India: New Patent manual

Today, Patent office published “Manual of Patent Office Practice and Procedure”

(Click Here)

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Karo Bio and Zydus Cadila extends earlier collaboration

Yesterday, Zydus cadila and Karo Bio announced that they extend their research collaboration on novel glucocorticoid steroids to one more year. This collaboration was concluded in early 2008 as three year program.

[Karo Bio Press Release]

By searching Karo Bio and Cadila in patentscope results patent application no: WO2011016050.

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New EPO “Register plus”/Espacenet interface

EPOline has updated EPO register plus (Now European Patent register)/Espacenet interface with new helpful features.

New URLs of [Register Plus] [Espacenet v5]

Features:

a) Register plus includes keyword search and search by opponent name as advanced search options

b) Quick exchange link given between Espacenet, European Patent register, and Publication server

c) Export result of Espacenet in Excel and we can try RSS feed now

d) “Smart search”to search biblographic data (i.e) we can enter up to 20 terms in search bar as maximum of 10/set

eg (10 terms) operator (10 terms), which means we cannot enter more than 10 terms without any one of the operators (AND, OR, NOT).

Register Alert service is not functional now (as on 17/03/2011), i think this equal to Email alert service – WebRegMT (Prosecution events monitoring).

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An interesting article from WSJ

Daiichi Yet to Gain from Ranbaxy Buy (WSJ)

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Fentora case

The district court has ruled in favor of Watson in a case related Fentora buccal tablet product.

[Law360] [Link]

This ruling is confined to first set of patents

Cephalon sued Watson, Barr and Sandoz for patent infringement of 6200604 & 6974590 for filing ANDA and PIV certification.

Cephalon’s statement “We remain confident in the strength of our claims with respect to the third patent. In the interim, we are reviewing the court’s opinion with respect to the first two patents and are evaluating our options, including an appeal.”

The Third patent is 6,264,981

Updated on 16/03

Cephalon Sues Government to Block Sales of Generic Painkiller Fentora (Bloomberg)

The drugmaker sued the U.S. government today in federal court in Washington seeking to revoke the Food and Drug Administration’s approval of the generic, made by Watson Pharmaceuticals Inc. (WPI), saying the product contains “a novel salt form” never approved by the agency.

Update 25/03/2011

Cephalon Wins FENTORA Patent Suit Against Watson (Press Release) (Bloomberg)

Cephalon announced that today the United States District Court in Delaware upheld the validity of Cephalon’s U.S. Patent Number US 6,264,981 (Expiry Oct 2019) patent and found that Watson Pharmaceuticals, Inc.’s proposed generic version of FENTORA(R) (fentanyl buccal tablet) infringes that patent.

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New Draft Patent Rule for improving Online filing

Indian Patent office has published yesterday new draft patent rule 2011. This amendment is basically to improve patent filing through online.

We may recollect the last published draft rules include “25% reduction when patent application filed online”.

This draft rule includes an ADDENDUM to first schedule which is “Note: All forms, applications, request, notice and petitions shall be filed using online transmission system unless otherwise specified in the rules

Published notification

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Time Limits to enter national phase

[SpicyIP] [SiNApSE]

SpicyIP and SiNApSE have blogged the recent judgement of madras high court on deadline to enter into national phase.

“….The application for extension is required to be made within the period prescribed. Therefore, proviso would come into operation for the purpose of calculating period of one month. On true interpretation of rule 138, it is held that application for extension is to be filed within one month after expiry of prescribed time under rule 20….”

Interestingly in a recent Draft Patents (3rd Amendment) Rules, 2010, Rule 138 is amended as “in sub rule (1), for the word, figures and letter “rule 24-B”, the words, brackets, figures and letter “sub rule (4) of rule 20, rule 24-B” shall be substituted

As per this new draft patent rule, time limit provided in rule 20 (4) is non-extendable.

Judgement is available Here

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CI & Patents (Pharma) News: 15/02/2011

1) Apricus Biosciences and Neopharm Group Sign Licensing Agreement for Vitaros (alprostadil) in Israel for up to $4.35 Million, Plus Royalties (Yahoo finance);

2) The Medicines Company and WilmerHale Law Firm Reach Settlement Agreement (Yahoo finance); Under the settlement agreement, The Medicines Company will receive approximately $18 million up front from WilmerHale’s professional liability insurers to cover certain past expenses. An additional $214 million will be available for damages in the event a generic bivalirudin is sold in the United States before June 15, 2015 as a result of the extension of the ‘404 patent being held invalid on the basis that the application for the extension was not timely filed.

