Showing posts with label General News. Show all posts
Showing posts with label General News. Show all posts

Wednesday, 6 January 2010

Power Plants for Liver Diseases

1. Karisalankanni:

Botanical Name: Eclipta prostrata
Used for treatment of:
 Liver disease (herb of choice for liver diseases)
 Ulcer
 Jaundice
 Fatty liver
 Splenomegaly
 Hemorrhoids and
 Indigestion

Source: http://ayurvedichomeremedies.blogspot.com/2007/11/liver-and-ayurveda.html

2. Kizhanelli:

Botanical Name: Phyllanthus Nruri
Family: Euphorliaceae
Hindi: Buin anvalah, Jar – amla
Telugu: Nelavusari
Tamil: Kizha Nelli, Kizkhai Nelli, Kilkkay nelli, Kizvai nelli
Used for treatment of:
 Jaundice
 Gonorrhea
 Urinary tract
 Frequent menstruation
 Dysentery
 Diabetes
 hepatitis B
 Also antifungal, antiviral, and anticancerous properties

Source: http://ayurvedham.com/english/tag/keezhanelli

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

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

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

Sunday, 26 July 2009

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

Monday, 13 July 2009

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 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

Monday, 6 July 2009

Novartis - Imatinib - India (High impact)



Imatinib = wiki article


Novartis patent application on imatinib is rejected by IPAB



Reported - News in media

European (swiss) News Channels [1] [2]


Trading markets [Link]

SpicyIP post [1] [2]

Livemint [Link]

Deccan chronicle [Link]

Business standard [Link]

The Telegraph [Link]

Little About [Link]

Economics Times [Link]

Business line [Link]

Wall street journal [1] [2]



& in ipnewsflash repeatedly updated by various news channels



Livemint report is detailed & comprehensive



My previous post on this blog [Link]

Wednesday, 3 June 2009

Share Market

I came across an interesting blog on share market. The blog is written and maintained by Mr. K.R Vijay Ganesh from Salem, India. Most of the information is in Tamil language that facilitates the localites to learn shares.

His blog educates the basics of share market, stocastic (indicators), and information on time frame, MACD, camrilla equation and more. People familiar with tamil can use the website: http://krvijayganesh.wordpress.com/

Friday, 29 May 2009

Singulair Patent Re-examination

The U.S patent office is re-examining the patent on Merck's popular asthma treating drug , SINGULAIR. The product is worth $4.5 billion per year.
The USPTO ordered re-examination as requested by Article One Partners LLC, who are experts in identifying improperly issued patents (invalid patents).
If this patent document with actual expiry dated 2012 is invalidated, the generic drug manufacturers will pitch into the market to produce cheaper version of the drug.

Wednesday, 27 May 2009

INNOGRAPHY

A new next generation intelligence tool is developed, Innography Spring '09™. The tool on intellectual property business intelligence based on the inputs and feedbacks from the professionals.

The tool can
  • Clearly Visualize Competitive Landscapes by Portfolio Size and Company Resources
  • Easily Examine Technology Landscapes by Portfolio Strength and Size
  • Quickly Target High-Value Licensing Candidates
  • Accurately Identify Litigation Activity by Plaintiff or Defendant

Contact here: http://www.innography.com/contact-us.aspx for free demo of the tool.

Wednesday, 18 February 2009

Article One- A Winning Prior Art Search

Article One Partners are research reward reform that motivates researchers for their excellent work though awards. The company had announced for winning prize of US$ 50,000 for identifying prior art for a patent US6,784,873 B1.

GARMIN'S DEFENSE AGAINST SP TECHNOLOGY'S PATENT INFRINGEMENT LITIGATION was successful with the help of two researchers.

The task was successfully achieved by Article One's most prolific Advisor, RickyJames and a computer science graduate working in the U.S. software industry, Patented (username).

