a new international patent agenda through World Intellectual Property Organization on behalf of the powerful big pharma of the developed countries. WIPO, controlled by these trilaterals, is trying hard to impose a 'Global Patenting System' at the forthcoming General Assembly session of WIPO in September.

A session of the PCT Working Group of WIPO held last May to push this agenda got withdrawn as the developing countries led by India, Brazil South, Africa and Argentina had strongly opposed the move. India' diplomatic mission in Geneva played a crucial role in defeating the proposal for Global Patenting piloted by Director General of WIPO at the Working Group meeting, it is learnt Informed sources said that the WIPO plan is to institute a system similar to the one that exists for international registration of Trade Marks under the Madrid System, a treaty already administered by WIPO. With the approval of Global Patenting at the General Assembly, developed nations are seeking to dilute the sovereignty of developing nations in determining patentability of applications for inventions and do way with flexibilities granted under TRIPS Agreement.

Under the TRIPS Agreement, developing nations are free to consider all the flexibilities before granting a patent to any new invention. While many developing nations do not have the expertise to scrutinize and determine patentability of a patent claim, India has adequate capabilities with full fledged patent control offices in the country.

The strategy of developed nations backed WIPO is to introduce 'automatic grant of patents in all member states' once PCT II is adopted at the General Assembly. This is what is 'combining of international and national processing of patent applications' as suggested by the USPTO to WIPO.

A serious implication of the proposed new global patent system is that patent laws adopted by the developing countries become irrelevant and ineffective. Besides this, challenging of patent claims will become almost impossible making monopoly marketing of pharmaceutical products quite easy for MNCs in India.

Now, India being a major manufacturer and exporter of generic drugs threatening sales of branded business of the big pharma, the target of this new agenda of developed nations seems to be mainly Indian pharma industry. Indian Pharmaceutical Alliance (IPA), representing large generic companies of the country, has already alerted the cabinet secretary, commerce secretary and ministry of external affairs in this regard.

M/s Teva on settlement phase: Settle with Ortho-McNeil-Janssen on Ortho Tri-Cyclen Lo litigation

noreply@blogger.com (Madhav Trivedi) — Tue, 28 Jul 2009 05:25:00 +0000

ORTHO TRI-CYCLEN® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

ORTHO TRI-CYCLEN® Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

Earlier Teva announced that to its press release dated July 7, 2009, the Company and Ortho McNeil Janssen have extended their agreement to cease shipments of generic versions of Ortho Tri-Cyclen Lo®, until the earlier of (a) the Court's ruling on the motion for preliminary injunction or (b) July 29.

Teva Pharmaceutical Industries Ltd has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the US District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive, Ortho Tri-Cyclen Lo.

Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances. The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent.

Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient

noreply@blogger.com (Abhishek) — Sun, 12 Jul 2009 11:01:00 +0000

"After more than a decade of research and testing, finally Daiichi Sankyo and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

PCI usually includes the placement of a stent to help keep the artery open.

Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition. "The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes

The approval was based on results from the pivotal Phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with Plavix(R) (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots (known as stent thrombosis) in patients treated with Effient compared with Plavix (a relative risk reduction of approximately 50 percent).
Important Safety Information about Effient
Antiplatelet medicines, including Effient, can increase the risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or "mini-stroke" (transient ischemic attack or TIA).
If patients are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (eg, warfarin) or taking NSAIDs (eg, ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.
If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient.
Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or death.
Patients should get medical attention right away if they develop any of the following unexpected symptoms: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots. These symptoms may be signs of a rare but potentially life-threatening condition called TTP, which has been reported with other medicines in this class.

For more information about Effient, including prescribing information, please visit www.Effient.com.

Budget exempts pharma industry from duty increament

noreply@blogger.com (Madhav Trivedi) — Tue, 07 Jul 2009 03:43:00 +0000

Giving a big sigh of relief to the pharma industry, especially the small and medium sectors, Union finance minister Pranab Mukherjee has left it unharmed while raising the excise duty on the most of the sectors from 4 per cent to 8 per cent, in his budget presented in the Parliament on Monday.

True to the apprehensions of the industry as a whole, the finance minister rolled back the blanket cut in excise duty from 8 per cent to 4 per cent announced as part of a stimulus package some months back. However, he spared the pharma industry from harsh step, while presenting his general budget which could enthuse many."With the government's proclaimed objective of introducing a Goods and Services Tax (GST) both at the national and State level, some more steps in that direction are necessary.

One measure that would facilitate the process is the further convergence of central excise duty rates to a mean rate - currently 8 per cent. I have reviewed the list of items currently attracting the rate of 4 per cent, the only rate below the mean rate. There is a case for enhancing the rate on many items appearing in this list to 8 per cent, which I propose to do, with the following major exceptions," he said, while including drugs and pharmaceuticals and medical equipment among exempted categories.

"The basic customs duty on influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B, rheumatic arthiritis etc. on the bulk drugs used for the manufacture of such drugs, has been reduced from 10 per cent to 5 per cents. They will also be totally exempt from excise duty and countervailing duty," according to the budget proposal.

