Lecture 3- Intellectual Property Protection

Question 1

What does IP stand for ?

Answer 1

intellectual property

Question 2

What are the 2 different types of Intellectual properties ?

Answer 2

1.Commercial Knowledge aka know how to do something and Copyright that
2.Registered Intellectual Properties aka Patents, Utility models
and Trademarks

Question 3

What are utility models ?

Answer 3

A utility model is a registered right that gives the holder exclusive use of a technical invention. The right is given in exchange for public disclosure of the workings of the invention and is granted for a limited period.

Question 4

What is a patent?

Answer 4

-A patent is a form of ‘industrial property’, which can be assigned, transferred, licensed or used by the owner.

-A patent confers upon its holder, for a limited period, the right to exclude others from exploiting (making, using, selling, importing) the patented invention, except with the consent of the owner of the patent

-Patents are territorial and give an exclusive right in the country where the patent has been granted as long as the patent is renewed each year through the payment of a renewal fee, e.g. an Irish patent is only valid in Ireland (Republic of Ireland only).

-Patents protect technological advances. New or improved products or processes are eligible for patents.

Question 5

what is intellectual property ?

Answer 5

refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.

Question 6

What are trade marks?

Answer 6

A trademark is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies a product or service from a particular source and distinguishes it from others. A trademark owner can be an individual, business organization, or any legal entity

Question 7

What is copy right?

Answer 7

A copyright is a type of intellectual property that gives its owner the exclusive legal right to copy, distribute, adapt, display, and perform a creative work, usually for a limited time. The creative work may be in a literary, artistic, educational, or musical form

Question 8

What is the difference between Patent, Trademark and Copyright?

Answer 8

A patent protects new inventions, processes, or scientific creations, a trademark protects brands, logos, and slogans, and a copyright protects original works of authorship.

Question 9

Where does the word patent come from?

Answer 9

Ancient Greece, latin is patens, to lay open

Question 10

What was the first law surrounding patents?

Answer 10

Venetian Patent Statute was a law created in Venice in 1474,
That gave inventors the right to be the only ones who could make and use their invention for ten years.
why? b.c of italian renaissance

Question 11

Are patents a societal bargain and what philosophy surrounds patents?

Answer 11

YES and Utilitarianism-advocates for society that foster the wellbeing on others and opposes actions the promote harm

Question 12

What are the right of exclusion ?

Answer 12

Based on geography , time period and intangible assets which are hard to quantify unlike tangible assets like buildings

Question 13

What is the ‘good’ or benefit of patents in society?

Answer 13

1. incentive to invest in R&D
2. incentive to invest
3. Incentive-to-commercialize
4. Incentive to disclose
5. Incentive to design around

Question 14

What does it mean by incentive to invest?

Answer 14

It suggests that patents are given to inventors to encourage them to invest in their ideas and bring them to the market.(safety, proven innovative, time period of insured no competitors,or generic drugs)

Question 15

What does it mean incentive to disclose ?

Answer 15

The incentive-to-disclose theory is a concept related to patents. It suggests that granting patent rights encourages people to share their knowledge with the public, which benefits society as a whole. Without this incentive, people may keep their discoveries secret, leading to wasted efforts and resources.
(make certain things public knowledge can see investors, structure of product, design and vague details about process)

Question 16

what does it mean incentive to commercialize ?

Answer 16

Incentive-to-commercialize theory argues that by granting the inventor patent rights, it will incentivize other parties, such as investors or manufacturers, to invest in the technology and bring it to market.

Question 17

what does it mean incentive to design around?

Answer 17

By forcing others to avoid the claims of a patentee, the patent laws encourage creativity and innovation.

Question 18

What does it mean incentive to invest in R&D ?

Answer 18

Exclusion rights provide stronger incentives to invest in research and development (R&D) because innovators expect to appropriate a higher share of the benefits they generate.

Question 19

How is aspirin patent?

Answer 19

Can not patent Aspirin but can patent aspirin use in treating certain disease. Bayer lost patent and rights to aspirin after world war due by US, Patent was register in 1899 in berlin. Can have right to name but can not patent drug that is wildly known.

Question 20

Why are patents important to big Pharma?
Hint theres 5 reasons

Answer 20

-High R&D costs
-so Return of investment (ROI) can be slow

-Long development process
-high risk
-Product sometimes easy to reverse engineer

Question 21

What are the stages in a drug development process and how long does it take?

Answer 21

Basic research, drug discovery, clinical trails phase 1-3. Regulatory approval/FDA. Phase 4 monitoring/ post approval research.

Question 22

What is the important rating from big pharma for patents ?

Answer 22

89% patents second was 47% know how and last was 13% trademarks and 6% copyright

Question 23

what is reverse engineering ?

Answer 23

Reverse engineering is a process or method through which one attempts to understand through deductive reasoning how a previously made device, process, system, or piece of software accomplishes a task with very little insight into exactly how it does so.
-May infringe of IP rights and copy rights

Question 24

What is a PPA?

Answer 24

A provisional patent application (PPA) is a document issued by the U.S. Patent and Trademark Office (USPTO) that helps protect a new invention from being copied during the 12-month period before a formal patent application is filed.

