Advanced One-Day Course (English)
When, how and for how long can I protect and monetize my biotech or pharma innovation? Being able to answer these questions is crucial whenever a Biotech or Pharma company decides to discover their products to the public and to the market - therefore we have set up this new workshop with two modules:
- Intellectual Property: Patents, Supplementary Protection Certificates (SPCs) and Litigation
- Regulatory Exclusivity and Reimbursement
Online Course with Zoom.
Module 1: Intellectual Property
- Patents: Process of filing and granting patents in Europe and the world
- Patentable subject-matter in the field of medicine: Overview and second medical use (new medical purpose)
- Digression: Patenting of medical devices with “double function”
- Supplementary Protection Certificates (SPCs): Definition and explanation, case law, comparison to other legislation, future of SPCs
- Patent litigation: Enforcement - case law; “Skinny labelling” - consequences for healthcare system and health insurance
- Practical Exercise 1: “Skinny labelling”
Module 2: Regulatory Exclusivity and Reimbursement
- Regulatory exclusivity in Europe and other countries: Overview, regulatory exclusivity, market access, research exclusivity, paediatric medicines exclusivity in the EU, manufacturing waiver
- Digression: Biosimilars
- Reimbursement and pricing negotiations with health insurance (AMNOG in force since 2011 with smaller amendments in 2013 and 2014): Benefit assessment of medicinal products, AMNOG process (result, risk, comparison to other countries)
- Practical Exercise 2: Reimbursement and pricing negotiations with health insurance (DE)
Some experience in the field of intellectual property protection in the context of the biotech and pharma industry is required. For example, attendance to the GLA Biotech & Pharma Summer School. Since the workshop will focus on the specificities and challenges of this sector, the attendee should be at least partially familiar with the following general concepts of intellectual property protection:
- Basics of intellectual property protection (incentivising innovation by granting time-limited monopoly, invention has to be novel, inventive and enabled)
- Life cycle of a patent (from drafting to infringement lawsuit): Pre–grant, i.e. strategy, research and application, further actions such as opposition, appeal, invalidity/nullity, infringement, licensing, cooperation
2-Half-Day Workshop. The qualification will comprise a total of 7,0 lessons.
The course will be held with a minimum of six and with a maximum of 16 attendees.
Please note that an early registration is recommended since the number of places available is limited and the demand might exceed availability.
The course is directed to staff from pharmaceutical or biotech companies who are bringing or planning to bring their products to the market, as well as life science researchers who are generally interested in the interplay between IP and regulatory approaches.
After course completion, attendees will have developed a good understanding of intellectual property and regulatory concepts at the complex interface between these fields. The attendees will be able to define the exclusivity period of a pharmaceutical product in light of patent rights, supplementary protection certificates (SPCs), litigation outcomes and regulatory considerations. A further learning goal is to convey a basic understanding of reimbursement mechanisms in Germany including negotiation strategies with public health insurance in the context of regulatory and scientific requirements. The successful participation will be certified by the Gläsernes Labor Akademie (GLA).
522,00 € per participant incl. VAT.
Private registrees will get a fee reduction of about 10%.
According to local law (§ 11 Berliner Bildungsurlaubsgesetz BiUrlG) educational leave applies.
Dr. Uwe Lohmeier per E-Mail:email@example.com
Version: 11 May 2021
Subject to modifications