The Challenges of Patenting in Pharma: Interview with Eric Ruhlmann, Actelion Pharmaceuticals

Eric Ruhlmann, European Patent Attorney Director, Senior Patent Counsel, Legal Department,
Actelion Pharmaceuticals Ltd, joins Pharma IQ, to discuss the latest challenges for patenting pharmaceutical inventions and trends in global patent law.

Pharma IQ: What do you find the most challenging aspects of patenting pharmaceutical inventions and how do you think this differs from other patenting?

E Ruhlmann: Before starting to answer your questions, I would like to state that the views that I will express here are personal and may not necessarily be those of Actelion, my employer. Besides, the answers provided in this interview are not meant to provide any legal advice.

Concerning your question, one of the most challenging aspects of patenting pharmaceutical inventions lies, in my view, in the time between the moment when the invention is made and the moment when the invention is used. For new medicines, 10 to 12 years will elapse until the freshly discovered molecule can be marketed. As a result, when you draft your patent application, you do often not yet know which aspect of your invention will be most important. Therefore, you have to phrase your text very carefully so that it may properly protect any potentially important aspect. Besides, the patent that you have drafted may be challenged in a lawsuit in about 20 years only, and the requirements may have changed by that time.

At first sight, patenting in the pharmaceutical field does not appear to be so different from patenting in other technical fields. In the patent laws around the world, there are not so many articles and rules that would be specific to the pharmaceutical field. Though there are usually a few exclusions from patentability specific to the pharmaceutical or medical field, the general requirements for obtaining a patent remain the same whether you consider the pharmaceutical or any other technical field. However, when looking a little more in detail, I would say that patenting in the pharmaceutical field is special in quite a few aspects:

• Firstly, more than in any other technical field, there are many types and forms of claims to reflect the variety of inventions that can be made. Patent attorneys have been - and are still - very creative to make sure that any significant aspect of a new pharmaceutical product, of a new pharmaceutical process or of a new pharmaceutical use can be covered by a suitably worded claim.
• Another aspect to be considered is that developing pharmaceutical inventions represents huge investments usually spread over 10 to 12 years. Properly protecting pharmaceutical inventions is therefore an absolute necessity to ensure a return on your investments.
• Besides, unlike in other technical fields, the policy of some countries – for example that of Brazil or India – is not so patent-friendly when it comes to pharmaceutical inventions, even when they may correspond to true innovations.

Pharma IQ: What are the most important changes in patent law that are impacting your business right now and how are these impacting the business?

E Ruhlmann: The most important change in patent law happened only a few weeks ago. The US have finally reformed their patent law, with measures having a major impact for patent practitioners.
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Firstly, the first-to-invent system is being abandoned in favour of the first-to-file system which has been in place everywhere else. This will make it much easier to assess patent situations where two different companies made the same invention at about the same time. Now it will only boil down to showing that you were the first to file, and not to showing that you were the first to invent in costly interference proceedings at the USPTO.

With their new law, the US will also introduce for the first time opposition proceedings. This provides an easier and cheaper system for challenging the validity of granted US patents. In my view, there is no doubt that opposition proceedings will be very popular in the coming years in the US, like oppositions against European patents.

Another important change, specific to the pharmaceutical field, results from the findings of the EU Commission inquiry. Abuse of patents, for example applying for and trying to enforce patents of dubious validity, can be punished by significant fines by the EU Commission. This is a strong message to those who would not already have understood the importance of ethics in our business: no patent applications should be filed when there is no defendable invention.

Pharma IQ: Please can you reflect on the trends in patent law globally and the national or regional differences?

E Ruhlmann: One global trend seems to be the fact that more and more patent offices are not so keen to grant broad patents unless these are reasonably well supported by concrete examples. More and more patent examiners do not hesitate to ask for evidence that an invention is likely to work over the whole scope claimed. This is in particular true for patent offices of South East Asia and Japan.

