INTELLECTUAL PROPERTY

INDUSTRIAL PROPERTY

COPYRIGHT

INTELLECTUAL PROPERTY

According to World Intellectual Property Organization (WIPO), it is divided into two categories:

INDUSTRIAL PROPERTY

inventions (patents), trademarks, industrial designs, and geographic indications of source

COPYRIGHT

literary and artistic works such as novels, poems and plays, films, musical works, drawings, paintings, photographs, sculptures, and architectural designs

Intellectual Property Office of the Philippines (IPOPHL)

Is the lead agency responsible for handling the registration and conflict resolution of intellectual property rights

Republic Act No. 8293 or the Intellectual Property Code of the Philippines

January 1, 1998 under the presidency of Fidel V. Ramos

Intellectual Property Office of the Philippines (IPOPHL)

was created by virtue of

PATENTS

A grant issued by the government through the Intellectual Property Office of the Philippines.

PATENTS

An exclusive right granted for a product, process, or an improvement of a product or process which is new, inventive and useful.

PATENTS

This exclusive right gives the inventor the right to exclude others from making, using, or selling the product of his invention during the life of the patent.

twenty (20) years

A patent has a term of protection of

PATENTS

In return, the owner must share the full description of the invention.

PATENTABLE INVENTIONS

Any technical solution of a problem in any field of human activity which is new, involves an inventive step and is industrially applicable, shall be patentable. It may be, or may relate to, a product, or process, or an improvement of any of the foregoing. (Section 21)

NON Patentable

Discoveries, scientific theories and mathematical methods;

NON Patentable

Schemes, rules and methods of performing mental acts, playing games or doing business, and programs for computers

NON Patentable

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provision shall not apply to products and composition for use in any of these methods;

NON Patentable

Plant varieties or animal breeds or essentially biological process for the production of plants or animals. This provision shall not apply to micro-organisms and non-biological and microbiological processes.

NON Patentable

Provisions under this subsection shall not preclude Congress to consider the enactment of a law providing sui generis protection of plant varieties and animal breeds and a system of community intellectual rights protection:

NON Patentable

Aesthetic creations; and Anything which is contrary to public order or morality.

Dr. Lourdes Cruz

isolation and characterization of a venom called conotoxin (from marine cone snails) was key to improvement of the substance as a biochemical probe for testing brain behavior

marine cone snails

isolation and characterization of a venom called conotoxin from

conotoxin (from marine cone snails)

was key to improvement of the substance as a biochemical probe for testing brain behavior

flower induction method made possible the availability of mangoes the whole year-round.

The Generics Pharmacy

For being a champion of accessibility of affordable medicine, while deftly using trademark as a strategic business tool, it is - the largest network of drugstores in the country - was awarded the Gawad Yamang Isip for Business (Negosyo).

MARK

means any visible sign capable of distinguishing the goods (trademark) or services (service mark) of an enterprise and shall include a stamped or marked container of goods.

Trademark

tool used that differentiates goods and servicesfrom each other.

Trademark

It is very important marketing tool that makes the public identify goods and services.

Trademark

It can be one word, a group of words, sign, symbol, logo, or a combination of any of these.

Trademark

refers to both trademark and service mark, although a service mark is used to identify those marks used for services only.

COPYRIGHT

the legal protection extended to the owner of the rights in an

original artwork.

“Original work

refers to every production in the literary, scientific and artistic domain.

COPYRIGHT

Works are protected by the sole fact of their creation, irrespective of their mode or form of expression, as well as their content, quality and purpose.

life of the author plus fifty (50) years after his death. The Code specifies the terms of protection for different types of works.

protection of copyright for original and derivative works is the l

WORLD INTELLECTUAL PROPERTY DAY Celebrated

PURPOSES OF THE IP SYSTEM

To enable the inventor to recoup the cost of the invention

PURPOSES OF THE IP SYSTEM

To serve as an incentive for future research and development

PURPOSES OF THE IP SYSTEM

To facilitate transfer of technology or licensing

PURPOSES OF THE IP SYSTEM

To encourage inventors to disclose their inventions

UTILITY MODELS

is a protection option, which is designed to protect innovations that are not sufficiently inventive to meet the inventive threshold required for standard patents application.

seven (7) years of protection

UTILITY MODELS

It is entitled to seven from the date of filing, with no possibility of renewal.

