America-Israel Patent Law

We Forgot About Your Patent Application. Sucks To Be You.

In 1995, the USA moved to a 20-years-from-earliest-filing-date regime. A few years later, in response to complaints that this effectively foreshortened patent term from the previous 17-years-from-grant if the USPTO was slow in examining cases, Congress enacted provisions for patent term adjustment (PTA, not be confused with patent term extension – PTE – for drug patents under the 1984 Waxman-Hatch amendment).  The formula for just how much adjustment a patentee is entitled to is a bit complicated, and there are pitfalls for the unwary, but the basic idea remains: examination shouldn’t take more than 3 years, and to the extent it does and that’s the fault of the USPTO, the term of the patent is adjusted accordingly to compensate.

There is no similar mechanism here in Israel, which is a pity. Particularly when the Israel PTO is as derelict in its duty as it was in a case I recently heard about from a colleague.

The application in question was filed more than 10 years ago as a national phase application.  A few years later, responsibility for the case was transferred to my colleague, who amended the claims to correspond to those granted in a foreign patent and requested allowance per §17(c) of the statute. The PTO sent a notice of allowance.  Two days later, it sent a letter withdrawing the notice of allowance.  The letter stated that the allowance was being withdrawn because certain of the claims did not comply with a particular Registrar’s Circular letter. 

And what was the issue with these claims?  They were worded, “Use of an XXX according to claim 1 for [doing YY]”. 

There is nothing in the statute per se that prevents the grant of claims worded that way. In fact, for many years, the Israel PTO granted such claims, many such claims were litigated over the years, and I am not aware of a single instance in which such a claim was found to be invalid on account of having been worded that way.  Nevertheless, at some point someone in the ILPTO decided such claims were not acceptable (because, it is asserted, they don’t recite a process and therefore don’t recite a category of statutorily patentable subject matter), and sua sponte the ILPTO stopped allowing them.

The letter went on to say that the application was being returned to the examination queue.  And there it waited. And waited.

And waited some more.

After two and a half years, my colleague submitted a letter requesting an interview with the examiner about the case.

It’s been more than a year since that request was submitted, and it’s still being ignored.  Wow.

My guess is that there’s a glitch in the ILPTO’s computer system, so that when a notice of allowance is mailed and then rescinded, the system doesn’t actually put the application back into the queue.  I base this on the fact that I had a similar occurrence with an application I was handling. 

Adding to the frustration is the fact that this could easily have been dealt with by telephone.  The examiner could have called my colleague and said, “Looks, claims m and n are not allowable because they’re in the wrong format, but if you let me do an examiner’s amendment, I’ll cancel them and allow the case under §17(c).”  Except that the Israel PTO doesn’t believe in Examiner’s amendments, God knows why not.  Note to Ophir Alon: please institute examiner’s amendment practice.  It will make life easier for all of us.  And fix the computer system so that an allowance is withdrawn, the application actually is thrown back into the examination queue.

But even without the examiner’s amendment tool available, the examiner could have phoned my colleague and proposed two possibilities.  The first is that the applicant send in a new set of claims with the offending claims cancelled.  Alternatively, since claims of the format “XXX according to claim 1 for use in doing YY” are deemed acceptable by the Israel PTO, the examiner could have asked the applicant to rewrite the offending claims in purpose-directed product format.  Although this would have taken the claims out of the framework of §17(c) (since each claim must be identically worded to one of the granted foreign claims), the examiner still could have examined the claims – and while not giving an official allowance under §17(c), could have effectively relied on the foreign grant to allow the set of claims in which the “Use of XXX” claims were replaced by “XXX for use…” claims.

But none of that transpired. In fact, the examiner didn't even send a letter spelling out these possibilities.  Instead, several years have gone by, and the patent application has languished because the ILPTO didn’t do what it’s supposed to do (and told the applicant it would do), viz. examine this patent application.

At least my colleague hadn’t paid the issue fee at the time the notice of allowance was withdrawn. If he’d done that, they wouldn’t have automatically refunded his money.  No, they would have insisted that he REQUEST the refund.  But that’s a blog post for another day.

