1. Only one New molecular entity (NME) has been approved by FDA in this month.
Drug Name: ISTODAX
Company: Gloucester Pharms
Active ingredient: ROMIDEPSIN
Review Class: Standard review drug
2. Four new formulations has been approved as shown below:
Drug Name: LYSTEDA
Company: Xanodyne Pharm
Active ingredient: TRANEXAMIC ACID
Review Class: Priority review drug
Drug Name: NEXCEDE
Company: Novartis
Active ingredient: KETOPROFEN
Review Class: Standard review drug
Drug Name: REVATIO
Company: Pfizer
Active ingredient: SILDENAFIL CITRATE
Review Class: Standard review drug
Drug Name: PENNSAID
Company: Nuvo Res
Active ingredient: DICLOFENAC SODIUM
Review Class: Standard review drug
3. One drug which is already in market (with out approval from FDA) for approved.
Drug Name: QUTENZA
Company: Neurogesx
Active ingredient: CAPSAICIN
Review Class: Standard review drug
4. A drug with out any NDA chemical type classification is also approved by US FDA
Drug Name: KALBITOR
Company: Dyax Corp
Active ingredient: ECALLANTIDE
Review Class: Unspecified
Thursday, 24 December 2009
Friday, 18 December 2009
Generic Drug Approvals by FDA - November 2009
A quick view on the Generic drug approvals by US FDA this month (Nov'09).
1. Akorn Inc and Alcon Inc has obtained two generic drug approvals this year for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION (0.4%, 0.5%); Notably, Apotex Inc and Sun Pharma has obtained one approval each (0.4%, 0.5% respectively) for the same drug.
2. One of the generic drug competitor, Barr Laboratories have got an approval on NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS (1 MG/0.005 MG)
3. Another generic drug competitor, Teva Pharmaceuticals and Matrix laboratories have obtained approval for LANSOPRAZOLE DELAYED-RELEASE CAPSULES (15 MG and 30 MG)
4. The Indian pharma company, Aurobindo Pharma and Roxane laboratories, Ivax Pharmaceuticals (a subsidiary of Teva) have got nod for PERINDOPRIL ERBUMINE TABLETS (2 MG, 4 MG and 8 MG)
5. Par pharmaceuticals got approval for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS (100 MG and 200 MG)
6. The drug, NICARDIPINE HYDROCHLORIDE INJECTION (2.5 MG/ML; PACKAGED IN 25 MG/10 ML) was approved for Generamedix Inc, Pharmaforce Inc, Vavinta LLC, Sun pharma and Wockhardt Ltd.
7. NIZATIDINE ORAL SOLUTION (15 MG/ML) was approved to Amneal Pharmaceuticals.
1. Akorn Inc and Alcon Inc has obtained two generic drug approvals this year for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION (0.4%, 0.5%); Notably, Apotex Inc and Sun Pharma has obtained one approval each (0.4%, 0.5% respectively) for the same drug.
2. One of the generic drug competitor, Barr Laboratories have got an approval on NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS (1 MG/0.005 MG)
3. Another generic drug competitor, Teva Pharmaceuticals and Matrix laboratories have obtained approval for LANSOPRAZOLE DELAYED-RELEASE CAPSULES (15 MG and 30 MG)
4. The Indian pharma company, Aurobindo Pharma and Roxane laboratories, Ivax Pharmaceuticals (a subsidiary of Teva) have got nod for PERINDOPRIL ERBUMINE TABLETS (2 MG, 4 MG and 8 MG)
5. Par pharmaceuticals got approval for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS (100 MG and 200 MG)
6. The drug, NICARDIPINE HYDROCHLORIDE INJECTION (2.5 MG/ML; PACKAGED IN 25 MG/10 ML) was approved for Generamedix Inc, Pharmaforce Inc, Vavinta LLC, Sun pharma and Wockhardt Ltd.
7. NIZATIDINE ORAL SOLUTION (15 MG/ML) was approved to Amneal Pharmaceuticals.
Sunday, 13 December 2009
Patent, Patenting and business
Patents are the concept which was originated to protect the investment made to make inventive, novel and not known technical development for benefiting people and/or society. This is an agreement between government and inventor (Or assignee) to grant exclusive rights for bring developed, novel benefiting innovation to people and to protect your money investment made to make such innovation. The granted rights are like physical property, could be sold to anyone. This patent right is valid to limited time duration (Normally 20 years). Patents enhance industrial growth by protecting huge money involved in research and development.
