ES- MERCK SHARP & DOHME BV / MERCK SHARP & DOHME ESPAÑA, S.A. v. LABORATORIOS LEON FARMA S.A. & EXELTIS HEALTHCARE, S.L.
Barcelona Commercial Court No. 5, 12 December 2017, Case Docket no. 660/2017.
With this decision Barcelona Commercial Court No. 5 revoked the precautionary measures requested by Merck Sharp & Dome and initially granted inaudita parte against Leon Farma & Exeltis Healthcare, due to the deficiencies incurred during the gathering of evidence filed by the plaintiff.
Merck Sharp & Dohme BV and Merck Sharp & Dohme España, S.A. (hereinafter, “MSD”) requested inaudita parte urgent interim relief against Laboratorios Leon Farma S.A. & Exeltis Healthcare, S.L. (hereinafter, “LF”) on the basis of MSD BV’s patent ES 2.171.283 (hereinafter, “ES 283”), the Spanish part of the European patent EP 876.815 B1, which expired on April 9, 2018, and protects a drug delivery system, preferably in a ring-shaped form suitable for vaginal administration, for the simultaneous release of a progestogenic steroid compound and an estrogenic steroid compound in a fixed physiological ratio over a prolonged period of time.
The defendants marketed a contraceptive ring named ORNIBEL® and had also obtained the marketing authorizations from the Spanish Agency for Medicines and Medical Devices (known in Spanish as “AEMPS”) for the product named ETONOGESTREL/ETINILESTRADIOL LEON FARMA®. The aforementioned products had received the criterion of generic medicines by the AEMPS; as such, they were interchangeable with the product marketed by the plaintiff, NUVARING®, due to having the same quantitative and qualitative composition in active ingredients and pharmaceutical form, and having demonstrated to the AEMPS their equivalency through adequate bioavailability studies.
The parties did not dispute that LF’s rings reproduced all the technical features of claim 1 of the MSD patent, ES 283, except for the following technical element: "said progestogenic compound being initially dissolved in the said polymer core material in a relatively low degree of supersaturation”.
The plaintiffs argued that in LF’s rings the progestogen (etonogestrel) is dissolved in the polymer to a relatively low degree of supersaturation, that is, above the saturation concentration of etonogestrel in the polymer, as required by ES 283. On the other hand, LF maintained the opposite: the etonogestrel is not dissolved to a relatively low degree of supersaturation, but at a concentration well below the saturation concentration (under- saturated).
The urgent injunctive relief requested by MSD was granted without hearing from the defendant, who subsequently filed an opposition writ against the granted measures. The filing of the opposition writ gave rise to a hearing in which both parties offered arguments and had the chance to file further evidence. Each party filed an expert report, and an additional third independent expert was appointed by Court.
For the purposes of obtaining the relevant information regarding the polyurethane used by LF in its implementations, the plaintiffs requested a preliminary verification of facts, which is an urgent request to conduct enquiries to substantiate facts that might constitute patent infringement, in order for the Court-appointed expert to receive information to draft her report. In this petition, information was requested from the AEMPS; however the request was not addressed against the defendants, who may have provided much more useful information. In this regard, the Commercial Court pointed out that the expert could have requested judicial assistance in order to obtain further evidence to support her report.
The Court also criticized the actions of the court expert in relation to her allegations regarding the impossibility of obtaining the commercial name of the polyurethane used by the defendant in its products. The court expert knew of the company which manufactured and provided the polyurethane used by LF in its contraceptive rings, yet she confined her research to the exchange of some emails with the company requesting confidential information, not disclosing her judicial expert status, a detail which might have led to greater cooperation by the manufacturer.
Since the court expert was unable to find out the commercial name of the polyurethane used in LF’s rings, she was not able to perform tests to measure the saturation concentration of etonogestrel. Nonetheless, she concluded in probabilistic terms that LF’s rings could possibly have the supersaturation required by the patent and therefore, the ORNIBEL® ring could possibly infringe patent ES 283. The conclusion reached is contradictory due to the fact that if no tests were carried out, since the specific polyurethane used was unknown, then the neutral and objective position would be either not opting for any option or at least considering that there may have been oversaturation or sub-saturation.
In light of the above, the Commercial Court concluded that the Court-appointed expert, who should be independent and act with the greatest objectivity, had acted like a witness rather than an expert, providing a partial report in favor of the plaintiff.
Barcelona Commercial Court No. 5 also referred to the expert report filed by the plaintiffs, which found that the defendant’s products infringed patent ES 283, based again on a probabilistic conclusion not supported by any assay or test. Also, during the hearing, the expert specified that there was an 80% probability that the etonogestrel was dissolved to a relatively low degree of supersaturation in LF’s rings, though not explaining her finding of such high probability. The Court found particularly striking the use by the expert of vague statistical conclusions within the framework of a technical-scientific report whose purpose is to inform or reflect scientific reality.
Finally, in relation with the expert report filed by the plaintiffs, the Commercial Court established that since no test or assays were performed, the conclusion was reached on the basis of two documents: a patent named Chemo WO’888 and LF’s ring’s data sheet. Both documents were known by the parties even before the filing of the preliminary verification of facts request, in June 2017.
In this regard, the Court also considered procedurally inconsistent that MSD requested a preliminary verification of facts in June but, before the deadline for the court expert to file her report based on the information obtained from the preliminary verification of facts (22 September), the plaintiffs had already filed the request for injunctive relief on September 11. Said injunctive relief was filed together with an expert report which based its conclusions on the aforementioned documents known by the expert before the preliminary verification of facts request of June 2017.
In contrast with the court expert and MSD’s expert reports, the expert report filed by the defendants was based on assays and experimental testing to determine the saturation concentration value of etonogestrel in the polyurethane used by LF in its products. Even if such tests had been omitted, LF’s expert report concluded deductively that LF’s ring was outside the scope of the claims of ES 283 simply by comparing the description of ES 283 and the technical data sheet of LF’s ring. LF’s ring’s technical data sheet does not require special conditions of conservation at low temperature; however, ES 283 discloses that the cold storage of the ring is necessary due to the supersaturation of the etonogestrel.
Finally, the Commercial Court established that there were serious doubts in relation to the success of the action on the merits, considering that the plaintiffs had at their disposal all the possible evidentiary and judicial conveniences to reach a conclusive opinion. The following options were proposed by the Court as the alternatives that the plaintiffs should have explored: it would have been logical to direct the preliminary verification of facts against the defendants directly – and not to go through the AEMPS – since LF could have provided at minimum a physical sample of the products instead of mere information (as was provided by the AEMPS); before filing the request for preliminary relief, it would have been pertinent to request additional preliminary verification of facts to obtain a sample from the manufacturer of the materials used by LF in its products; and also, as one of LF’s products had been launched into the market prior to the hearing date, it would have been possible to buy a sample in order to carry out tests and assays.
Therefore, the Court considered that MSD not only had the burden of providing evidence of patent infringement, but also had the greatest availability and ease of evidence to do so. Furthermore, since the decision was rendered within an interim injunction procedure in which the Court is not allowed to evaluate the merits of the case, it was not possible for the Commercial Court to analyze whether the infringement existed based on the doctrine of equivalents. Even though this was alleged by MSD in its complaint, the triple identity test or the obviousness by equivalence criteria were neither explained nor applied.
On the basis of the foregoing, Barcelona Commercial Court No. 5 decided to revoke the interim injunction measures granted inaudita parte since it considered that there were serious doubts that LF’s rings reproduced the essential technical feature at stake protected by claim 1 of ES '283 and, therefore, that it directly infringed the patent.
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