Intellectual Property Issues for Bacteriophages

Abstract

The processes involved in obtaining a patent can be both complex and expensive. While an initial filing may be both simple and inexpensive (or even free), the later stages can become highly complex and require expert advice. There is no denying that patents are important, both in the early stages of work to demonstrate that the technology is protectable to potential investors and in the later stage to protect a valuable product during commercialization. This is particularly the case for replicating biological agents, given that “copying” them is so straightforward. However, before electing to file for a patent, it is necessary to consider the value that will be generated. Filing too early risks any patent expiring before the technology is commercialized, while filing too late carries many risks, from inadvertent disclosure to competitors obtaining protection first. There are also specific issues with bacteriophages, where many of the basic technologies are very clearly within the public domain, and thus new inventions must meet an increasing patentability threshold. It should be noted, however, that these can involve naturally occurring bacteriophages as well as novel genetic constructs.

Glossary

EPO

The European Patent Office

Freedom to operate

Confirmation that an invention is not going to infringe an existing patent. May also address novelty over the prior art. Often assessed by an extensive (and expensive) search process, but rarely conclusive.

Generic

The generic of a drug, a competitor produced after patent cover expires, defined by US FDA as “A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.”

Infringement

Exploitation of a patented technology (within a jurisdiction where a patent applies) without permission (typically in the form of a license) from the patent holder.

Inventive step

The requirement that a patented invention should not be obvious to “a person skilled in the art”

Myriad judgement

The USPTO’s interpretation of 35 U.S.C. § 101, “Inventions patentable” in view of the US Supreme Court decision in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. in 2013 which decided that “products of nature are unpatentable.” Later interpretations of this have shown greater flexibility than the initial teachings.

Novelty

The requirement that a patented invention has not be detailed elsewhere prior to filing a patent.

PCT

Patent Cooperation Treaty of the World Intellectual Property Organization.

Priority date

The date of the first, local filing of a patent application, usually 1 year before the international PCT filing, and thus 21 years before patent expiry.

Priority year

A term of up to 1 year following local filing before progression to the international (PCT) stage, during which novel matter may be added to a patent (though it will generate a later priority date for such material).

Reduction to practice

The ways in which a patented invention has been shown be both practical and achievable (also, Exemplification).

Safe harbor

In the USA, EU, and Canada, the ability under various local laws to conduct research preparing for regulatory submissions within the area of an existing patent without infringing that patent.

Submarine

A now extinct class of “hidden” patent in the USA that was only published on award.

Undue burden

The requirement that patent documentation should contain sufficient detail that “a person skilled in the art” would be able to replicate the invention as instructed solely by the documentation

Unity of invention

The requirement that a patent filing should only cover a single invention.

USPTO

United States Patent and Trademark Office.

WIPO

The World Intellectual Property Organization, which manages the international stage of a patent in the 193 member countries around the world.