America-Israel Patent Law

Israel PTO Issues Clarification About Work During Coronavirus Shut-Down

As if life weren't exciting enough these days, the ILPTO issued a clarification (in both Hebrew and in English) to its earlier announcement about work arrangements during the coronavirus shut-down: since the statute imposes a 90-day limit to record a pledge against a patent, the ILPTO will continue to process the recording of such pledges. And if you're a patent practitioner trainee and you're now on unpaid leave, you should read the announcement.

Abbvie To Suspend Enforcement of Kaletra Patents (Maybe); Probably Unrelated to Israel

After last week's fanfare (in Israel, anyway) about the Israeli government exercising rights under section 104 of the patent statute to allow importation of a generic of Abbvie's Kaletra tablets, this week reports are surfacing that Abbvie is suspending enforcement of its Kaletra patents worldwide, or possibly waiving its rights altogether, if the reporting in The Financial Times is accurate.  The FT piece seems to imply that Abbvie took this course of action as a result of Israel's action, but that conclusion is questionable.  As one person working for the state of Israel noted, it's clear that Abbvie couldn't meet demand at the present time, so why not allow others to supply the drug?  And given the unimpressive results from tests in China in January, it's likely that Abbvie suspects, or possibly already knows, that the drug will be ineffective against COVID-19.  In which case it's a publicity win for Abbvie. 

It's worth noting that there's nothing on Abbvie's site about this.  While the FT report begins by stating, dramatically, "AbbVie is giving up its patents on a combination drug that is being studied as a coronavirus treatment", the FT story later says "The company gave notice of the change last week, according to a document seen by the Financial Times..."  Inasmuch as that document isn't presented on FT's site, Abbvie evidently only showed it under an agreement of confidentiality. 

Since Kaletra is used to keep HIV/AIDS in check, but not to eradicate the disease, and therefore must be taken regularly by patients, it's difficult to believe that Abbvie would willingly forfeit profits from the drug in those countries where patent protection is still in force.  Perhaps Abbvie has simply indicated it won't enforce its patent against importers who import for purposes of COVID-19 testing.  Time will tell.

English Translation of Israel PTO Notice About Work Arrangements Under Coronovirus Shut Now Available

Further to yesterday's blog post, today the ILPTO published an English translation of its notice about work arrangements during the Coronavirus shutdown.

Update March 27: the ILPTO published a further clarification on March 25. English version here. If you're recording a pledge against a patent, the 90-day limit to do so still applies, and the office will record the pledge. If you are a patent practitioner trainee on now unpaid leave, you should read the update.

Updates from Israel PTO Re: Work During Coronavirus Shut-Down

On Saturday night, March 21, the Israel cabinet agreed to reduce the number of public sector employees still working.  Yesterday, March 22, the Israel PTO published a four-page explanation of how it is implementing this decision, which remains in effect until May 1, 2020 or until the ILPTO publishes a new notice, whichever comes later.  [Update, March 24: the ILPTO has now published its own English translation of the notice.]  The main points are that:

• many employees were already working from home, and will continue to do so; registration certificates will continue to issue, and the Patents, Trademarks and Designs Journals will continue to publish at the end of each month;
• the ILPTO will strive to meet its obligations under treaties (e.g. providing PCT search reports on time), and to issue renewal certificates on time, but certain services (recording assignments, licensing new practitioners, notices of formal defects in PCT national stage applications, daily notices of outgoing correspondence) will be delayed at least until after Passover (April 15, 2020);
• the ILPTO will continue to accept submissions electronically and, for those parties permitted to do so, in person or by regular post, but in-person meetings and proceedings before the ILPTO, including hearings in adjudicatory proceedings, will remain in suspension;
• deadlines for filing new applications, responses to office actions and the like will not be held in abeyance, but non-statutory deadlines in adjudicatory proceedings will be suspended;
• applicants or other parties in proceedings before the ILPTO who are unable to timely make submissions as a result of coronavirus-related circumstances may request extensions or reinstatement based on those circumstances, which will be taken into account when deciding whether or not to grant the extension or reinstatement;
• in cases in which the ILPTO has an announced policy capping the number of extensions, that cap will be temporarily be waived, but statutory deadlines (e.g. for opposing a patent application or requesting a patent term extension) cannot be waived;
• in order to allow applicants/owners to file requests for extension/reinstatement, at least until May 1, 2020, no files will be closed for an applicant’s/owner’s failure to take an action, nor will the ILPTO send pre-file closure notices (which in many instances are a prerequisite for closing a file).

