America-Israel Patent Law

WIPO Helps Out. Again.

Last week I went to log into my ePCT account.  WIPO gives you a choice of doing with or without "strong" identification, but only the latter allows you take certain actions.  There are three ways to do "strong" identification, namely with a digital certificate provided by WIPO, by getting a code sent by SMS which you then input, or with a one-time password.  I'm set up for SMSes, but normally I use the digital certificate.  This time, though, I got an error message telling me that there was no WIPO certificate in my browser.  Suspecting that recent update of my browser might be the culprit, I sent a message to WIPO, and within an hour received instructions for how to fix the problem. (If I'd been more ambitious I could have found the same instructions on WIPO's website).  Problem solved.  Yet another reason we like WIPO.

Israel PTO Incapable of Preserving the Order of Applicants and Inventors in Patent Applications

Classic joke: Schwartz dies, and as his family is going through his things, in the pocket of one of his suits they discover a 15-year-old claim check for a pair of shoes under repair.  They assume it’s unlikely the shoes are still there, but just in case, Schwartz’s son goes to the shop, which is still in business.  He shows the claim check to the proprietor, and asks, “Is there any chance you still have these shoes?”  The proprietor takes the claim check, and after rummaging through his stock for a few minutes, says, “They’ll be ready Tuesday!”

In response to yesterday’s post, I received an email from a colleague here in Israel, who related the following story:

Some time ago, he filed an Israel patent application, listing as applicants Inventor A and Inventor B in that order.  Last week, he filed another Israel patent application for the same two inventors, but this time he reversed the order of inventors, viz. Inventor B and then Inventor A.  To his surprise, on the filing receipt the inventors were listed in the order Inventor A, Inventor B.  So he asked the Israel PTO to rectify the mistake.  In response, the ILPTO sent him a notice published by the previous Commissioner in May 2014, and directed him to the fourth and fifth paragraphs of that notice.  Translated, those paragraphs read,

“Recently, our attention has been drawn to the fact that, due to limitations in the PTO’s computer system, we cannot preserve the order of the applicants and inventors in the filing receipt, and these are automatically arranged in order of the customer number recorded for each party in the operating system.  Therefore, an applicant or inventor who previously filed a patent application in Israel will appear on the filing receipt before a new applicant or inventor.  The PTO is working to upgrade the computer system in a way that will enable, inter alia, complete correspondence between the details in the application filing form and the data in the computer system, including the order in which the applicant and inventors appear.

“Therefore, at this stage it is possible that the order in which the applicants and inventors appear in the filing receipt will not match the order on the filing form.  At this stage you [viz. the community of applicants and their representatives] are asked to refrain from asking us to make corrections in such cases.”

Clearly this has been a high-priority item with the ILPTO in the interim. At least Schwartz’s shoes would be ready by Tuesday.

Legally, of course, the order of the applicants or inventors is irrelevant.  But people can be finicky, and sometimes they want the parties to be listed in a particular order.  So now we practitioners are left trying to explain to our clients why the order on the filing receipt isn’t the order in which we listed the parties.

To make matters worse, in 2014 we still filed using a filing form that we filled out ourselves.  We submitted several copies, and one of those copies would make its way back to us, stamped by the ILPTO, showing that we had indeed listed the inventors in the order they indicated.  But since June 2016, we’ve been required to submit electronically.  Unlike the USPTO, which requires applicants to provide data like applicant name and address, inventor names and addresses, etc., on an Applicant Data Sheet, which can be filled in online but which most practitioners (or their staffs) fill in offline and submit as a completed document, the ILPTO only allows the inputting of the information online.  So we have no record of the order in which we inputted the data, since the ILPTO does not provide this as part of the filing process.

There are at least two possible workarounds to this, neither of which is optimal.  One is to take a screen shot of each completed screen in the submission process.  That’s the less time-consuming option.  The other option is more complicated: instead of choosing all the applicants or inventors from the ILPTO’s list of existing applicants and inventors, each with its associated customer number, one could choose only the first-listed applicant from the list of existing applicants, and then manually enter each subsequent applicant as a new applicant, in the order in which the applicants wish to appear.  This will result in the creation of a new applicant name and customer number in the ILPTO’s computer system, and will guarantee that the order of applicants is preserved.  It will also result in multiple entries and customer numbers for the same entity in the ILPTO’s computer system, but that’s the ILPTO’s problem.

This is the body that assesses the patentability of computer-related inventions in Israel.

More Fun With the Israel PTO Electronic Filing System

We've refrained from ragging on the ILPTO electronic filing system for a while. Partly that's because criticizing IL-EFS is like shooting fish in a barrel, partly that's because no one wants to hear a perpetual complainer. If you don't like reading whines/rants/gripes, read no further. But if you too suffer using IL-EFS, you can commiserate about the following encounters, some recent, some from a while ago.