Patent law has been fairly harmonised in the last two or three decades, the latest harmonisation episode being the amendment of US patent law. Therefore, national or regional differences mainly consist in having a few more or a few less exclusions from patentability, in having substantive examination performed or not by the local patent office, or in offering the possibility to oppose to patents after allowance or grant.

However, in contrast to the current practice elsewhere, China and Canada recently decided to require patent applicants to provide experimental data in the text of the patent application so as to show that they were in possession of the invention at the filing date. Whether other important jurisdictions will introduce such a requirement in the coming years remains open. In any case, if you wish to obtain a patent in Canada or in China, this is a point that you should definitely keep in mind when drafting your patent application.

Pharma IQ: For which tasks would you use patent law firms and for which would you not?

E Ruhlmann: In cases where representation is compulsory and you cannot represent your company, you have to use patent law firms.

In addition, I would recommend using the services of a patent law firm where its expertise or experience is superior to the one you have in-house. For “big cases” too, employing a patent law firm can be highly useful: you mitigate risks by letting an external patent counsel confirm that you have made the right analysis of the situation.

There are some other cases where you may also want to use the services of a patent law firm. If you want to avoid that your company is contaminated by confidential information from another company which you are considering collaborating with or buying, you will prefer that an independent external patent counsel studies the documents containing the confidential information. Thus, if in the end you do not enter a deal, the other company may not later argue that you have used some of its confidential information for your own business.

Last but not least, if there is a temporary work peak which cannot be absorbed by the in?house staff, you will of course be happy to entrust some of the work to a patent law firm.

There are actually only few cases where I would not use a patent law firm. Firstly, if you can do the work in-house, you will of course do so rather than using a patent law firm. Besides, if the timing is tight for performing a defined task, you will also prefer to do this in-house because in this case you do not expect that involving a patent law firm will accelerate things.

Pharma IQ: Generics play an important role within the industry, would you agree? if so how?

E Ruhlmann: I fully agree with this statement. The threat of generics pushes the innovative pharmaceutical companies to find new/improved products to stay in business. Actually, the generics industry needs the innovative industry to provide new products and the innovative industry needs the generics industry as motivation to invent new products that can replace those lost to the generics industry.

Another point that can be made is that in some cases the generics industry may help to protect the public against patent abuse. Indeed, they may successfully challenge invalid patents and thus clear the way for certain products towards the generics market.

Pharma IQ: What are the key considerations when drafting and filing patent applications?

E Ruhlmann: The first consideration that one should have when drafting a patent application is the following: when should the patent application be filed?   Is there any known competition that would make it more urgent than usual?   How important is the invention?   Is the purpose of the patent application simply defensive?   Depending on these criteria, you may decide on how urgently your patent application should be filed.

Another important parameter is the amount of experimental data available. Some experimental data will be required already in the text of the patent application if it is filed in Canada or in China; otherwise the claimed subject-matter will not be considered enabled and a patent will not be granted there. Therefore, filing too early, that is, without including experimental data in the text of your patent application, is certainly not recommended.

Besides, if your invention is not far from the closest prior art, you will also need experimental data in order to know how you compare with the closest prior art, the question will be whether you are unexpectedly better than the closest prior art, which will provide you a basis for justifying the existence of an inventive step.

Another question that you should deal with is to make sure that the invention belongs to or will be assigned to your company. If your company has a collaboration with another company or with a university, it is very important that you check to whom the rights of the inventors on their invention are assigned. If your company does not own (or does not yet own) the invention, you should not file the corresponding patent application...

Last but not least, you should pay attention to designating the right inventors in accordance to US patent law. Making false inventor designations could jeopardise your patent in the US. For this reason, correct inventorship determination should definitely not be considered superfluous.

Pharma IQ: And what about Supplementary Protection Certificates / Patent Term Extensions – what are the main challenges here?

