Clearing the patent field


Article as published in the Spring 2007 Edition of Pharma Technology”, Cavendish Group International, London, United Kingdom




Clearing the patent field



A patent that protects an invention can be opposed by competitor companies, through procedures that take place outside the courtroom


            Patents prevent competitor companies from using or selling the specific inventions which the patents protect, such as new compounds or antibodies. Of course, the possibility to license the technology exists. However, the patent owner is often unwilling to grant licences to competitors, or the terms they are prepared to negotiate may simply be too expensive. Alternatively, simply using the invention and risking being sued for infringement of the patent can be very costly and damaging to a company.


            However, there is another strategy that can be used by companies to deal with patents blocking the field. Opposition proceedings are a means by which the validity of a patent is challenged to try to revoke the patent – that is, to remove it – or at least to reduce its scope of protection by partial revocation. It is a strategy that is effectively used by both small and large-scale companies wishing to clear the way to operate in a specific area. Oppositions are not filed at a court, but at the patent office that granted or intends to grant the patent. In some countries, however, the decision can later be appealed through the court system.


            A patent can only be opposed on specific grounds. In Europe these include the grounds that the invention is not new, not inventive, not industrially applicable, as well as the formal grounds that the patent does not sufficiently describe the invention, or that it has been amended in an inadmissible way after it was filed.


            Lastly, the patent can be opposed in Europe if the subject matter of the invention falls under one of the areas which are excluded from patentability. Of these exclusions, the ones that are most relevant to the pharmaceutical and biotechnology industries include if the invention is contrary to morality, if it is a plant or animal variety or an essentially biological process for the production of plants and animals, if it is a mere discovery, if it is a method for treatment of the human or animal body by surgery or therapy, and if it is a diagnostic method that is practised on the human or animal body.


            The interpretation of what falls under these exceptions can be highly controversial. A well known opposition in the biotech area was the so-called “oncomouse case”, which involved a patent for a mouse genetically predisposed to cancer. Understandably the arguments in this case especially focused on whether the invention was contrary to morality. After many years of debate the patent did eventually survive the challenge, albeit in a restricted form.


            To support an argument that the invention is not new or inventive, in Europe the opponent may rely on evidence that was already considered by the patent office. In such cases it is wise to present arguments as to why the evidence should be reconsidered. However, what normally has more chance of success is to submit new evidence to support any allegations. So when considering whether to mount an opposition, further searches of specialised databases are usually first conducted to try to uncover new documents.


            Oppositions are an important way of bringing to the attention of the patent office information that simply could not otherwise have been available to the office. A competitor working in the field may have proof of public prior use of an invention, or of an occasion when details of the invention were publicly discussed, such as during a lecture.


            Recently, a case was decided in Europe on a patent that covered a method of using neem tree oil for fungicidal purposes. The opposition was mounted on the basis of evidence presented by an employee of an Indian agricultural company of prior use of the claimed invention, and on documents not found by the European Patent Office in their initial search. The case resulted in the patent being fully revoked.


            One major advantage of oppositions is that they are significantly cheaper than beginning a challenge in court. Additionally, since patent offices are specialised in this area, they understand the issues being raised. In Europe, there is no centralised European patent court. So challenging the validity of a patent through the judicial system would mean having to fight the patent in each of the applicable national courts, which can eventually be very expensive. On the other hand, an opposition provides a means of “central attack”, conducted through one central body, the European Patent Office (EPO). The effect of the decision is valid for all the relevant European states, significantly saving cost and effort. Oppositions through the EPO have a high success rate, with about two thirds of opposed patents being either partially or completely revoked.


            The opposition system is not without drawbacks. If the patent survives the attack, it can end up being stronger than ever and this will strengthen the position of the patent owner in any future licensing negotiations. The procedure in Europe can also be very long, especially if a case is appealed, in which case it will typically run for five or six years, sometimes even longer.


            European oppositions must be filed within a limited period – within nine months after the patent is granted. This system is called post-grant opposition. Many companies actively monitor the patent rights of their competitors either themselves or through their patent attorneys, so that they are ready to mount a possible challenge within the deadline.


            In Australia the situation is even tighter, as an opposition has to be lodged within three months of the patent office officially advertising that it will accept the patent, but just before the grant is finalised. This pre-grant opposition system means it is even more important for a company operating in the Australian market to be actively monitoring patent activity in their field.


            In the US, opposition proceedings are currently unavailable, although they have been included in proposed reforms to the patent law there. Currently the closest procedure to an opposition system in the US is the “inter partes” re-examination procedure. This is conducted through the US Patent and Trademark Office (USPTO). However, the issues that can be raised are relatively limited. Evidence of prior use can not be presented as it can be in Europe. Also due to a so-called “estoppel provision” a party may not assert later in court that a patent is invalid on any issue they did or could have raised during the inter partes re-examination. Because of this, many potential requesters prefer to wait, so that they are not later prevented from arguing the issue again in court. An “ex partes” re-examination system also exists, although it is not widely used by third parties. Instead this system is normally used by the patent owners themselves to examine problematic documents only uncovered after the grant of their own patent.


            Japan has replaced its opposition system with a “trial for invalidity” procedure, which despite its name is conducted by the patent office and has some similarities to the European opposition system.


             China also has an invalidation system. Drug manufacturers have used it to challenge Pfizer’s patent on the use of Viagra to treat impotence. Reportedly on the day the patent was granted in 2001, a group of generic companies began an invalidity procedure at the Chinese patent office. In 2004 the office declared the patent invalid. The final decision on the matter in China will, however, be had in court.


            Many jurisdictions in the world have an opposition system where the validity of a patent can be challenged. Companies intending to operate in each of these individual marketplaces can use these procedures effectively, by actively monitoring patent activity in a given area and the patent rights of specific competitors. When a problematic patent right is uncovered, a search and analysis should then be conducted for documents or arguments to decide whether an opposition would have a chance of success. Such an analysis should be tailored to the actual grounds available in that jurisdiction. If the analysis indicates that the patent is likely to be considered invalid, then an opposition can be filed within the applicable time frame in order to try to clear the patent field.


Tamaris Bucher

BOHEST Intellectual Property