Patents & IP news: 20/01/2011

1) Biocon says revenue from Pfizer deal to begin in fiscal 2012 (Bloomberg); Pfizer and Biocon recently entered into agreement. Under this agreement, Pfizer will have exclusive rights to commercialise Biocon’s drugs recombinant human insulin, Glargine, Aspart and Lispro globally with certain exceptions, such as Germany, India and Malaysia, where Biocon will have co-exclusive rights (ET) (Pfizer press release)

2) Meda debuts leukemia drug Ceplene in the UK (The Pharma letter); Ceplene (histamine dihydrochloride) that prevents relapse long term – and maintains remission of people with acute myeloid leukemia (AML) – has been launched in the UK by Meda Pharmaceuticals, which has licensed the product from the USA’s EpiCept.

3) Strides Arcolab Limited’s wholly owned subsidiary, Agila Specialties, has signed an agreement with BioChimico of Brazil to set up a joint venture company for the Brazilian hospital market (India PRwire)

4) Mylan Pharmaceuticals Inc. has agreed to end its declaratory judgment suit against Ethypharm SA over the schizophrenia drug FazaClo (law360)

5) US Litigations

1) Prometheus Laboratories vs Roxane Laboratories (product: Alosetron HCl) patents in suit: 6,284,770 (Exp. Oct 5, 2018) filed at District of New Jersey on Jan 14, 2011.

2) Takeda Pharmaceutical vs Cadila Healthcare (Product: Pioglitazone Hcl) patents in suit: 5,965,584 (Jun 19, 2016) & 6,329,404 (Jun 19, 2016) filed at Southern District of New York on Jan 14th, 2011.

3) Pamlab LLC v. Acella Pharmaceuticals (????) View on RFC

Novo nordisk – repaglinide combination patent invalid

Yesterday, The district court of Michigan ruled that OB listed 6,677,358 (exp: Jun 12, 2018) patent is invalid and unenforceable.

Press release

“… The district court ruled that the patent, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, is invalid and unenforceable … ” “…We are disappointed with today’s ruling. We believe that it is contrary to the evidence and we intend to appeal the ruling,” says Jesper Brandgaard, executive vice president and chief financial officer of Novo Nordisk…”

The ANDA applicant who involved in trial, is Carco Pharma Subs of Sun pharmaceuticals.

Note: For the same product, there is a dispute on patent (‘358) and their use code and section viii label carve out.

Patents & CI News: 18/01/2011

1) Cipro goes digital with Patent Journal (Cipro notices); This is bit late news. Last three months electronic journals are available for download here

2) Domain Therapeutics, Merck Serono enter agreement to develop drugs for Parkinson’s disease (pharmabiz)

3) MonoSol Rx, LLC the developer of PharmFilm® drug delivery technology, filed an amended patent infringement and false marking lawsuit today against BioDelivery Sciences International, Inc, MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc. in the United States District Court for the District of New Jersey. Patents in suits are 7,824,588 & 5,800,832. (Yahoo finance). This “PharmFilm” technology is used in Zuplenz (Ondansetron) marketed by Strativa Pharmaceuticals & Suboxone (Buprenorphine/Naloxone) marketed by Reckitt Benckiser.

4) Indian Patents Act Undergoes Changes (AGIPNEWS)

5) PROLOR Biotech Signs Exclusive License Agreement With Yeda for Long-Acting Peptides and Small Molecules Including Oxyntomodulin for Anti-Obesity Applications (Yahoo finance)

Patents & CI News: 17/01/2011

1) Astellas Enters into License Agreement with TOLMAR -Expansion of Territory for Eligard in Asia, Middle East, Africa and CIS (press release); Astellas has in-licensed rights of Eligard (Leuprolide acetate)

2) Aspen completes buyout of Sigma pharma business for $900 million (thepharmaletter) (Pharmaceutical News) “… Sigma’s pharmaceutical business consists of an extensive product portfolio of branded, generic and OTC products which include many well-known and trusted Australian brands as well as five manufacturing facilities…”

3) Orexo licenses Abstral to Invida for in Asia Pacific (thepharmaletter); Abstral is immediate release transmucosal tablet, used for treating cancer pain and rights are Abstral is given to Invida. This agreement extends to Australia, India, Philippines, South Korea, Singapore, Indonesia, Malaysia, Taiwan, Thailand, Vietnam, and New Zealand. Orexo has filed some patent applications.

