Seminar 6 - 7: Biotech Patents Flashcards
What are the criteria for patenting biotechnological inventions under Directive 98/44/EC?
Biotech patents require biological material isolated from nature or obtained via technical processes and must involve industrial application.
What does Rule 26(3) EPC define as “biological material”?
Biological material includes any material containing genetic information capable of reproduction.
Why are human genes in their natural form non-patentable under Directive 98/44/EC?
Human genes in their natural form are non-patentable, but isolated genes obtained via technical processes are patentable if their industrial application is disclosed.
What is the purpose of Article 9 Directive 98/44/EC in biotech patents?
Article 9 extends patent protection to genetic material only if it performs its intended function, such as coding for a specific protein.
What was the significance of the Monsanto case (C-428/08) in genetic material patentability?
Patent protection applies only if the genetic information actively performs its patented function in the material.
What is the scope of protection under Article 8(1) Directive 98/44/EC for biotech patents?
Patent protection extends to the original biological material and its derivatives, provided the patented characteristics remain intact.
How does Article 8(2) Directive 98/44/EC expand process patent protection in biotechnology?
It includes material directly produced by the process and any derivatives retaining the patented characteristics, beyond general process patent limits.
What are the general morality exclusions for biotech patents under Article 53(a) EPC2000?
Inventions contrary to ordre public or morality, such as cloning humans or germline modification, are excluded from patentability.
What activities are excluded from patentability under Rule 28 EPC2000?
Activities include cloning humans, modifying human germline genetics, and using human embryos for industrial or commercial purposes.
What did the Brüstle case (C-34/10) determine about human embryo patentability?
It excluded patents requiring embryo destruction or industrial use but allowed therapeutic uses benefiting the embryo itself.
What was the clarification in the International Stem Cell Corp. case (C-364/13)?
Non-fertilized ova stimulated by parthenogenesis are not considered human embryos if they cannot develop into humans.
How is the term “use” of human embryos interpreted under Article 6(2)(c) Directive 98/44/EC?
Strict: Direct use in the invention. Middle: Dependent on prior destructive use. Widest: Reliance on non-destructive prior research.
What is “purpose-bound protection” in DNA sequence patents?
Purpose-bound protection limits patent rights to the specific function disclosed in the patent, allowing others to patent new uses of the same DNA sequence.
What are the ethical concerns regarding genome editing in biotechnology?
Germline editing raises concerns about safety, societal impacts, and misuse for human enhancement, while somatic cell editing is less controversial as it is not inheritable.
Why was Myriad Genetics’ isolated DNA sequence patent not eligible?
Naturally occurring DNA sequences are not patentable, but cDNA is eligible as it is synthetically created and does not occur naturally.
What was the Mayo decision’s impact on patent eligibility?
It established that claims involving natural laws must include an inventive concept that transforms them into a patent-eligible application.
Why was Sequenom’s patent on detecting cffDNA in maternal blood rejected?
The method relied on a natural phenomenon and used conventional techniques, lacking an inventive concept.
What made Vanda Pharmaceuticals’ drug dosage adjustment patent eligible?
It included specific treatment steps tied to a novel treatment protocol, distinguishing it from reliance on natural laws.
What are the challenges in the CRISPR-Cas patent landscape?
Challenges include overlapping patents (thickets), licensing complexities, and the need for multiple licenses for traits (e.g., in plants).
What is the scope of protection for genetic material in biotech patents?
Protection extends to any material containing the patented genetic information, provided it performs its intended function, such as coding for a protein.
