Seminar 3 - 4 Pharma Patents Flashcards
What types of subject matter are excluded from patentability under Art. 52(2) & (3) EPC?
Scientific theories, aesthetic creations, and methods of doing business are excluded unless they include technical features.
Why are medical treatment methods not patentable under Art. 53(c) EPC?
To protect the freedom of the medical profession to treat patients without patent constraints. Products like drugs used in these methods remain patentable.
What is the rationale for excluding diagnostic methods performed on the body from patentability?
To ensure that essential diagnostic practices remain freely available for medical use.
What technical steps in diagnostic methods meet the “practiced on the body” criterion?
Both invasive steps (e.g., drawing blood) and non-invasive steps (e.g., external sensors or diagnostic machines) are included if they involve interaction with the human/animal body.
What are the four diagnostic steps required for patent exclusion under Art. 52(4) EPC?
Data collection, comparison with standard values, symptom identification, and deductive diagnosis.
What is a “first medical use” claim under Art. 54(4) EPC?
A claim allowing patentability of a known substance or composition used as a medicament for the first time. Example: Compound X for the use as a medicament.
What is a “second medical use” claim under Art. 54(5) EPC?
A claim allowing patentability of new therapeutic uses for a known substance. Example: Compound X for the use in the treatment of disease Z.
Why were Swiss claims prohibited after January 28, 2011, under G 2/08?
Art. 54(5) EPC introduced explicit protection for second medical uses, making Swiss claims redundant and prohibited for new applications.
What are examples of new therapeutic applications under second medical use claims?
Different illnesses, patient groups, modes of administration, functional effects, or novel dosage regimes.
What concerns are raised by second medical use claims in pharmaceutical patents?
“Evergreening” concerns, where companies use these claims to extend patent protection and delay generic competition, potentially increasing healthcare costs.
What was the central issue in the Warner-Lambert case regarding second medical use claims?
Whether the generic manufacturer infringed Swiss-form claims by enabling off-label use of pregabalin for a patented indication.
What is the “outward presentation” test in assessing infringement of Swiss-form claims?
Infringement is assessed based on the product’s packaging, labeling, and information leaflet, focusing on its intended use as presented.
What are the legal challenges for diagnostic tests under U.S. patent law?
Under Mayo v. Prometheus, correlations between samples and biological sequences are not patentable, limiting protections for diagnostic tests.
What is the significance of G 2/08 for second medical use claims?
G 2/08 broadened the scope of patentable uses under Art. 54(5) EPC, including dosage regimes, while requiring novelty and inventiveness.
What areas of vaccine technology are protected by patents?
Vaccine platforms, delivery systems, vaccine products, manufacturing methods, and medical devices used in administration.
