Secondary Pharmaceutical Patents and Drug Discovery

Flashcards covering key vocabulary related to secondary pharmaceutical patents, drug discovery, patent law concepts, and specific chemical terms from the lecture.

Secondary Pharmaceutical Patent

A patent that protects a range of aspects other than the direct active pharmaceutical ingredient (protected by the corresponding primary pharmaceutical patent).

Chiral Switch

The development of a single enantiomer from a chiral drug that has previously been developed (and often approved and marketed) as a racemate or as a mixture of diastereomers.

Enantiomer Patent

A patent that claims a single enantiomer of a chiral compound that has been claimed in the corresponding previous patent as a racemate or as a mixture of diastereomers.

Selection Patent

A patent claiming an invention that selects a group of individually novel members from a previously known class, on the basis of superior properties.

Improvement Patent

A patent that claims an invention in which its elements were disclosed in the prior art, yet includes an inventive step that was not suggested or disclosed in the prior art.

Dosage Patent

Patents directed to a product in the context of its dosage regimen (schedule of dose, frequency duration, etc.), which provides novelty and nonobviousness.

Method of Use Patent (Second Medical Use Patent)

A patent directed to a product in the context of its medical use (indication), which provides novelty and nonobviousness.

Person Skilled in the Art (PSITA)

A skilled practitioner (or a group of practitioners) in the relevant field of technology who is possessed of average knowledge and ability and is aware of what was common general knowledge in the art at the relevant date.

Obvious to Try

A patentability criterion for establishing prima facie obviousness wherein it is examined whether a person skilled in the art would have possessed any reasonable expectation of success of obtaining a beneficial technical effect of the claimed invention.

Unexpected Results

A term used to assess the nonobviousness of a claimed invention. It needs to be shown that the results were superior as compared with the prior art, to a nonobvious extent.

Teaching Away (Patent Law)

When a person skilled in the art, upon reading a reference, would be discouraged from following the path set out in the reference or would be led in a divergent direction.

Lifecycle Management (LCM)

Optimizing the marketing lifetime performance of pharmaceutical brands, within the context of the company’s overall business, product, and project portfolio.

Evergreening

The business strategy to extend the duration of the effective protection derived from a portfolio of Intellectual Property Rights to increase the appropriability of an innovation or set of business-related innovations or technologies.

Product Hopping

A pharmaceutical manufacturer stopping the marketing of a drug formulation under patent expiry, yet concomitantly marketing a new formulation that is patent protected.

Pay for Delay (Reverse Payment)

A term that relates to drug manufacturers offering generic companies payments not to bring lower-cost alternatives to market.

Me-Too Drug

A drug within the same chemical class as another already on the market.

Plausibility (Patent Validity)

A condition of patent validity, particularly for second medical-use patents, requiring that the claim to therapeutic efficacy must be credible and disclosed in the specification.

Omeprazole Cycle

The mechanism by which omeprazole, a prodrug, acts in vivo as a proton-pump inhibitor (PPI) through an active achiral sulphenamide intermediate formed under acidic conditions.

Tautomerism

The existence of a molecule as a rapidly interconverting mixture of structural isomers, such as the 5-methoxy and 6-methoxy forms of esomeprazole.

Pyramidal Inversion Mechanism

The accepted mechanism for the thermal racemization of chiral sulfoxides, involving the sulfur atom briefly becoming planar in the transition state.

What is the primary goal of Secondary Pharmaceutical Patents?

To protect aspects other than the direct active pharmaceutical ingredient, aiming to extend market exclusivity and optimize brand performance.

What is the overarching aim of "Lifecycle Management" (LCM) in pharmaceuticals?

To optimize the marketing lifetime performance of pharmaceutical brands, often utilizing a portfolio of Intellectual Property Rights including various types of secondary patents.

What common discussion arises regarding "chiral switches" and "enantiomer patents"?

Discussions often revolve around whether the isolation of a single enantiomer from a known racemate or mixture provides sufficient novelty and nonobviousness, especially if it offers superior therapeutic properties or reduced side effects.

How do "Obvious to Try" and "Unexpected Results" influence patentability discussions?

These are key criteria for assessing the nonobviousness of an invention; "obvious to try" can negate patentability, while "unexpected results" (superior outcomes compared to prior art) support it.

What is the main controversy surrounding "Evergreening" and "Product Hopping"?

They are controversial business strategies perceived as attempts by pharmaceutical companies to extend patent monopolies beyond their initial term, potentially delaying generic drug competition and keeping drug prices high.

Why is "Pay for Delay" (Reverse Payment) a contentious practice in the pharmaceutical sector?

It is controversial because it involves brand-name drug manufacturers paying generic companies to delay introducing lower-cost alternatives to the market, which can suppress competition and inflate drug costs.