It is intended to give an inventor time to pitch the idea, test its commercial feasibility, or refine a product before committing to the expensive and time-intensive process of a formal application.

Question 25

What is the PCT?

Answer 25

The Patent Cooperation Treaty is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states.

Question 26

How long do you have a patents for ?

Answer 26

Well you have provisional patent application so that Y0 and for 12 months get to decide if you want to continue with patent. than from Y1-Y21 so 20 years have patent then you can get a patent extension from y21-y26

Question 27

What is a SPC?

Answer 27

Supplementary protection certificates (SPC) may be obtained in relation to individual medicinal and plant protection products disclosed in a patent. The certificate extends the protection conferred by the patent beyond its 20-year term for a period of up to five years.

Question 28

Why was a SPC created ?

Answer 28

Supplementary protection certificates was formed b.c during development of drug/clinical trails a patent will obviously be in place but drug cant be commercially sold till regulatory market authorization is given so SPC is to offfset this loss of time not being able to sell to make R&D worth while.

Question 29

What is PTE ?

Answer 29

Patent term extensions (PTE) extend the term of a patent covering a pharmaceutical product that undergoes regulatory review in order to obtain marketing authorization.
USA
Eu- is SPC

Question 30

What are the two types of PTE?

Answer 30

1.patent term restoration (an extension Patents with PTR typically protect the active ingredients of products. Generic entry typically occurs upon expiry of PTRs )
2. pediatric exclusivity (To encourage innovator pharmaceutical companies to conduct additional research on safety and effectiveness for pediatric patients, the United States has enacted separate provisions for granting a six-month extension of patent term known as “pediatric exclusivity.”)

Question 31

What are the patent requirements ?

Answer 31

1. NEW Article 54 of EPC
   2.Inventive Article 56 of EPC
2. Disclosure of Invention Article 83 of EPC eg sufficiency of disclosure
   4.Existence of ‘prior art’ will block patent
   application
   5.Industrial application (Art. 57
   EPC)
   6.Morality clause (Art 53 EPC)

Question 32

what is disclosure of invention / patent mean ?

Answer 32

Disclosure of Patent- The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

Question 33

What does article 54 new invention and article 56 inventive mean ?

Answer 33

-NEW Article 54 of EPC, An invention shall be considered to be new if it does not form part of the state of the art.

-Inventive Article 56 of EPC, An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious (USA)to a person skilled in the art. This is judged by people skilled in art

Question 34

What is Sufficiency of disclosure?

Answer 34

Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention.

Question 35

What is the USA possession test ?

Answer 35

USA Possession Test for patents refers to a standard used by the U.S. Patent and Trademark Office (USPTO) and courts to determine whether an inventor is entitled to a patent based on the adequacy of the written description of the invention in the patent application.

Question 36

How can prior art block a patent?

Answer 36

Prior art refers to any evidence that your invention was already in public domain. This includes publications, products, public demonstrations, or anything else that discloses your invention.
If prior art exists, it can prevent your invention from being considered novel or non-obvious

Question 37

What is european patent -6-Month Clause for Abuse or Exhibition?

Answer 37

In Europe, under the European Patent Convention (EPC), there is a 6-month grace period for disclosures that were made due to an abuse (such as unauthorized disclosure) or if the invention was shown at an officially recognized exhibition.

you still have 6 months from that disclosure date to file a patent without it being considered prior art.

Question 38

What do the USA and Australia of EU 6 month clause instead ?

and which one is better for applicant?

Answer 38

-1-Year Grace Period (‘Bar Date’)-1-year grace period before the filing date, which allows inventors to publicly disclose their invention and still file a patent application within one year.

-USA one is better This grace period provides inventors with more flexibility, allowing them to disclose or test their invention publicly while still retaining the ability to seek patent protection.

Question 39

what does publish and perish mean?

and how is a NDA an exception ?

Answer 39

“Publish AND Perish” in the context of patents refers to the risk that an inventor faces if they publicly disclose their invention before filing a patent application, which could lead to the invention being considered prior art and thus block or invalidate the patent application.

NDA exception:If the inventor discloses their invention under a Non-Disclosure Agreement (NDA), the disclosure is not considered public, and thus it does not constitute prior art.

Question 40

what is industrial application article 57 of EPC ?

Answer 40

Industrial application under Article 57 refers to requirement means that the invention must be capable of being used in any kind of industry in a practical or useful way. e.g useful material and useful methods for all industries

Question 41

What is morality clause ?

Answer 41

“morality clause,” sets out specific exclusions from patentability based on ethical and moral grounds

Question 42

What is Paris Convention for the Protection of Industrial Property (1883)?

Answer 42

-international treaty
-provide a framework for the protection of industrial property, such as patents, trademarks across countries
-central features of the Paris Convention is the right of priority. This allows an inventor to file a patent application in one member country and then file corresponding applications in other member countries within a specific time frame (usually 12 months for patents) while maintaining the original filing date as the priority date

example :if an inventor files a patent application in France on January 1, 2024, they can file a corresponding application in another member country (e.g., the U.S. or Japan) by January 1, 2025. These subsequent applications will be treated as if they were filed on January 1, 2024, the date of the first filing.