Patents and their governing laws are very different from country to country, since each country has their own way of interpreting and also depends countries' industrial growth and requirement. Before 2005, India have not had granted product patent for pharmaceutical/agrochemical innovations, to protect India's generic industry.
In the name of globalization, to protect foreign investments and exploring new markets, many international agreements and co-operations, were established
1) Paris conventions
2)Patent cooperation treaty (by WIPO; UN)
3) TRIPS (by WTO; UN)
4) Regional treaty like
European patent convention (EPC), Eurasian patent organization (EAPO), The cooperation council for the arab states of the Gulf (GCC), African regional intellectual property organization (ARIPO), African intellectual property organization (OAPI).
TRIPS agreement is major break through to bring minimum standards in countries' patent/IP and related laws to enhance international business activities in unexplored big markets like many asian countries, africa, latin america and like.
New Developments are
1) patent prosecution highway (PPH) cooperation between large volume patent offices to prevent repeated work
2) Community patent for European union (enhanced version for EPC)
3) IP5 (joined project by major 5 IP offices)
Disclaimer:
there may be some errors since these are my personal views on patent and related law
Sunday, 6 December 2009
Data Exclusivity India
Introducing data exclusivity in indian system is now hot topic. Data Exclusivity is a kind of protection granted for safety and efficacy data established during clinical trials, which is submitted by drug companies to regulatory agencies for evaluation and subsequently for approval.
Duration of Exclusivity varies from country to country, normally 5 to 10 years. During this exclusivity time no generic players dossier will be accepted by agency for approval. This exclusivity protects innovator companies' interest on investment made for clinical studies for particular drug/drug product regardless of patent protection. This protection is granted by regulatory agencies.
As of now, India does not provide any data exclusivity to innovator companies. Being a member country in WTO, this is the obligation for India to introduce such protection to protect interest of large/innovator companies as a part of TRIPS agreement.
Recently as per news articles on Economics time and business standard, WTO and Health ministry conducting questionnaire to introduce data exclusivity in Indian system of drug approval.
Indian pharmaceutical alliance (IPA) is a group of indian pharmaceutical companies, has raised objection on this issue.
To note, India has introduced product patent protection to chemical/pharmaceutical patents as a part of TRIPS agreement on 2005.
News Update:
ipkat post on data exclusivity in EU [Link]
Thursday, 3 December 2009
FDA nods for access to investigational drugs
FDA nods access to the investigational drugs that are not yet approved by FDA to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.
Closing Conference of the European Year of Creativity and Innovation 2009
A conference on Creativity and Innovation 2009 in Sweden will be held on 16th-17th December 2009.
The conference is handled by The International Programme Office for Education and Training, in collaboration with the Government Office of Sweden.
"The conference aims to provide a forum for European policy-makers and stakeholders to share and reflect on experiences related to creativity and innovation growth. The event will also highlight successful examples of innovation activities presented at various events across the Europe over the past year."
For address and further information on the conference, please visit here: http://www.programkontoret.se/sv/Languages/English/Conferences-during-the-Presidency-of-the-EU/Closing-Conference-of-the-European-Year-of-Creativity-and-Innovation-2009/
The conference is handled by The International Programme Office for Education and Training, in collaboration with the Government Office of Sweden.
"The conference aims to provide a forum for European policy-makers and stakeholders to share and reflect on experiences related to creativity and innovation growth. The event will also highlight successful examples of innovation activities presented at various events across the Europe over the past year."
For address and further information on the conference, please visit here: http://www.programkontoret.se/sv/Languages/English/Conferences-during-the-Presidency-of-the-EU/Closing-Conference-of-the-European-Year-of-Creativity-and-Innovation-2009/
Friday, 27 November 2009
USD600000
Goal Zero has got its US design patent as a Milestone patent – USD600000 issued by USPTO on September 15, 2009. The patent disclose, design of a battery system that works in conjunction with a solar briefcase that recharges the system using sunlight. The patent copy was presented to Robert Workman, the CEO of Goal Zero by Secretary Kappos and Senator Orrin Hatch (R-Utah).
