Lecture 4 Flashcards
How much will pharma lose in sales 24 months are losing patent?
Pharma will lose 75% of a
product’s sales within 24 months after losing patent exclusivity
why do biotech companies suffer from non-obvious allegations in regards to patents ?
Biotech build on previously know knowledge, so patent section of innovation determined based on experts that experts think its not obvious.
Who is Louis Pasteur and what did he patent ?
and what is exception ?
In 1873 Louis pasteur patented living organism( microbes), it was yeast for beer making. In 1970s the patent laws changed products of nature not statutory subject
matter.
exception: Coverage could be obtained for
compositions containing living things
(microbial spores in sterility tests)
– Also: note ‘purification exception’ (eg,
adrenaline)
What is the Diamond vs.
Chakrabarty, 1980 case
Dr. Ananda Chakrabarty, a microbiologist working for General Electric, developed a genetically modified bacterium (a strain of Pseudomonas) capable of breaking down crude oil.
He applied for a patent and was denied in 1972 why b.c considered a living organism.
The relevant law in question was 35 U.S.C. § 101, which defines patentable subject matter.
Chakrabarty’s legal team argued that the genetically modified bacterium was a new “composition of matter”
What was the outcome of diamond vs Chakrabarty 1980 case?
The Court held that genetically engineered living organisms are patentable because they are the result of human intervention and manipulation, making them man-made inventions rather than naturally occurring entities.
what percentage of patents are from Biotech companies ?
biotechnology represents about 4% of all
patents applications filed
How many biotech patents go through?
30% compared to pharma 50%
Evergreening !
- New Chemical Entities- aka innovative/game changers, long clinical trial period Who owns clinical data after patent expiry?
» US grants 5 years protection on clinical data after patent expiry before competitors
can use it - Me-too drugs-Already patent protected
* Innovation often low
3.Generic drugs- copies, made when patent expires , no innovation, Consumers benefit: Price typically 30% below innovator products
What does FTO search mean ?
Freedom to operate search aka is it safe to use and sell product in a country without infringing patents
What is considered in a FTO freedom to operate search?
- Must know competitors
- Scope boundaries of claims
- What countries competitor patent is for
- Expired? renewal fees paid means patent 20 year still enforce
- Patent is enforce but is it valid can question that
How long is a FTO search and how much ?
2 weeks and 6,000 grand
what part of patent eligibility effects biotech companies the most ?
Morality - b.c they are so inventive pushing boundaries, public opinion matters
Factors to consider when deciding on patent protection ?
-need protection in selling market and manufacturing country
-need data on expected sales and production costs
-scope of patent protection varies depending on country eg recombinant host cells OK for US, but not India
-cost of patent needs to be consider
-Patent agent only able to file an
application in their own country
What are patent agents ?
Patent agents (also called patent attorneys in some jurisdictions) are licensed professionals authorized to represent inventors and businesses in filing and prosecuting patent applications before a particular country’s patent office.
Patent agent only able to file an
application in their own country
In regards to Publish or perish rule why would you bother publishing ?
academic reputation
What does ‘state of the art’ term refer to ?
In European patent law, the term “state of the art” refers to all existing knowledge or publicly available information relevant to an invention before a given date. It is a critical concept in determining whether an invention is novel (new) and inventive (non-obvious), which are key requirements for patentability under the European Patent Convention (EPC).
What should you consider when making claims ?
-Breadth of patent claims: need to be
broad enough to capture all possible
value
– Must be balanced with adequate disclosure
– If claims are too narrowly drawn: may give
opportunity for competition to “design
around” them
Biotechnological inventions shall also be
patentable if they concern ?
-Biological material which is isolated from its natural
environment or produced by means of a technical
process even if it previously occurred in nature;
– Without prejudice to Rule 28, paragraph 2, plants or
animals, if the technical feasibility of the invention is
not confined to a particular plant or animal variety
– A microbiological or other technical process, or a
product obtained by means of such a process other
than a plant or animal variety
What part of human body can not be patented ?
Basically all of human body especially The human body, at any stage of its formation or development, and the discovery of its elements, including the sequence or partial sequence of a gene, cannot be patented.
What part of human body could potential be patented ?
An element isolated from the human body or produced through a technical process, including a gene sequence or partial sequence, can be patented, even if its structure is identical to a natural element.
What must be disclosed in patent regarding sequence of gene or partial sequence ?
The industrial application of a
sequence or a partial sequence of a
gene must be disclosed in the
patent application
What are genes and gene fragments treated like in patents ?
treated like just chemicals
What 3 countries allow ORFs and SNP’s to be patented ?
Japan, Canada, Australia and EU
but conditions apply
These gene fragments can be patented in some cases (including Japan, Canada, and Australia), but with limitations or requirements. What are these?
- Utility requirement
-Isolation and purification: If a gene or fragment is isolated and purified through human intervention (the “hand of man”), it becomes patentable. The idea is that it becomes a “different chemical entity” when isolated.
-Greater value than in its natural state: The purified or isolated gene must have a value or function that exceeds what it has in its natural form.
