America-Israel Patent Law

Yet More on Ben & Jerry’s

I’ve written twice before about the saga of Ben & Jerry’s ice cream in Israel, specifically about (a) the 2021 decision by the B&J board to not renew the license of its Israeli licensee of over 30 years, Avi Zinger (and two companies he owns) because he refused to capitulate to a demand that he not sell in areas of Israel that were occupied by Jordan from 1948 through June 1967, viz. Judea and Samaria, and (b) the licensee’s suit against B&J and its parent company, Unilever, filed earlier this year in New Jersey, to force Unilever to continue to allow the licensee to produce Ben & Jerry’s ice cream in Israel and to sell it throughout the country, including in Judea and Samaria.

In June Unilever and the licensee settled that suit by agreeing, among other things, to transfer to the licensee all of the Unilever’s Ben & Jerry’s intellectual property in Israel, and that henceforth the Israeli licensee would be the owner of the that IP and would continue to sell manufacture Ben & Jerry’s ice cream throughout Israel, provided that its labeling be in Hebrew and Arabic, and not in English.  On that basis, the licensee’s suit against Unilever was dropped.

But that wasn’t good enough for some of the Jew-haters at B&J in Vermont: soon thereafter, Ben & Jerry’s board – or rather, a group of members of that board – sued Unilever in federal court in New York, seeking to nullify the agreement with the Israeli licensee.  Those B&J board members subsequently filed an amended complaint. Last week Unilever filed a memorandum of law in support of its motion to dismiss the case at the pleadings stage.  Unilever’s grounds for dismissal are numerous, and include the point that neither of Avi Zinger’s companies were named as defendants, so that as non-joined “indispensable parties”, the suit can’t go forward.  But the real crux of the motion is that in 2000, when Unilever took over Ben & Jerry’s, it assumed responsibility for all commercial decisions about IP, and that Ben & Jerry’s board therefore doesn’t have a basis to sue.

In the meantime, Avi Zinger & Co. continue to produce and sell Ben & Jerry’s ice cream, Unilever has assigned its Ben & Jerry’s trademarks in Israel to one of Avi Zinger’s companies, and at least here in Israel, they’re proceeding on the assumption that this is a done deal. Notice the signage on the Ben & Jerry’s factory, which I toured recently courtesy of Alyza Lewin, who spearheaded the Avi Zinger’s suit against Unilever and the subsequent negotiations that led to the settlement. The English lettering has been removed, and covered over with Hebrew lettering only.  I have to say I was a bit disappointed to discover there were no Oompa-Loompas working in the factory, but, as is usually the case in industrial manufacturing, there were some cool machines (how do you get all the caps for the tubs of ice cream oriented in the right position?) … that we weren’t allowed to photograph.

…But Persists In Another Dumb Idea

My last post concerned the USPTO wisely backing down from its proposed “voluntary CLE”.  This post concerns its ongoing insistence to plow ahead with its “docx filing” requirement.

In late October, at the AIPLA Annual Meeting, then-AIPLA president Patrick Coyne interviewed PTO Director Kathi Vidal. While some of her remarks in response to his questions were covered by IPLaw360, one statement in particular seemed to fly under the radar of that publication as well as the prominent patent blogs.

Specifically, Ms. Vidal was asked about the docx filing program, and she responded that (a) she appreciated AIPLA’s input on the matter, and per the suggestion of AIPLA and others, the PTO had begun to allow the submission of a pdf file along with the docx file, and (b) although that option was originally intended to be available only until January 1, 2023, when failure to file in docx format would incur a $400 fee, the PTO is delaying implementation of that rule until July 1, 2023, and thus the ability to file a pdf file along with the docx file, without financial penalty, will continue until then.

Readers familiar with the USPTO’s docx filing program and its many deficiencies will understand Vidal’s remarks are but one more instance of the PTO’s repeated failure to listen to the community of patent filers and to comprehend the problems with the docx filing requirement that this community has expressed on multiple occasions.

In this particular case, what AIPLA, and others (including yours truly) asked for was not the privilege of being able to submit a pdf document in addition to the docx file, but vice versa: to continue to have applicants submit user-created pdf files as the definitive documents, but to be encouraged to submit docx files in addition to the pdf files, to help the PTO do whatever it is it wanted to do with docx files.  This, in fact, is the way people filing PCT applications using WIPO’s ePCT already operate, and it works extremely well.

