Lecture 4 continued

Question 1

Are bacteria and Cells patented?

Answer 1

Isolated from nature and genetically modified: For an organism to be patentable, it must be isolated from its natural environment and may need to be genetically modified.

• patent must state if isolated entity has been made public.
  -The patent can also cover the method of producing the material using the cells,

Question 2

What is biopiracy and PIC?

Answer 2

To prevent biopiracy (the unauthorized use of biological resources), the patent application should specify the origin of the bacteria and include a Prior Informed Consent (PIC) statement.

Question 3

Can plants be patented ?

Answer 3

Yes but plants must be transgenic aka genetically modified
Not possible with plants
isolated from nature
But plant breeders rights
exist

Question 4

Can animals be patented?

Answer 4

yes but must be trangenic Not possible with animals in nature
A transgenic goat comprising a nt
sequence encoding human
glucocerebrosidase, wherein the
human enzyme is secreted into the
goat’s milk

Question 5

what stopped humans being genetically modified ?

Answer 5

Biotech Directive 1998

Question 6

What is a method- process patent?

Answer 6

A method or process patent covers a series of steps or procedures that lead to a specific result or product

Question 7

Can imaging be patented ?

Answer 7

Diagnostic method performed on the human body not patentable
– Computer programmes not patentable
* But!
* Imaging an artery is allowable, while trying to patent a
method of diagnosing heart disease is not patentable

Question 8

Can diagnostic assays patented in EU?

Answer 8

EU: Yes: In the European Union, diagnostic assays can be patented. However, there is no explicit definition of a “diagnostic method,” which leaves some flexibility in interpretation.
Must be in vitro: The diagnostic methods must be conducted in vitro, meaning they are performed outside of a living organism, typically in a lab setting (e.g., testing blood or tissue samples).

Question 9

Can diagnostic assays be patented in US?

Answer 9

In the U.S., certain diagnostic methods are not patentable due to restrictions established by the Supreme Court. Specifically, these methods fall outside the scope of 35 U.S.C. Section 101, but there is exceptions

Question 10

Exceptions to supreme court ruling about diagnostic assays ?

Answer 10

Law of Nature: In the 2012 case of Mayo Collaborative Services v. Prometheus Laboratories

Natural Products: In Myriad Genetics (2013),

Abstract Ideas: The 2014 case of Alice Corp v. CLS Bank International

Question 11

what was the Mayo Collaborative Services vs Prometheus Laboratories ?

Answer 11

In the 2012 case of Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court ruled that optimizing drug treatment methods was too routine and conventional, thus not patentable.

Question 12

what was the Myriad Genetics case ?

Answer 12

Natural Products: In Myriad Genetics (2013), the Court ruled that isolated natural products, such as DNA or proteins, could not be patented if they were not significantly transformed from their natural state.

Question 13

what was the Alice Corp vs CLS bank case?

Answer 13

Abstract Ideas: The 2014 case of Alice Corp v. CLS Bank International determined that abstract ideas, such as mathematical concepts or mental processes, are not patentable, including computer methods for assessing risk.

Question 14

What is the budapest treaty ?

Answer 14

The Budapest Treaty was established in 1973 and later amended in 1980. It provides an international framework for the deposit of biological materials, such as microorganisms, in relation to patent applications.
Recognises virtual impossibility of reproducing a microorganism
from a description in the patent specification
* All states party to the Treaty are obliged to recognize
microorganisms deposited as a part of the patent disclosure
procedure with an international depositary authority
– 34 international depositories

Question 15

what happens id Invention involves biological material no publicly available ?

Answer 15

If an invention involves biological material that is not publicly available and cannot be sufficiently described, it will only be considered disclosed under Article 83 if:

A sample of the biological material is deposited with a recognized institution, as per the Budapest Treaty, by the patent application filing date.
The application includes relevant information about the characteristics of the biological material available to the applicant.

Question 16

rules for deposit of biological material ?

Answer 16

For the deposit of biological material in a patent application:

The depositary institution and accession number must be included in the application.
If deposited by someone other than the applicant, the application must state the depositor’s name and address, along with documentation showing the depositor’s authorization for the applicant to reference the material and consent to its public availability.
Access by third parties is restricted until the patent publication date (EU) or grant date (US), allowing for experimental use only.

Question 17

exception to patentability ? article 53

Answer 17

Inventions whose commercial exploitation would violate public order or morality, even if not prohibited by law in all Contracting States.
Human cloning, germline modification of humans, and the use of human embryos for commercial purposes.
Plant or animal varieties and essentially biological processes for producing plants or animals (with an exception for microbiological processes and their products).