Congratulations to RickyJames and Patented who successfully identified prior art for the patent no. 6,784,873 B1. Ricky James won US$ 35,000 for identifying prior art WO 91/12578 A1 and Patented won US$ 15,000 for identifying prior art from a book called “Programming Microsoft® Windows®”.

Monday, 16 February 2009

Pharma And Obama

On 10th Feb’09, The US president Barack Obama received a letter from the US companies that invest a huge amount in R&D, explaining their concerns about Patent Law in the country.

The letter included the following topics:

 Recent Patent Reform Proposals
 Flawed Justifications
 Reducing Penalties for Patent Infringement
 Recent Changes to U.S Patent System
 Investment & Jobs are at Stake
 One Area of Consensus – Improvements are need at the USPTO


The letter concludes with proposals to change the U.S patent system, stating, “As proposals are made to change the U.S. patent system, we encourage you to consider the impact of these proposals on all stakeholders, not just a narrow group. Manufacturers and other patent stakeholders make great investments in inventing new products for sale at home and abroad, and we rely upon a balanced patent system that is good for all innovators. Drastic changes, such as reducing penalties for patent infringement, will discourage innovation, resulting in reduced investment and lost jobs at a time when the
United States can least afford it.

The justifications made for the legislation introduced in the 110th Congress do not withstand scrutiny. There is no explosion of patent litigation. There is no explosion in patent damages. The statistics simply do not bear out such assertions. We do not oppose all legislative efforts to improve the patent system, but we feel that any legislative changes should benefit the broad spectrum of patent stakeholders. We urge you to resist changes that would benefit only a narrow group of stakeholders.

Substantial improvements to the system can be made by improving the operations of the USPTO, and many of these changes can be made administratively. We believe improving this agency is an area where consensus can be found among all stakeholders. Our goal is for the U.S. patent system to continue to be the best in the world, and that it continue to encourage the kind of investment, product creation, and job creation that our companies generate. We look forward to working with you, other policymakers and other stakeholders to ensure this outcome.”


List of companies that signed the letter include,
Amidex, Inc, Cummins Inc, DePuy, DexCom Inc, Dow Corning, DuPont, Exxon Mobil Corporation, Medical Device Manufacturers Association, MedRad, Texas Instruments and Zimmer Inc etc.

Source: Patent Baristas

Thursday, 12 February 2009

Concerns in Patenting Protein

Till date there is no controversial issue on patenting a large number of proteins, unlike genomic sequences. Also, all the research and protein patenting activity has not yielded large rewards in-turn unless the protein is used as a drug target or as therapeutics.

These days large-scale protein identification is making identifying proteins easier. Projects in the US and Japan have shown that they can quickly determine the structure of thousands of previously unknown proteins, providing many new drug development targets to patent.

Concern: if that patent is broadly written, others may be prevented from working on it, effectively 'ring-fencing' the protein.

Current Scenario: In the past US researchers have relied on a research exemption to avoid this problem, but this might be set to change. In a recent ruling by the Supreme Court, the research exemption was used by Duke University to defend its work on a technology patented by a previous employee. The Supreme Court decided in favour of the employee, stating that the University was not indulging in philosophical inquiry, as allowed by the research exemption, but in active research for gain. If precedent is set and the research exemption is disallowed for those working with patented proteins, work could be hindered.

Further steps to find a solution: The NIH has funded a study at the National Academy of Sciences to look into the potential impact on research of broadly interpreted patents on proteins and other biological molecules.

Wednesday, 4 February 2009

Patent Search

A European project has created a powerful patent search service for SMEs. It is a major step forward as patents and patent information are extremely valuable.

We live in a knowledge economy, and patents are the legal tender. They define a company’s or individual’s stake and they are the mechanism by which ideas can be both exchanged and, at the same time, protected.

But getting patent information can be difficult. There are many databases scattered across Europe and the rest of the world, and the search options are limited: they are either cheap but restricted, or effective but very expensive. You must either go through each source for information, or pay hefty fees to a specialist who does it for you.

