“IP rights for COVID-19 vaccines and related knowhow should be licensed, not waived”

2020-’21 has proven to be a crucial juncture for healthcare, life sciences and patents. Legance IP partner Monica Riva and associate Francesco Chierichetti walk us through some of the key issues of the day.

Posted Wednesday, June 16th 2021
“IP rights for COVID-19 vaccines and related knowhow should be licensed, not waived”

In terms of regulation, what is the patent landscape like in Italy for innovators?

A patent is the strongest means by which one may protect an invention that represents an original solution to a technical problem.

Under Article 45 of the Italian Industrial Property Code (IPC), in order to be eligible for a patent, an invention must: (i) have an industrial application, and (ii) be new, and not obvious (in other words, it must not be a natural development of the existing state of the art).

Patents have a duration of 20 years from filing date. An exception is made for Supplementary Protection Certificates (SPCs) for pharmaceutical patents, which afford a limited extension of the protection period. SPCs were introduced to encourage innovation, as a way of compensating for the time it takes to obtain regulatory approval for pharmaceutical inventions. They are therefore intended to provide partial compensation for the longer administrative procedures that are required before a pharmaceutical product may enter the market. An SPC comes into force after the original patent expires and can provide protection for a patent-protected product for up to another five years.

In addition to the protection that patents provide, protection for an invention may also be sought by means of a utility model. Utility models consist of products capable of making machines or parts of machines, tools or objects of general use, easier to use, or more effective in use. Accordingly, a utility model will invariably be a new form of an existing product. Utility models tend to be much cheaper and easier to obtain because the requirements are generally less strict than they are for patents. Chemical and biotechnological inventions cannot be protected as utility models.

Under Article 98 of the IPC, consonant with Article 39.2 of the TRIPS Agreement, technical industrial expertise may be protected as a trade secret where the information:

(a) is secret, meaning not generally well-known among or readily accessible to experts and operators in the field;

(b) has commercial value, because it is secret; and

(c) has been made subject to reasonable measures to keep it secret, by the person lawfully in control of the information.

In Italy, trade secrets remain protected for so long as they are commercially viable, and reasonable steps to keep them secret continue to be taken.

A rights-holder has a number of options when responding to an infringement of patent rights, depending on the scale and nature of the infringement and the value of the patent infringed. They might commence civil and/or criminal proceedings, and/or alert customs authorities where there is counterfeiting. A number of interim remedies may be available through the Italian civil courts.

 

How would you improve the current regulatory framework surrounding patents?

One of the biggest challenges for professionals in this field is the regulation of inventions made by means of artificial intelligence. Given that an AI system has no legal personality, the question arises as to who may be entitled to exploit an invention obtained by means of AI. Should this be the person who has developed the AI software that created the invention, or the person who provided the data and started the process that ultimately led to the invention? And what should be the scope of the rights granted to that person? Should these be the same rights as would be granted to a patent holder, or would it be more appropriate to design a new, bespoke form of protection? These are all questions that lawmakers at both the national and the EU level will have to address. As far as Italy is concerned, last April the Ministry of Economic Development began a consultation process involving key players in the IP industry as it looked for ideas on how IP legislation may be supplemented in response to technological developments.

Separately, we feel that changes to the legislation are desirable to govern situations in which the owner of a patent is compelled to grant a licence. New rules are needed, identifying clear criteria for when such mandatory licensing should apply. Currently, the IPC only requires a patent holder to grant a licence where they have not made use of it for a certain period.

 

You are a seasoned litigator. Could you talk us through the most interesting topics you have dealt with over the last year?

Every year we deal with many interesting cases regarding patents, which may or may not result in litigation. This past year in particular we have dealt with patenting an app, to the fullest possible extent given the EPO’s stance in this area. In connection with litigation currently before the Milan courts, we have acted on the reformulation of patent claims, following a review by experts in the field. This is always a difficult task as it may not end up broadening the scope of the protection that the patent provides.

Another area that is currently closely debated area is contributory infringement. This year, we have dealt with a case of contributory infringement in connection with staple goods. Our client manufactured products that could be used in a manner that did not constitute patent infringement. Accordingly, we argued that no infringement had occurred, although nowadays even products that are capable of a variety of lawful uses may still constitute an infringement. Contributory infringement is currently perhaps the most hotly debated area in IP matters being litigated in the Italian courts.

 

When working with patent prosecution agencies, what are the key qualities you look for?

Above all, their professionalism and good organization, for obvious reasons. We try to rely on agencies that have an excellent reputation and are multidisciplinary: in the field of patents, it is important to have assistance from technicians and engineers with specialist expertise in the particular field in which the patent features. Accordingly, it is important for the agency to have engineers and technicians specialising in a range of sectors.

 

As I write, the European Parliament is split on the issue of waiving patent rights for COVID-19 vaccines. What is really at stake here, how should the question be resolved, and what stance will Russia eventually take on its own Sputnik vaccine patent?

It is true that we are going through a critical period where the paramount interest to be protected is the health of the public. Nonetheless, in our view a blanket waiver or suspension of the IP rights for COVID-19 vaccines is not the proper solution.

We believe that the best solution requires cooperation between the public and private sectors. It is necessary to work together with, not against, the patent holders, in order to achieve the considerable expansion in vaccine production that is being sought. Where demand exceeds supply, in our view licensing offers the best way forward. Some special measures would be needed, so as to encourage the licensing not just of patents but also of the knowhow that is needed to manufacture vaccines, under terms that are fair to all parties.

Patents have already seen limitations imposed upon owners’ absolute rights, as evidenced by both the FRAND (Fair, Reasonable And Non-Discriminatory) and SEP (Standard-Essential Patent) licences and the much-debated “misuse doctrine”. The best approach in our opinion is to follow sensible intermediate solutions that do not obliterate the patent. That said, an absolute, unconditional defence of patents would no longer make much sense either, given the exceptional nature of the period through which we are living.

 

How does Legance plan to develop and strengthen its position in the patent litigation arena?

Our IP department is accomplished, with excellent litigators able to engage with patent issues of all kinds, from across all fields of industry and commerce. The secret of a successful case is a lawyer who understands the technical issues and makes the points they wish to bring to the court's attention intelligible and clear. In the field of patents, more than possibly any other, it is a clearly articulated case that makes the difference.