Are we moving towards global patenting?

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Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-07-01-2009, Volume 21, Issue 7

Patents are an important tool for protecting innovative products, uses or processes intended for commercialization.

Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling, using or importing the patented invention without the patent owner's permission. A theoretical ideal for an innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a decision is usually made as to where to file and process patent applications.

A common patenting strategy is to file an international patent application under the Patent Cooperation Treaty (PCT) within 12 months of filing a first patent application at the applicant's national patent office. Filing an international patent application allows the patent applicant to delay filing separate patent applications in each territory (country or region) where protection will be sought in any of the current 141 PCT states until 30 or 31 months from the priority application filing date. However, differences in patent law and practice worldwide impact not only how patents may be obtained, but also the scope of protection they afford. How then can a single patent application, such as a PCT application, be used successfully to obtain a valid patent in different territories? I'll return to this question after reviewing certain aspects of the patenting process.

The three patent offices that dominate the world patenting arena are: the European Patent Office (EPO), the US Patent & Trademark Office (USPTO) and the Japan Patent Office (JPO). Although there are similarities in the patent laws of these territories, there are also important differences. The following are summaries of the differences; these are not intended to provide a complete account of the patenting processes or differences.

European Patent Office

The EPO is responsible for examining and granting European patents that can then be effected in any designated European Patent Convention (EPC) contracting state (numbering 35 at present).

The EPO operates a firsttofile system, which means that the first person to file a patent application for a particular invention will have preferential entitlement to obtain patent rights in the invention over another person who subsequently files an application for the same invention. The firsttofile system is intended to create objective legal certainty as to entitlement where copending applications are directed to the same invention.

The EPO has limitations on what it regards as an invention; for example, discoveries, scientific theories, mathematical methods and aesthetic creations are not deemed inventions. Furthermore, certain innovations, even if they are inventions, are excluded from patentability.


Examples of unpatentable inventions are methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body. The latter provisions do not apply to products, in particular substances or compositions, such as pharmaceutical drugs, for use in any of these methods.

When assessing novelty and inventive step — two essential criteria for patentability of an invention — the EPO can take into account anything that has already been made available to the public by any means, including a written or oral description or by use, before the filing date of the patent application. This requirement for 'absolute' novelty means there is no territorial or language limitation on what may constitute a publicly available description. Therefore, an innovator who wishes to obtain a valid European patent should not publicly disclose the invention before filing the patent application.

The EPO uses a problem and solution approach in determining whether a notional skilled person in the relevant field would require an inventive step to conceive of the differences between the invention and the closest prior disclosure, when faced with the problem addressed by the invention.

As with most patent offices, the EPO will determine the subject matter for which patent protection is sought in an application by examining the claim or claims, and using the description and drawings for interpretation. In practice, the EPO typically grants relatively broad claims if the claim scope is considered to be commensurate with the contribution to the technical field of the invention.

On a practical level, a noteworthy aspect relating to EPO examination practice is that an application undergoing examination must contain only one independent claim per claim category (product, process, apparatus or use), with a few exceptions allowed.

After the granting of a patent by the EPO, the patent becomes a bundle of separate national patents, each of which must be processed and, in some cases, translated to allow the patent to become effective in the designated EPC states. However, a European patent may be attacked centrally at the EPO by a third party who files an opposition within 9 months of the date of granting. Although a final decision regarding the validity of a European patent following an opposition may take many years, it will render the patent void in all the EPC states where it was effected if it is revoked.

US Patent & Trademark Office

The USPTO operates a firsttoinvent system where, in theory, a patent for an invention should be granted to the person who first conceived then reduced the invention to practice (for example, by empirical verification of an idea) and, subsequently, filed a patent application. This person may be challenged under an interference procedure for entitlement to a patent by another person who subsequently files a patent application for the same invention. Interference procedures are costly and lengthy, and the need to provide evidence of conception of an invention and reduction to practice is one reason why any innovators interested in obtaining US patents for their inventions are encouraged to keep meticulous records of relevant R&D.

In the US, an invention is considered to belong to the inventor or inventors, although the invention can be assigned to another party. Inventors should be correctly determined and named on a patent application, as deliberate misrepresentation can render a subsequent US patent unenforceable.

Rather than absolute novelty, the USPTO implements relatively complicated laws on what constitutes noveltydestroying disclosures for a patent application. An important law is that a disclosure less than 12 months prior to the date of the patent application need not count against the application — the socalled 'novelty grace period'. However, if another party has disclosed the invention in a printed publication anywhere in the world, or in public use or on sale in the US, within 12 months of a patent application, then the applicant will need to prove that he invented the invention prior to that disclosure (or in some instances, prior to the date of invention by the other party).

