Lecture 4

Question 1

How much will pharma lose in sales 24 months are losing patent?

Answer 1

Pharma will lose 75% of a
product’s sales within 24 months after losing patent exclusivity

Question 2

why do biotech companies suffer from non-obvious allegations in regards to patents ?

Answer 2

Biotech build on previously know knowledge, so patent section of innovation determined based on experts that experts think its not obvious.

Question 3

Who is Louis Pasteur and what did he patent ?
and what is exception ?

Answer 3

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)

Question 4

What is the Diamond vs.
Chakrabarty, 1980 case

Answer 4

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”

Question 5

What was the outcome of diamond vs Chakrabarty 1980 case?

Answer 5

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.

Question 6

what percentage of patents are from Biotech companies ?

Answer 6

biotechnology represents about 4% of all
patents applications filed

Question 7

How many biotech patents go through?

Answer 7

30% compared to pharma 50%

Question 8

Evergreening !

Answer 8

1. 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
2. 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

Question 9

What does FTO search mean ?

Answer 9

Freedom to operate search aka is it safe to use and sell product in a country without infringing patents

Question 10

What is considered in a FTO freedom to operate search?

Answer 10

1. Must know competitors
2. Scope boundaries of claims
3. What countries competitor patent is for
4. Expired? renewal fees paid means patent 20 year still enforce
5. Patent is enforce but is it valid can question that

Question 11

How long is a FTO search and how much ?

Answer 11

2 weeks and 6,000 grand

Question 12

what part of patent eligibility effects biotech companies the most ?

Answer 12

Morality - b.c they are so inventive pushing boundaries, public opinion matters

Question 13

Factors to consider when deciding on patent protection ?

Answer 13

-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

Question 14

What are patent agents ?

Answer 14

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

Question 15

In regards to Publish or perish rule why would you bother publishing ?

Answer 15

academic reputation

Question 16

What does ‘state of the art’ term refer to ?

Answer 16

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).

Question 16

What should you consider when making claims ?

Answer 16

-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

Question 17

Biotechnological inventions shall also be
patentable if they concern ?

Answer 17

-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

Question 18

What part of human body can not be patented ?

Answer 18

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.

Question 19

What part of human body could potential be patented ?

Answer 19

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.

Question 20

What must be disclosed in patent regarding sequence of gene or partial sequence ?

Answer 20

The industrial application of a
sequence or a partial sequence of a
gene must be disclosed in the
patent application

Question 21

What are genes and gene fragments treated like in patents ?

Answer 21

treated like just chemicals

Question 22

What 3 countries allow ORFs and SNP’s to be patented ?

Answer 22

Japan, Canada, Australia and EU
but conditions apply

Question 23

These gene fragments can be patented in some cases (including Japan, Canada, and Australia), but with limitations or requirements. What are these?

Answer 23

• 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.

Question 24

What is utility requirement?

Answer 24

Utility requirement: To be patentable, the gene or fragment must demonstrate usefulness. Simply existing in nature, such as naturally occurring genes within the human body, is not enough to qualify for a patent.

Question 25

Why does John Sulston hate the idea of patenting genes ?

Answer 25

John Sulston: gene patents could have a “chilling impact on
research, obstruct the development of new genetic tests, and
interfere with medical care … rather than fostering innovation “

Question 26

what was the U.S. Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics outcome ?

Answer 26

The Court ruled that naturally occurring DNA sequences, even when isolated from the human body, cannot be patented. This is because they are considered products of nature

The Court held that synthetic DNA (cDNA), which is artificially created in the lab by removing non-coding regions (introns) from natural DNA, can be patented. cDNA is not found in nature and is considered a human-made invention

Question 27

Myriad Genetic tried to patent BRAC genes Was this allowed ?

Answer 27

Isolating a gene from the human body does not transform it into something patentable. For example, the BRCA1 and BRCA2 genes
theyre naturally occur in the human genome

Question 28

What is Utility Criteria ?

Answer 28

Utility Criteria: In U.S. patent law, to be patentable, an invention must meet the utility requirement, which means it must have a specific, substantial, and credible utility or use.

Question 29

Utility criteria: Specific meaning ?

Answer 29

This means the utility must be clearly defined. Simply stating that a polynucleotide (a chain of nucleotides, such as DNA) can be used as a “gene probe” is not valid

Question 30

Utility Criteria: substantial

Answer 30

“substantial” refers to the requirement that the claimed utility of the invention must be more than just theoretical or trivial; it needs to be meaningful and significant.

Question 31

Utility Criteria : Credibility

Answer 31

credible” in the context of utility criteria means that the claimed usefulness of an invention must be believable, supported by evidence, and based on realistic expectations, rather than speculation or unlikely outcomes.

Question 32

Can antibodies be patented ?

Answer 32

Yes and No
EPO: considers preparation of Mab or
polyclonal Ab to be routine:
– So not patentable
- Inventor must show that the Ab is difficult to produce

Question 33

What is considered a hard to produce antibody?

Answer 33

if there are difficulties with isolation
– or
* if claimed antibody has unexpected, advantageous
properties such as:
– Higher binding affinity
– Unexpected antagonistic or agonistic effect
– Low cross-reactivity
– Differential binding to monomer vs dimer
– Must not be obvious from what is already
known
– Not allowed: claims relating to lower
immunogenicity or maintenance of affinity of humanized antibodies.

Question 34

antibody novelty based on what ?

Answer 34

1.structure
2.binding
3.function

Question 35

antibody novelty : structure

Answer 35

Specific Structure: The patent must specify the antibody’s high affinity for its target and include details about its Complementarity Determining Regions (CDRs) or the entire antibody sequence.

Variable Domains: It should specify the heavy and light variable domains,
also include fab sequence, experimental support

Question 36

Antibody: Target

Answer 36

-Target Specification:The patent must clearly identify the target antigen (Ag), such as a new antigen or a unique epitope (specific part of the antigen).
-An antibody that binds to a unique epitope of an already known antigen is patentable
-The epitope targeted by the antibody can be linear (a specific sequence of amino acids) or conformational (dependent on the three-dimensional structure).
The antibody must demonstrate unexpected and advantageous properties related to its binding.
-Possession of Antibodies:

Question 37

Antibody Novelty: function

Answer 37

Functionality: The antibody must exhibit a specific function that is considered innovative or surprising, such as:

Blocking a specific receptor.
Effectively neutralizing an antigen (Ag).
Inducing apoptosis (programmed cell death).
Suppressing the body’s immune response.
Resulting in fewer side effects compared to existing antibodies.
Exhibiting synergistic effects, cross-species reactivity, or reduced aggregation.
Treating a new disease with a known antibody.

Assays Required: The applicant must provide assays or experimental data to demonstrate these functional features

Burden of Evidence: The applicant bears the burden of proof to establish the novelty of the claimed invention, demonstrating that it provides unexpected technical effects.