4) GSK Signs License to Market Bilastine in Spain and Poland (Pharmalive). Bilastine is new Antihistaminic which owned by Faes Farma. Bilastine seems to be protected in India by product 233119 (1071/DEL/2000) as well as two process related patents IN186319 & IN217140.

5) Glenmark: Disappointed With US Jury Decision On Tarka Patent Case (WSJ)

6) Lincoln Pharma wins patent for Nasal Drug Delivery System (pharmabiz) (209056 1421/MUM/2004 ????)

Dabigatran Polymorphic patent application rejected

Dabigatran is an anticoagulant thrombin inhibitor marketed by Boehringer and marketed as Pradaxa. The Dabigatran’s product patent is granted in india (370/DEL/1998 granted as 225735). It is marketed as dabigatran etexilate mesylate. This mesylate salt form of dabigatran prodrug (etexilate) is protected by WO2003074056 and WO2005028468.

The ‘056 patent application is also granted in India as 231731 (2251/DELNP/2004) and  the ‘468 application equivalent 924/DELNP/2006, is now rejected by IPO which covers polymorphic form of dabigatran etexilate mesylate

Decision is available at IPO site

Abbott Vs Glenmark – damages $16 million against glenmark – Tarka

A federal jury has awarded Abbott Laboratories $16 million in a suit against Glenmark Pharmaceuticals Ltd. over a generic version of Tarka (Trandolapril and Verapamil)

http://www.law360.com/ip/articles/220381

Updates

Glenmark received approval in the month of May 2010 and launched at risk.

“….Glenmark had received U.S. Food and Drug Administration approval to market the copy, and notified Sanofi and Abbott that it wouldn’t wait for the results of the trial. Mumbai-based Glenmark began sales in June after U.S. District Judge Dennis Cavanaugh in Newark rejected a request by Sanofi and Abbott to stop sales. As the first to challenge the patent, Glenmark had exclusive rights to the generic market for Tarka for six months.

Glenmark reported in October a 26 percent jump in sales of generics in the U.S., a market that accounts for 68 percent of the company’s generic-drug revenue. The introduction of the Tarka copy helped boost sales, the company said…”

ET report

“… While Glenmark officials could not be reached for comments, sources said the company will appeal against the verdict...” (this is jury verdict, can it be appealed???)

[Bloomberg] [PTI report] [ET report] [Financial express]

CI & Patents: 15/01/2011

1) Merck, Parexel Reach Biosimilar Development Deal.

2) Sanofi-aventis Enters into Two Research & Development Collaborations with the University of California, San Francisco  “….The first  collaboration promotes innovative research in pharmacological science and in multiple therapeutic areas, such as oncology, aging, diabetes and inflammation. The second collaboration is an oncology partnership that will focus on project-based collaboration to accelerate the progression of research through the clinical proof of concept stage…”

3) Merck Patent medicine journal includes new entry (addendum C): Patent number is 221123 (exp: 15-Jul-2018); Medicine protected: Not identified (will be updated)

4) US litigations

(i) Glaxo sues over prostate-drug patents (Link): GlaxoSmithKline vs Anchen Pharmaceuticals Inc/Banner Pharmacaps (product: Dutasteride) filed at Delaware District on Jan 12, 2011 (View on RFC)

(ii) Shire Canada Inc vs Alkem Laboratories Ltd (product: Lanthanum carbonate) patents in suit: 7,465,465 & 5,968,976; filed at District of Illinois on Jan 12, 2011 View on PriorSmart.

(iii) Allergan vs Sandoz (product: Tropsium chloride) patents in suit: 7,781,448; 7,781,449; 7,759,359; 7,763,635 & 7,410,978; filed at Delaware on Jan 12, 2011 View on PriorSmart.

(iv) Aventis Pharma S.A vs Sandoz Inc (product: Docetaxel) patents in suit: 5,714,512; filed at Delaware on Jan 12, 2011 View on PriorSmart.

(v) Bayer Schering Pharma AG vs Sun Pharma (product: Drospirenone; Ethinyl Estradiol) patents in suit: RE37564; RE37838 & RE38253; filed at District of Nevada on Jan 12, 2011 View on PriorSmart

India: patent rules (amendment) draft published

Indian patent office has published draft amendment to patent rules.