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.

Keep Your Eye On The Ball - joint program of AIPLA/IDC, September 23 - registration is open

Subject matter eligibility under 35 USC §101, and the requirements for compliance with the written description and enablement requirements of 35 USC §112, have been areas of rapid legal development for several years. Unfortunately, these areas remain in flux: in the past year, the USPTO has issued new §101 and §112 guidance, with more expected by the end of the summer; the Patent Trial and Appeal Board continues to turn out decisions that affect USPTO policy in these areas; the Court of Appeals for the Federal Circuit seems to vacillate in its rulings; and Congress is now considering new legislation that would affect not only §101 but the scope of PTAB review. 

The American Intellectual Property Law Association (AIPLA) and the Zvi Meitar Institute of the Interdisciplinary Center (IDC) invite patent practitioners, inventors and other interested individuals to a half-day session in which these topics will be discussed, along with a brief update on the state of obviousness-type double-patenting.  Presenters will be experienced US practitioners representing different disciplines, including Kevin Noonan (McDonnell Boehnen), Daniel Sherwinter (Kilpatrick Stockton), Aaron Feigelson (Leydig Voit & Mayer), David Postolski (Gearhart Law), William Mandir (Sughrue Mion), and yours truly.

The cost of the program will be 190 shekels, and participants must register in advance. 

Register online at https://www.eventer.co.il/aiplaconference.

Download AIPLA inv_6

 

 

How To Rip Off Your Clients Without Them Knowing They’re Being Had

There’s a deadline approaching in a case I filed in Israel for a US colleague.  Over the years I’ve handled a number of Israel filings for this person, and although we’ve taken extensions for this practitioner’s cases several times in the past, in view of the impending deadline he asked me to confirm something:  “You don’t typically file a request for extension prior to each month’s due date, right? You do it as we do in the US, wherein you pay the required extension fees when you actually file the response, no?”

I confirmed that in Israel, as in the USA, there’s no need to obtain extensions prospectively, but that, as in the US, the extension may be obtained at the time the response is filed.  And that, in our office, that’s our normal practice.  That way, if no response is filed, no extensions are taken and no unnecessary expenses incurred. But I added, “It probably won't surprise you to hear that there are offices in Israel that request another month extension each time a deadline comes up, and bill accordingly.”

My colleague responded that he wasn’t surprised, but then went on to surprise me: “we had another firm [in Israel] tell us that it can be seen as a ‘lack of diligence’ if you don’t” obtain an extension prospectively.

Wow. “Lack of diligence”? Balderdash. Not only is there nothing in the statute or regulations that says extensions must be obtained prospectively, not only has the practice of the ILPTO for at least as long as I’ve been doing this (23 years and counting) been to grant extensions at the time the response is filed, and not only is there no case law that says that this practice is evidence of a “lack of diligence”, but the statute itself says that extensions may be obtained retroactively.  There’s no mention of the word “laches” in the case law either; to the extent the case law uses the Hebrew term שיהוי, which translates as “delay”, with respect to the patent statute, it’s in reference to delay in bringing suit, not delays in prosecution.  Besides, if delay or laches was an issue, why would it matter whether the extension was obtained prospectively or retroactively?  Either way, it would be asserted that the applicant failed to engage in diligent prosecution.

Unfortunately, telling clients that kind of baloney is a great way to milk them for more money. And in most cases they’ll never be the wiser. Which is why the other firm my colleague engaged told them they need to obtain extensions prospectively.

A related bit of taking liberty with the truth, in which some offices apparently engage, is telling clients that they must pay excess claim fees for each claim over 50.  Fees for claims 51 and up aren’t due upon filing, they’re due at a later stage, and the need to pay them can be obviated by reducing the number of claims to 50 or fewer.  But if you charge your clients for the extra claims and for attending to payment of the extra claim fees, why would you suggest reducing the number of claims? 

This is actually an issue that I often see in the other direction: US associates who pay for all claims over 20 in PCT US national phase filings, even if it’s clear that many of those claims will be restricted out and not examined.  Paying those fees and charging for it is good for the firm’s profits, but often not in the client’s interest. 