US patent law does not restrict what subject matter may be patentable; rather, any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, is deemed patentable. Notably, methods for treating the human or animal body by surgery or therapy and diagnostic methods are patentable in the US. However, it is not possible to sue a medical practitioner with respect to various medical activities for infringement of a US patent granted on a patent application filed after 29 September 1996.

Recently, US courts have introduced a technical element requirement for patentability — particularly in the field of business methods and computer programmes. Here, a new test for whether or not a process or method is potentially patentable requires it to be either tied to a particular machine or apparatus, or operate to change articles or materials to a different state or thing. However, there remains uncertainty regarding the scope and implementation of this test.

Instead of assessing whether an invention has an inventive step, the USPTO determines whether it would have been obvious to the notional person of ordinary skill, aware of prior disclosures, to derive the invention. The USPTO may combine the features of several different disclosures to make this determination.

The USPTO usually allows multiple independent claims within a patent application (as long as the claims are not unduly repetitive), but tends to be relatively restrictive on what is considered a 'single' invention. It may, for example, be necessary to pursue claims to a new drug and pharmaceutical use of the drug in separate US applications (for example, a 'divisional' or 'continuation' application split from a 'parent' application).

The USPTO generally grants claims of narrower scope than the EPO, but this practice should be viewed in the context of the doctrine of equivalents, which applies during US infringement proceedings postgranting. Under the doctrine of equivalents, an infringement may be found by a US court if an alleged infringing product (or use, for example) has features that are deemed to be equivalent — although not necessarily identical — to product features set out in a granted claim. Determining equivalence can be complex.

Another noteworthy feature of the USPTO system is that patent applications are required to describe the best way of performing the invention devised by the inventor(s). Also, there is a strict requirement that the applicant, inventor(s) and others associated with a patent application are candid and honest in their dealings with the USPTO — a socalled 'duty of candour'. This includes revealing any information, including any prior publications, that may be relevant to the validity of the patent application. Failure to comply with the duty of candour can invalidate a resultant patent.

Finally, the USPTO will grant an extension to a patent term (normally 20 years from the date of filing the patent application) where there has been a delay by the USPTO in processing the application. Patent term extensions may prolong the life of the patent by up to several years.

Japan Patent Office

Following changes to Japanese patent law in recent years, the JPO operates in a similar way to the EPO in several aspects, including a firsttofile system, a requirement for absolute novelty requirement and what constitutes patentable subject matter.

The JPO also makes an assessment of whether an invention has an inventive step, but does not use the EPO's problemandsolution approach. In practice, convincing the JPO of an inventive step in some technical fields may be more difficult than either the EPO or the USPTO, confirming the generally-held belief that assessing inventive step is somewhat subjective.

The JPO does not limit the number of independent claims in a patent application, provided that the claims cover the same invention, although fees tend to make a large number of claims uneconomical. The JPO's approach to the concept of unity of invention is more closely aligned to that of the USPTO than the EPO, so multiple divisional patent applications may be needed to cover all technological aspects of an invention.

In certain technology areas, such as pharmaceuticals, the JPO has a higher enablement or support requirements than either the EPO or the USPTO. Suitable worked examples of an invention must be present in the patent application to obtain a reasonable claim scope; later providing postfiling examples as evidence of what is achievable using the invention may not be acceptable.

The scope of claims granted by the JPO generally tends to be intermediate between equivalents in the EPO and USPTO. For determination of infringement, a doctrine of equivalents can be applied by Japanese courts.

Is a single application realistic?

Can a single patent application, such as an international patent application, be used successfully as a basis for obtaining a valid patent in different territories? Yes, if the differences between patent offices are considered when drafting the original patent specification. With the help of a competent patent attorney, an adequate and full description can be prepared, including the best way of performing the invention and as many further examples as possible. Narrow, intermediate and broad definitions of the invention should be considered and explicitly set out in the application so that these statements can form the basis for suitable claims as required. Nevertheless, the final content and scope of resultant patents in different territories is likely to be different. Although some harmonization of global patent laws has already taken place, there is more to be done before a global patent is a possibility.

Michael Austin Roberts is a European Patent Attorney and UK Chartered Patent Attorney at Reddie & Grose (UK).Tel. +44 1223 360 350 Fax +44 1223 360 280