Argentina: Polymorph patents under fire

by Ignacio Sánchez Echagüe (Marval, O’Farrell & Mairal, Argentina)

Eli Lilly and Co. (Eli Lilly) sued Laboratorios Beta (Beta) for patent infringement of its patents AR2719B1 and 253,521 related to schizophrenia. Beta, in turn, filed a nullity action against Eli Lilly seeking to invalidate both patents at stake.

The decision of first instance was handed down in favor of Eli Lilly. This decision ordered Beta to refrain from importing, manufacturing, formulating and/or commercializing a pharmaceutical product containing the subject matter protected by the patents at issue. Also, this decision rejected Beta’s nullity action.

Beta appealed from this decision, which was finally revoked by a decision issued on March 15, 2016 by Division I of the Federal Court of Appeals.

The second instance decision was mainly grounded on two arguments: (i) lack of novelty of the subject matter protected by Eli Lilly’s patents, and (ii) patentable subject matter.

  • Lack of novelty of the subject matter protected by Eli Lilly’s patents

The decision on appeal considered, based on the official expert’s report, that the claimed subject matter was anticipated by US patent 5.229.382 (filed May 22, 1992 and granted July 20, 1993), which had been granted three years before the filing date of the oldest Lilly patent.

It is relevant to mention that the official expert had considered that the process described on US patent 5.229.382 produced the subject matter claimed on the Eli Lilly’s patents (inherent novelty). Therefore, the US patent affected the novelty of the Argentine patents.

  • Patentable subject matter

The appeal decision was also grounded on the lack of patentability of polymorphs.

It should be noted that this argument should have not been considered (was outside the thema decidendum) since Beta itself, and the decision expressly acknowledges, had stated that “…it is not necessary to decide on the patentability of new polymorphs of known substances, but only to determine whether this polymorph was worldwide known or, to the contrary, was new…”. Therefore, the case was not related generally to the patentability of polymorphs per se but to the novelty of a specific polymorph.

In any event, and as an additional argument, the appeal decision applied the Patentability Guidelines for Pharmaceutical Inventions (2012), which prohibit the patentability of polymorphs. These patentability guidelines were retroactively applied to a granted patent (patent 253,521 lapsed during litigation and no nullity decision was handed down in its respect), in spite of the fact that they expressly mention that they are only internal guidelines to be used by patent examiners during prosecution.

Moreover, there was no need to apply these guidelines since the court already found the invention to be unpatentable due to lack of novelty.

It remains to be seen whether the other divisions of the Federal Court of Appeals of the city of Buenos Aires (where most of the patent cases are decided) will follow or not this decision.

Click here to the judgment.