We elaborate on each of these below.

There are two ways in which the coronavirus outbreak affects the ILPTO: fewer people are physically in the ILPTO, and by order of the Cabinet, the ILPTO’s workforce needs to be reduced; and parties with matters before the ILPTO may be unable to meet deadlines.  Yesterday’s letter clarifies how the ILPTO is dealing with both of these aspects.

In the main, the ILPTO is attempting to maintain a “business as usual” approach.  Thus the ILPTO will still do intake on new patent, trademark and design applications; examiners will still examine cases, although the pace of examination will slowed; the Office will continue to publish the Patents, Trademarks and Designs Journals each month; and the Office will issue registration certificates, although the Notice recommends that, given possible disruptions in Israel Post, registrants download copies of the certificates.  The ILPTO will likewise strive to meet its obligations under international treaties, such as PCT examination, and it will deal with requests for immediate processing of applications, e.g. due to the inventor’s age. 

However, certain less-critical functions will be suspended altogether: the processing of changes in ownership or the name of the applicant/owner, recording of liens and the like (except for changes in local address for service, which will still be processed); the processing of registration of new practitioners and registration for practitioner examinations (except for complaints against practitioners); the sending of notices regarding formal defects in PCT national stage applications; and the emails that the ILPTO sends to practitioners, informing them of the cases in which correspondence issued, to enable practitioners to track that correspondence (in case a piece of correspondence wasn’t received). 

For over a week the ILPTO has not been receiving the public, and this will continue, which means inter alia that there will be no in-person examiner interviews, nor will any hearings in adjudicatory matters take place.  The notice states that there will, however, be someone answering the telephone during regular business hours. With most personnel remaining at home, it is unclear if callers will be able to obtain the clarifications they seek, even if they get through to the ILPTO.

Perhaps of greater to interest to parties with deadlines in matters before the ILPTO is the question, “Whither my deadline?” 

The first thing to note is that the Commissioner has discretion about granting deadlines in many matters, but certain deadlines are set by statute and cannot be extended.  Specifically, in patent matters, the following deadlines are not extendible:

• for third parties to request immediate examination of another’s patent application per §18(c);
• for filing an opposition to patent a application under §30,
• for payment of renewal fees per §56 and §57,
• for opposing the reinstatement of a patent under §61,
• for notifying the Commissioner of the granting of extension orders for reference patents in the USA and Europe under §64E(e)(2),
• for opposing the grant of a patent term extension (PTE) under §64F,
• for paying the fees to keep a PTE in force under §64M,
• for submitting a PTE application under §64O,
• to oppose under §73(c) the revocation or cancellation of a patent, and
• to oppose a change in the Register under §170(c).

Similarly, the deadlines for opposing a trademark registration and for paying trademark renewal fees per §24 and §33 of the Ordinance cannot be extended, and the deadlines for certain actions in design registrations are likewise not extendible.  (From the wording of the Notice, it sounds like the Commissioner would like to have the authority to extend some of these deadlines, but knows that he doesn’t, and may seek a change in legislation at a later time to address this.)

Second, in all other cases the Commissioner has discretion to grant extensions.  In some instances, though, he has published notices according to which, a priori, he has limited the number of extension available.  Thus, for example, during the substantive examination phase of a patent application, the ILPTO’ stated policy is that it will grant extensions without a showing of cause upon the payment of a fee, but that it will not grant more than four months of extension at one time, and not more than 12 months’ extension total over the course of examination.  The Notice says that at least until May 1, 2020, these caps will not be emplaced, and that extension periods falling within the period of March 22, 2020 through May 1, 2020 inclusive will not be included in capped period.

