Since the first gene was cloned, 35 years ago, the field of biotechnology has grown from the realm of science fiction to the reach of the global economy. Biotechnology innovators understand the importance of developing an international market for their products and obtaining worldwide patent rights to protect their investments.
But patent systems are still adapting to the unique issues presented by biotechnology inventions and different countries have different legal and practical requirements for patent protection. Innovators seeking to protect their inventions in several countries should be aware of the similarities and differences across patenting systems.
This article focuses on the U.S. and Europe, two major markets for biotechnology inventions, and highlights some of the factors that should inform patent strategies when patent protection is pursued in both places.
Patentable Subject Matter
Both the U.S. and Europe generally permit patents to be granted on biotechnology inventions with some limitations. Although Europe does not permit patents on methods of treating humans, it does permit medical-use claims that can provide a similar scope of protection.
In Europe, if a construct has been described in the prior art, but not as a pharmaceutical product, or not for treating a specific disease, a patent can be obtained on the construct for use as a medicament or for use in the treatment of the disease.
In the U.S., however, if a construct has been described in the prior art for any purpose, the construct cannot be patented. Instead, innovators must rely on method patents to protect inventions that are based on new uses of a known substance.
The basic requirements for patent protection in the U.S. and Europe are similar. Both systems require the invention to be useful, as in the U.S., or have industrial applicability, as in Europe, and to make a contribution over the prior art such that the invention is both “novel and not obvious” (U.S.) or “possesses inventive step” (Europe).
The systems differ, however, on what qualifies as prior art. The U.S. has a first-to-invent system that rewards the first inventor with a patent. Thus, it provides a one-year grace period during which publications by the inventor will not defeat patentability. The U.S. also permits an inventor to eliminate prior art that was published within one year of his patent application by establishing an earlier date of invention, as evidenced, for example, by laboratory notebook entries. In contrast, Europe has a first-to-file system that defines prior art with reference to relative publication dates and effective filing dates.
The systems also give different prior art effects to their own patent applications. European patent applications have only a limited prior art effect before they are published, while U.S. patent applications are citable as prior art for any purpose as of their filing dates, even if they were not published until 18 months later.
Due to these differences, the same patent application being pursued in both the U.S. and Europe can face different prior art in each system. An unpublished U.S. application filed a few months earlier by the same inventor will not create prior art issues in the U.S., but in Europe, a prior unpublished European application can prevent the grant of a later application if the first application describes the invention of the second application.
Similarly, an inventor’s publication of the invention a few months before the application is filed will not be prior art in the U.S., but could very well block the inventor from obtaining a patent in Europe.
This lack of a grace period in Europe raises the importance of filing at least a provisional application before any aspect of the invention is made public. Even where a prior publication does not completely bar a patent, it could result in a different scope of protection being obtained in Europe versus the U.S. If such circumstances arise, innovators should take care to ensure that both patents encompass at least their planned commercial embodiments, if at all possible.
Both patent systems require the patent application to describe the invention and provide sufficient detail so that others can practice the invention; however, the implementation of these requirements is quite different. The U.S. written description requirement is satisfied for a given invention as long as someone reading the patent application can understand that the inventor had made that invention, without regard to literal description.
Europe’s basis requirement is much stricter, requiring the invention to be unambiguously disclosed in the application. The strict European requirement places a premium on careful patent application drafting and encourages applicants to specifically describe different permutations, combinations, and subcombinations of the invention.
For example, an application that discloses a product with feature A and a product with feature B might support a U.S. claim to a product with features A and B, but might not support such a European claim, unless the application also mentions the A and B combination.
As a result of these differences, amendments that will be permitted in the U.S. might not be permitted in Europe, and strategies that might not be possible in Europe might be successful in the U.S. Thus, it might be easier to amend the U.S. claims to avoid unexpected prior art, or to encompass an aspect of the invention that was not the original focus of the application, while similar strategies in Europe may run up against basis rejections.
Presumption of Validity vs. Opposition
Important differences between the U.S. and European patent systems also arise after the patent examination process is over. Once a European application is accepted, its grant is published, commencing a nine-month opposition period. During that time, any third party can oppose the patent on grounds including: lack of invention (e.g., issues of nonpatentable subject matter or lack of novelty, inventiveness, or industrial applicability), inadequate disclosure of the invention, or lack of basis for the invention in the original application.
The European opposition process can be valuable to competitors because it affords an opportunity to challenge, in a single proceeding, a patent that, after expiration of the opposition period, would have to be challenged on numerous fronts by attacking each national patent in a separate national proceeding.
Once a U.S. application is allowed by the Patent Office, it is granted as a patent and enjoys a presumption of validity. A U.S. patent can only be invalidated by clear and convincing evidence of invalidity in a court proceeding or in a reexamination proceeding in the Patent Office. Unlike European oppositions, U.S. reexaminations can be based only on prior art. This is a significant limitation for biotechnology patents, where the prior art may be scant, but where other patentability issues often arise, such as whether a patent adequately supports the full scope of its claims.
Enforcement of Patent Rights
Both patent systems have little in common at the enforcement stage. A U.S. patent is enforceable against any act of infringement within its boundaries. If a U.S. patent is found to be invalid or unenforceable in any court proceeding, it cannot be asserted against other would-be infringers in other U.S. jurisdictions.
A European patent must be validated in each European country in which patent protection is sought to obtain national patent rights. Each national patent is an independent property right that must be enforced—or challenged—on a country-by-country basis. While this means that a patent owner may retain patent rights in one country even after losing them in another, it also means that he must incur the expense of enforcement proceedings on several fronts in order to keep competitors out of the European market.
Although there are ongoing efforts to create a system for centralized patent enforcement in Europe, conflicting goals and priorities of the stakeholders have so far resulted only in gridlock.
PTO vis-a-vis EPO
In addition to these legal differences, there are institutional differences as well between the U.S. and European patent offices, which are reflected in their differing views of their roles and their relationships to applicants.
While the U.S. Patent Office recognizes its constitutional obligation to promote the progress of science and the useful arts by securing, for a limited time to inventors, the exclusive right to their respective discoveries, it measures the quality of its performance with reference to the rate of improper allowances, without considering the rate of improper rejections and other actions that unduly delay and increase the costs of the patenting process.
On the other hand, the European Guidelines for Examination instruct examiners to be constructive and helpful and not pursue unimportant objections. These institutional differences are reflected in the basic course of the patenting processes.
The U.S. gives applicants only one opportunity to respond to rejections by making amendments or submitting rebuttal evidence. After that, the admission of further amendments or evidence is at the examiner’s discretion, unless additional fees are paid for continued examination.
In Europe, the process is more open-ended, with no set limits on the number of times an applicant can amend the claims or present new arguments for patentability.
These differences are also reflected in current patent reform efforts. The U.S. Patent Office is addressing its overwhelming backlog of patent applications by promulgating regulations that would shift many of the burdens of patent examination to applicants, such as prior art searching and analysis, which would increase patent prosecution costs.
Meanwhile, the European Patent Organization just implemented EPC 2000, which aims to provide a more flexible and user-friendly structure, while keeping in line with the latest developments in international patent law.
These examples of some of the differences between the U.S. and European patent systems demonstrate that a one-size-fits-all approach to patent protection is not likely to result in the strongest patent protection available in either location. Innovators seeking to protect their inventions in the U.S. and Europe could benefit from working with both U.S. and European patent attorneys early in the patenting process, before the invention is published and before any patent applications are filed. They may thus improve their global patent position by coordinating but not copying patent strategies in both systems.