Liad Whatstein of Liad Whatstein & Co has kindly provided the following updates on patent term extensions on biological drugs and filing deadlines in Israel.
Israeli PTO clarifies rules on Patent Term Extensions for Biological Drugs
In a recent precedential decision, the IL PTO held for the first time that biological products which contain an earlier approved protein may be eligible for PTE if it can be shown that structural differences between the proteins such as differences in glycosylation have an impact on the activity or pharmacokinetic profile of the protein. If sufficient evidentiary basis is provided with the PTE petition, this important decision will make it possible to obtain PTE orders for biological drugs which contain as the active ingredient proteins that carry the same INN (international nonproprietary name) as in previously approved drugs.
The decision involved a petition filed by Bayer to extend the term of a patent claiming the production method of the drug KOVALTRY, a recombinant human coagulation Factor VIII. Under Israeli law, patent term extension can only be granted when the regulatory approval “is the first regulatory approval permitting the use of the compound in Israel for pharmaceutical purposes”. The examiner cited against the PTE petition several earlier registrations of Factor VIII products and, in particular, an earlier Bayer Factor VIII product, KOGENATE. The examiner’s position was that earlier registrations of products containing Factor VIII preclude the eligibility for PTE of later products containing Factor VIII, irrespective of differences in the properties or methods of manufacture of the protein.
On appeal, the Commissioner upheld the rejection of the PTE petition for KOVALTRY but adopted a significantly more flexible approach. The Commissioner recognized that an approach whereby any earlier registration of a protein of the same name precludes eligibility for PTE for later products does not take into account potential differences between biological products. The Commissioner therefore set a two-step test to determine eligibility for PTE for biological products. First, a biological drug that has been approved as a biosimilar will not be eligible to PTE. Second, if the drug was approved as a new drug, it will be necessary to evaluate whether the protein is structurally different from similar proteins which have been previously approved and whether such structural differences have an impact on activity. Structural differences can among others be in the amino acid sequences, the three-dimensional conformation or glycosylation. Functional differences can among others relate to pharmacokinetic parameters of the drug such as bioavailability or half-life or to different immunogenic effects.
In the present matter, the drug was approved as a new biological drug. The patentee demonstrated that it manufactured the drug using a recombinant process which is different from the recombinant process used to manufacture the earlier Factor VIII drug. The patentee also showed that the later Factor VIII product differs from the previous product in the level of highly branched sialylated glycans and the level of α-gal-linked glycans. The Commissioner recognized that even minor structural differences can result in functional differences which will support a PTE. However, the patentee failed to produce evidence to establish that the structural differences are translated into a different pharmacokinetic profile or to any benefit to patients. Therefore, even under the Commissioner’s flexible approach, the PTE petition was denied but the principles determined in the decision are very significant for future reference by patentees (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC).
New rules for determining the 90-day deadline for filing a PTE petition under Israeli law
Under Israeli law, a petition for Patent Term Extension must be submitted within 90 days from “the date of registration of the pharmaceutical preparation” in the Israeli Drug Register. The deadline is non-extendable. Late filing will result in the loss of eligibility for PTE.
Under the PTO traditional practice, the PTO has counted the deadline as of the date of registration which appears on the Marketing Approval. In a new decision, the Commissioner of Patents held that the 90-day deadline is to be counted from the date of delivery of the marketing approval by the Ministry of Health to the owner of the registration and not from the date of registration. The date of delivery may be a few days after the date of registration. Furthermore, if the registrant proves that the marketing approval did not reach it on the delivery date, the 90-day deadline will start upon the date of actual notice that a marketing approval was issued (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC).
This new decision should also be seen as another favorable development following the 2016 PTO change in practice with regard to the determination of the date of the earliest Marketing Approval in the Recognized Countries for the calculation of the 14 years cap for the PTE duration. The PTO aligned its position with the CJEU ruling in case C 471/14 Seattle Genetics which held that the calculation of the duration of supplementary protection should be based on the EMA MA notification date rather than the EMA MA grant date. In late 2017, after discussions at the Knesset Law Committee in which Liad Whatstein & Co. took part and despite protest by the Israeli generic industry, new Regulation 2(c)(3) of the PTE Regulations endorsed the 2016 PTO change in practice.
Thanks Liad!
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