Cinacalcet: Injunction granted against Barr/Teva

Posted on 08/01/2011 by Guna

Amgen today announced that district court of delaware has granted injunction preventing launch of Teva and Barr’s generic versions of cinacalcet.

Teva and Barr has received tentative approval from FDA on early 2010. Teva has tentative approval for 90 MG only; approved on April 2010 and Barr has tentaive approval for all strengths (30, 60 & 90 MG);  approved on May 2010.

Three patents were the subject of the injunction: U.S. Patent No. 6,011,068 (“the `068 patent”) and U.S. Patent No. 6,031,003 expire Dec.14, 2016, but the `068 patent is the subject of a patent term extension which will extend the term toMarch 8, 2018.  U.S. Patent No. 6,211,244 expires Oct. 23, 2015.

Amgen press release and Note: Teva had sued Amgen for patent infringement of 7,449,603 in May 2009. The ‘603 patent is related to process of preparing cinacalcet.

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CI & Patent News: 08/01/2011

Posted on 08/01/2011 by Guna

1) Dr Reddy’s ties up with UK-based research organisation Argenta:

“… In a statement, John Montana, managing director of Argenta, said the company would work with Dr Reddy’s to identify “novel and differentiated drug candidates for multiple targets meeting unmet clinical needs in pain and inflammation”…..”

2) Request for reexamination for Liponavir/Ritonavir is filed by public patent foundation (Published in last week journal); Patent: 6,703,403; Re examination Application No: 95/000,569; Patentee: Abbott (PUBPAT)

3) NextWave Pharmaceuticals Announces Launch of NEXICLON™ XR – First Extended-Release, Once-Daily Clonidine Oral Suspension and Tablet

4) Aurobindo, Wyeth Settle Spat Over Generic Effexor (law360)

5) US Litigations recently filed complaints

1) Pfizer Inc. et al v. Sandoz Inc (Lyrica Oral solution; Vfend Voriconazole injection); Patents involved in suit 5,364,938 & 6,632,803 (will be updated); View at RFC

2) Alaven Pharmaceutical, LLC v. Seton Pharmaceuticals, LLC (probably Metoclopramide injection) View on RFC

3) APP Pharmaceuticals, LLC v. Navinta LLC (Ropivacaine HCL Injection); Patents in suit 5,670,524  and 5,834,489 View on PriorSmart

4) Aventis Pharma S.A. et. al. v. Accord Healthcare Inc. (Product: Docetaxel Injection); Patents in suit: 5,714,512 and 5,750,561; View on PriorSmart

5) Pronova BioPharma Norge AS v. Apotex Corp (Product: Lovaza; Capsule oral); Patents in suit: 7,732,488; View on PriorSmart

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CI & Patent News 05/01/2011

Posted on 05/01/2011 by Guna

1) New national collections now available (Link): We are aware that there are two search service provided by WIPO Patentscope; One is PCT application search and the other one is National collection search. Now National collection database is updated with national patent collections of Colombia, Costa Rica, Guatemala, Panama, Peru and Uruguay.

2) Meda Acquires Additional two OTC Products in the US from GSK (link). Last month three products were acquired from GSK

3) Spain: Modification of EP translations (PatLit). Untill Oct 1992 spain did not allow product claim in product patent and patents filed before 1992 were referring to process instead of product. Now spain supreme court allowed patentees to file modified translation with product claim.

4) Merck KGaA focuses on diabetes in India, lines up five products (livemint)

5) RPG Life Sciences introduces the first generic version of ketoanalogue – alfalog (pharmabiz)

6) LUPIN signs strategic agreement with FARMANGUINHOS, Brazil for the supply of its 4 in 1 combination drug (Rifampicin + Isoniazide + Ethambutol + Pyrazinamide) for tuberculosis for 5 years

India: some IP decisions in past one month:

1) Yaz (Drospirenone; Ethinyl Estradiol) — Bayer — lN/PCT/2002/410/CHE (WO2001015701) — Refused

2) Kaletra (Lopinavir; Ritonavir) — Abbott — 339/MUMNP/2006 (WO2005039551) — Refused

3) Valturna (Alskiren; Valsartan) — Novartis — 212199 (724/cHENP/2003) — WO2002040007 — Revoked

4) Detrol LA (Tolterodine) — Pfizer — 211539 (IN/PCT/2000/84/CHE) — WO2000012069 — Patent held valid

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Natco applied CL for Pfizer drug Maraviroc

Posted on 05/01/2011 by Guna

Natco applied for Compulsory Licenses for Pfizer’s HIV drug Maraviroc

Maraviroc seems to be protected by 204132 (885/MUM/1999) and other pending applications 867/BOM/1999 and 1939/MUM/2006. ‘132 patent is granted on Jun 08, 2007 published in Gazette no 23/2007.

