GenericsWeb - The Search is Over

Generics Industry Feature Articles

This page contains a list of articles published at www.genericsweb.com and in our e-newsletter INNsight (click here to register). Browse the list below for articles of interest or search our archives. You can also consult the entire list of Drug In Focus articles, analysing patent protection on over 30 molecules including Atorvastatin, Venlafaxine, Rosiglitazone, Famciclovir, Ropinirole and many more.

Patent Searching and IP Management
Patent protection
Litigation
Markets
Legislation and litigation
IP Strategy
Paragraph IV
Licensing
SPCs


Patent Searching and IP Management - GenericsWeb
19/04/12	How to create a generic drug IP strategy using comprehensive patent information (Webinar archive)
19/07/11	Navigating the patent minefield in development of Generic Drugs 1: How to identify key IP protection (Webinar archive)
19/01/11	Strategic Filing of SPCs – Questioning the Validity of SPCs Across Europe (Webinar archive)
22/02/10	Infringement of Process Patents in Australia. The vexed case of intermediates
22/01/10	How to Calculate Expiry Dates and Data Exclusivity in Key Territories
03/02/08	When does the patent expire?
01/04/07	Use of patents in drug lifecycle management
01/01/07	The changing face of patents in generic pharmaceutical development: Facts and figures
20/07/06	Generic Pharmaceutical Patent Searching I: Getting the info you need
19/06/06	Generic Pharmaceutical Patent Searching II: Managing your patent info
20/09/05	How to Avoid Patent Infringement in Developing APIs and Generics (Click here for Chinese version)
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Patent protection - GenericsWeb
15/09/10	Strategic use of Supplementary Protection Certificates - Part II
15/06/09	Strategic use of Supplementary Protection Certificates - Part I
11/11/08	The practicalities of paediatric extensions to the Supplementary Protection Certificate
15/07/08	Formulation patents in pharmaceutical development
15/04/08	Molecular form: Patentability of known active ingredients
15/12/07	Tolterodine Polymorph Patent Highlights Ongoing Quality Issues in USPTO
01/05/07	Fluvastatin and Atorvastatin: A comparison of patent protection (Part 1)
01/08/07	Fluvastatin and Atorvastatin: A comparison of patent protection (Part 2)
17/05/07	Alendronate Once-A-Week Formulation Patent Threat Still Alive in Australia
26/03/07	Levitra® - Opportunity for Proactive Generic Companies?
02/02/07	Esomeprazole Remains Under Threat
26/04/06	Full Story of Relpax Patent Protection Not Told by Orange Book?
05/08/06	Avandia Patents Afford Protection Against Generic Competition
10/11/06	More to Veterinary Anthelmintic ProHeart® than Green Book Indicates
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Litigation
15/05/13	A Further Limitation on the Ability of the Generic Drug Companies to Chase the Profits of Innovators?
15/01/13	U.S. Supreme Court to Decide Key Issues in Two Pharma Cases
15/11/12	How the “Park Doctrine” can Trigger Criminal and Civil Liability for Generic Drug Executives for Unknowing or Unintended FDA Violations
15/09/12	Recent Developments in Portuguese Pharma Litigation
15/07/12	The Court of Justice of the European Union declares that the Republic of Poland infringed Art. 6 of Directive 2001/83
15/02/12	Court of Justice SPC Rulings
15/02/12	FDA’s Draft Guidance on “Biosimilar” Pathway Leaves Key Questions on Specific Clinical Data Requirements and Interchangeability Unanswered
15/12/11	A New Test for Obviousness of Pharmaceutical Formulations in the U.S. Federal Circuit
15/09/11	FTC Releases Report On Authorized Generic Drugs
15/08/11	FDA’s Approach To Biosimilars - Totality Of The Evidence and Risk-Based?
15/08/11	Who owns U.S-government-funded inventions?
15/07/11	Big Win for Generics in the U.S. Supreme Court
15/06/11	U.S. FDA Proposes User Fees for Biosimilar Products Comparable to Fees for Branded Biologic Drugs
15/04/11	America’s Top Court Rules on Adverse Drug Event Disclosures and Will Next Decide Generic Drug Preemption
15/03/11	Biosimilars - Faster Development and Approval?
15/02/11	U.S. FDA Proposes User Fees for Applications for New Generic Drug Applications
15/01/11	U.S. Supreme Court to Decide an Important Case for Generics in the U. S. Market
15/12/10	Italy: Italian Intellectual Property Code: Tougher Times For Generics
15/11/10	Escaping from Alcatraz: The Federal Circuit and Compound Patents
15/10/10	Brand and Generic Drugs on Trial Together in U.S. Courts
15/09/10	Canadian Amlodipine litigation
15/08/10	Some litigation practice issues for generic pharma in Australia
15/08/10	Pay for Delay – The State of the Law