In some instances in which the Commissioner has discretion to grant an extension or to reinstate an application or registration, there is a criterion for granting the extension/reinstatement, either by dint of the statute or self-imposed by the ILPTO.  Thus, for example, a patent applicant who fails to file an application within the priority year may request an extension for the priority claim, and per §164 the Commissioner may only grant such extension if he determines that the failure to timely file in Israel was due to circumstances over which the applicant had no control and that could not be prevented.  In other instances, a showing of “reasonable cause” must be made.  The Notice points out that inability to file a document or pay a fee on time due corona virus-related circumstances may constitute circumstances that amount to “reasonable cause” or circumstances over which the applicant had no control, but that each case will be judged on its own merits.  Requests for extension on such basis may be made either before the initial deadline, or retroactively.

The Notice states that deadlines in adjudicatory proceedings are suspended at least until May 1, 2020 or further notice, whichever is later, but that the adjudicators will continue “to work as normal”, which we understand to mean that decisions in cases in which all hearings and submissions have concluded will continue to issue.

The Notice says that, in any event, in order to allow parties that have missed deadlines to make their case for extension/reinstatement, until May 1, 2020 or further notice, whichever is later, no files will be closed for failure to take a required action, nor will the ILPTO send pre-file closure notices, which in many instances are a prerequisite for closing a file.

Finally, it is to be noted that the ILPTO would have been closed anyway for Passover, from April 8 through April 15, 2020, inclusive.  Hence any deadlines that fall on these dates would in any event have been statutorily deferred to April 16, 2020, and thus filings or payments due on these dates will be considered timely if made on or before April 16, 2020.

 

Update, March 27:

(a) the ILPTO published an English version of its March 22 announcement.

(b) on March 25 the ILPTO issued a further clarification in both Hebrew and English: since the statute imposes a 90-day limit to record a pledge against a patent, the ILPTO will continue to process the recording of such pledges. And if you're a patent practitioner trainee and you're now on unpaid leave, you should read the announcement

A Few More Thoughts On Israel’s Exercising Its Right to Exploit Abbvie’s Patents

As I mentioned yesterday, the Minister of Health signed an order this week allowing the state to import generic Kaletra (a combination of lopinavir and ritonavir) to be used, potentially, against COVID-19.  I’d like to share two observations about this.

The first is that, despite the increasingly strict isolation measures the state has been putting in place over the past several weeks – people are now supposed to leave their homes only in very limited circumstances – these strictures are being emplaced in a manner that English speakers would says comports with the Rule of Law: the state is following its own legal procedures, to the point that implementation of the latest set of restrictions was delayed by several days until they could be properly published in the Israeli equivalent of the Federal Register. 

This approach can be seen in how the Health Minister’s order allowing importation of generic Kaletra came about, and what the order says. The state didn’t say, “We’re the state and we can infringe willy-nilly”, let alone start importing generic product without informing the patentee or its licensed importer.  The state followed the patent statute. The order itself invoking the state’s statutory rights was prepared by a team of lawyers from several state offices who worked behind the scenes, and those lawyers are not anonymous, but are well-known to people who work in IP in Israel. And, I as noted yesterday, the order is fairly limited in its scope: it’s for a specific solid-state formulation, and is only to be used in corona virus treatment, not treatment of HIV/AIDS. Moreover, the order was issued because the patentee, Abbvie, can’t keep up with demand. Presumably, if Abbvie could keep up with demand, the state would not exercise its rights to import.

Additionally, the patentee will be entitled to compensation for the infringement. It remains to be seen where that will be set, but no one expects Abbvie to walk away from this with nothing.

It instills a measure of confidence that even in tough times, the state makes an effort to follow its own laws. That’s not a given in many parts of the world.

The second observation is that of the three patents listed in the order, the inclusion of two of them is questionable. IL 173939 and IL 207260 are a parent and divisional, and they claim a solid pharmaceutical form per se and a method of making a solid pharmaceutical form. The independent claim of IL 173939 reads,

1. A solid pharmaceutical dosage form which comprises a solid dispersion of at least one HIV protease inhibitor selected from the group consisting of lopinavir, ritonavir, and a mixture thereof, at least one pharmaceutically acceptable water-soluble polymer having Tgof at least 50ᵒC, wherein said water-soluble polymer constitutes from 50 to 85% by weight of the total weight of the dosage form, and at least one pharmaceutically acceptable non-ionic surfactant having HLB value from 4 to 10.

