Brazil: AGU defines role of ANVISA and INPI

Posted on 01/02/2011 by Guna

Quick background for readers who are new to brazil patent scenario: In brazil, the pharmaceutical product and related patents’ grant (it is not much clear here; what kind of patent application are linked) is linked to its regulatory agency ANVISA (Brazilian National Health Surveillance Agency). The Brazilian Patent Office (INPI) will send the patent application files to ANVISA in order to obtain official approval, which will state reasons for giving or denying its approval. Related reading click here

In a recent decision,  Attorney general of union defines the role of ANVISA and INPI. According to AGU’s opinion, INPI will analyze the patentability requirement and ANVISA’s role will be restricted to evaluating safety and efficacy.

Nearly 145 pharmaceutical patent applications are pending due to the disagreement.

[patentlybiotech] [AGU’s press release translated] [Original press release]

Posted in Patent case | Tagged , , , | 1 Comment

CI & Patent News: 31/01/2011

Posted on 31/01/2011 by Guna

1) Eli Lilly Petitions for Certiorari in Sun v. Eli Lilly (Holman’s Biotech IP Blog); Eli lilly asks supreme court to review. The petition for certiorari is is a type of writ seeking judicial review (Wiki). Recently Federal court denied to en banc rehearing (Link)

2) Dr. Reddy’s Provides Update on the Fexofenadine-Pseudoephedrine 24 Hour Litigation (Businesswire); District court of New jersey vacated preliminary injunction granted against launch of DRL’s generic product.

3) Generics Weigh In on Biological Drugs (WSJ)

4) J&J Loses Stent Case (WSJ)

5) Novartis’ Lescol Patent Enforceable, Judge Says (Law360);

6) Cipla promoters in sale talks with global firms (ET report)

7) Ranbaxy sign MOU with the Government of Russia Yaroslavl Region (NSE updates); Ranbaxy would establish collaboration with academic institutions in Yaroslav region for research and clinical trials.

8) MSF Statement: Johnson & Johnson/ Tibotec AIDS Drug Licenses Leave Out Too Many Patients (Don’t trade our lives away); This licensing will provide low cost medicines  only to India and certain african region. The low cost generic drugs manufactured in India still cannot be exported to Latam and many countires.

9) Endo Pharmaceuticals to defend Lidoderm’s patents (Reuters); This para IV challenge involves two topical patch formulation patents 5,741,510 (Expiry: Mar 30, 2014) and 5,827,529 (Expiry: Oct 27, 2015). The US patent ‘529 is assigned to Lactec and the exclusive licensee is Endo pharmaceuticals.

Posted in Daily interesting IP news | Leave a comment

Novartis sues Medimmune, Biogen and Alexion

Posted on 30/01/2011 by Guna

[Bloomberg]

Novartis sues Medimmune (subsidiary of astrazeneca), Biogen and Alexion pharmaceuticals on US patent 5688688. The target products are AstraZeneca’s Synagisrespiratory treatment; Biogen’s Tysabri for multiple sclerosis; and Alexion’s Soliris, used to treat a life-threatening form of anemia

View complaint on prior smart Filed on Jan. 26, 2011; at District Court for the District of Delaware.

Posted in Patent case | Tagged , , , , , , , | Leave a comment

Zydus and Bayer forms Joint Venture in india

Posted on 29/01/2011 by Guna

[Bayer Press Release] [Cadila Press Release]

Bayer and Zydus cadila yesterday announced and signed to form Joint venture in India named Bayer Zydus Pharma.

Bayer Zydus Pharma will operate in key segments of the Indian pharma market with a focus on: women’s healthcare, diagnostic imaging, cardiovascular diseases, anti-diabetic treatments, and oncology. Bayer Zydus Pharma’s future product portfolio will not only include in-licensed and originator brands, but also patented pharmaceuticals from Bayer HealthCare’s pipeline. The combined portfolio will encompass among others such popular brands as Glucobay®, Xarelto®, Nexavar® and Yaz/Yasmin® from Bayer HealthCare as well as products currently marketed by Zydus Cadila such as Euglim® , Progynova® and Ultravist®.

Note: Yaz/Yasmin patent application rejected in pre grant opposition and Nexavar’s (sorafenib) patent validity is also challenged by Cipla.

Update (17/11/2011): Bayer to bring innovative products into India (link)

Posted in Daily interesting IP news | Tagged , , , , | 1 Comment

Tibotec licenses Rilpivirine (non exclusive) to Matrix, Hetero and Aspen

Posted on 27/01/2011 by Guna

[J&J Press release] [Yahoo Finance] [Mylan Press Release]

Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute  the investigational non-nucleoside reverse transcriptase inhibitor rilpivirinehydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults

Mylan President Heather Bresch said: “This agreement represents additional recognition for Mylan’s Matrix in the antiretroviral (ARV) market, in which Matrix is a leader. It also marks a significant step toward the future access of this important new product being developed by Tibotec Pharmaceuticals for patients living with HIV/AIDS. By obtaining this license at this time, we can now begin our research and development phase for our formulation to ensure that a generic version will be available in developing countries as quickly as possible. This was an important step in ensuring that novel ARV treatments available in more fortunate countries are accessible to patients in need all over the world.”

Under the agreement, Matrix will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product. Fixed-dose combinations contain multiple medicines formulated into one tablet helping to simplify HIV therapy and are preferred by public health treatment programs.

Rilpivirine is new drug (in pre-registration stage) which is from class of non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz.