Question 18

More exceptions to patentability ? article 53

Answer 18

Methods for treating the human or animal body through surgery, therapy, or diagnostic methods practiced directly on the body, as this would interfere with the Hippocratic Oath.
However, products (substances or compositions) used in these methods can be patented.
Methods for treating or diagnosing body tissues after they have been removed from the body are patentable, but the tissue cannot be returned to the same body.

Question 19

When are trademarks renewed ?

Answer 19

every 10 years indefinitely but can be opposed

Question 20

For trademarks whats the difference between R, TM and SM?

Answer 20

® (Registered Trademark): Indicates a trademark that has been officially registered with a government authority, granting statutory rights and legal protection.

™ (Trademark): Signifies an unregistered trademark, which does not have statutory rights. It relies on common law protection, typically after use for over five years.

SM (Service Mark): Similar to ™, it indicates an unregistered trademark used to identify services rather than goods.

Question 21

What category of words can not be trademarked ?

Answer 21

-Generic: These are common terms for products or services and cannot be trademarked. For example, “hydrocortisone” is a generic term for a specific medication.

-Descriptive words uselful in marketing but cant be trademarked

-Arbitrary: These are common words used in an unrelated context (e.g., “Chiron” has no specific meaning related to a product).maybe trademarked

Fanciful: These are coined terms specifically created for a product (e.g., “Herceptin,” which suggests intercepting the HER2 gene). Fanciful marks are considered the strongest and most protectable type of trademark.

Question 22

Steps in registering a trademark ?

Answer 22

• do search for similar trademarks
  -do data base screening of trademarks via eg phone
  -legal opinion
  -makes sure its not generic trademark
  -trademark registration is cancellable on the grounds that the mark
  has become generic (Aspirin)

Question 23

What is the life term of Copyright?

Answer 23

its life time of author or 70 years

Question 24

Does a copyright need to be registered ?

Answer 24

No but date of creation proof needed and witness

Question 25

Whats a registered design ?

Answer 25

protects visual design (shape,
configuration, appearance) of a product which
are not functional
– Lines, contours, colours, shapes, textures, materials of
the product or its ornamentation

Question 26

For a registered design what is the term length and max term length with renewal ?

Answer 26

5 years and max 25 years

Question 27

How much is a registered design and in eu how much of a grace period do you get for disclosure ?

Answer 27

1,200 and 12 month grace period

Question 28

How to keep information secret ?

Answer 28

employment and confidentially agreements

Question 29

How many patents are made in error ?

Answer 29

About 300,000 patents
granted in error each
year at USPTO

Question 30

where do you challenge a patent, how long do they take and whats the percentage of success ?

Answer 30

in a civil court, 4 years and 43% success rate

Question 31

why is there a incentive to settle outside of court with challenging a patent?

Answer 31

Very costly legal fees and patent insurance exists

Question 32

what is the havard oncomouse ?

Answer 32

The Harvard Oncomouse is a genetically engineered mouse designed for cancer research, developed at Harvard University.
It carries an activated oncogene, making it prone to tumors, particularly breast cancer

First animal to be patent and alot of backlash for morality of it.

But it was patented

Question 33

What was the myriad genetics case?

Answer 33

Myriad Genetics held patents for the isolated forms of the BRCA1 and BRCA2 genes. These patents allowed the company to control testing for mutations.
This created on monopoly for testing unethical
In response to the situation, the Association for Molecular Pathology (AMP),filed a lawsuit against Myriad Genetics.
In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics, Inc. that naturally occurring DNA sequences, such as the BRCA1 and BRCA2 genes, cannot be patented. But synthetic cdna can be patented.

Question 34

The Promega vs. Roche case

Answer 34

The Promega vs. Roche case involved a legal dispute over patent infringement related to PCR (Polymerase Chain Reaction) technology.
in 2016, a jury ruled in favor of Promega, finding that Roche had infringed on its patents and awarding Promega significant damages.
Settlement: The case concluded with a settlement that allowed Roche to continue selling its PCR products under specific conditions.

Question 35

What is the legal battle of Crispr technology/ patent ?

Answer 35

University of California, Berkeley vs Broad Institute affiliated with MIT

Patent Applications: UC Berkeley filed its first application in May 2012, while the Broad Institute followed with its application in December 2012. Both entities claimed priority for their respective technologies,

The U.S. Patent and Trademark Office has issued rulings favoring the Broad Institute in multiple instances. However, UC Berkeley continues to challenge these rulings, asserting that it was the original developer of the technology