Source: USPTO annual report 2009
Source: USPTO annual report 2009
Intellectual Property Monetization
A process of extracting value from Intellectual Property is termed as IP Monetization. The process involves research on the patented technology in order to raise partnership/collaboration, licensing the technology. In other words, the service provides a single platform to extract revenue/value from its IP portfolio.
According to TTC groups, the service includes,
- Thorough technology and market assessments for commercial/investor interest
- Evaluation and recommendation of appropriate funding scenarios and deal structure:
- Valuation of up-front investment, milestone payments, maintenance fees royalty structure, etc.
- Create detailed pro-forma financial models with scenario analyses, incorporating market models into revenue build
- Packaging commercial strategy and value propositions for recommended capital vehicle and deal structure, including preparation of robust business/development plan(s) to support raise, accompanied by non-confidential and confidential marketing materials
- Developing the funding strategy and contact lists
- Assembly of Offering Memorandum documents; review by legal counsel and auditors, as needed
- Presentation of investment opportunity to targeted investors/strategic partners
- Negotiation of deal terms with interested investors
- Search and recommend CEO/CFO/Senior management, as appropriate
- Search and recruit Scientific Advisory Board, as appropriate
- Search and recruit Board of Directors from non-investors, as appropriate
- Executing the commercial strategy—including dimensionalizing the technology and value propositions, and packaging the corporate entity—in an ongoing manner intended to increase valuation, engineer consent amongst gatekeeper constituents and steward the evolution of the company and its technology portfolio
According to TTC groups, the service includes,
- Thorough technology and market assessments for commercial/investor interest
- Evaluation and recommendation of appropriate funding scenarios and deal structure:
- Strategic (corporate and corporate venture funds)
- Private equity
- Venture capital and specialty Life Sciences hedge fund market investors
- Patient and disease advocacy groups
- Segment angel
- New (stand-alone) company vs. licensing of technology(ies)
- Valuation of up-front investment, milestone payments, maintenance fees royalty structure, etc.
- Create detailed pro-forma financial models with scenario analyses, incorporating market models into revenue build
- Packaging commercial strategy and value propositions for recommended capital vehicle and deal structure, including preparation of robust business/development plan(s) to support raise, accompanied by non-confidential and confidential marketing materials
- Developing the funding strategy and contact lists
- Assembly of Offering Memorandum documents; review by legal counsel and auditors, as needed
- Presentation of investment opportunity to targeted investors/strategic partners
- Negotiation of deal terms with interested investors
- Search and recommend CEO/CFO/Senior management, as appropriate
- Search and recruit Scientific Advisory Board, as appropriate
- Search and recruit Board of Directors from non-investors, as appropriate
- Executing the commercial strategy—including dimensionalizing the technology and value propositions, and packaging the corporate entity—in an ongoing manner intended to increase valuation, engineer consent amongst gatekeeper constituents and steward the evolution of the company and its technology portfolio
USPTO Annual Report 2009
USPTO has now released its Annual report - 2009.
Read it from here: http://www.uspto.gov/about/stratplan/ar/2009/2009annualreport.pdf
Read it from here: http://www.uspto.gov/about/stratplan/ar/2009/2009annualreport.pdf
Friday, 31 July 2009
Abbott Vs. Medtronic
Medtronic Inc will pay $400 million to Abbott Laboratories for infringing Abbott’s patent US5451233 on stent titled, “Angioplasty apparatus facilitating rapid exchanges” by marketing Xience.
Both the companies agreed not to sue each other over stents and stent-delivery systems for at least 10 years, Fridley-based Medtronic said Monday in a statement.
Recently Medtronic announced that paid J&J $270 million to settle all royalty disputes regarding certain stent patents.
Notably, late last month, a jury in Texas said Abbott should pay J&J’s Centocor unit $1.67 billion in royalties on the arthritis drug Humira, the biggest patent verdict in U.S. history. While Abbott is challenging the verdict, this is indeed good news to Abbott Laboratories.
Source: Morningstar, finance-commerce, Medicaldevicestoday
Recently Medtronic announced that paid J&J $270 million to settle all royalty disputes regarding certain stent patents.