15/07/10	Epidemiology: The First Defense to Pharmaceutical Products Liability Actions
15/06/10	A Proposal to Curb Misuse of ‘Exceptional Case’ Allegations Against ANDA Applicants
15/05/10	U.S. Court Extends Long-Arm Jurisdiction to Foreign Manufacturers
15/05/10	Delaying Generic Drugs: The Legal Landscape Surrounding Reverse Payment Agreements To Protect Patent Holders
15/04/10	Sanctioning ANDA Plaintiffs For Poor Behavior
15/03/10	False Marking Claims in the U.S.: Different Kind of Patent Litigation
15/02/09	Courts Are Divided on Whether Failure to Warn Claims Against Generic Drug Manufacturers Can Be Preempted
10/11/08	United States: Even After Patent Has Expired, District Court Has Jurisdiction To Set Exclusivity Date
10/03/08	Favourable patent decision for research based pharma in Spain
15/01/08	An early route to market for generics?
15/08/07	Arrow points towards clarity: Arrow V Merck - Alendronate again...
15/06/07	More about parallel imports - Boehringer V Swingward
10/06/07	Canada: generic manufacturers may not be required to address all listed patents
01/06/07	Generics Emboldened in Australia
15/04/07	Parallel importation
14/01/07	Angiotech, Conor - not so obvious
10/11/06	Scottish Polymorphs
03/10/06	Interlocutory Injunctions
20/08/06	Mayne v Debiopharm
03/10/06	Interlocutory Injunctions
13/07/06	IVAX v Chugai
16/05/06	Patented medicines for developing countries
10/03/06	Patent term extensions in Australia
01/03/06	Paediatric use - proposed regulation
10/02/06	Bolar Provision: A global history and the future for Europe
01/02/06	John Woolfe’s impact on crucial outcomes for the generics industry
01/01/06	Contracts: avoiding the pain
01/12/05	Directive 2004/27/EC – New European Data Exclusivity Provisions
29/09/05	SPCs - when can they be granted?
30/08/05	Injunctions and Cross-undertakings
30/07/05	Patent Revocation
30/06/05	AstraZeneca - Abuse of Dominant Position
31/05/05	Data Protection: High Court Allows Registration of Alendronate 70mg
30/03/05	Multi-party Actions - Who Pays The Costs?
30/04/05	Mayne Pharma V Pharmacia, Servier V Niche Generics
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Markets
15/04/12	Watson-Actavis – birth of a new generic supergiant?
15/03/12	Falling product prices
15/01/12	Biosimilars – what happened?
15/12/11	The Mayan calendar – it all ends in 2012
15/10/11	Current Developments on Biosimilar Drug Regulations in Mexico
15/09/11	Facing two ways
15/07/11	Jumping off a cliff
15/06/11	EU Court advisor positive on negative SPC term extension
15/05/11	Teva strikes again
15/04/11	Free Trade Agreements – who benefits?
15/03/11	European Council authorises enhanced cooperation on creation of a unitary EU patent
15/01/11	Are patent deals slowing cheaper drugs?
15/12/10	Canadian generics – are they overpriced?
15/11/10	Biosimilars – movement in the US
15/09/10	European generic tenders – another nail in the coffin?
15/07/10	Big Pharma swallows the Generic medicine
15/06/10	Europe swings the pricing axe
15/04/10	Biosimilars – A US regulatory mechanism at last
15/03/10	The Race for Ratiopharm
15/01/10	CPhI India - how does it compare?
15/10/09	CPhI - has it grown too big?
15/09/09	Illegal generics
15/07/09	US Biosimilars
15/06/09	A sinister conspiracy?
15/04/09	Big Pharma Vs Generics
15/01/09	Roll up, roll up; companies for sale
15/11/08	The FDA gets tough
15/10/08	How to make more money by not launching
16/08/08	Star wars – The generic empire strikes back
15/04/08	The Japanese (generic) puzzle
15/03/08	Teva – generic world champion as a model of evolution?
15/12/07	AstraZeneca - on the ropes?
15/11/07	Biosimilars - breaking through at last?
15/08/07	The German Drug Reforms – a fatal blow to the German industry?
15/06/07	The China Syndrome - regulatory meltdown?
10/05/07	Merck Generics – the consolidation continues (again!)
15/03/07	The continuing battle over Lipitor
10/01/07	Biosimilars - inflated expectations?
12/11/06	Germany - rising costs
15/11/06	Spain - a work in progress
12/10/06	The consolidation continues - part II
10/05/06	Generics as R&D experts
12/06/06	The story so far
10/05/06	US generics - evolution or revolution?
10/04/06	European generics - steaming ahead or grinding to a halt?
01/03/06	Authorised generics - what are they?
01/02/06	Asia – the next big thing in generics – but at what price?
01/01/06	A shaky future for US companies?
01/12/05	CPhI then and now
25/09/05	Generics then and now
28/08/05	Teva - a case study
27/07/05	The consolidation continues
26/05/05	Europe - The generics pricing squeeze
25/04/05	Europe - The North-South divide
14/03/05	Generics superheroes
28/02/05	A Passage to India?
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Legislation and litigation