In another relief to the medical devices industry, the customs duty will also be reduced from 7.5 per cent to 5 per cent on two specified life-saving devises used in treatment of heart conditions. These devises will be fully exempt from excise duty and CVD also.Besides, along with the other small scale units, the pharma sector also will benefit from the budget proposal for boosting the bank loans for them. Besides, in a relief to the SME sector, the existing special incentive upto two per cent for exports will continue further.

Though the industry was looking for further increase in the weighted deduction for R & D in the pharma sector from the current 150 per cent, it did not come through though the finance minister extended the benefit to more areas. The budget has allocated Rs 155.25 crore for the pharmaceutical department.

German drugmaker Bayer sued Israeli generic competitor Teva

noreply@blogger.com (Neelam Satija) — Thu, 02 Jul 2009 10:55:00 +0000

German drugmaker Bayer (BAYG.DE) sued Israeli generic competitor Teva (TEVA.TA) in a U.S. court for infringing its patent covering “Levitra".

The patent at issue in the suit is Bayer Schering Pharma's U.S. Patent No. 6,362,178, expiring in 2018." Levitra, was first approved by U.S. regulators in 2003, and is sold by Schering-Plough and GlaxoSmithKline Plc in the U.S. and competes with Pfizer Inc.’s Viagra and Eli Lilly & Co.’s Cialis.

The drug, whose active ingredient is vardenafil hydrochloride, generated $341 million in sales last year for Bayer, the company said in its annual report.

Teva is seeking U.S. Food and Drug Administration approval to sell a generic version of the drug. Teva filed ANDA application with Paragraph IV certification, in which Teva contends that it won’t infringe any valid or enforceable patent on this medicine. Under federal law, Bayer’s suit triggers an automatic 30-month period in which the FDA can’t approve Teva’s application, unless a judge rules in the generic-drug maker’s favor before then.

Denise Bradley, a spokeswoman for Petak Tikva, Israel-based Teva, said the company has no comment on the suit, which was filed in federal court in Wilmington, Delaware. Teva is the world’s biggest generic-drug maker.
Lets wait and watch who will win!!!!!!!!!!!

Pfizer Sues Matrix (Mylan) on worlds largest selling drug “Atorvastatin”.

noreply@blogger.com (Madhav Trivedi) — Mon, 29 Jun 2009 06:52:00 +0000

Pfizer is suing Matrix (Mylan) for filing an ANDA to manufacture a version of the blockbuster cholesterol drug Lipitor in 10-, 20-, 40- and 80-mg strength tablets.

Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.
Pfizer’s patents on Atorvastatin which are in the light:

US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV

US6087511 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin.

US6274740 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof.

As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.

In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.
“Defendants have taken immediate and active steps” to sell Lipitor copies in the U.S. and “Pfizer will be irreparably harmed” if Canonsburg, Pennsylvania-based Mylan succeeds, according to the complaint.

Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.

Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.

Mike Laffin, a spokesman for Mylan, didn’t immediately return voice and e-mail messages seeking comment on the lawsuit.

Pfizer fell 63 cents to $14.13 in New York Stock Exchange composite trading at 4:15 p.m. Mylan fell 56 cents to $13.06 in Nasdaq Stock Market trading.

The case is Pfizer Inc. v. Mylan Inc., U.S. District Court, District of Delaware (Wilmington).

COMPLIANCE WITH cGMP IS MUST ---OTHERWISE FDA CAN TAKE ACTION

noreply@blogger.com (Neelam Satija) — Sat, 27 Jun 2009 04:27:00 +0000

U.S. Marshals, at the request of the Food and drug Adminstration , seized drug products manufactured at Caraco Pharmaceutical laboratories limited (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

This action follows Caraco’s continued failure to meet the FDA’s Current Good Manufacturing practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.

Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, health care providers consider alternative treatments that are safe and effective.

Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov.

Sanofi sued Teva over Eloxatin patent: Court Grants Teva Summary Judgment of Non-Infringement on Eloxatin®

noreply@blogger.com (Madhav Trivedi) — Tue, 23 Jun 2009 10:46:00 +0000

Sanofi-Aventis has sued Teva Industries Ltd. over Teva's plans to sell a generic version of the French drugmaker's cancer treatment Eloxatin.

The lawsuit, filed in federal court in New Jersey, comes on the heels of a similar suit filed by Sanofi against Sandoz, a unit of Novartis.

Eloxatin had nearly 1.7 billion euros in sales in 2006 for Sanofi, the world's third largest drugmaker.

In an amended complaint, Sanofi alleged that Teva's plan to make and sell a generic version of the drug infringed a patent for which it was an exclusive licensee.

Teva filed a new drug application with the FDA for a generic product, oxaliplatin injection, according to the complaint. Oxaliplatin is the active ingredient in Eloxatin.

Sanofi is seeking an order blocking Teva from making or selling the generic product in the United States.

Teva and Sanofi could not be reached immediately for comment.

Recently

Teva Pharmaceutical Industries Ltd. announced that the US District Court for the District of New Jersey has granted summary judgment in Teva's favour on the issue of non-infringement with regard to Debiopharm's US Patent No. 5,338,874.

The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.