Patent Opposition Database

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Glossary of Terms

Below are commonly used terms related to patent oppositions and patents.

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Abandonment

The decision by a patent applicant to no longer pursue a patent application. An application is considered abandoned when an applicant fails to respond to a pending issue of the Patent Office. Generally, an applicant is free to abandon his or her patent application at any time.

Active pharmaceutical ingredient (API)

The chemical substance responsible for a product’s effect. Also called ‘substance’.

Claim

Claims are the part of the patent application where the inventor defines the legal scope of a patent and what will be protected by patent law.

Data exclusivity

A legal provision that data collected for the purpose of obtaining marketing approval (e.g. the results of clinical trials) may not be used for a specified period by the regulatory authorities to grant approval to a generic equivalent.

Data protection

An obligation imposed on third parties to protect test data (e.g. the results of clinical trials) – usually collected in order to comply with government regulations on the safety, efficacy and quality of a broad range of products (e.g. drugs, pesticides, medical devices). The TRIPS Agreement provides for the protection of such data against unfair commercial use.

Disclosure

The first public disclosure of details of an invention. This may be deliberately revealed outside the patent system to make the invention unpatentable, or what is described in a patent application. In return for a patent, the applicant must make a full disclosure of the invention for which patent protection is sought.

Divisional patent

A type of patent application which contains matter from a previously filed application.

EPO

The European Patent Office is a regional patents office created by the European Patent Convention to grant European patents, based on a centralised examination procedure.

Evergreening

A term popularly used to describe patenting strategies that are intended to extend the patent term on the same compound.

Examination

The examination of the patent application, undertaken by a patent examiner, to determine whether the application complies with all the legal requirements for patentability set out in the legislation.

First-line drug

A drug used as part of the first resort to treat a disease.

Generic drug

According to WHO, a pharmaceutical product usually intended to be interchangeable with the originator product.

Industrial applicability

A patentability requirement according to which the invention should be capable of being made or used in an industry.

International Nonproprietary Names (INN)

A nomenclature system used to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property.

International Search Report

Report established by the International Searching Authority containing citations of documents considered to be relevant for the claimed invention (relevant prior art), the classification of the subject matter of the invention and an indication of the fields searched as well as indications of any electronic data base searched. Furthermore, it may contain remarks concerning unity of invention.

International preliminary examination report

A preliminary, non-binding opinion, established by the International Preliminary Examining Authority on the request of the applicant, on the questions whether the claimed invention appears to be novel, to involve an inventive step (to be non-obvious), and to be industrially applicable.

Inventiveness or ‘inventive step’

An invention is considered to include an inventive step if it is not obvious to a skilled person in the light of the state of the art. At the EPO, the inventive step is one of the most important criteria (along with novelty and industrial application) that need to be fulfilled in order to obtain a patent. The US PTO employs the concept of “non-obviousness”, which is equivalent to the inventive step criterion of the EPO in a legal context.

Legal standing

The legal right to initiate a lawsuit; the ability of a party to bring a lawsuit in court based upon their stake in the outcome.

Novelty

If an application for a patent is to be successful, the invention must be novel (new). The invention must never have been made public in any way, anywhere, before the date on which the application for a patent is filed (or before the priority date).

Originator pharmaceutical product/originator brand

Generally the product that was first authorised worldwide for marketing, normally as a patented product, on the basis of the documentation of its efficacy, safety and quality. Used in contrast to ‘generic’ product.

PLHIV

People living with HIV/AIDS.

Patent

An exclusive right awarded to an inventor to prevent others from making, selling, distributing, importing or using the invention, without licence or authorisation, for a fixed period of time. In return, the patentee discloses the invention to the public. There are usually three requirements for patentability: novelty (new characteristics which are not “prior art”); inventive step or non-obviousness (knowledge not obvious to one skilled in the field); and industrial applicability or utility.

Patent Cooperation Treaty (PCT)

An international treaty which was signed in 1970 and entered into force in 1978. The PCT provides the possibility to seek patent rights in a large number of countries by filing a single international application (PCT application) with a single patent office (receiving office). The PCT procedure consists of two main phases: (a) an “international phase”; and (b) a PCT “national/regional phase”. PCT applications are administered by the World Intellectual Property Organisation (WIPO).

Patent landscape

The patent situation for a specific technology in a given country, region or on the global level.

Patentability

The relevant legal conditions that an invention must meet to be granted a patent.

Prior art

Publications or other public disclosures made before the filing (or priority) date of a patent application against which the novelty and inventiveness of the invention in the patent application is judged.

Revocation

Termination of the protection given to a patent on one or more grounds, such as a lack of novelty.

Second-line drug

Used when the first-line drugs are no longer effective.

TRIPS

Trade-related Aspects of Intellectual Property Rights. The TRIPS Agreement signed in 1994 is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property rights.

US FDA

United States Food and Drug Administration. The FDA is responsible for protecting and promoting public health through the regulation and supervision of pharmaceutical products.

US PTO

United States Patent and Trademark Office. The USPTO administers the examination and granting of patent rights in the United States.

Withdrawal

An application for a patent may be withdrawn at any time before it is granted.

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