Working with known materials in life sciences: Key patent considerations

11 November 2020

Life science companies who are in the early stages of research often ask 'how will I know if I have something patentable'. In many areas of life science where the prior art landscape is crowded and research builds upon the work of one or many that came before, identifying patentable inventions can be particularly challenging.

Generally it is understood that developments such as the discovery of a new drug molecule or a new polymer are patentable inventions. It is also understood that, specifically in the field of medical treatments, the use of a known therapeutic for a new disease is patentable.

What people do not often realize is that they could have generated new intellectual property, i.e. a patentable invention, while working within a broader 'known' concept or with 'known' materials.

In the patent world, these are called selection inventions. Essentially, a selection invention is an invention that falls under a prior art disclosure but has not been disclosed in individualized form in the prior art. The invention may lie in the selection of a particular element from a broader group of elements, or the selection of a sub-set or sub-range.

To be patentable, the selection must be novel and non-obvious in view of the broader disclosure.

For example, if a prior art document only discloses use of 'a metal' (genus), then an invention claiming use of 'copper' (species) is novel over the broader disclosure of a metal.

The requirement for non-obviousness is generally met if the selection is shown to have a new, unexpected or surprising advantage that was not disclosed in the prior art relating to the broad concept. However, there must also not be motivation to arrive at the invention, nor the expectation that it "ought to work", in making the claimed selection. For a species selection, the chance that the species is not obvious over the genus increases with the size of the genus. Other factors such as if the prior art teaches against or away from using the selected element or range also play a part in the obviousness assessment made by the Patent Offices. In the example used above, if copper were shown to have a new or superior property compared to other metals then this could indicate that the claimed use of copper is non-obvious.

Below are some examples of selection inventions in the life science sector based on real-life cases:

Selection of a species from a genus

  • Prior art: A genus or class of compounds is disclosed for treating a disease using a generic structural formula. Invention: A compound falling within the genus is found to have greater efficacy compared to other compounds falling within the same genus.
  • Prior art: A family of adjuvants is disclosed to improve efficacy when combined with a particular drug. Several examples of adjuvants in the family are used to exemplify the improved efficacy. Invention: An adjuvant falling within the same family but not exemplified in the prior art is found to improve bioavailability of the drug, which is not seen for other members of the adjuvant family.
  • Prior art: A racemic compound having one chiral center is disclosed. Invention: One of the enantiomers is found to be less toxic to humans than the other enantiomer and the racemate.

Selection of a sub-range or sub-set

  • Prior art: A 500 base pair RNA sequence is disclosed to enhance expression of a nucleic acid encoding a protein. Invention: It is found that a 120 base pair fragment of the RNA sequence provides even greater expression enhancement.
  • Prior art: A polymerization process is disclosed to be performed in the range of 20-100°C in the presence of a catalyst and the temperature used in the examples provided is either 80°C or 90°C. Invention: It is found that if the reaction is carried out in the range 35-40°C, the amount of catalyst required can be significantly reduced.
  • Prior art: A drug compound is disclosed to treat a known disease at a dosage of between 10 mg – 500 mg per day and the dosage used in the example is 50 mg once per day. Invention: It is found that a dosage of 15-20 mg twice per day produces most effective results in patients and minimizes side effects.
  • Prior art: A compound is known to treat breast cancer by interacting with a particular cell marker. Invention: The same compound is found to interact with a different cell marker making it particularly effective at treating a group of patients exhibiting a sub-type of drug-resistant breast cancer cell.

Note that the above examples are illustrative and the assessment of patentability, in particular non-obviousness, may vary depending on the examining jurisdiction and on the prior art that is cited by the patent office.

As always, it is best practice to talk to your IP advisor as early as possible during an R&D project (or even before conducting research) to get an idea of what types of IP could arise from the project and to avoid any accidental disclosure of patentable subject matter.

If you have any questions on selection inventions, please get in touch with Edith Penty Geraets.

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