The Israel Patent Statute was enacted in 1967. Despite being amended several times since then, most recently in 2012, it has always contained two provisions to enable third parties to exploit a patent against the patentee’s wishes.
One way, set forth in sections 116-128 of the statute, is via compulsory license, which is when a competitor of the patentee tells the Patents Commissioner that the patentee is being unreasonable about licensing terms and that this is hurting the public, and the Commissioner grants the competitor a license to practice the patent. Until early 1995, this modus operandi was commonly used by local drug manufacturers. Then, in the space of about a month, the Tel-Aviv District Court ruled that the ILPTO shouldn’t have issued compulsory licenses for acyclovir (Zovirax) and fluoxetine (Prozac) and found the licensees to have infringed the patents. That pretty much ended compulsory licenses in Israel, but for good measure, a few years later, Israel amended the statute to comply with GATT-TRIPs, tightening up the requirements for a compulsory license. I don’t think any have been granted in the past 25 years.
The second way is when the state itself wishes to exploit the patented invention for the sake of national security or for the maintenance of the supply of essential goods and services. That’s codified in sections 104-106, and hitherto had never been used. That changed this week, when the Health Minister signed an order allowing the importation of a drug that combines two anti-retroviral active ingredients, lopinavir and ritonavir. The drug is sold by Abbvie under the name Kaletra, and is presently approved for use in combination with other retroviral drugs to keep AIDS under control in infected patients.
There are presently nine patents listed in the FDA Orange Book for Kaletra, although one of them lists the expiration date as January 19, 2020, and so should probably be removed. These patents claim solid pharmaceutical dosage forms as well as methods of treating AIDS. The order lists three Israel patents still in force that ostensibly cover the product, namely IL 173939, 185930 and 207260. Inasmuch as the prescribing information says that the drug was first approved by the FDA in 2000, whatever patents there are in Israel that cover the current product are unlikely to have too much more life to them. (IL 173939 and its child 207260 will expire at the latest in August 2024; 183930 will expire at the latest in February 2026, but for reasons I'll discuss in another post, it's not clear this patent needed to be included in the order.)
There’s some hope that Kaletra will also be useful in treating COVID-19 (novel coronavirus), and a Korean hospital announced in February that it had successfully treated a patient with a combination of lopinavir and ritonavir, so there’s suddenly a demand for the drug, and not only in Israel, where there as of this writing still fewer than 500 reported coronavirus infections (and no deaths). But Abbvie can’t meet that demand. So the authorities are exercising their right under sections 104-106 of the statute to import generic Kaletra from countries in which there is no patent protection, most notably India.
The MOH (or rather, the team of lawyers in the Justice Ministry, MOH and ILPTO behind the Order) was careful to couch the order as applying only to importation of a particular version of the drug (containing 200 mg liponavir and 50 mg ritonavir), from a particular manufacturer, and for treating coronavirus only ; the state is not allowing itself to import for treating AIDS. And per the statute, Abbvie will be entitled to compensation for the importation, though just how much will be determined at a later date, either by agreement between the state and Abbvie, or in the absence of such an agreement by the Compensation and Royalties Committee that is established by the ILPTO on an ad hoc basis.