PHARMACEUTICAL PATENTS and its’ AFFECTS on GENERIC MARKETS

It will be held on March 16th, 2007 in Istanbul, TURKEY.

Why should attend?

• Intellectual property is a major factor in Western generic markets and a major defence tool for branded companies
• The way in which patents and data exclusivity interconnect is potentially very complicated and hard to understand
• Local variations at a national level mean that there is not just one solution that works everywhere across Europe
• An understanding of these issues is vital for companies wanting to enter these markets
• The costs of making a mistake can be very high in legal costs and delays in reaching the market
• This seminar will highlight the major issues in Europe and the USA and provide you with a good basic understanding
• It will help you to avoid expensive pitfalls and costly mistakes and delays

The registered companies so far;

Biofarma, Boehringer Ingelheim, Eczacibasi, Farmapatent Consultancy, Frik Pharmaceutical, Istanbul Patent ,  Merck Sharp Dohme, Med Pharmaceutical, Mehmet Gun Law Office, Nobel Pharmaceutical, Nutifarma, Orna Pharmaceutical, Santa Farma Pharmaceutical, Sanofi Aventis Deutschland, UAB Valentis Pharma Lithuania….

PATENTS and SPCs

• Patent types – Molecule, synthesis, usage
• National patents
• European patents – EP system, varying expiry dates
• SPCs – why do they exist, how do they alter expiry dates?
• US patent systems
• US Patent extensions
• Compulsory licensing – essential drugs
• The Amlodipine example – Maleate vs. Besylate

• Definition of patent / SPC exclusivity periods
• Explanation of data exclusivity
• Legal background
•  Possibility of overlap – data exclusivity after patent expiry
• Absence of patent issues from European regulatory process
• Recent case histories – AstraZeneca vs. Ratiopharm (Nexium) / Pfizer vs. Ranbaxy (Lipitor)

• What does it mean?
• Why does it exist?
• Impact on registration
• EU Situation before – 6 years or 10 years?
• EU Situation after – 10 +1 years

• New EU législation – Directive 2004/27/EU
• Changes introduced – data exclusivity, Bolar Clause, Definition of a generic, European Reference Product, Sunset Clause
• Previous situation
• Winners and losers

• USA – Hatch Waxman Act 1984
• Purpose of legislation
• Changes introduced
• Roche-Bolar
• Orange Book
• Paragraph IV applications
• 180-day exclusivity
• Mcain-Schumer Act 2002

Registration Form  

Please do not hesitate to contact us if you have questions or need further information:

Mrs.  Esra Onur
MK Consultancy Training
Tel: 00 90 212 347 62 55
Faks: 00 90 212 347 62 58
www.mkistanbul.com

• Valuing Pharmaceutical Innovation (14/10/2008)
• Chugai Pharmaceutical Co. Ltd (07/10/2008)
• New tariffs for MA in Romania (01/07/2008)

• SEMISOLID DOSAGE FORM (12/04/2007)
• Vardenafil (23/03/2007)
• Health Innovations (20/02/2007)

• Moxidectin (02/11/2006)
• Rosiglitazone maleate (06/09/2006)
• Sanofi vs. Lupin (22/07/2006)
• Relpax (24/05/2006)
• Patent Expiry Dates (01/03/2006)
• Evergreening (23/02/2006)
• IP case - Atorvastain (02/01/2006)
• IP Case - Sildenafil (22/12/2005)

---