That leaves SMEs, the majority of Europe’s enterprises, in a bind: either they struggle with the awkward, difficult and time-consuming cheaper search (which ends up costing money in any case because of the time personnel must devote to the work), or they incur serious costs using professionals.

Unsuspected value

The final option is to ignore patents altogether, but this is a costly option, too. Costly in terms of the lost opportunities, as most SMEs don’t even begin to suspect the value of the information discovered through patent searches.

Innovall, an eTEN-funded project, is keen to see SMEs not miss out on the value of patenting and patent knowledge.

For example, one company that participated in the Innovall project, a tyre manufacturer, sought a solution to a problem it was having with waste rubber extruded through the mould during the manufacturing process. By using Innovall’s search service the tyre company discovered a useful patent in the baking industry of all things.

“It shows how useful and valuable information can be discovered, even if it relates to a completely different industry,” explains Alfredo Silva, coordinator of the Innovall project.

Google for patents

Innovall was set up to explore the best way to make patent search simple. The solution was to create a web portal that essentially acts as the Google for patents. The search engine connects with eight large databases, with hundreds of thousands of patent records.

There are three layers of search that companies can choose from. The most basic level is the ‘function’ search, which looks for patents in terms of what they do. This may be basic, but it is also very powerful, as the example of the tyre company shows.

Even better, Innovall has used ontologies, which are dictionaries that translate different terms to help define a search. “For example, you might be looking for a friction device, but the system will also search for words like drag, brake, decelerate and so on,” explains Silva.

That’s just the beginning. A ‘company’ search will look up all the patents registered by one company, a competitor perhaps, and it will list information such as what country, branch or even department submitted the patent. Finally, Innovall can search by ‘product name’, completing the range of services.

The results take a bit longer than a standard Google search, but given the nature of the search, this is to be expected.

Keen hunters

The 60 organisations – and hundreds of individuals within them – who are currently actively testing the system are very enthusiastic about the results and the information that Innovall retrieves.

These ‘testers’ will be a key part of the next step. Innovall hopes to convert them to a core group of users of the service when it goes live in earnest. This will boost efforts to commercialise the service, because it must become sustainable if it is going to survive.

Right now, Innovall is considering a variety of business models. One plan is to leave the ‘function’ service free, and then charge tiered subscriptions for more detailed or specific searches.

For now, the project will continue to perfect the technology until March 2009, when they hope to have their business plans finalised and ready for prime time.

The Innovall Market Validation project received funding from the eTEN programme.

Sunday, 30 November 2008

WIPO New Courses enrollment starts

The wipo Academy introduces some distance learning courses like Basics of Patent Drafting/ Patent information search, Patent & Trademarks 

The enrollment for those courses starts from tomorrow (1st Dec), link given below

Saturday, 29 November 2008

Search patent information (Patents/ Patent News/ Patent Cases)

This post includes Patent information (Patents/ Patent News/ Patent Cases) search and what are the tools are available to search

Patents/ Patent Application search:

United States: USPTO: http://www.uspto.gov

  Patent Database: patft.uspto.gov/ appft.uspto.gov  (Granted Patents: PATFT & Application: AppFT)

  Patent Assignment: http://assignments.uspto.gov/assignments/?db=pat

  PAIR (Patent Application Information Retrieval): http://portal.uspto.gov/external/portal/pair

  US patent Gazette: http://www.uspto.gov/web/patents/patog/

  Orange book (Official listing of Patent linked marketed Pharmaceutical product): www.fda.gov/cder/ob/

European Union: EPO: http://www.epo.org

  Publication Server: https://publications.european-patent-office.org/PublicationServer/search.jsp

  Register Plus/ WebRegMT: www.epoline.org/portal/public/registerplus

  Bulletin: http://www.epo.org/patents/patent-information/european-patent-documents/european-patent-bulletin/download.html