UTILITY MODELS

may be any useful machine, implement, tools, product, composition, process, improvement or part of the same, that is of practical utility, novelty, and industrial applicability.

INDUSTRIAL DESIGN

Is the ornamental or aesthetic aspect of an article. The design may consist of three-dimensional features, such as the shape or surface of an article, or of two-dimensional features, such as patterns, lines or color.

INDUSTRIAL DESIGN

applied to a wide variety of products of industry and handicraft: from technical and medical instruments to watches, jewelry, and other luxury items; from house wares and electrical appliances to vehicles; from textile designs to leisure goods.

INDUSTRIAL DESIGN

To be protected under most national laws, it must be non-functional. This means that an industrial design is primarily of an aesthetic nature and any technical features of the article to which it is applied are not protected.

Copyright Infringement

Consists in infringing any right secured or protected under the Code.

Copyright Infringement

It may also consist in aiding or abetting such infringement

Copyright Infringement

The law also provides for the liability of a person who at the time when copyright subsists in a work has in his possession an article which he knows, or ought to know, to be an infringing copy of the work for the purpose of:

• Selling or letting for hire, or by way of trade offering or exposing for sale or hire, the article

Copyright Infringement

Distributing the article for the purpose of trade, or for any other

purpose to an extent that will prejudice the rights of the

copyright owner in the work.

Copyright Infringement

Trade exhibit of the article in public

Premarketing

studies conducted to evaluate the safety and efficacy of the new compound

PRODUCT LAUNCH

These include:

Ø Manufacturing scale-up and serialization

Ø Printing of final product label information, packaging and

artwork

Ø Product storage, shipping and distribution arrangements

Ø Production staff and quality team availability

A maximum of 15 calendar days

days is given by the FDA in the processing of CSP.

1) Letter of Application

2) Name and contact details of Specialist of the patient

3) Prescription

4) Medical Abstract of Patient

Ø The requirements for securing a CSP are the following:

1) Acquired Immune Deficiency Syndrome (AIDS)

2) Cancer

3) Life-threatening conditions

Patients having the following conditions are allowed to use

CSP:

Compassionate Special Permit (CSP)

Orphan drugs/biological products are registered following a facilitated registration process and may be accessed by patients using a

Compassionate Special Permit (CSP)

special permit signed by the FDA Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

Biologics License Application (BLA) Process (CBER)

submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards

Form 356h

specifies the requirements for a BLA.

Form 356h

This includes:

§ Applicant information

§ Product/Manufacturing information

§ Pre-clinical studies

§ Clinical studies

§ Labeling

Biologics License Application (BLA)

is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).

21 CFR 600 – 680.

The BLA is regulated under

NDA

Applicable for new drug

NDA

Money requirement is high

NDA

12-15 yr is required

NDA

Cost of drug is high

NDA

Non clinical and clinical study are essential

ANDA

Applicable for generic drug

ANDA

Less money compare to NDA

ANDA

1-2 year required

ANDA

Cost of drug is less

ANDA

Bioavailability and bioequivalent study essential

NDA

Brand name drug

ANDA

Generic name

toxicity, efficacy, pharmacokinetic properties, bioavailability, or

inadequate drug performance.

New drug applications may fail for a variety of

reasons, including

Labeling

accurately and objectively describes the basis for approval and how best to use the drug.

Labeling

In cases where FDA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information

action package.

FDA REVIEW

The project manager assembles all individual reviews and

other documents, such as the inspection report, into an

senior FDA official makes a decision.

FDA REVIEW

This document becomes the record for FDA review. The

review team issues a recommendation, and who will make the decision

6 to 10 months

FDA REVIEW

If it is complete, the review team has how many months

to make a decision on whether to approve the drug.