E Ruhlmann: As a preliminary remark, it is worth mentioning that Supplementary Protection Certificates (“SPCs”) and Patent Term Extensions (“PTEs”) constitute an area of patent law that is often not so well known to patent practitioners in the pharmaceutical field. An obvious reason for that generally limited knowledge is that there are usually limited occasions on which such knowledge is needed. It’s only if you are responsible for a marketed product that you will probably have the chance to be confronted one day to SPCs and PTEs. Therefore, for many, the first challenge will be to acquire the knowledge relating to SPCs and PTEs.

Based on my own experience, I would say that the next challenge would be to have a good coordination with your colleagues responsible for Drug Regulatory Affairs. This coordination is essential to meet the deadlines in each relevant country. To give an example, in the US, you have only 60 days from the FDA approval of your product to request a Patent Term Extension. If your colleagues for the Drug Regulatory Affairs department do not inform you shortly afterwards that the FDA approval has been obtained, you are likely to get informed too late to take the necessary steps for extending the term of your US patent.

Another challenge is to catch up with changes of local laws. There are certainly still a few countries where no SPC or PTE is possible today and where it will become possible to obtain SPCs or PTEs in the future. Therefore, it is important to keep an eye on possible changes so as to be sure not to miss new opportunities for extending the life of your products. In this regard, building a good network of local agents, who will keep you informed about the evolution of their local laws, can definitely help.

Finally, your company may from time to time have the luxury of having more than one patent that can be extended by an SPC (in Europe) or a PTE (in the US). Then you will have to select the patent that you will use as basis for the SPC or PTE. You will of course first consider the patent that offers the longest protection. However the latter is often much narrower and weaker than the patent wherein your product was first described. Therefore, you will usually decide to go for the safe option, that is, retain for basis of your SPC or PTE the patent wherein your product was first described.

Pharma IQ: Finally tell me a few words about paediatric exclusivities – what are the main challenges here?

E Ruhlmann: The preliminary remark that I made regarding SPCs and PTEs earlier applies even more to paediatric exclusivities. As a rule, patent practitioners will not be so familiar with paediatric exclusivities because, like for PTEs and SPCs, you need to be responsible for a marketed product so that you are confronted with them. On top of that, paediatric exclusivities have been introduced fairly recently: the USA were the first to introduce a paediatric exclusivity in 1997, paediatric exclusivities could not be obtained before 2008 in the European Union. These paediatric exclusivities are nevertheless extremely important, since they can provide you with additional 6 months of exclusivity for your marketed products in Europe and in the US; this means a valuable prolongation of the product life cycle.

In my view, the first challenge is that, notably in Europe, a number of questions are outstanding regarding how the laws about paediatric exclusivities should be interpreted. Unfortunately, we have little case law yet to help us in this task in Europe. The first important decision of the European Court of Justice should come soon and I am sure that others will follow in the coming years.

Like for SPCs and PTEs, the next challenge would be to have a good coordination with your colleagues responsible for Drug Regulatory Affairs. Again here you need their active participation so that you can meet the deadlines for requesting the paediatric exclusivities.

Similarly, you need to monitor changes of local laws. Like for SPCs and PTEs, there are certainly a few countries where no paediatric exclusivity is possible today and where it will become possible to obtain such exclusivity in the future.

Finally, for patent practitioners working in the area of orphan medicinal products, it is important to know that no 6-month extension of the SPC can be obtained for such products according to EU Regulation 1901/2006. For orphan medicinal products, the only possibility is the 2-year extension of the 10-year market exclusivity granted in the European Union for orphan medicinal products. This 2-year extension is usually not interesting as it overlaps usually with the SPC patent protection and thus does not extend the overall exclusivity period. You may then want to try to design ways around the exclusion provided by EU Regulation 1901/2006 so as to try to obtain a 6?month extension of the SPC, such as withdrawing the orphan designation before you have started benefiting from the 2-year extension of the 10?year period of orphan drug exclusivity. It is however not sure how a court would interpret EU Regulation 1901/2006 when confronted with such situation.

Interview conducted by Helen Winsor.