  OPS: http://ops.espacenet.com/

India: http://www.patentoffice.nic.in

  Indian patent/ Application search & patent office journal/ Gazette are available at: http://www.patentoffice.nic.in/ipr/patent/patents.htm

Canada: http://cipo.gc.ca/

  Patent Search: patents1.ic.gc.ca/intro-e.html

  Gazette: http://napoleon.ic.gc.ca/cipo/patgazarc.nsf/f_maincpor_e?OpenForm

Australia: http://www.ipaustralia.gov.au/

  Australia specification search: http://pericles.ipaustralia.gov.au/aub/aub_pages_1.process_simple_search

  Auspat: (For Legal status/ Document link): http://pericles.ipaustralia.gov.au/ols/auspat/startAgain.do?previousPage=quickSearch

  Old Data search: http://apa.hpa.com.au:8080/ipapa/qsearch&ei=

Singapore: http://www.ipos.gov.sg

  SurfIP (Patent Search): http://www.surfip.gov.sg/

  E-patents (Singapore patent search): http://www.epatents.gov.sg/PE/

Japan:http://www.jpo.go.jp/

  Patent Search: http://www19.ipdl.inpit.go.jp/PA1/cgi-bin/PA1INIT

  IPDL: http://www.ipdl.inpit.go.jp/homepg_e.ipdl

Newzealand: http://www.iponz.govt.nz/cms

  Patent Search: http://www.iponz.govt.nz/cms/banner_template/IPPATENT

Uinted Kingdom (UK): http://www.ipo.gov.uk/

  Patent Search: http://www.ipo.gov.uk/patent/p-find/p-find-number.htm

WIPO: http://www.wipo.int

  PCT Patentscope (World Patent Application): http://www.wipo.int/pctdb/en/

 Private Search engines:

Google: www.google.com/Patents

http://www.patentretriever.com/

http://www.freepatentsonline.com/

http://www.patentgenius.com/

http://www.priorsmart.com/

http://www.patentlens.net

http://www.ipnewsflash.com/get_pdf.php

http://free.patentfetcher.com/

http://www.wikipatents.com/

http://www.freshpatents.com/

http://www.pat2pdf.org/

http://www.patentsurf.net/

http://www.pattools.com/

http://www.patentbuero.ch/service/main.htm

http://india.bigpatents.org (indian patent)

http://www.tmpsearchers.com (indian patents)

and many others

Patent & Patent law Blogs/ websites, patent cases:

http://www.ag-ip-news.com/

http://www.biospace.com/

http://delawareiplaw.com/

http://depatentlaw.morrisjames.com/

http://drugpatentexpiry.blogspot.com/

http://www.drugpatentwatch.com/

http://duncanbucknell.com/

http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

http://www.eyeonfda.com/eye_on_fda/

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/

http://www.fda.gov/medwatch

http://www.fdalegislativewatch.com/

http://promotetheprogress.com/

http://genericpharmaceuticals.blogspot.com/

http://genericspatent.blogspot.com/

http://pipeline.corante.com/

http://indianpatentoppositions.blogspot.com/

http://www.intellectualpropertylawblog.com/

http://www.theiplawblog.com/

http://www.ipmenu.com/

http://www.ipnewsflash.com/

http://ip-updates.blogspot.com/

http://www.ipfrontline.com/

http://ipkitten.blogspot.com/

http://www.ipr-helpdesk.org/

http://jiplp.oxfordjournals.org/

http://www.managingip.com/

http://www.mondaq.com/

http://www.orangebookblog.com/

http://www.patentarcade.com/

http://www.patentbaristas.com/

http://www.patentdocs.net/patent_docs/

http://www.patentlyo.com/patent/

http://www.patenthawk.com/blog/

http://patentcircle.blogspot.com/

http://www.pharmalive.com/

http://pharmtech.findpharma.com/

http://www.pharmabiz.com/

http://www.expresspharma.com

http://www.pharmalive.com/

http://www.pharmalot.com/

http://www.pharmasianews.com/

http://www.ipnewsflash.com/

http://www.okpatents.com/phosita/

http://www.pli.edu/patentcenter/

http://www.pubpat.org/

http://spicyipindia.blogspot.com/

http://www.stemcellpatents.com/

http://inventblog.com/

http://patentlibrarian.blogspot.com/

http://thepriorart.typepad.com/

http://www.researchandmarkets.com/

http://online.wsj.com/

http://www.orglex.com/

http://patentdaily.wordpress.com/

http://www.infringementupdates.com/

http://thespcblog.blogspot.com/

http://www.wapatents.com/

http://pharmalyst.blogspot.com/

http://pharmapatents.blogspot.com/

http://thetouchstoneeffect.blogspot.com/

http://caselaw.lp.findlaw.com/casesummary/

http://www.lawyerscollective.org/

http://www.justia.com/

and many others and whenever i find information i will update this post

Monday, 29 September 2008

Conference

Source: Orange Book Blog and Google

Title: CBI "Paragraph IV Disputes" Conference
Venue: Philadelphia
Date: October 15-16
Agenda:
"Strategies to Optimize Patent Lifecycle from Drafting to Maturity"
"Preparing for Paragraph IV Challenges -- Generic Pre-suit Strategies"
"Best Practices in E-Discovery -- Overcoming Obstacles, Controlling Costs and Maximizing Benefits"
"The KSR Decision and ANDA Litigation"
"Implications of Recent Developments and Trends in Litigating Paragraph IV Disputes" (I'll be speaking on this topic as one of the panelists)
"Citizen Petitions and Their Impact on Generic Entry"
"Interpreting Forfeiture Provisions -- An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy"
"The FTC, Antitrust Law and Settling Paragraph IV Litigation," presented by Markus Meier, Assistant Director, FTC



Title:
ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 15-16
Venue: New York
Date: October 15-16
Agenda:
"Constructing, Adjusting, and Executing a Pharmaceutical Patent Life Cycle Management Plan"
"View from the FTC," presented by Saralisa Brau, Health Care Services and Products Division, FTC
"Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies"
"Eye on the Bench: Identifying Judicial Trends in Pharmaceutical Patent Cases"
"Mastering the Intricacies of the 180-Day Generic Market Exclusivity"
"Plotting a Course Into Safe Harbor for Branded Pharma"
"View from the FDA," presented by Elizabeth Dickinson, Office of Chief Counsel, FDA
"Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases"
"Factoring the Role, Challenges, and Impact of Orange Book Listings and Delistings in Patent Portfolio Management"


Title: 2008 Competitive Intelligence Summit
Venue: Rome, Italy
Date: October 20-22
Agenda:
CI and its Relationships with Different Functions Inside the Company
CI Performed by a Single CI Practitioner
CTI: Innovation and Intelligence
Many Facets of Global CI
New Analytical Tools and E-Platforms for the CI Practitioner

Saturday, 9 August 2008

Patents and Drug Approvals - Brief view

How patents are playing key role in drug approvals?
In US, the drug approvals are linked to patents. The Orange book is electronic listing of Approved drugs in US and corresnponding patents covering any of one or all API, formulation and method of use.
All NDA applicants are required to submit patent information related to their product and patent information submitted by NDA applicant will be listed in orange book.
When generic company wants to market generic version of approved product, they have to file ANDA with patent certifications. The patent certifications, as i explained in previous post, are four different types which are Para I, II, III and IV. Paragraph III is the certification included with ANDA when generic company ready to wait till patent expiry and Paragraph IV is challenging patent listed in Orange book stating that the listed patents are invalid or not infringed by ANDA submitted upon manufacture, distribute and sale.
When the generic company files ANDA with para IV certification, innovator will file legal suit in district court and result in 30 month stay on drug approval. If generic company win the suit, the 180 day exclusivity offered to generic company, during this 180 days no further generic drug (ANDA) approval will not made.
The para IV filings plays key role for generic companies and Para IV filing are listed by FDA without disclosing identity of orginator. Link: http://www.fda.gov/CDER/ogd/ppiv.htm
and it is important to mention is "maintaining patent protifolio is become companies intellectual asset".
In india dispute is going on to link drug approvals with patent as like US system, if interested read this articles
1. http://www.livemint.com/2008/05/02224246/Drug-companies-oppose-bid-to-l.html (Accessed 9th Aug 2008)
2. http://www.pharmaceutical-business-review.com/article_news.asp?guid=22F598E9-6257-46E5-B107-D11DA389D018 (Accessed 9th Aug 2008)
Please write comments