Natco has applied for CL in November 2010 (as per ET report).

ET report

…. Pfizer has time till May to reply, as Indian patent law allows an innovator company to respond within six months of receiving a notice for voluntary license. If it does not allow Natco to make cheap drugs, the Indian pharma company can approach the government for CL, that will allow it to sell a lowpriced version of the drug after paying royalty to Pfizer….

[Original link]

Updates

204132 (885/MUM/1999) is again published on 31st Dec 2010 as 204132 (885/BOM/1999)

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India: Lopinavir+Ritonavir Abbott Application Rejected

Posted on 03/01/2011 by Guna

Formulation patent application which covers Lopinavir+Ritonavir combination is rejected in India. This application was opposed by i-mak, Matrix, Cipla and Osaka.

Application No: 339/MUMNP/2006 (National phase of WO2005/039551)

Applicant: Abbott

Opponents: i-mak, Cipla, Matrix, Osaka

Interesting Note: This application is related pharmaceutical composition comprising Lopinavir, ritonavir, Water soluble polymers and surfactant. Interestingly this patent application is not rejected under 3(d) and 3(e).

The Controller stated in her decision that “… a pharmaceutical composition and the invention lies in the  selection of suitable surfactants, therefore it cannot be a mere admixture, hence the claims cannot be held as not patentable under section 3(e)….”

Decision is available here

For 339′ application, a divisional application is filed 726/MUMNP/2009; which is also opposed by Cipla and Matrix

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Aliskiren Combination patent revoked in India

Posted on 29/12/2010 by Guna

Aliskiren is, a renin inhibitor, marketed by Novartis.

Aliskiren combination is protected by WO2002040007 and its equivalent patent is granted in India  [212199  (724/cHENP/2003)].

The  ‘199 patent is revoked in post grant opposition filed by Sun Pharma

Decision is available at IPAIRS

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CI & Pharma News: 28/12/2010

Posted on 28/12/2010 by Guna

1) Jazz Pharmaceuticals Announces New Patent Issued for Sodium Oxybate (Press Release). The New patent 7851506 is expires on Dec 22, 2019 and listed in Orange Book. Note: Recently Jazz pharma has sued Roxane for ANDA filing.

2) Cephalon Wants FTC To Disclose Secret Drug-Industry Patent Deals (link)

3) Cubist submits Citizen petition for Daptomycin against generic drug approvals (Business Wire) (Citizen Petition)

4) Autralia to revise divisional application filing practice (Managing IP)

5) Meda Strengthens Allergy Product Portfolio in Europe with EpiPen® Auto-Injector (Business Wire)

6) Strides to buy out Australia’s Ascent Pharma (ET)

7) Jordan’s Hikma in talks to buy 30% in Unimark Remedies (ET)

8)Patent Complaint: Salk Institute for Biological Studies v. Ferring Pharmaceuticals, Inc (View on RFC)

9) Brazil: Patent Term extension of Clopidogrel patent is denied. (IP tango). Clopidogrel product patent (PP1100113 B1-5K) is filed as pipeline patent in brazil. Pipeline patent normally expires 20 years from the date of first foriegn filing and patent term of the pipeline patents may be extended based on whether or not patent term extension is granted in home country. In Clopidogrel case, Patent term extension is denied in brazil.

10) AstraZeneca and Abbott End License Agreement for the Development of CERTRIAD (Pharma Live)

11) Novartis Plans $500 Million Investment in Russia (Pharmtech)

12) Gedeon Richter Ltd. Forms China JV with Marketing Partner Rxmidas Pharmaceuticals (Biospace)

13) Ligand Pharmaceuticals Inc. Earns $1 Million Upfront Payment from Pfizer Inc. on Sublicensing of Tanaproget (Biospace)

13) FDA approves Novartis’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide)anti-hypertensive

14) Watson Announces Novel Oral Contraceptive Approval (Yahoo Finance)

15) Pre-grant and Post-grant Opposition by same parties – strategy and impact (indianpatentopposition)

16) Surya Pharma arm buys US-based ActivOn for USD 22 mn (ET)

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CI & Patent News: 14/12/2010

Posted on 14/12/2010 by Guna

1) Paragraph IV litigations

Cephalon, Inc. Vs Apotex, Inc (Product: may be Armodafinil )

Complaint filed at Delaware District Court on December 14, 2010

2) Meda acquires three OTC products from Glaxo in the US (Business wire); Product information is not disclosed. Glaxo markets totally five OTC product (TAGAMET HB; ABREVA; NICORETTE; COMMIT; ALLI) in US.