3) Malaysia IPO: Patents (Amendment) Regulations 2011 will be effective from the date of 15th Feb 2011 (MYIPO)

4) Antwerp court stops infringement of valsartan/HCTZ SPC based on patent claiming valsartan alone (thespcblog)

5) BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Program (Yahoo finance)

6) Eisai Concludes License Agreement for New Aricept Transdermal Formulation in japan (pharmalive); An adhesive skin patch containing donepezil hydrochloride seems to be protected by WO2007129427.

7) GSK Pharma to launch vaccine, cancer drugs in 2011 (Livemint); “The two oncology drugs, Revolade and Votrient, would be launched by end of first quarter or early second quarter“; The two cancer drugs seem to be protected in India. Revolade (eltrombopag) seems to be protected by 213176 (IN/PCT/2002/1666/MUM) and Votrient (Pazopanib) seems to be protected by210284 (818/KOLNP/2003).

8) Medivir AB Signs Dengue Deal with Johnson & Johnson (Press release)

· Collaboration with Janssen Pharmaceutica N.V. focused on dengue virus

· Both parties to contribute 50:50 resources to the research program

· Strengthens Medivir’s presence in infectious diseases and utilises strong know-how in the discovery of protease inhibitor drugs

9) Obama: Shrink Exclusivity And End Pay-To-Delay (Pharmalot) (WSJ)

10) Venus launches $2 mn super speciality cancer segment (BS)

11) Q-Med settles with Genzyme in US patent dispute (reuters); Genzyme Corporation filed a complaint in the District court of Massachusetts against Medicis alleging that Medicis is infringing on a patent held by Genzyme by marketing Restylane®, Perlane®, Restylane®-L and Perlane®-L in the United States . Now Q-Med said it would make a lump sum payment to Genzyme and Medicis had been released from any liability relating to the lawsuit. (View on RFCexpress); Patent involved: 5,399,351 (assigned to Genzyme Biomatrix)

12) Mylan Launches First Generic Version of Vfend® Tablets (Yahoo finance)

13) Actavis launches Anastrozole on day one in seven major European markets (Press release)

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CI & Patents News (Pharma): 14/02/2011

1) Brazil to produce generic AIDS and hepatitis drugs (thepharmaletter); Brazil’s health authority, ANVISA, has licensed the generic version of tenofovir to the official laboratory Fundacao Ezequiel Dias (Funed – run by the government of the state of Minas Gerais). This has been made possible by a public-private partnership, facilitated by the Department of Science, Technology and Strategic Inputs (SCTIE) at the Ministry of Health.

2) Sandoz has 10 biosimilars in pipeline (Biospace)

3) Sun Pharma Freezes Generic Eloxatin Sales (law360)

4) AstraZeneca Targets Korean Co. Over Nexium Patents (law360); View on RFCexpress

5) Novartis Sues Mylan for Generic Fluvastatin ANDA (Philip Brooks’ Patent Infringement Updates); Novartis filed complaint on two district courts (Delaware) (West Virginia Northern District Court)

6) Pharma patents in Mexico: an assessment of the current position (IP Tango)

7) EPOorg: Beta version of new EPO website now available (EPO)

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Brazil Pipeline patents – Term extension

[IP Tango] [INPI]

Yesterday Brazil Superior Court of Justice (STJ) denied patent term extension for two pipeline patents. One product is pramipexole which is protected by PP1100678-1 and another product is Dipyridamole and Aspirin which is protected by PP1100593-3 . Both the patents are from Karl Thomae GmbH (Boehringer).

The pramipexole patent (PP1100678-1) expires actually on 22/12/2004 but the patent term extension requested till 16/12/2010, and the dipyridamole patent (PP1100593-3) expires on 13/08/2006 but the patent term extension requested till 09/07/2012.

This decision is also in line with earlier decisions on patent term extension for Pipeline patents (sildenafil, Atorvastatin, Imatinib & Clopidogrel). Pipeline patents of brazil will expires 20 years from the first filing date (ie priority date).

Updated 13/07/2011

[IP Tango] [INPI BR]

Another pipeline patent term extension is refused and INPI’s view on pipeline patent system is upheld. Dronedarone is protected by PP1100771-0KB1 in Brazil and it expires on August 2010. Generally, patent term for pipeline patents will be calculated from first priority date of parent country. Since many patent applicant re-filed the patent application abandoning earlier filed applications or first filed during Jan 1, 1995 to May 14, 1997, to get benefited from pipeline patent system.

In dronedarone case, the earlier application was filed on 05/08/1991 as PI9103354-3 A2 (Abandoned) and which was re-filed as pipeline patent application on 12/05/1997 and granted as PP1100771-0K B1.

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