For further reading:
1. generic drug product development by leon shargel and isadore Kanfer, published by Marcel dekker (2005)
2. http://www.fda.gov/cder/orange/default.htm
3. http://www.fda.gov/cder/regulatory/applications/ANDA.htm
4. http://www.fda.gov/cder/regulatory/applications/NDA.htm

Stem Cells and Patent Dispute in US

Stem cells are cells which have potential to develop into any any kind of cell in the body, in technical term they are characterized by the ability to renew themselves through mitotic cell division and ability to differentiate into diverse range of specilized cell types.

The Wisconsin Alumni Research Foundation (WARF) is the non profit technology transfer office of the University of Wisconsin-Madison, and involved in stem cell research and holds many patents on stem cells. WARF gains income by licensing patented technology to many companies in US and worldwide. WARF holds significant patents on human embryonic stem cells the patents are U.S. Patent Nos. 5,843,780 (claiming primate embryonic stem (pES) cells); 6,200,806 (claiming human embryonic stem cell (hES) cells); and 7,029,913 (hES)

The request for re examination was made by nonprofit organisation the Foundation Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT) saying that the work done by university researchers are obivious and works are non-patentable and also impeding scientific progress.
On march 2007, The patents, US Pat. Nos. 5,843,780, 6,200,806, and 7,029,913, cover all embryonic stem cell research in the U.S. The USPTO granted each of the requests in September 2006 and rejected all claims of each of the patents .
In recent decision on re-examination of '913 patent, USPTO has amended claim to narrow down the scope of claim.
For Further reading:
1.http://en.wikipedia.org/wiki/Stem_cell
2.http://en.wikipedia.org/wiki/Wisconsin_Alumni_Research_Foundation
3.http://www.pubpat.org/warfstemcell.htm
4. http://patentbaristas.com/archives/2007/04/03/warf-stem-cell-patents-knocked-down-in-round-one/
5. http://patentdocs.typepad.com/patent_docs/2007/04/warf_stem_cell_.html
6. http://patentbaristas.com/archives/2008/03/03/ding-warf-wins-round-2-as-stem-cell-patent-upheld/
7. www.stemcellpatents.com

Drug Approval Process in US/ EU

In this post, i write about process by which drug approvals are made in big markets like US and Europe. The drugs are being developed over many years and have to cross many barriers to get marketed.
There are regulatory Authorities to regulate drug market to ensure safety and effectiveness of marketed drug.
IN US, Food and Drug Administration (FDA)
IN EU, European agency for the Evaluation of Medicinal products (EMEA)

In brief, key stages of drug development
1. Preclinical studies: to establish drug's merit to progress into clinical trials and it includes animal studies and API related studies and formulation (Tablet, capsule in small scale) Investigational new drug (IND) submitted to FDA CDER and FDA checks preclinical studies are perfomed whether in compliance with GLP or not, when clinical trial commences CDER start to monitor the trial.
2. Phase I: conducted with small group of people, to establish merits to progress into patients trials, for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
3. Phase II: conducted in larger group people, to further evaluate safety
4. Phase III: to provide pivotal trial evidence to prove safety and efficacy and FDA uses this data to decide whether to approve or not.
At the end of Phase III, Innovator/sponsor submit New drug application (NDA) FDA CDER checks and concludes the safety and efficacy established in clinical trials