That claim, and several other claims of the ‘939 patent, are presumably infringed by the importation of generic Kaletra.

The independent claim of 207260 reads,

1. A method of preparing a pharmaceutical solid dosage form, comprising:preparing a homogeneous melt of at least one HIV protease inhibitor selected from the group consisting of lopinavir, ritonavir and a mixture thereof,at least one pharmaceutically acceptable water-soluble polymer having Tg of at least 50ᵒC,andat least one pharmaceutically acceptable non-ionic surfactant having HLB value from 4 to 10, wherein the melt is prepared by melt-extrusion; allowing the melt to solidify to obtain a solid dispersion product; and forming tablets, wherein the tablets further comprise one or more additives selected from the group consisting of flow regulators, disintegrants, bulking agents and lubricants.

If the manufacturer uses an infringing process to make its product, then importation of the drug constitutes infringement, and Abbvie will argue it is entitled to compensation for such infringement.  But it’s also possible that this claim is not infringed by the process by which the generic Kaletra is manufactured, in which case the state will argue that Abbvie isn’t entitled to such compensation.  The bottom line is that to obtain royalties on the basis of the ‘260 patent for the importation of the generic drug, Abbvie will need to show that the imported material is prepared by the claimed process.

The third patent listed in the order, IL 185930, has two independent claims:

1. Use of a solid dispersion comprising lopinavir and ritonavir; at least one pharmaceutically acceptable water-soluble polymer having Tg of at least 50ᵒC, wherein said water-soluble polymer constitutes from 50 to 85% by weight of the total weight of the dosage form; and at least one pharmaceutically acceptable non-ionic surfactant having HLB value from 4 to 10, in the preparation of a medicament for treating HIV/AIDS in a patient in fasted state.

3. Use of a solid dispersion comprising lopinavir and ritonavir; at least one pharmaceutically acceptable water-soluble polymer having Tg of at least 50ᵒC, wherein said water-soluble polymer constitutes from 50 to 85% by weight of the total weight of the dosage form; and at least one pharmaceutically acceptable non-ionic surfactant having HLB value from 4 to 10, in the preparation of a medicament that is taken without food for treating HIV/AIDS in a patient.

Both of these claims are in “Swiss” format, a format that is used in many countries that prohibit the patenting of methods of treatment of people (often on moral grounds), as a way to get around such prohibitions. The intended use recited at the end of these two claims would presumably be understood by a court in Israel as limiting these claims to methods of preparation of formulations that are intended for use in treating HIV/AIDS. Since the Health Minister’s order is limited to importation for the treatment of corona virus, that importation presumably doesn’t infringe.

Then again, maybe it does: the generic drug that will be imported is made in India, and as all approvals of the drug worldwide at this time are for the treatment of HIV/AIDS, Abbvie will likely argue that the manufacture of the drug product meets all the limitations of these two claims – the drug is being made for treating HIV/AIDS – and that the fact that Israel is importing the drug for an off-label use doesn’t change the fact that the drug was manufactured for the treatment of HIV/AIDS.  Abbvie will thus seek additional compensation on this basis.

What I find particularly interesting about the inclusion of the ‘260 patent in the Minister’s order is that a few years ago, the Israel PTO sua sponte stopped accepting Swiss style claims, on the grounds that such claims do not recite a product or process.  That reversal of position contradicted decades of precedent in which such claims had been accepted by the ILPTO, and in which such claims had been litigated and not once found to be invalid on the grounds that Swiss claims per se are unacceptable. 

It is tempting to think that the fact that one of the lawyers involved in preparing this week’s importation order works in the ILPTO signals a change of heart on the part of the ILPTO, but that’s probably reading too much into it: my understanding is that the lawyers who drafted the order didn’t actually look at the patents, and merely listed those that they were told by the patentee or the patentee’s licensed importer might be infringed by unauthorized parallel importation.  If the state and Abbvie are unable to come to terms about the appropriate compensation, and the matter goes to the Compensation and Royalties Committee for adjudication, the question of the permissibility of Swiss claims per se may finally be addressed head-on.