The primary concern with requiring filing in docx format is that the PTO uses proprietary software to convert the user’s docx document to something else, and it’s THAT something else that will become the official document. Since in many cases it will not be practical, prior to filing, to check this converted form line-by-line to ensure that the conversion did not create errors in the document (e.g. in mathematical formulas), filing in docx opens the door to malpractice suits.  Hence it is expected that a significant number of practitioners will continue to file in pdf, and to pass on the $400 fee to their clients. The more cynical among us believe the PTO knows this, and is using this docx requirement as an underhanded way to extort money from the public.

In any event, although more than a month has gone by since Ms. Vidal made her remarks at the AIPLA meeting, no official announcement has come forth from the USPTO regarding delay in the docx requirement. Which is a pity, because as of October 1, the USPTO did not have approval from the Office of Management and Budget (required under the Paperwork Reduction Act) to move forward with its docx program.  Since such approval must come three months in advance, the USPTO cannot legally move forward with the docx program on January 1.  If a lawsuit is filed against the USPTO to enjoin the docx requirement and imposition of the $400 fee – and I’m aware of at least one individual who is preparing to file such a suit – it is not only likely that and injunction will be granted, and that ultimately the USPTO will lose (just as it lost 15 years ago in the battle over the claims and continuation rules), but the USPTO will wind up with significant egg on its face, as it has been persistently duplicitous in its pursuit of the docx debacle.

USPTO Permanently Backs Down from One Dumb Idea…

In October 2020, the USPTO proposed a scheme of voluntary continuing legal education (CLE) for patent practitioners.  The PTO would be among the CLE providers, and would make a public notation of those practitioners who fulfilled the requirements.  The proposal was almost universally panned in the comments that were submitted (including comments from David Boundy, from Neil Ormos, from this writer, and surprisingly forceful comments from the AIPLA). 

Last year, the PTO blinked, and said it was temporarily shelving the proposed CLE requirement.  Now the PTO reports that in a Federal Register notice to be published on November 14, 2022, it is killing the CLE requirement. 

This is a most welcome development. Among other things, for reasons explained in the comments, the proposed plan was not going to “improve patent quality”, and would place an additional, unnecessary burden on practitioners without realizing any substantive benefits.

And yet, the PTO’s tilting at windmills persists, as revealed in recent remarks by PTO Director Kathi Vidal concerning docx filings.  I’ll report on that in another blog post, hopefully soon.

Why Not Use Global Dossier To Comply With Israel Prior Art Disclosure Requirements?

Someone I met at the recent AIPLA meeting (the same person I mentioned in my previous post, who serves as in-house patent counsel for a company with a tight budget) complained about the duty of disclosure requirements for patent applicants in Israel, particularly in light of the advent of the Global Dossier program.

For the uninitiated, Global Dossier is a program in which several of the world’s large patent offices (colloquially known as the IP5) participate: USPTO, EPO, JPO, SIPO, and KIPO. It’s available for free and allows users to easily access documents from patent application files in these countries, usually including English translations of non-English documents issued by those offices.  Both WIPO’s Patentscope and the EPO’s Espacenet enable users to see patent examination files via Global Dossier.

One example of the usefulness of Global Dossier is a way in which the Israel PTO already utilizes it. When making a request to expedite prosecution under the Patent Prosecution Highway (under which an application will jump the queue if the claims pending in Israel are amended to correspond to claims allowed by a foreign patent office with which the Israel PTO has a PPH agreement), an applicant can provide a copy of the necessary documents, or, if those documents are available via GD, instruct the Israel PTO to obtain the documents via GD.  In a recent PPH request I filed in which I told the Israel PTO to obtain the document via GD, the PPH request was granted the next day.

This takes us back to my interlocutor’s question/complaint: given the availability of GD, and the disclosure requirements in other countries, why can’t the Israel PTO simply make use of GD and rely on the searches and applicant disclosures in IP5 countries, instead of requiring applicants themselves to submit the information and documents? It’s a legitimate query, especially in light of the facts that (a) based on Israel PTO office actions, it seems that examiners already make use of GD, and (b) the disclosure requirements in the USA are similarly stringent to those in Israel, and thus could probably safely be relied upon.  