Rilpivirine seems to be protected by WO 2003/016306 and its indian equivalent is granted as 222987 (00265/DELNP/2004)

Posted in Daily interesting IP news | Tagged , , , , , , | Leave a comment

GSK loses Advair (fluticasone/salmeterol) case in Netherland

Posted on 26/01/2011 by Guna

GSK loses Advair (fluticasone/salmeterol) case in Netherland.

…GSK said in a statement a court in The Hague had ruled in favour of joint claimants, Novartis units Sandoz BV and Hexal AG, in deciding that the Dutch part of the European patent for Advair, as well as the supplementary protection certificate (SPC), was not valid…

– GSK says considering appeal to a higher court

– Ruling in favour of Novartis units Sandoz, Hexal

Detailed post could be found at Kluwer Patent Blog

English translated version of Advair duch court decision (The SPC blog)

Patent: EP0416951 (Expires with SPC Sep 06, 2013)

Orginal link (1) (2)

Posted in Patent case | Tagged , , , , | Leave a comment

Patents & CI News: 26/01/2011

Posted on 26/01/2011 by Guna

1) Watson Confirms Welchol(R) Oral Suspension Patent Challenge (press release); View on RFC. Impax may be first to file for Colesevelam HCI powder for oral suspension.

2) Amgen Buys a Cancer Drug Maker (link)

3) Sanofi-Aventis in-licenses Oxford BioTherapeutics antibody for the treatment of solid cancers (the pharma letter)

4) Mylan Announces settlement agreement Lipitor & Caduet (Yahoo finance 1) (Yahoo finance 2)

5) Teva Receives FDA Action Letter (deficiency letter) For Generic Lovenox® (enoxaparin sodium) inj. Sandoz is the first generics for enoxaparin.

6) Fexofenadine is approved for OTC use for allergy in USA (Sanofi)

7) US complaint: Warner Chilcott v. Teva Pharmaceuticals (product: probably risedronate) View on RFC express

8) Merck Funds India Project for Vaccine to Rival Its Own, FT Says (Bloomberg)

Posted in Daily interesting IP news | Leave a comment

Orion sued Mylan for Comtan® (Entacapone 200 MG) tab

Posted on 25/01/2011 by Guna

Orion Corporation has filed a patent infringement lawsuit in the United States to enforce Orion’s U.S. patent No. 5,446,194 (Expiry: Oct 2013) covering Comtan® against Mylan Pharmaceuticals Inc. (Mylan).

[Press Release from Orion] – Not in english [Complaint copy]

Orion has sued Sun pharma for the same product on Nov 2008 (Reuters) and settled the litigation recently on Jan 2010 (link).

…. Sun will be able to launch generic versions of other strengths of Stalevo product on  2 October 2012 and generic versions of Comtan product on 1 April 2013, unless certain conditions relating to launch are fulfilled even earlier….

Posted in Patent case | Tagged , , , | Leave a comment

Patents & IP News: 24/01/2011

Posted on 24/01/2011 by Guna

1) Teva in court over Astra’s  Seroquel EU patent (CNBC)

2) MEDA Positive Opinion for Retigabine in Europe (Biospace)

3) Natco may seek compulsory licence for Bayer’s cancer drug (ET Report); Sorafenib is protected by IN215758 (IN/PCT/2001/00799/MUM) which is equivalent of WO 2000/042012 (expiry: Jan 2020). The ‘758 patent is issued on March 2008, the three year period expires on March 2011.

4) Jupiter Biosciences in talks to buy Swiss pharma co for $10 m (ET)

5) Novartis International AG (CH) – Novartis gains approval for Gilenya® (Fingolimod) as a first-line disease modifying oral therapy for multiple sclerosis in Switzerland and Australia (press release)

6) Anti-Cancer Agent AMG 386 Enters into Phase III Clinical Trials in Japan (Press Release)

7) Writ petition questioning competence of IPAB (Patent Circle) (Livemint)

8) Expert panel to recommend regulatory guidelines for biosimilars soon (Pharmabiz)

Posted in Daily interesting IP news | Leave a comment

India case: Setting aside patent grant

Posted on 21/01/2011 by Guna

As per Indian patent act, a patent cannot be granted without disposing pre grant oppositions, if any. There were some cases in indian law for such incidents, where patents had been granted without disposing pre grant opposition.

1) The valganciclovir case was the prominent case where controller had granted patent to Roche without giving opportunity for hearing to the opponent (Network of HIV+ people). This case could be read in detailed here. Madras High court set aside patent grant and asked controller to hear pre grant opposition and dispose with merit. (order)

2) The next case was a patent related to Humira granted to applicant Abbott without disposing pre grant opposition filed by Glenmark. In this case, IPO sent a letter to patentee as patent is cancelled. Abbott had filed writ to delhi high court and high court asked controller to consider the pre grant opposition as post grant, because pre grant opponent is eligible person interested to file post grant opposition. (SpicyIP) (Order)

3) The third order was related to filing of serial oppositions to delay the patent grant and this was related to misuse of pregrant opposition provision in patent act. (SpicyIP) (Order)

Another related order in this line is Neon Laboratories Vs Troikaa Pharma. Toikaa Pharma is Ahemadabad base indian pharma company involved in specialty pharmaceuticals. Recently launched Diclofenac injection (Dynapar)  and filed patent application 95 96/MUM/2005. Neon Lab has filed opposition on 96′ application and requested hearing. Controller without hearing Neon lab, has granted patent to Troikaa. In this order, Bombay high court set aside patent grant and asked controller to hear Neon lab.

Posted in Daily interesting IP news, Patent case | Tagged , , | 1 Comment