The IP-WRAPPER: Pharmaceutical, Chemical and Biotechnological Inventions (PCBIs)

2) "Substance or Composition" vs. "Device"

Hi IP curious and welcome back to the IP-WRAPPER: Patenting Strategy of Pharmaceutical, Chemical & Biotechnological Inventions (PCBIs). The IP-WRAPPER is a non-print fully-digital series to bring you in contact with important questions in the world of intellectual property and linking these questions to your daily work life.

In the last IP-WRAPPER I raised several questions and promised to answer them accordingly. The assembly of the list of questions followed a certain order in which you may ask yourself what type of invention you are dealing with. The final goal should be to determine if your invention is worth patenting, proceeding with your application or upholding your patent.

Please be aware that the decisions in your individual case is always a complex matter. Furthermore, such a decision always involves the evaluation and balancing of case specifics. Therefore, the IP-WRAPPER and any other posts by Dr. Manuel Pescher, Manuel Pescher IP Services or PESCHER IP cannot be used to make any of Dr. Manuel Pescher, Manuel Pescher IP Services or PESCHER IP liable for your decision. Nevertheless, in case you seek any advice based on your case, please feel free to contact Dr. Manuel Pescher

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Are you using a "substance or composition"?

Many of you may ask:

Why does it matter if my invention refers to a "substance or composition"?
What is the difference between a "substance or composition" and other subject matter?

Pharmaceutical, chemical and biotechnological inventions play an increasingly important role in modern technology, not only since the rise of the pandemic. These technologies usually involve chemical compounds that are used, e.g. in chemical synthesis or as bioactive agent. A prominent example of the latter are antibiotics and other drugs.

The spheres of nano-medicine and macrostructures start to merge

Nowadays, "nano-medicine" is approaching on the horizon. "Devices" with a potential medical implication and use become smaller and smaller. Modern research focuses on biomimetic systems. These systems are designed to mimic biological function, e.g. protein function. These "devices" could potentially be used to replace non-/male-functional proteins or other biological structures in medicine and diagnostics, e.g. without the need of intervening into the somatic genetic code (also known as gene therapy). This approach could solve many potentially ethically problematic and therefore highly debated issues. On the other hand, synthetic materials and their building blocks becoming larger and larger and gain complexity. As a consequence, the spheres of the "nano-world" and the "macroscopic world" start overlapping. For prosecution practice with the European Patent Office (EPO), it is important to know which sphere your invention belongs to. This can have tremendous effects on patent drafting and prosecution practice with the EPO.

First and foremost, medical treatment methods are subject matter excluded from patentability. Therefore, be careful not to draft an application seeking protection regarding subject matter excluded from patentability for prosecution with the EPO. This is where "devices" vs. "substances and compositions" play a crucial role. Devices used in medical treatment methods can indeed be patented at the EPO. The same holds true for the respective "substances and compositions".

Second medical use claims (SMUCs)

The main differences between these two categories reside in the "second medical use claims" (SMUCs). The disclosure of a device does always "co-discloses" all different ways of its usage. This means, once the device is disclosed (and potentially claimed), you cannot claim any (further) use. This also holds true, even though a further use was not intended or imagined at the time of disclosure of the device.

This is different for SMUCs. A "substance or composition" does not disclose all potential medical uses at its date of disclosure. Therefore, a second or even a third medical use can be claimed, in case this second or third medical use fulfills the general criteria of patentability (novelty and inventiveness). This is therefore an exception to the general principles for other types of invention as discussed above. The question arose in the past, in which cases one is dealing with a "substance or composition" vs. a "device".

"Substance or composition" vs. "device" - T1758/15

The Board of Appeal (BoA) had to deal with this question in its decision T1758/15. Therein, a collagen filler undoubtedly known from prior art was used to reduce the radiation impact on healthy tissue. This effect was achieved by the collagen filler introducing a spatial distance between the irradiated tissue and the underlying healthy tissue. The first reflex for many biologists and chemists in addressing the question of "substance or composition" vs. "device" would be to refer to collagen as a "substance or composition". This assumption is mainly based no collagen being clearly a chemical compound. Nevertheless, the BoA referred to the effect of the collagen being a purely physical mechanism, not a chemical one. Therefore, collagen was determined as a "device" in this setting, excluding it from claiming second medical use. Conclusively, "substance(s) or composition(s)" must have a clear chemical effect, even in a biological setting to be eligible for second medical use claims.

Therefore, it is of utmost important to know in which setting your application is located - a physical interaction rendering your subject matter a "device" or a chemical interaction rendering your subject matter a "substance or composition".

Based on this, you should draft your application accordingly, to be prepared for any upcoming prior art during search or examination phase at proceedings with the EPO.

What's your opinion?

What do you think will be the next big thing in the PCBI field?

What do you consider a good way forward regarding dealing with PCBIs at the EPO? The way it is done or do you prefer another way?
How is done at your national / regional intellectual property office (IPO)?

Reach out by using the information:

Manuel Pescher IP Services

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E-Mail: ip-protection[at]manuelpescher.com