The unhelpful answer to the question is, Applicants have to jump through hoops because the statute in Israel (still) requires that applicants provide these disclosures. §18(a)(1) and §18(a)(2) of the statute say that, in assessing the allowability of claims of the patent application, the examiner may rely on publications cited against foreign patent applications for the same invention or known to the applicant to be relevant to patentability. §18(b)(1) says that the examiner will require the applicant to furnish the documents mentioned in §18(a)(1) and §18(a)(2). And §18A imposes an obligation on applicants to update the Office regarding the lists in §18(a)(1) and §18(a)(2) up until the time of acceptance of the patent application.  So at present, there’s not really a way around the statutory language that was written in pre-GD times.

Except, of course, that a lot of what is required is dependent on the Israel PTO, and it sometimes relaxes the requirements, at no detriment to the applicant or the public. The most obvious case in point is that the statute says that applicants must provide copies of documents relied upon by foreign patent offices, but in practice the Israel PTO has for a good number of years said that applicants only need to provide copies of such documents that are not patent documents (like journal articles), as ILPTO can themselves easily access patent publications. This relaxation of the requirement doesn’t meet the letter of the law; but I have not yet heard of a situation in which an opposition to the grant of a patent, or a challenge to the validity of a patent, was upheld on the grounds that the applicant merely provided the ILPTO with the number of a cited patent publication and not with an actual copy of the cited patent publication. 

So in the present case, the ILPTO could say something like, “With regard to disclosures under §18(a)(1) and §18(a)(2), we will consider the applicant’s duty to be fulfilled if the applicant refers the Office to the documents cited by, or provided by the applicant to, IP5 offices, which are available via Global Dossier.”  Inasmuch as this would reduce costs for patent applicants in Israel, it would make filing in Israel a more attractive proposition for some applicants. The onus would still be on the applicant to make sure that its IP5 prior art disclosures were up to date, and there would be the risk that something relevant wasn’t reported to the ILPTO, and thus could serve as grounds for a challenge to the grant or validity of a patent. But the overall workload for the applicant would be lessened. And if indeed the examiners already use GD, there would be no loss of information provided to the ILPTO either.

A Time I Was Right But Wish I Wasn’t

Exactly one year ago, I wrote about the Israel PTO’s announcement of its plan to issue patent office actions (examination reports) in English for those who wished to receive them in English. And one of my predictions was that certain firms wouldn’t be as forthcoming as they could be with their clients about this.

Last week, I met someone at the AIPLA Annual meeting who confirmed my suspicion. He was already frustrated with his Israel counsel’s habit of translating office actions, and had instructed them to simply send him a copy of the OA, and he would ask them for clarification if Google translate wasn’t clear. But he’d never been told that he could ask for the OAs to be issued in English. Color me shocked…not.

Support for Electronic Patent Filing: WIPO vs USPTO

Yesterday, after Europe had gone to bed, a subscriber to Carl Oppedahl's PCT listserv asked a question: what does one do when filing a PCT application when one of the inventors has a single name, if ePCT gives a warning when there's no second name?

One response was, "No inventor name is required on a PCT application, so just file without the inventor name, and then afterward send WIPO a letter explaining the issue and asking them to add the name."

This morning, after Europe woke up, Ann Bardini from WIPO wrote a response and explained what to do in this situation in ePCT.

"In ePCT please fill in the portion of the name that applies for the person in question, in your case the first name, and leave the last name field blank.  When you confirm with the OK button, ePCT will display an error message that requests that you add a dash “-“ in the last name field in place of the name: [screenshot]  The equivalent applies if it the person is providing only a last name. "

The fact that she responded was in itself a great thing.  But then she added, "We have taken this approach in an attempt to steer users towards typing the same value in the case of a missing portion of a natural person’s name. It might not be the best way of doing it, as users such as yourself do not necessarily attempt to click on the ‘Add’ button with a mandatory value missing in order to see that validation message.  We might improve this in the future by putting more explicit information in the GUI itself, although this remains a very rare scenario as far as we are aware to date."

So they not only listen to users, but let users know they're listening, and try to address users complaints.  And even say when a particular issue might be so rare as to not warrant further adjustment.

Wow.