15/09/15	Current Issues for Generics in the U.S. Marketplace
15/08/15	Teva v Leo
15/05/15	International Report – IP Court Interprets Scope of Bolar Exemption
15/04/15	The Emerging Biosimilars Marketplace in the U.S.: One Big Step Forward, with Others to Follow in a Complex Playing Field
15/12/14	FDA’s New Guidance on Plant Inspections Provides Industry with a Roadmap to Avoid Agency Sanctions
15/08/14	Biosimilars in the U.S.: Current Status and Challenges Ahead
15/07/14	Liability for Medicinal Product Advertisements
15/05/14	How We Learned to Love IPR for Pharmaceutical Patent Cases
15/03/14	Generic Pharmaceutical Meeting Airs Key Challenges Facing the Industry
15/01/14	SPCs: A Preliminary Ruling From The CJEU In Actavis v Sanofi
01/10/13	U.S. Biosimilars Development Continues Notwithstanding Legislative and Regulatory Hurdles
28/07/13	Supreme Court Bars Design-Defect Claims Against Generic Drug Companies
28/06/13	U.S. Supreme Court Finds Patent Settlements Subject to Antitrust Scrutiny
18/07/12	The Validity of Branded Drug Patent Litigation Settlement Agreements Are Primed for U.S. Supreme Court Review
18/06/12	Generics Demand Product Samples From Brand Companies For Bioequivalency Tests; Congress Falls Short in Providing a Remedy
18/06/12	Preliminary Injunction Against Generics: a Toughening of The Paris Court
18/05/12	Two Big Wins for Generics Clarify Non-infringement Strategies for Method of Use Patents
18/05/12	Compulsory License Granted To NATCO
18/04/12	Federal Circuit Confirms ANDA Filer May Carve Out Patented Uses To Avoid Infringement
18/03/12	Not Just the FTC Anymore: California’s Top Court to Weigh In on “Pay for Delay”
18/01/12	The Impact of PLIVA v. Mensing on Personal Injury Claims against Generic Drug Manufacturers
18/11/11	All Change for EU Paediatric Extensions
18/11/11	Patent Settlement Agreements Remain a Focus in the U.S. Congress
18/02/11	From Conception to Rejection: Yasmin UK Patent Nullity Case
18/02/11	Interim Injunctions and the Modafinil Case – The End of an Era?
08/11/09	Biosimilars Provision Included In House Health Care Reform Bill
25/10/09	Pharma Industry Under Antitrust Scrutiny
15/09/09	Obvious (not) to try - the Calcipotriol Monohydrate Case
15/08/09	Antitrust sanctions for litigation dirty tricks?
15/07/09	Levofloxacin Patent and SPC upheld on appeal
15/06/09	Australian: Patent Term Extension Available If Has Pharmaceutical Characteristics
15/05/09	EPO gets tough on applicants - The changes.
20/04/09	Memantine, new rights for old drugs?
15/02/09	Pain Relief for Generics in UK Infringement case
15/12/08	Patentee Cleans up in Anti-infective Enantiomer Patent Case
19/08/08	The issues in the UK Olanzapine case
18/05/08	UK Escitalopram appeal judgment - frequently asked questions
15/04/08	Escitalopram enantiomer patent claims upheld in court
10/03/08	Obvious Combinations
16/02/08	Pharmaceutical Sector Inquiry
24/01/08	United States: Follow-On Biologics And Patent Reform
15/07/07	Apotex blows a hole in Perindopril patent thicket
10/05/07	UK Enantiomeric form patent held non-obvious but invalidated for insufficiency.
16/03/07	Paediatric Regulation - what it means for the generics industry
01/09/06	Follow-on Biologics legislation
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IP Strategy
18/02/10	Satisfying the Requirements for Industrial Applicability - England & Wales Court of Appeal Provides Guidance For Biotech Inventionson
08/01/10	European Harmony on Selection Patents
15/08/07	Pharmaceutical & Biotech Lifecycle Management (II)
15/07/07	Lifecycle Management (I) are generics launching earlier than ever?
04/04/07	IP freedom to operate put simply
02/12/07	Lilly wins Zyprexa
10/08/06	US Court of Appeal Lipitor judgement
20/05/06	European Court of Justice SPC rulings
15/07/06	Value for money in global patent litigation
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Paragraph IV
05/08/06	The Plavix Patent Case
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Licensing
15/05/09	How to grow your generic business through licensing partnerships
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SPCs
10/06/07	SPC News
01/07/06	Medicinal Product SPCs in Europe from 1991 to 2005
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