This draft amendment mainly includes

(i) certain new rules (Rule 19A to Rule 19J) related to India as Internalnational searching authority (ISA) and fee (schedule V);

(ii) Rule 9 is substituted with new Rule 9 (now it includes new sub rules), For filing nucleotide and amino acid sequence new fee is proposed;

(iii) Rule 18 is substituted with new Rule 18 (Appropriate office);

(iv) added “sub rule (4) of rule 20” in Rule 138 (31 months time period as non-extendable time period) and some other amendments

Comments could be send to sk.lal@nic.in before 21st Jan 2011.

Link

Addendum in Schedule I: Twenty five percent reduction in fee, if you file and prosecute the patent application on-line (note: registering online account is very difficult at ipindia.nic.in).

additional links [SpicyIP] [Genericpharmaceuticals&IP]

CI & Patent News 12/01/2011

1) Sandoz announces phase II clinical trial for biosimilar version of leading monoclonal antibody rituximab “…. But Novartis’s decision will see highly unusual direct competition between the two Swiss pharmaceutical groups, which are among the world’s leaders by sales….” (FT)

2) Vertex maintains 2010 outlook, reveals launch plan for hep C drug telaprevir and progress of other programs (thepharmaletter). Shasun would supply Telaprevir API to Vertex. Telaprevir is patented in india. (212710/242/KOLNP/2003)

3) Lilly and Boehringer Ingelheim Announce Strategic Alliance to Bring New Diabetes Treatments to Patients Worldwide (Press release).  “…. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced a global agreement to jointly develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage development. Included are Boehringer Ingelheim’s two oral diabetes agents—linagliptin and BI10773—as well as Lilly’s two basal insulin analogues—LY2605541 and LY2963016 as well as the option to co-develop and co-commercialize Lilly’s anti-TGF-beta monoclonal antibody….”

4) Interesting article on Patent term extension in Australia and case law (Patent Baristas)

5) Biocon’s oral insulin fails experiment

6) US complaint filing

(i) Pfizer vs Novel Laboratories (Pregabalin; Lyrica); patent in suits: 6,197,819; 5,563,175 & 6,001,876; View on PriorSmart

(ii) Apotex vs Forest Laboratories (escitalopram); patents in suit: 6,916,941 & 7,420,069; View on PriorSmart

7) Indian patent office decisions:

(i) 1995/DEL/2006 assigned to Les servier which is equivalent to WO2007028905 and titled “Use of agomelatine in order to obtain medicaments which are intended for the treatment of sleep disorders among depressed patients” is rejected by IPO on 3(d) and 3(e). Decision

(ii) 925/CHE/2003 assigned to Novartis which is divisional of IN202379 (IN/PCT/2001/783/CHE) and equivalent to WO2000033878. This application is refused on insufficiency and prior claiming Decision

(iii) 1873/CHENP/2007 assigned to Shin poong pharma which is equivalent to WO2006049391. This invention is pertaining to combination of two anti malarial drug. The controller stated that synergestic therapeutic effect requirement under section 3(d) and 3(e) is demonstrated, but refused to grant because lack inventive step. Decision

India Case: Atazanavir

A news article posted on Medicins San Frontieres (MSF) states that two key patent applications related to HIV drugs are rejected in India in pre-grant opposition.

It further states that those two drugs are Atazanavir and Lopinavir and Ritonavir. Lopinavir+ritonavir patent application (339/MUMNP/2006)  is rejected on 30th Dec 2010 and decision is not yet available at IPO site, but available at NGO site (i-mak).

Atazanavir product patent application is filed in india as 805/MAS/1997 and its divisional 310/CHE/2007. The 805′ application is abandoned under section 21(1) and status of 310′ application is not available (whether opposed or not; not sure).

Atazanavir is further protected by two process related applications (6425/DELNP/2006 & its divisional 2933/DELNP/2009) which include polymorphic claims also. Among these two applications, 6425′ application is opposed by Matrix and Cipla.

It is not sure which application(s) is/are rejected by IPO (310′ or 6425′). No related decision is available publicly. The same news article says that application is related to Atazanavir bisulfate (??? to be updated). The 6425′ application includes atazanavir bisulfate polymorphic claim.

Related stories: [MSF article] [Indian patent opposition] [i-mak]