1.  When you file something via IL-EFS, it emails you an acknowledgement that you filed whatever it was you filed.  There's always a lag between when you click "submit" and when the acknowledgement email is sent.  If you're lucky, that lag is only a few minutes, but until now our record was around 48 hours.  The IL-EFS has now outdone itself: two weeks ago we paid a fee in a particular Israel patent application.  This morning we received the acknowledgement email.  Yay!  (To be fair, since this was a file in which a payment was made, we were able to download a payment receipt immediately, and the system generates payment acknowledgement emails immediately as well, so we weren't really concerned about the delay in email acknowledgement of the submission per se.  Still, until now, we couldn't see anything in the ILPTO database showing that the fee had been paid. Within a day the database should be updated to show the response filed two weeks ago. We hope. As of this minute, the ILPTO's patent database is down.) 

2. We filed third-party prior art submissions in someone else's patent application. The system won't take .zip files, only .pdf files, so the choices are to (a) attach each file individually before uploading, or (b) combine all the files into a single .pdf, then attach and upload that.  The former choice is particularly onerous, as, unlike PAIR or ePCT, which allow the user to first choose the application of interest, then choose the action and upload the documents, the Israel system (i) first makes the user choose the action he wishes to take, then (ii) indicate the file number, and only then (iii) does the system tell the user whether or not he can take that action.  Denial of the ability to take action may be because the user isn't associated with that application (even though a power of attorney may have been filed), or the system may think the application is at a stage where a particular action isn't authorized (see the next entry for more on that). 

Additionally, the system is fickle about pdfs, but doesn't explain why it won't accept a given .pdf.  So if you go through (i), (ii) and (iii) but the system gags on your .pdf, you've gotta start over again. This is why filing a single .pdf may not be an option. That and size limits on uploads.  But have no fear: if you succeed in uploading your pdfs and filing them, the IL-EFS will confirm that success by emailing back to you the same files you uploaded, all 20 MB of them...sometime within 24 hours of the upload. Because, apparently, that's easier than immediately issuing a filing acknowledgement form that lists all the files submitted. (The USPTO does this, and includes a number generated by a hash function to indicate the size of the pdf submitted.) Or having the uploaded documents automatically entered into the publicly visible database immediately upon uploading. (The USPTO does this too, although sometimes there are delays between submitting things via EFS and being able to see them in PAIR. But in at least 90% of the cases, there aren't.)

And if you have a problem with the IL electronic filing system? Don't worry, there's tech support. Sort of. Five days a week, for maybe eight hours each day, if the one ILPTO employee assigned to the task is at work that day and answers the phone. Otherwise, in the words of Rev. Johnson, "Son, you're on your own!"

3. By law, after the three month period for filing oppositions expires, an Israel patent application becomes a patent. Renewal fees that accrued prior to grant are then due within three months of the grant date. But the ILPTO is sometimes slow about actually issuing the patent certificate after the opposition period expires. So when we went to pay a renewal fee in a case that became a few days before, but for which the patent certificate hadn't yet been mailed, IL-EFS told us, "the application is not at a stage at which you can take that action".  At least it didn't say it in that fake-calm Hal 9000 voice. Apparently the ability to pay the renewal fee is linked to the system recording the status of the patent as "granted" rather than pending", but the system doesn't automatically update that status upon termination of the opposition period without an opposition being filed.  We're sure that when the patent certificate is sent out, the patentee won't be given additional time to pay that first set of renewal fees to compensate for this particular bug in the system.

4. In a point related to point 3, a client asked us to request suspension of examination. But in order to that you first have to respond to the ILPTO's pre-examination letter.  So we filed the response to the pre-examination letter, then went to request the suspension...and the system said, "the application is not at a stage at which you can take that action".  Here too, we had to wait for the IL-EFS to generate the acknowledgement email - in this case it took about an hour - before we could submit the suspension request.  Why can't we just file everything together?

Free Speech, The Right to Petition, and Patent Infringement: A Thought on Hatch-Waxman and ANDA Filings

This is longish post, prompted by a comment made by Dennis Crouch at his PatentlyO blog.  Since much of it deals with the background of the Hatch-Waxman amendment, with which some readers are familiar, I’ll cut to the chase: in discussing the recent CAFC decision in Valeant v Mylan, Dennis suggested that there may be a first amendment issue lurking in the fact that 35 USC §271(e) says it’s an act of patent infringement to submit a paragraph IV ANDA to the FDA. He thinks this might be an infringement of the constitutional right to petition the government and the right to free speech, both enshrined in the First Amendment of the US Constitution. I think that suggestion is baloney.

