In a recent decision, in which our firm successfully represented the Manufacturers’ Association of Israel (“the MAoI”), the Tel-Aviv District Court denied an appeal by Takeda Pharmaceutical Company Limited (Takeda) on a decision of the Commissioner of Patents (“the Commissioner”), not to grant patent term extension with respect to Takeda's pharmaceutical product "Dexilant®".
Patent term extension (“PTE”) provides patentees with the opportunity to extend the term of certain patents protecting pharmaceutical products, for an additional term beyond the statutory 20-year period of patent protection. Therefore, PTEs are of great value for patent holders and attempts to obtain PTEs, even when the requirements set out in the Patent Law are not fulfilled, are not uncommon. As PTEs delay generic competition, they serve the purpose of maintaining high drug prices for longer periods of time, at the expense of the public. The MAoI, which our firm represents in various patent litigations, often initiates or joins legal proceedings in the context of unjustified PTEs.
In its decision, the Court accepted the MAoI’s position and upheld the Commissioner's findings that the substance, Dexlansoprazole (the R enantiomer of the racemate Lansoprazole), was already included in a pharmaceutical product previously approved for medicinal purposes in Israel. It was held that it is irrelevant that the former pharmaceutical product contained the enantiomer, Dexlansoprazole, in the form of a racemic compound, together with another enantiomer (Levolansoprazole), in the solid state, and that the only way to separate the enantiomers was in a solution. It was held that the legal test that should be applied, when considering whether the first marketing approval requirement has been met, is the "inclusion" test, that was set forth in the Lundbeck case. According to that test, the registration of a pharmaceutical product containing an enantiomeric form of a racemate that has already been registered will not be considered the first marketing approval enabling use of the substance contained in the pharmaceutical product for medicinal purposes in Israel. For further elaboration see the following:
A. THE BACKGROUND TO THE DECISION AND THE COMMISSIONER’S DECISION IN THE OPPOSITION PROCEEDING
In Israel, PTE is granted only if certain requirements are met, as set out in Section 64d of the Patents Law. One such requirement is that the marketing approval of the pharmaceutical product is the first marketing approval enabling use of the “substance” contained in the pharmaceutical product for medicinal purposes in Israel ("the first marketing approval requirement"). The first marketing requirement lay at the heart of the Takeda case that was brought before the Court in the appeal on the Commissioner’s decision in this regard.
A particularly important Israeli case law in the context of the first marketing approval is the Lundbeck case, where an application for a PTE was filed in connection with a pharmaceutical product containing an isolated enantiomer, despite the previous registration of a pharmaceutical product containing a racemic mixture containing that enantiomer. It was held in the Lundbeck case that the PTE application did not comply with the "first registration" requirement, as the pharmaceutical product containing the enantiomer had already been registered in the racemate.
The circumstances in the Takeda case were quite similar to the Lundbeck case: The active ingredient in Takeda's pharmaceutical product is Dexlansoprazole, the R enantiomer of the Lansoprazole racemate and the Lansoprazole racemate was previously registered as a pharmaceutical product (Prevacid®).
Takeda tried to draw a distinction between its case and the Lundbeck case, by claiming that the ruling in the Lundbeck case concerned a racemic mixture, while the Lansoprazole racemate involves a racemic compound. Takeda further claimed that the Lansoprazole racemate comprises both the R enantiomer (Dexlansoprazole) and the S enantiomer (Levolansoprazole) in one crystal lattice, that cannot be separated (in the solid state) into two enantiomers. It was, therefore, asserted that Dexlansoprazole, in its isolated single crystalline form, is a different substance, which was not included in the formerly approved pharmaceutical product containing Lansoprazole.
As previously reported (A Racemic Compound? a Racemic Mixture? The Fight over PTE/SPC for enantiomers Goes On!), the MAoI initiated opposition proceedings against the ex parte decision holding Takeda’s patent eligible to be granted a PTE. The Commissioner accepted the MAoI’s position that the marketing approval of a pharmaceutical product containing a "racemic compound" equally applies to the first marketing approval of a pharmaceutical product containing each of the separated enantiomers. In this context, the Commissioner held that it is irrelevant whether the enantiomers in the Lansoprazole racemate may be isolated in their solid state or not, as claimed by Takeda.
The Commissioner also rejected Takeda's interpretation of the term "substance" (i.e. that the active ingredient in the former pharmaceutical products containing the Lansoprazole racemate is its form - a crystal). The Commissioner stated that the term “substance” cannot be considered only in a particular state of matter, as this would lead to a situation in which an active ingredient contained in a pharmaceutical product will be deemed a different active ingredient when dissolved in the human body.
In July 2018, Takeda filed an appeal with the District Court of Tel-Aviv. In September 2018, Prof. Israel Agranat, a professor emeritus of chemistry specializing in Chiral drugs, filed a motion to join the proceeding as an amicus curiae. As will be detailed below, the District Court denied both the appeal and the motion filed by Professor Agranat.
B. THE DISTRICT COURT’S DECISION
The Court accepted the MAoI's position and held that Takeda is not entitled to a PTE. Referring to Takeda's argument that the former product included a racemate comprising two enantiomers, the Court held that it was of no importance that the former pharmaceutical product contained a "racemic compound" comprising both enantiomers. The legal test, that should be applied – both with regard to racemic mixture and racemic compound – when considering whether the first marketing approval requirement has been met, is the "inclusion" test.
In this context, it is immaterial whether the separation of the enantiomers involves any special effort or technology. Hence, there is no need to examine whether it would be possible to separate the enantiomers in their solid state (the state in which the pharmaceutical product was allegedly registered) or only in solution. Instead, it would be relevant to consider whether the "substance" (in this case: Dexlansoprazole) was already included in a former pharmaceutical product, wherein the "substance" is not limited to the original form in which the pharmaceutical product was registered; as the term "substance", as defined in the Patents Law, means the active ingredient in a medicinal product, or salts, esters, hydrates or polymorphs of the said ingredient.
The Court also addressed the rationale underlying PTEs. The purpose for enacting the PTE legislation was to enable patent owners to be compensated for the period of time taken to obtain, from the Israeli Ministry of Health, marketing approval of a new drug. The Court attributed weight to the fact that, during the process of obtaining regulatory approval for the purpose of licensing the Dexilant® product, Takeda relied on experiments conducted with regard to the former pharmaceutical product, which contains the racemate. The Court also mentioned, in this context, that Takeda's said conduct raises doubts regarding its good faith.
The Court ruled that there is no justification to allow Professor Agranat to join the proceedings, inter alia, since he wishes to raise new factual arguments that were not raised in the opposition proceedings before the Commissioner.
As mentioned above, the Commissioner's principled determinations remained intact and the Court denied Takeda's appeal.