Israel Makes First Use of Statutory Provision Allowing Patent Infringement By State

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.

Enough With These "Coronavirus" Emails!

I've lost track of the number of emails I've received from law firms around the world, letting me know that they're still operating despite the coronavirus, and informing me of the steps they're taking to protect the health of their employees and their clients. Guys, unless your firm consists entirely of octogenarians, it's not going to wipe out your entire firm, and I'm not worried that I'm going to have an urgent filing in Timbuktu and no one will be around to attend to it. In fact, coronavirus probably isn't going to claim anyone at your firm. If I do have something urgent, I'll clarify first that you can deal with the matter right now, whether or not you've sent me a reassuring email beforehand. And I personally am not really not worried about being infected by this virus, or by any other pathogen, from someone located hundreds or thousands of of miles away.

The emails aren't limited to law firms. I think every retailer I've ever dealt with online has sent me something to reassure me that they're still in business. And in the case of travel-related companies, hoping I'll book a flight or reserve a hotel room or a rental car.  But I put law firms in their own category, because, as a lawyer friend of mine once pointed out, "If we weren't risk-averse, we would have gone to business school."

The Israel PTO informed us that it would carry on with examination of patent, trademark and design applications as usual, but there would be no in-person meetings with members of the public, and all hearings in adjudicative proceedings are deferred until further notice. Then last night the PM told us the public sector is going to be pared back even further, so I expect an announcement today that ILPTO examiners will be working from home.

What I'm surprised about - and this is the cynic in me talking - is that I haven't yet seen an attempt by a law firm to capitalize on the current situation, in the way, for example, that lots of firms tried to make money in 1999 by scaring people about the potential "Y2K" disaster that never materialized. But clearly, some people are being advised by lawyers. I saw a letter circulated to residents at a retirement home, explaining that, as precautionary steps, no visitors would be allowed, social functions and gatherings would be prohibited, meals would be delivered to residents' rooms, and residents would need to practice "social distancing" in the common areas that were still open (which, the letter didn't state but is an obvious conclusion to be drawn from it, precludes playing card games or board games or doing puzzles. You can still do mad-libs, though, and charades.). Those steps are, of course, justified by the advice being given by the health authorities (although there were no government orders mandating such action in that particular home at that time), but I couldn't help thinking that the letter could just as easily have said, "Dear residents, if we don't take these steps and one of you contracts coronavirus and as a result is injured or dies, we could be exposed to significant financial liability. But we have no exposure if you all die of boredom, so this one's a no-brainer."

Looking forward to a resumption of normalcy, sometime.

Purim Post, 5770 (2020)

This has nothing to do with patents. I suppose it's IP-related in that, with regard to copyright, this is an example of parody and/or fair use. But since the coronavirus scare is affecting everyone in Israel (they just announced that EVERYONE who enters the country, no matter from where, has to stay at home for 14 days), and has led to the cancellation of some Purim celebrations, I thought this would be appropriate.  With apologies to The Knack (and if you're too young to know the original, released in 1979, click here):

 

Ooh, you’re an infectious one, infectious one

When you gonna infect my bod, Corona?

Ooh, you’ll cause my nose to run, my nose to run

Cause me to use all my tissues, Corona

You haven’t yet been stopped, we cannot yet immunize

You especially like the lungs of the older kind

My my my aye ah wooo

M m m my Corona

 

Don’t get any closer huh, don’t you huh

‘Cause I don’t want you coming through my eyes, Corona

And I don’t want to breath you, no I don’t, don’t want to breath

spittle that has been aerosolized, Corona

You haven’t yet been stopped, we cannot yet immunize

You especially like the lungs of the older kind

My my my aye ah wooo

M m m my Corona

M m m my Corona

 

When you gonna get to me, get to me?

Is it just a matter of time Corona?

Is a matter of fate, matter of fate?

Or will we soon inoculate ‘gainst you, Corona?

You haven’t yet been stopped, we cannot yet immunize

You especially like the lungs of the older kind

My my my aye ah wooo

m m m m m m m My my my aye ah wooo

M m m my Corona

M m m my Corona

M m m my Corona

M m m my Corona