A few weeks ago, Michael Richarson from WIPO similarly responded to ePCT user questions on the listserv, including suggesting a workaround for a particular problem - twice in the same week!

Meanwhile, the USPTO remains tone-deaf and obstinate when it comes to fixing Patentcenter, which has many problems, some of them since alpha-testing more than three years ago; and when it comes to its plan to force users (as of this coming January) to file in "docx" format, which isn't a single format but which the USPTO claims is. 

This is why, as someone based outside the USA (and thus not constrained to using the PTO in the absence of a "foreign filing license"), I invariably file PCT applications at WIPO via ePCT.

Who Files Documents At the Israel PTO After 6 PM?

Went to login to file something at the Israel PTO, and got the notice at the bottom of the login window below:

If you don't read Hebrew, it says, "There may be disruptions in the web sites starting at 18:00 today".

Hey, who files stuff after 6 PM? The Israel PTO doesn't work then, why should patent applicants?

And which "web sites"? The problem actually seems to have already struck in the patents database, which is presently inaccessible.

Heaven forfend that they do maintenance work on their systems AFTER midnight. (To be fair, there have been occasions in the past when they have pushed off work to that time slot. So why make the mistake now?) In the present case pushing off work until after midnight would be even better, because it would be early Friday morning, which isn't a workday and Israel and therefore any deadlines are pushed off until Sunday.

But lately the USPTO has also been doing systems maintenance beginning at 10 PM eastern time on weeknights, viz. two hours before the business day ends for those who file electronically. Evidently someone in Israel doesn't want to be left out of the party.

 

Pfizer’s Paxlovid: A New Drug Without A Patent

That title is a bit misleading, because Paxlovid does have patent protection. But that wasn't the case when it was first approved. 

“Paxlovid” is the name given to Pfizer’s product for the treatment of COVID-19 infections. The product is actually a combination of two antivirals, ritonavir, which has been around since the 1990’s, and nirmatrelvir, which is brand-spanking new.  (For an account of how this molecule was conceived in the first half of 2020, and how testing revealed some non-obvious choices of substituent groups, see here.)  The two drugs are packaged as separate pills but sold in a single box as “Paxlovid”. 

Paxlovid was first approved for use on an emergency basis in December 2021 for patients age 12 and up.  It remains approved on an emergency use basis (the most recent update to the “FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS” was updated less than a week ago, on August 26, 2022), although a study published last week in the New England Journal of Medicine by a team of Israeli researchers concludes that nirmatrelvir does little for young patients. As practical matter, here in Israel it is available only to those aged 60 and over.

Pfizer filed a series of provisional applications covering nirmatrelvir (then called PF-07321332) between September 3, 2020 and May 29, 2021, culminating in a US non-provisional filed August 5, 2021.  The corresponding PCT/IB2021/057281 was filed August 6, 2021 and published as WO 2021/250648 on December 16, 2021; it has since been nationalized in at least 20 countries.  The first patent to issue in this series was US11351149B2, which issued on June 7, 2022 – more than five months after the initial emergency FDA approval.  As of this writing, there is no Orange Book entry for nirmatrelvir, meaning the ‘149 patent is not listed in connection with the drug (which may be due to the authorization being an emergency use authorization rather than a standard FDA drug approval). 

Pharma patents have been part of my work since I started in the patent field. I don’t recall any case in which a drug received approval before a patent covering the active ingredient had issued.  Presumably, the even if standard FDA approval for Paxlovid is forthcoming in only a few years, the earlier initial emergency approval relative to the patent issuance will preclude the granting of a patent term extension for the ‘149 patent: if timing of patent issuance and FDA approval are such that 14 or more years of patent life remain at the time of FDA approval, no PTA will be forthcoming (35 U.S.C. §156(c)(3)).

Request of Israel PTO: Please Include the COMPLETE versions of the Regulations on Your "Statute and Regulations" Page

The Israel PTO's web site includes a page that has links to the Patents Statute and the relevant implementing Regulations, of which there are three sets: the 1968 regulations that pertain to most of the ILPTO's patent operations, the 1996 regulations adopted to enable implementation of the PCT, and the 1998 regulations regarding patent term extensions.  The 1968 regulations contain several addenda, which are rather important: the fees for various things, like the patent filing fee, extension fees, and issue fees are all established in the "second addendum".

