Abortion pill: effect on patentability

Voluntary interruption of pregnancy (abortion) is prohibited in some countries, authorized in others.

But in all countries, it provokes numerous debates based essentially on its morality, i.e. whether it contravenes morality, public order, religion or nature.

The abortion pill belongs to the category of medicines insofar as it is subject to marketing authorization, at least in Europe and the United States, and must be prescribed by a doctor. The two main active ingredients in the abortion pill are mifepristone, launched on the European market in 1982, and misoprostol.

The issue addressed here is the patentability of the abortion pill itself. Indeed, most patent laws provide for exceptions to patentability, including inventions whose commercial exploitation would be contrary to ordre public and morality, as well as therapeutic treatment methods applied to the human body.

In the European Patent Convention (EPC), these exceptions to patentability are explicitly named in article 53 and rule 28.

Article 53 of the European Patent Convention provides that :

“European patents are not granted for:

• inventions the commercial exploitation of which would be contrary to ordre public or morality; such a contradiction cannot be inferred from the mere fact that the exploitation is prohibited, in all or several of the contracting States, by a legal or regulatory provision ;
• […..] ,
• methods of surgical or therapeutic treatment applied to the human or animal body, [……]; this provision does not apply to products, in particular substances or compositions, for the implementation of one of these methods.”

Therefore, it could be concluded that the patentability of the abortion pill may be open to challenge under the EPC on the grounds that its commercial exploitation would be at least contrary to accepted principles of morality and/or that its use would be aimed at a method of therapeutic treatment of the human body.

As mentioned earlier, most patent laws provide for exceptions to patentability. Most of them, but with the notable exception of US patent law, contain no article or rule specifying which inventions are excluded from patentability. Indeed, 35 U.S.C. § 101 simply defines what is patentable.

To that end, would this mean that all inventions, including the abortion pill and its use, would be unquestionably patentable in the USA?

This is not the case, the United States has ratified the TRIPS agreements and these agreements contain clauses concerning Intellectual Property.

In particular, articles 27.2 and 27.3 of the TRIPS agreements define exclusions from patentability, which are intended to protect ordre public or morality, including the protection of human or animal life. They also aim to protect against serious harm to the environment.

Thus, the patentability of inventions that are contrary to public policy or morality or those that harm life could be challenged in the United States on the basis of articles 27.2 and 27.3 of the TRIPS agreements. This would be the application of Case Law created by US courts. So, the question is, have article 53 of the EPC and articles 27.2 and 27.1 of the TRIPS agreements been used to oppose the patentability of the abortion pill?

The answer is “NO”.

What has been patented are the mifepristone and misoprostol molecules, themselves.

To be noted, the patents covering these molecules did not include any claims to protect an abortion pill, a method of abortion using it, or the use of mifepristone and/or misoprostol to perform an abortion. Therefore, there was nothing to suggest that the commercial use of mifepristone or misoprostol was contrary to ordre public or morality.

In fact, to the writer’s knowledge, the rejection of patent applications or the invalidation of patents on these grounds has never occurred in the United States.

In Europe, the patentability of a mouse genetically modified to develop cancer naturally was challenged on the grounds of moral contrariety, due to the suffering caused to these mice when they developed cancer and were used to test different protocols and drugs against cancer they developed.

But in the end, the European Patent Office concluded that these mice could be patented, because what had to be measured diligently was the balance between the animal’s suffering and the benefit to mankind provided by the invention.

In conclusion, the patentability of the abortion pill was not challenged as it had not been subjected to the patentability test. What we can see here is that even if an invention seems to present risks in regards to its patentability, it can be validly and easily protected by a patent, depending on the wording of the claims.