Notably, late last month, a jury in Texas said Abbott should pay J&J’s Centocor unit $1.67 billion in royalties on the arthritis drug Humira, the biggest patent verdict in U.S. history. While Abbott is challenging the verdict, this is indeed good news to Abbott Laboratories.
Source: Morningstar, finance-commerce, Medicaldevicestoday
Sunday, 26 July 2009
Merck's step-2 on Merck-Schering plough merger
Merck, on 24th July'09 has proposed settlement of litigations involving between the two companies. The company explains that it has agreed to settle the suits in order to avoid further costs and inherent uncertainity of litigiation.
Details about the same published in Merck's website: www.merck.com
Kaye Scholer LLP
Information on a U.S based LLP
Kaye Scholer LLP, is one of the leading pharma/biotech legal practitionar in the United States.
Expertise: Vast expertise in presenting complex patent cases to juries, employing full-time scientific advisors, former federal prosecutors and former patent examiners to reinforce the argument.
Recent Success: Kaye Scholer LLP has successfully defended a district court victory at the United States Court of Appeals for the Federal Circuit in a patent infringement case for client Comdata Stored Value Solutions, Inc. On April 30, 2009, the Federal Circuit affirmed the decision of the United States District Court for the Middle District of Florida, which had entered judgment in favor of Comdata and three other gift card companies in a patent infringement suit brought by the plaintiff Every Penny Counts, Inc. In affirming the district court, the Federal Circuit agreed that the patent-in-suit could not be construed to cover the purchase of a gift card.
Alan M. Fisch (Partner, Litigation, Washington Office) argued the appeal and was joined on the brief by team members Jason Hoffman, Coke Morgan Stewart (both Counsel, Litigation, Washington Office), Bill Sigler (Litigation, Washington Office), and Kevin Jakel (Litigation, Washington Office). This is the third Federal Circuit victory for Alan and his team in the last ten months.
Clients: Pfizer, Genentech, Novartis, Sanofi-Aventis, Purdue Pharma, Wyeth and Hoffmann-La Roche.
Client feedback: ‘ Kaye Scholer LLP is highly responsive, and sensitive to our budgetary needs’
Office Location: Washington DC, Shanghai, Palm Beach, New York, Los Angeles, London , Chicago and Frankfurt
Source of information:
http://www.legal500.com/firms/50515/offices/50335#
http://www.kayescholer.com/news/firm_news/20090501
Kaye Scholer LLP, is one of the leading pharma/biotech legal practitionar in the United States.
Expertise: Vast expertise in presenting complex patent cases to juries, employing full-time scientific advisors, former federal prosecutors and former patent examiners to reinforce the argument.
Recent Success: Kaye Scholer LLP has successfully defended a district court victory at the United States Court of Appeals for the Federal Circuit in a patent infringement case for client Comdata Stored Value Solutions, Inc. On April 30, 2009, the Federal Circuit affirmed the decision of the United States District Court for the Middle District of Florida, which had entered judgment in favor of Comdata and three other gift card companies in a patent infringement suit brought by the plaintiff Every Penny Counts, Inc. In affirming the district court, the Federal Circuit agreed that the patent-in-suit could not be construed to cover the purchase of a gift card.
Alan M. Fisch (Partner, Litigation, Washington Office) argued the appeal and was joined on the brief by team members Jason Hoffman, Coke Morgan Stewart (both Counsel, Litigation, Washington Office), Bill Sigler (Litigation, Washington Office), and Kevin Jakel (Litigation, Washington Office). This is the third Federal Circuit victory for Alan and his team in the last ten months.
Clients: Pfizer, Genentech, Novartis, Sanofi-Aventis, Purdue Pharma, Wyeth and Hoffmann-La Roche.
