News & Comment

Indirect infringement of intellectual property rights can be found when a party actively induces a third party to infringe a patent, or contributes to that infringement.

Patents on microorganisms are far from new. In the brewing and baking industries, yeast has traditionally played an important part and patents for new types of yeast were granted in Belgium in 1833 and in Finland in 1843. But how can you patent a microorganism?

Although methods of medical treatment per se are not patentable in Europe, the use of agents or products in the preparation of medicaments for such treatments are. The drawbacks of such limited protection is clear. The European Patent Office is becoming ever more stringent in their requirements for the presence of experimental data in support of the medical use to be present in the application on filing. Whether Europe will ever harmonize with the US in allowing the protection of medical methods is not clear. Until then the burden on inventors to obtain patent protection for medical-use-type inventions is significant and the return is far from adequate.

The Paris Convention allows an inventor to file an initial 'priority' patent application and then to file foreign patent applications on the basis of that 'priority' application up to 1 year later. This year gives the inventor time to evaluate the invention before committing to the expense of filing foreign patent applications.

The doctrine of obviousness-type double patenting has been used with considerable success in recent years to defeat later-issued claims in the patent estates of new drug innovators (see box). This judicially created doctrine is grounded in policy, rather than the language of the Patent Statute, with the explicit goal of preventing the 'unjustified time-wise extension' of a patent owner's right to exclude others from practicing the patented invention.

Major patents on blockbuster drugs continue to expire. Each drug requires huge investment and many years of R&D before marketing. How can return-on-investment be maximised?

Escalating drug prices are at the centre of the raging debates on the seemingly uncon-trollable costs of providing healthcare. Making available generic substitutes for the more expensive, patented drugs is a core element of many healthcare cost-reduction plans. In the United States, the Orange Book serves to promote expedited entry of generic drugs into the marketplace while simultaneously protecting the interest of drug patent owners.

The European Patent Convention (EPC) states that a patent or patent application cannot be amended in such a way that it contains subject matter that extends beyond the content of the application as filed. It seems that the European Patent Office (EPO) is interpreting this provision with ever-increasing severity. This article considers the effects of this and related provisions to inventors in obtaining patent protection for their inventions in Europe and also consider the consequences of 'flouting the rules'

The doctrine of inherent anticipation, in which anticipation is found despite the absence of express disclosure in a prior art reference, has recently enjoyed a remarkable revival. In the past few years, various three-judge panels of the Court of Appeals for the Federal Circuit have significantly expanded the reach of this doctrine, increasingly affirming the inherent anticipation of claims that had been crafted specifically to extend the scope or the duration of pharmaceutical patent protection.

What happens if someone else claims to have invented your invention? In the United States, only the first inventor has rights to patent protection of an invention. When two or more parties claim to have invented the same invention, an interference determines the actual first inventor, who will subsequently be awarded the patent rights.

Patent systems were designed to encourage and reward innovation. A system that prevents research into the subject matter covered by a patent would be inconsistent with such goals, and so the patent systems of most countries contain a provision that exempts from infringement experiments performed relating to the subject matter of a patent. In this article, the extent of the exclusion for experimental acts in Europe, particularly the UK, is discussed. I consider what constitutes an experimental act and to what extent the experimental use provision can effect scientific development.

US patent law lacks the robust post-grant opposition procedure available to third-party challengers under the European Patent Convention. Instead, US law offers two variants of post-issuance re-examination proceeding, each of which permits limited third-party challenge to patent validity. Neither is widely used, but ex parte re-examination, in which the third party is precluded from participating in the proceedings after filing the initial re-examination request, has proven to have some value as a tool in defence of actual or threatened infringement litigation.

The life-sciences press is peppered with headlines such as 'Court holds that Ranbaxy did not infringe GSK patent' and 'Court awards Applied Medical Resources Corp., $43.5 million because Tyco Corporation had infringed Applied's patent'. But what amounts to an infringement? How does the court decide whether Ranbaxy can make its generic version of the antibiotic Ceftin or that Tyco has to pay such a large sum?

Recent decisions of the European Patent Office (EPO) indicate the ever-increasing need for experimental support in a patent application. This article reviews the experimental support requirement and looks at how the presence or absence of such support can influence the scope of patent protection obtained.

You are a biotech company that has just been granted a patent connected with drug discovery. What do you do with it? The costs of drug discovery and development are so prohibitive that only large companies have sufficient resources to proceed with such an undertaking. Therefore most biotech companies will need to involve a larger third party at some stage in order to develop the product and get it to market. When should your average biotech company try to tie the knot with a big pharma partner?

If you believe that a European patent has been wrongly granted, you can challenge the validity of the patent using the European Patent Office's Opposition procedure. This can result in a limitation of the scope of the patent or even its complete revocation. Oppositions are filed against about 5–6% of granted European patents.

The specification of a United States patent must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art ... to make and use the same”. This statutory language has been construed to embrace two overlapping but distinct disclosure mandates: a 'written description' requirement and an 'enablement' requirement.