In the recent case of BTG International Limited1, the Registrar of Patents granted a temporary patent term extension order for Patent No. 105078, holding that under certain circumstances a temporary extension order will be granted despite the fact that no formal extension order was granted to the US Reference Patent before the date of expiry of the Israeli patent. The decision was subsequently challenged in an opposition lodged by the Israeli Manufacturers Association, which is currently pending.
Zytiga® is a novel drug, whose active pharmaceutical ingredient is arbiterone acetate, and is indicated for certain prostate cancer treatments. This drug is protected, finter alia, by Israeli Patent No. 105078 (“the Patent“), which was set to expire on March 16, 2013, and by a US patent (“the US Reference Patent“) that is set to expire in February 2014. Both patents are owned by BTG International Limited.
Zytiga® received US marketing approval on April 28, 2011, and Israeli marketing approval on June 11, 2012, more than nineteen years after the application date of the Patent.
As required in section 64D(5) of the Patents Law, 1967 (the “Law“), where a drug received a marketing approval by the US FDA, a PTE of the Israeli patent may be issued only if the term of the US reference patent has been extended. In addition, according to the Law, a decision to grant an extension order should be given before the expiry of the Israeli patent.
In the case at hand, the US marketing approval was granted only in 2011, and no formal extension order was to be granted to the US Reference Patent prior to the date of expiry of the Israeli Patent.
Therefore, in order not to be deprived of its right to an extension order, BTG requested that the Registrar publish a notice of intention to grant an extension order on the basis of the information before him, to shorten the term for third party opposition so that the term ends before the expiry of the Patent, and to grant a temporary extension order to complete all relevant proceedings. In the framework of its request, BTG argued, inter alia, that the US Reference Patent’s eligibility for an extension order was recognized by the USPTO, thereby fulfilling the essential requirements under the Law. Furthermore, the specific circumstances of the case at hand, including the delays in the receipt of marketing approvals and in the grant of the US extension order, should also be taken into consideration in favor of granting atemporary extension order.
In February 2013, the Registrar granted the Patent a temporary extension order, for a period of six (6) months or until the conclusion of a possible opposition, whichever is earlier. The Registrar held that a temporary extension order should be granted under the specific circumstances of the case, namely, the delay in the marketing approvals of the drug Zytiga® (granting the drug an effective protection period of only 10.5 months) and the delay in the procedure to grant the US Reference Patent an extension order, which will most likely be granted. In addition, the Registrar ruled that the issuance of the temporary extension in this case is also in line with the purpose of the Law; in particular, balance is achieved between the possibility of utilizing a product whose development requires large investments, on the one hand, and the public interest that the right of competitors not be deprived excessively, on the other.
On March 12, 2013, the Israeli Manufacturers Association lodged an opposition against the Registrar’s decision. The Manufacturers Association argues, inter alia, that the Registrar lacked power to grant a temporary extension order. The opposition is pending and BTG has yet to respond to it.
This case may clarify the situations in which the Patent Office may issue temporary extensions. The outcome will be reported in due course.
IL Patent Number 105078, in the name of BTG International Ltd (Motion to issue a notice of intention to grant an extension order, shorten the opposition period and grant a temporary patent extension order) [before Registrar of Patents Asa Kling, 12 February 2013].
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