Client feedback: ‘ Kaye Scholer LLP is highly responsive, and sensitive to our budgetary needs’
Office Location: Washington DC, Shanghai, Palm Beach, New York, Los Angeles, London , Chicago and Frankfurt
Source of information:
http://www.legal500.com/firms/50515/offices/50335#
http://www.kayescholer.com/news/firm_news/20090501
Saturday, 18 July 2009
Time lines of Indian Patent Act
Time lines in Indian patent act
1) To file complete specification after provisional: within 12 months from the date of provisional filing
2) U/S 8 time within statement of undertaking (status of similar/equivalent applications in other countries) to be filed is "6 months from the date of application"
3) U/S 10 & U/R 13: Declaration of inventorship is to be filed within one month from the date of filing of complete specification
4) U/S 11A & U/R 24: publication of applications is ordinarily be 18 months from date of filing of application or date of priority date, whichever is earlier
5) U/S 11B & U/R 24B: Examination of applications: Request for examination is to be filed within 48 months from the date of filing of application or from the date of priority; whichever is earlier.
6) U/S 12 & U/R 24B (3): first examination report may be sent to applicant within 6 months from the date of request for examination or from the date of publication; whichever is later
7) U/S 16: Divisional applications may be filed, if applicant desired or as a remedy for objection raised in examination, "any time before the grant of patent"
8) U/S 21: Time to Application in order for grant is 12 months from the date of first examination report
9) U/S 25(1) & U/R 55: To file pre-grant opposition/representation: any time before the grant of patent; ordinarily no patent will be granted before 6 months from the date of publication.
10) U/S 25(2): To file post grant opposition: within one year from the date of publication of grant of patent
11) U/S 53: Term of patent is 20 years from the date of filing of application for the patent. [in case of PCT application, term of patent will be 20 years from the date of filing of international application, not from the date of indian national pahse application]
12) U/S 55: Term of patent of addition is equal to term of main patent
13) U/S 60: Application for restoration of ceased patent: within 18 months from the date of patent ceased to have effect.
14) U/S 61 & U/R 85 Opposition to restoration of patent: within two months from the date of publication of restoration
15) U/S 84: Compulsory license: any time after expiry of three years from the grant of patent
16) U/S 135: Convention Applications: within 12 months from the date of basic application
17) U/R 20 (4) (i): National phase application: within 31 months from the date of priority [U/R 20(2) no application will be processed before expiry of this time period]
Monday, 13 July 2009
What are Counterfeit Drugs?
Drugs that are illegally imported to a country are termed as counterfeit drugs. These drugs are both dangerous and may potentially cause financial damages to the patent holder.
What are Gray Market Drugs?
Drugs that are manufactured by the patent holder and exported to foreign market, and these drugs when re-sold into the US, they are referred to as Gray Market Drugs. These drugs are not counterfeit drugs.
Read it from site http://www.lventre.com/druginfr.html, written by Louis Ventre, Jr. The site is contentful and more interesting legal information is available in the site.
Read it from site http://www.lventre.com/druginfr.html, written by Louis Ventre, Jr. The site is contentful and more interesting legal information is available in the site.
Defending an Infringement case
I read an interesting article from a website “PatentandProperty” written by Kenneth B. Herman and Christopher J. Harnett.
The article provides a background on
The article provides a background on
- the infringement case,
- how to deal with the infringement case,
- applicable rules,
- safety measures and
- success formulae with live example
For details, visit http://pubs.acs.org/subscribe/journals/mdd/v04/i07/html/07patents.html
Sunday, 12 July 2009
Granted Pharma Patents on 10/07/2009
The Indian Patent journal is published every week on Friday
Last Friday (10/07/2009) some important granted patents on pharma/biotech are published here
Monday, 6 July 2009
Novartis - Imatinib - India (High impact)
Thursday, 2 July 2009
An Historical Verdict!
A case filed by Centocor -a subsidiary of Johnson & Johnson against Abbott laboratory’s product, HUMIRA has turned in favor of Centocor. Abbott must now pay $1.67 billion as its HUMIRA infringes Centocor’s US7070775. That is, $1.17 billion for lost profits and $504 million as a reasonable royalty. The case was filed in 2007, and the verdict is awarded on 30th June’09 in Marshall, Texas.
Notably, Bayer has also filed a case late last year against Humira...
Source: http://thepriorart.typepad.com/the_prior_art/2009/06/centocor-v-abbott-ed-texas-jury-awards-largest-patent-verdict-ever.html
Notably, Bayer has also filed a case late last year against Humira...
Source: http://thepriorart.typepad.com/the_prior_art/2009/06/centocor-v-abbott-ed-texas-jury-awards-largest-patent-verdict-ever.html
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