By way of background: Hatch-Waxman is the 1984 US law (which amended both the Food, Drug & Cosmetic Act and the Patent statute) that was a boon for both drug innovation and for the generic drug industry.  Until that time, a generic drug manufacturer (“GDM”) had to wait until a patent (or patents) expired before even undertaking experiments to begin manufacturing a patented drug, including experiment to obtain data to be submitting to the FDA in support of the request for approval of the generic drug. Under H-W, prior to patent expiration those generic drug manufacturers can do almost everything necessary to bring the product to market.  GDMs can thus seek FDA approval for their drugs prior to patent expiration, so that they can be ready to go to market as soon as the patents expire.  (H-W also instituted a tightly circumscribed mechanism for limited patent term extension for drug patents, but that’s not germane to the present discussion.)

Additionally, instead of replicating all of the (time consuming and expensive) clinical work of the originator, it’s sufficient for a GDM to show that its generic drug is bioequivalent to an approved drug.  The GDM can thus submit an “abbreviated new drug application”, aka an ANDA, to the FDA.

Under H-W, patentees submit to the FDA lists of patents that cover their approved drugs; the FDA compiles these in a publication commonly referred to as “the Orange Book”.  When filing an ANDA, a GDM must make a certification with respect to the patent status of the drug.  The GDM may certify that there are no relevant patents in the Orange Book, or that there are patents but the GDM will not market the drug until after those patent expire. 

But H-W includes a provision to encourage challenges to patents, or to encourage companies to work around patents, in order to get generics to market earlier (and thus reduce drug prices): the ANDA filer may certify that there are patents, but that those patents are invalid and/or not infringed.  Under H-W, the submission of an ANDA containing such a certification, known as a “paragraph IV” certification, constitutes an act of infringement (as codified at 35 USC §271(e)), and if the patentee sues the ANDA filer for infringement within 45 of being notified of the ANDA filing, the FDA is precluded from examining the ANDA submission for 30 months.  But the first ANDA filer that is successful in its challenge gets 180 days of exclusivity vis-à-vis other GDMs.

ANDA litigation is somewhat anomalous, in that it’s only the submission of the ANDA with the paragraph IV certification that constitutes infringement – no actual infringement has taken place, because, in the absence of FDA approval, no product has yet been sold or put on the market.  So in the case of ANDA litigation, the patent infringement/validity question is normally resolved before any traditional infringement has taken place, the GDM is thus not potentially on the hook for a large damage award since the patentee hasn’t suffered an actual injury, and usually the public gets lower-cost generic drugs at an earlier stage than it would have in the pre-H-W era.

So much for a run-down of the Hatch-Waxman regime.  If you’ve hung with me for this long, you’re surely asking, “What does all of this have to do with free speech?”  In my view, nothing, but last week, in discussing the CAFC’s, Valeant v Mylan decision, Dennis Crouch suggested it does.

The Valeant decision actually focused on something completely different, namely the question of the proper venue for entertaining an ANDA infringement suit, following the Supreme Court’s 2017 TC Heartland decision.  That question boils down to where the act of infringement occurred or where the defedant’s place of business is located.  The court held that in this case, since the ANDA was submitted from Mylan’s headquarters in West Virginia, that’s where the act of infringement occurred, and so venue was proper in WV, not in New Jersey where the suit had been filed.  But in discussing the case, Dennis Crouch, a law professor and blogger, suggested that by defining a paragraph IV ANDA submission as constituting infringement, 271(e) might run afoul of the First Amendment, stating

“There has been some debate about the how to think about §271(e).  It seems odd that “to petition the Government” constitutes an act of infringement. (Quoting the First Amendment, U.S. Const.).”

and then going on to write,

“Although I have not developed this argument, the court’s straight-read of the statute here places the provision on rocky First Amendment grounds regarding both speech and gov’t petitions.  The court considered some of these issues in the personal-jurisdiction context in Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999)”

I find both assertions puzzling, and the first one to be misleading.  The First amendment reads,

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”

As an initial matter, the FA guarantees the right to petition for the redress of grievances.  An ANDA filing can probably reasonably be construed as a petition, but it is not a petition for a redress of a grievance.  It is a petition that is entirely the result of federal legislation. The FDCA creates something called an ANDA, and 35 USC §271(e) doesn’t curtail the ability to do that. Indeed, as I explained above, the relevant provisions of both the FDCA and the Patent Statute were enacted simultaneously, as part of a single package, with the passage of the Hatch-Waxman amendment.  To paraphrase, all that 35 USC §271(e) says is, “The FDCA allows GDMs to try to piggyback on the work done by others, by filing something called an ANDA; but understand that such a filing, under certain circumstances, may constitute patent infringement.” Indeed, H-W was designed to encourage paragraph IV challenges and the ensuing litigation, as a means of getting generic drugs to market more quickly.  So no right to petition is curtailed by 35 USC §271(e), let alone a right to petition “for redress of grievances”.  That aspect of the First Amendment is not implicated by the H-W scheme. 