So why does the version of the 1968 regulations found on the "statutes and regulations" page not contain the second addendum?

It turns out that a version of the regulations containing the second addendum - at least as it was updated in 2017, without reflecting the current fees as of 2022 - can be found on a different page.

Please, ILPTO, update the link on the "statutes and regulations" page to link to a version of the regulations that include the addenda.

Initial Israel Patent Renewal Fees (Follow-Up Post) and Mailing Dates/Deadline Dates

In May I wrote about the problem with the way in which the Israel PTO notified patentees of the initial renewal fees that are due within three months of the grant of the patent: by including such notice on the back of the patent certificate, which was (and still is) sent by regular Israel Post, the Office risked the patentee either not receiving the certificate and renewal fee notice (because of the unreliability of Israel Post), or the patentee ignoring the notice because of its being printed on the back of the patent certificate.  I wrote then that there was an easy solution to the problem:

“[T]he Israel PTO already sends the attorney of record an email notice when the patent is granted, which currently reads, “You are informed that the [patent] application has matured into a patent and the Office’s records have been updated accordingly.  The patent certificate will be generated and uploaded to the Office’s web site in the next few days.”  It would take minimal effort to add a sentence to that letter that says, “In accordance with Regulation 86, you are reminded that the first renewal fee is due three months from the date of grant of the patent.”  Such a reminder would likely reduce the number of patents that lapse for non-payment of the first renewal fee(s).”

Evidently someone at the Israel PTO was paying attention, as this morning I received such a notice of renewal as part of an email attachment telling me the patent had granted, which notice included the following language:

For your attention: a renewal fee must be paid within three months of the date of grant of the patent (which appears on the first page of the patent certificate).  This period may only be extended for six months, subject to payment of an extension fee.

Non-payment of the renewal fee in the aforesaid time period will result in lapse of the patent without prior warning!

Additional details regarding renewal fees can be found on the back of the patent certificate.

This appears to be a new and welcome addition to the ILPTO’s standard notification of issuance of the patent.  Of course, the patent certificate wasn’t included with the email, and as of this writing it still hasn’t been posted on in the database, so that’s the next thing the ILPTO can work on.  Nevertheless, this is progress of a sort: it fulfills the ILPTO’s duty to remind patentees – at least those represented by counsel – of the deadline for the first renewal fee.  However, as I noted in the previous blog post, I suspect that most practitioners don’t wait for the ILPTO, and simply docket the relevant dates of their own accord. I don’t know if pro se inventors – the ones most in need of such reminders – receive these kinds of notices by email.

The non-inclusion of the patent certificate led me to discover a discrepancy within the ILPTO’s system.  Notice of the allowance of the patent in question published in the Patents Journal on April 1, which meant that oppositions had to be filed by July 1.  Since July 1 was a Friday, when the Israel PTO is officially closed, the deadline for filing oppositions was by law extended to Sunday, July 3.  This means that the patent should have granted today, July 4, and presumably that’s why the letter I received informing me of the grant of the patent was sent today and not yesterday. 

But when I look at the “nesach” for this patent from the ILPTO database – sort of the official printout of the status of the patent – it shows the grant date as July 2, not July 4, thus foreshortening the deadline to pay the first renewal fee by two days.  I suspect that the ILPTO’s systems that calculate deadlines have been programmed accordingly, but clearly this is a glitch in the system.  I’m curious what the patent certificate itself will say regarding the grant date.  To be safe I docketed for October 2, but the discrepancy could become an issue if someone goes to pay their renewal fee on October 3.

It’s also interesting that the current Patents Journal was published on July 1, which was a Friday (as was April 1 of this year), when the ILPTO is officially closed.  I know that the USPTO publishes its Gazette every Tuesday, regardless of the date – my grandfather had a patent issued by the USPTO on December 25, when the USPTO was clearly closed, so in that respect publication of the Israel Patents Journal on a day when the ILPTO is closed isn’t unusual.  But what will happen when the first of the Gregorian month falls on Shabbat (Saturday)? Publication on that date would be legally and politically problematic.  We’ll see what happens on October 1, 2022.  (January 1, 2022 was also Saturday, but because of the change in the electronic publication format of the Patents Journal, all publications that would have taken place then were pushed off until February 1, 2022.)