3) Reckitt Benckiser to buy India’s Paras for $726 mn (ET)

4) Inspire Announces Launch of DIQUASTM Ophthalmic Solution 3% (diquafosol tetrasodium) by Santen in Japan (Yahoo finance)

5) New dosing recommandation for Darunavir is approved by FDA (J&J Press release);  Ritonavir is HIV protease inhibitor and also CYP3A4 (a metabolic enzyme); This reduces metabolic clearance of other agent administered with ritonavir . We aware of approved combination of Lopinavir and Ritonavir.

6) USPTO Implements Pilot Program Extending Provisional Application Period (Patent Docs) (USPTO)

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CI & Patent News: 11/12/2010

Posted on 11/12/2010 by Guna

1) Paragraph IV litigation

1) Astellas Vs Nycomed (Tacrolimus ointment 0.1% Protopic)

Complaint filed at District of New Jersey on Dec. 7, 2010

Patents in suit: 5,385,907; 5,665,727; View on PriorSmart; This is third complaint filed by Astellas

2) Shionogi Pharma & CIMA Labs Inc Vs Mylan[ (ORAPRED ODT) Prednisolone ODT; 10MG, 15MG, 30MG]

Complaint filed at Delaware District Court on December 09, 2010; View on RFC

Patents in suit: 5178878; 6024981; 6221392; 6740341

2) BREAKING: ‘Small’ EU Patent To Come Soon (BLOG@IPJUR.COM) (tweet);  …In the European Council Competitiveness, today 11 Member States have expressed their agreement to cooperate for the realization of EU patent..

3) Mylan received approval of Adalat® CC (Nifedipine extended release tablet) (Press release)

4) Bayer has submitted new data for new oral contraceptive regimen of Yaz (ethinylestradiol/drospirenone) in Europe (Decentralized; Natherland as reference member state) (Press release)

5) Teva filed citizen petition requesting FDA to refrain approvals of Copaxone generics.  (RTT News)

6) EU India: Drug seizure matter update (Generic pharmaceuticals)

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CI & Patent News: 09/12/2010

Posted on 09/12/2010 by Guna

1) Alnylam Says It Won Europe RNA Patent Dispute (PharmaLive)

2) NovaBay Pharmaceuticals and Galderma Expand Their Agreement to Include Impetigo (Yahoo finance)

3) Orexigen® Therapeutics’ Investigational Drug Contrave® Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity (Yahoo finance)

4) Strides acquires Inbiopro (A KPO) (press release)

5) Abbott Laboratories Subsidiary Kos Pharmaceuticals Reaches $41M Settlement  (link)

6) AusPat beta Launched (The Patent Librarian’s Notebook); Now Auspat enables users to search Australian patents full text from 1906. File wrapper of AU patent application will soon be made made available (early 2011)

7) Bayer plans to significantly expand capacities in China (Link)

8) US Government’s Interference in India’s Tenofovir Proceedings (i-mak) (spicyIP)

… Gilead’s patent applications for tenofovir disoproxil (2076/DEL/1997) and tenofovir disoproxil fumarate (896/DEL/2002) were rejected following various pre-grant oppositions. The decisions of the Indian Patent Office (IPO) as relating to Cipla’s and Intermed Lab’s oppositions can be read here and here. Gilead has since filed an appeal to the Intellectual Property Appellate Board (IPAB)…

9) Active Biotech and Teva announces successful completion of Laquinimod for Multiple sclerosis (link)

10) Elder sees rev jump on Bulgaria drugs launch (Livemint)

11) P IV Litigations:

Mylan Vs Ethypharm (FazaClo; Clonazapine OD Tablets; 25 MG, 100 MG, 12.5 MG, 150 MG, 200 MG) Declaratory judgement for non infringement of 6106861(assignee: Ethypharm). Filed at District of Delaware on Dec. 7, 2010 View on PriorSmart

Brief fact: For FazaClo ODT product, three patents (6024981, 6221392, 6106861) are listed in OB. Mylan has filed ANDA with P IV on all three patents.  CIMA lab is assignee for ‘981 and ‘392 and has sued Mylan on these two patents. Ethypharm is assignee of ‘861 patent not sued Mylan within 45 days, hence Mylan requested for declaratory judgement for ‘861 patent.

12) Roche provides update on leading late-stage pharmaceutical pipeline (Press Release)

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