Additionally, no speech is being prohibited or curtailed by 35 USC §271(e).  GDMs can file their ANDAs, and say whatever they want.  It might be imprudent for them to say something like, “We actually think the patents we’re challenging are valid and infringed” in a shareholder report, but a GDM is still free to say so, even as it files its ANDA asserting that those patents invalid and/or not infringed.

As noted, the filing of an ANDA is only defined as an act of infringement if it includes a paragraph IV certification. The ANDA filer can choose not to go to market until after the patents expire, in which case the ANDA filing doesn’t constitute infringement. If the ANDA filer makes a paragraph IV certification, the patentee may choose not to sue for infringement, in which case the FDA will process the ANDA, without the 30-month stay.  And in the worst case scenario, there’s litigation and the ANDA submission is found to constitute infringement, in which case, as noted, there are no damages (since there’s no FDA approval and nothing has been sold), and the ANDA filer merely needs to wait until the patents have expired.

Of course, the GDM has the option of foregoing the ANDA route and instead developing its own data and submitting that as a regular NDA rather than an ANDA, in which 35 USC §271(e) wouldn’t come into play.

Moreover, the ANDA filer has benefited from the safe harbor of Hatch-Waxman, which says that doing the acts necessary to compile the data for the ANDA submission (e.g. synthesizing the active molecule) *doesn’t* constitute infringement, even though those acts normally *would* constitute infringement.

Finally, there’s no criminal penalty attached to a paragraph IV ANDA filing – the remedies for patent infringement are civil.

In short, I don’t see where there are any first amendment issues here – neither from the free speech aspect, nor from the right to petition aspect.

The sheer inanity of the suggestion that 35 USC §271(e) might not pass constitutional muster is brought into sharp relief when one consider the alternatives to the present arrangement under H-W. One alternative is the pre-Hatch-Waxman arrangement, under which the acts necessary to prepare an FDA submission constitute infringement, and thus competitors need to wait until the patents expire before even beginning to prepare generics – or they need to send such work offshore, to a country where such acts don’t constitute infringement. This is where we would be if the Supreme Court were to strike down the entirety of Hatch-Waxman as unconstitutional.

Another alternative is to provide the safe harbor of H-W, but without stipulating that submitting an ANDA to the FDA constitutes infringement. Then the ANDA filer may get FDA approval, but then will have to decide whether or not to launch “at risk”. And if, as is likely an, infringement suit follows, the patentee’s ability to obtain an injunction is uncertain, and the ANDA filer may be subject to a damage award if it does launch at risk.  This would be the situation that would result were the Supreme Court to decide that the provisions of Hatch-Waxman are severable (severability being on many lawyers’ minds this week in the wake of arguments about Obamacare before the Supreme Court in California v Texas), and that §271(e) specifically is unconstitutional.

It doesn’t appear to me that either of those alternatives is better than the present system under H-W.  Indeed, I think Hatch-Waxman is one of the few pieces of federal legislation that actually accomplished what it set out to accomplish and serves the public well.  Would it be worth it to the public to jettison the present H-W system on the basis of a specious First Amendment argument? In this connection, see Judge Gajarsa’s discussion in Zeneca v Mylan that Dennis mentioned on this point.

Bottom line: there’s no First Amendment issue with 35 USC §271(e), and it’s pity that this suggestion was made by Dennis in his blog.

Israel PTO and EPO Extend Patent Prosecution Highway Program

The Israel PTO announced last week that its PPH and PCT-PPH agreements with the European Patent Office, which were due to expire in January 2021, have been extended indefinitely.  These programs allow applicants to expedite the examination of an application in one of these jurisdictions based on a positive examination report or PCT Written Opinion prepared in the other jurisdiction, without the payment of an additional fee to the relevant patent office.  Download PPH & PCT-PPH ilpto epo 2020-10-29

The ILPTO has PPH and PCT-PPH agreements with the USA, EPO, Japan, and several other countries, as explained here. 

Sadly, as explained in a previous blog post, PPH can be used to expedite examination, but the ILPTO has in recent years taken the (unnecessarily) stringent view that allowance of claims in Israel under section 17(c) of the statute may only be obtain on the basis of granted claims in an approved foreign jurisdiction, not on the basis of an allowance or an indication in a PCT WOISA that claims are allowable.