Brief explanation of how process happeans
(Available at
http://www.fda.gov/cder/handbook/develop.htm)
The NDA is evaluated based on the safety and efficacy established in clinical trials and scientifc dats. and Phase IV, this post marketing studies to access the drug's safety, effectiveness and monitored for unexpected health risks. CDER could put hold at any stage in this development cycle.
The above mentioned processes are when new drugs investigated for marketing approval and what is generic drugs? the generic drug applications are called Abbreviated New drug application (ANDA), No need to establish clinical trial data (safety and efficacy) generic drug manufacturers, generic drugs could enter the market after patent protection on formulation/product expired.
Orange book is FDA CDER's listing of approved products and corresponding patent protection, generic drug applications (ANDA) are evaluated for their bioequivalency with innovator/Sponsor product.
ANDA: FDA approved generic based on
1. contains same active agent as an approved (reference listed drug product)
2. should be identical dose, strength and route of administration
3. have same use/ indications
4. be bioequivalent
ANDA applicant has to file ANDA with any of one or more certifications for patent(s) listed in Orange Book (OB)
paragraph I ceritification: No patent information found in OB for which ANDA submitted,
Paragraph II certification: Listed patents are expired for which ANDA submitted,
Paragraph III: to seek approval after listed patent expiry
Paragraph IV: to challenge listed patent, saying Patent(s) listed are invalid, will not infringe to manufacture, use and sale.
Exclusivity:
Exclusivities are to protect the interest and benefit the innovator or generic applicants
Innovator's:
New Chemical entity: 5 years for first time approval of new chemical molecule
pediatric exclusivity: 6 months added to patent lifetime or existing exclusivity, but it will not stand alone.
3 years exclusivity for any significant changes, if new clinical studies conducted by innovator/ sponsor for new indication/dose etc.
generic applicant:
180 day's exclusivity: On filing ANDA with para IV certification and challenging innovator patent(s) listed in OB. First ANDA filing will get 180 days exclusivity on challenging and wining the case. it prevents other generic players from approval.
In EU, Drug approval process is regulated by European agency for the Evaluation of Medicinal products (EMEA), this agency give marketing authorization (MA) in european union (EU) member countries to market drug products. This is called centralized procedure.
In decentralized procedure/ Mutual reconization procedure: This applies to conventional drugs. Applications are made to individual member states selected by applicant.
In EU, two steps to get marketing Authorization,
1. Clinical trial Application
2. marketing Authorization Application (MAA)
Clinical trial Applications are approved in member state level and MAA approved at centralized level. Innovator/Sponsor submit clinical trial application in each member state where trials are to be conducted. In UK clinical trila applications are to be submited to medicine control agency (MCA).
Upon sucessful completion of clinical trials, MAA is to be submitted to EMEA in centralized procedure, four different MAAs are there, it depends on type of medicinal product.
In Mutual regonization procedure, if Once drug approved by any one member state, it is eligible to file MAA in other EU member states through Mutual regonization procedure.
Reference:
1. Drugs from discovery to approval by Rick Ng, PhD, published by John Wiley & Sons, Inc (2004)
2. Pharmaceutical project management 2nd edition, edited by Tony Kennedy
3. generic drug product development, leon shargel and Isadore Kanfer, Marcel Dekker (2005)
4.
http://www.fda.gov/cder/about/smallbiz/generic_exclusivity.htm (Accessed 9th Aug 2008)
5.
http://clinicaltrials.gov/ct2/info/understand (Accessed 9th Aug 2008)
6.
http://www.fda.gov/cder/handbook/develop.htm (Accessed 9th Aug 2008)
Today i got interest to write many things on drug approval, snice i read first two books listed in reference. Please write comment on mistakes i made.

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