How are pharmaceutical patents pronounced?

On 1 January 2019, the partially revised Patent Act and the associated implementing provisions entered into force together with the ordinary revision of the Therapeutic Products Act. This was decided by the Federal Council at its meeting on 21 September 2018. According to the Federal Institute of Intellectual Property (IPI), the partial revision brings improvements for medical professionals, pharmaceutical manufacturers and consumers.

"Firstly, the threat to the freedom of medical treatment, which arose due to the amended case law of the Enlarged Board of Appeal of the European Patent Office, is remedied. To this end, the prescribing of medicines by medical personnel in individual cases and the individual preparation of medicines in pharmacies are now excluded from the effect of the patent," according to a statement from the IPI.

"Second, it encourages the development of safe paediatric medicines. As an incentive against the supply gap in the field of paediatrics, the revised PatA provides for a six-month extension of protection for pharmaceutical manufacturers - as compensation for paediatric studies with medicines carried out", one reads further.

This protection would be provided either by an extension of an existing supplementary protection certificate or by a newly introduced paediatric protection certificate.

However, such general provisions are difficult to understand for individual companies or producers of medicinal products. "It is no longer a question of pure patent protection, but of protection by means of a supplementary protection certificate," emphasises Felix Addor, Deputy Director and Legal Counsel of the Swiss Federal Institute of Intellectual Property (IPI).

Deadline for the first application optimized?
The purpose of this certificate is to compensate for any reduction in the patent term, which is limited to a maximum of 20 years, to a maximum of five years, and now 5.5 years for paediatric products, as a result of the marketing authorisation procedure.

Felix Addor explains, "The six-month extension of protection for paediatric medicines is, in a sense, 'return on investment' for the fact that, since 1 January 2019, pharmaceutical manufacturers have been obliged to always include paediatric studies (showing the effects of the medicines when administered to children and adolescents)."

"The hurdle to obtain IP protection for a drug is very high."

However, such studies collect a lot of data to assess the efficacy, safety and quality of the drug. Swiss pharmaceutical companies invest a lot of time and money in this. However, it also happens that drugs are "copied" in the meantime before they appear on a market intended for this purpose.

For a start-up operating in the life sciences, for example, the most important protection is undoubtedly patent law. Only a patent grants a monopoly that prevents third parties from using their invention. In an early phase, IP protection classes (IP comes from the English term Intellectual Property, see box "On IP protection of remedies") or topics are equally relevant.

"The hurdle for medicines to obtain IP protection is very high," explains Felix Addor, co-head of the Interdepartmental Working Group on Health, Innovation and Intellectual Property, among others.

First-time notifier protection is significant
For example, a registered trademark that protects the company's name or products can be invaluable. Without IP or trademark protection, a company may be forced to change its name or name products, which can result in significant costs.

The protection of filed data ensures that no other company may refer to or use one's own data during the protection period after market authorisation. The so-called first filing protection has another important meaning in the patent system. It provides the incentive to allocate funds for research and development.

On the other hand, the drug market also has its downsides in terms of public distribution. It could be that no patent is obtained for a certain product because, for example, patent disputes hinder the distribution of a pharmaceutical product. In such a case, first filing protection remains a "primary" investment incentive.

This also applies to the increasing tendency to develop new indications on the basis of well-established active substances. However, consumers, such as chronic patients, do not necessarily benefit from this.

A good 8 to 12 years pass before a new drug is approved on the market. Patent protection for a new medicine is now expected to take only 10 years on average, or even less for paediatric medicines: To keep up with such conditions, the Patent Act has been revised.

Patent protection in (application) practice
So there are reasons not always to patent an active ingredient straight away. In addition to regulatory reasons, there are always strategic objectives: For example, it is not always advisable to apply for a patent for a research platform in order to protect a screening process for active substances.

The patent applications are published 18 months after submission - and thus everyone, including other researchers, has access to the process. In this scenario, it may make sense to wait until the first molecule emerges from the platform and then protect the product.

There are also advantages to patenting an invention. In principle, it is always a balancing of patent concepts and market claims. This is because even a law firm or corporate division specialising in patents must simultaneously compare provisions of the European Patent Office (EPO), the ordinary revision of the Therapeutic Products Act (HMG) and the partial revision of the Invention Patents Act (PatG).

This can take time. After all, the EPO is part of the European Patent Organisation, of which Switzerland is also a member. One year after the first application, a subsequent application can already be initiated, covering over 150 countries worldwide. However, the entire procedure up to the approval of the application can take more than five years.

The biggest difference in the handling of pharmaceutical products compared to, for example, short-lived computer software of health apps is therefore in the product life cycle. However, this is not always beneficial for drug manufacturers and consumers, and ultimately also for doctors and drug publishers.

After all, pharmaceutical manufacturers today place much more emphasis on the "total package", they build up an IP portfolio which not only protects a drug, but also concerns its manufacturing process, various formulations, dosages, treatment regimes.