Simply having a patent on something doesn’t actually protect your invention. That patent has to actually hold up in court. Patents may discourage someone from copying you, but they’re just a piece of paper until they’re tested in court.
So we should be using the word “patentable” to refer to something that, if patented, would be enforceable.
This week, we’re continuing a multi-part issue on patenting phage therapeutics (see part I here). Our main source for this article is a paper by Kelly Todd, Duke University School of Law J.D. / M.A. student.
What makes something patentable?
For something to be patentable, it needs to be an invention or discovery of something new and useful.
- You can patent a new process / machine / manufacture / composition of matter.
- You can patent a new and useful improvement of one of these.
- You can NOT patent a law of nature / natural phenomenon / abstract idea.*
*An important exception
Recently, the US Supreme Court stated that if a law of nature / natural phenomenon / abstract idea involves an inventive concept, it may still be patentable. To find out if it is patentable, something called the Mayo/Alice test can be applied.
The Mayo/Alice test:
- Does the patent involve a law of nature / natural phenomenon / abstract idea?
- If yes, does it involve an inventive concept?
- If yes, it may be patentable.
- If no, it is not patentable.
The problem
There’s been a lot of confusion about what will and will not qualify as patentable under this new rule. Drug developers are confused, and so are the courts themselves. Since 2017, about 90% of patents subjected to the Mayo/Alice test have failed it, while some (very similar) patents have passed. This is concerning to many people patenting technologies in the life sciences, because they can’t be confident their patents will hold up.
Patenting a phage: it depends how you classify it
- New composition of matter? (not likely acceptable if natural phage or directed evolution-modified phage, maybe acceptable if CRISPR-modified phage, though CRISPR engineering may be becoming “obvious” / may not hold up forever)
- New method or process of producing a [modified] phage? (might fare better, but must be produced by more than just a “well-understood, routine, conventional activity already engaged in by the scientific community”)
- New method or process of treating a condition, using a phage? (may be best option for phage patenting, if the patent were to describe the treatment of a condition that had never before been treated by that phage [may qualify as an inventive application of a natural product])
Throw everything at the wall and see what sticks?
Few phage patents have been filed, but those that have been filed employ vastly different patenting strategies, such as:
- Patenting methods of treatment
- Patenting phage enzymes instead of whole phages
- Patenting use of phages in animals
- Patenting phages directly
This diversity of phage patenting strategies may reflect the fact that no one yet knows what the best strategy is, when it comes to patenting phages.
Importantly, no case has been brought to court that directly addresses the patentability of phage therapy, so this uncertainty makes sense.
Does patent enforceability matter?
Having a patent (even if it has never been tested in court) can hold value as a signaling mechanism for investors. Therefore, patent enforceability may not matter all that much. Put another way, it may still be worth filing patents related to phages, even if their enforceability is hard to predict right now.
Thanks for reading!
– Jessica <>={
Next week, we’ll talk about ways of incentivizing investment in phages that go beyond patents. If you can’t wait until then, read Duke University School of Law J.D. student Kelly Todd’s article on phage patentability here.
References:
Kelly Todd, The Promising Viral Threat to Bacterial Resistance: The Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives, 68 Duke Law Journal 767-805 (2019)
Available at: https://scholarship.law.duke.edu/dlj/vol68/iss4/3