The situation reminds me of this Dilbert cartoon.

Final Versions of New Circulars: Is the ILPTO Ignoring Court Precedents?

Last month the ILPTO published final versions of two circular notices; the drafts of these notices were discussed at length here, here, here, here and here.  The final versions aren’t terribly different from the draft versions, with the most noticeable change coming in the parts that relate the claiming of nucleic acid or protein sequences, but that’s a topic for another post.

One of the things that didn’t change from the proposed circulars was the announcement by the ILPTO that it would limit the use of “Swiss”-style claims (but continue to allow purpose-directed product claims).  This particular change in ILPTO policy is interesting in two respects.  First, it’s not clear that it accords with case law. And second, if not, it evinces an inconsistency between the ILPTO’s position on Swiss claims and its position on “overlap” between claims.

First, a word on “Swiss” claims.  As is well-known to practitioners who prosecute pharma patents, few countries allow claims on methods of treatment of people, the USA being the most notable exception.  In those jurisdictions where such claims aren’t allowed, a common practice that developed over the years was to allow claims of at least one of two formats: purpose-directed product claims, and “Swiss claims”.  The former are of the format, “Compound X for use as a medicament [for the treatment of disease Y]”.  The latter are of the format, “Use of compound X in the preparation of a medicament [for the treatment of disease Y]”.

Hitherto, the ILPTO has allowed claims of both formats; in the case where a medical use for the compound had never been suggested before, it wasn’t even necessary to include “for the treatment of …”.  The justification for “Swiss” claims was that they recited a process.  Indeed, in ex parte proceedings from the early 1990’s, the ILPTO ruled that the claim “Use of 3’-azido-3’-deoxythymidine in the preparation of a medicament for the treatment or prophylaxis of a human retrovirus infection” was, in substance, the same claim as “A process for the preparation of a formulation according to any one of claims 1 to 14 which comprises bringing 3’-azido-3’-deoxythymidine into association with the said pharmaceutically acceptable carrier”.  Upon appeal to the Tel-Aviv district court, the court upheld that finding – thus implicitly giving its imprimatur to the “Swiss” claim format.

Such claims have likewise been found in numerous patent applications that were subject to opposition proceedings before the ILPTO, and in numerous patents asserted in infringement proceedings in District Courts (some of which were subsequently appealed to the Supreme Court).  At no point has a court in Israel held that “Swiss” type claims are per se deficient.

In the new circular, however, as in the draft, the ILPTO states,

“9. Section 3 of the statute establishes that a patentable invention must be a product or process.  Therefore claims of the form “X for use as a paint” are not allowable.

“10. In claims for a process it is required that the novel and inventive steps for effecting the process be recited. Therefore claims of the format “Use of X in the manufacture/preparation of Y” will not be allowed unless they recite novel and inventive steps.

“11. Claims for the new use of a known product may be worded “Product X for use as a medicament”.”

As I noted when commenting on the draft circular, sections 9 and 11 just re-state what has been long-standing policy, and section 10 introduces serious mischief potential.  As I said previously:

Section 10 … seems to imply that process steps need to be included in Swiss-type claims.  But if we’re already going to avail ourselves of the fiction that this type of claim describes a process – and in every country that accepts Swiss-type claims, it is that fiction that makes that claim format acceptable – then why require the recitation of process steps?  Only two possibilities exist for Swiss claims: they recite the use of compound as a medicine, period (i.e. either the compound itself is new compound, or its use as a medicine is new), or they recite a new use of a compound already known as a medicine.  In the first case, the novelty of the compound per se, and/or the novelty and inventiveness of using the compound in preparing a medicine, would seem to be sufficient to confer novelty and inventiveness to the claim as a whole. Yet I can foresee some examiners saying that the claim must nevertheless include process steps for formulating the medicine.  Likewise, in the case of a known pharmaceutically active compound, hitherto the addition of the words “for the treatment of Y” have been considered by the ILPTO to be sufficient to confer novelty and inventive step. It’s not clear if section 10 is meant to change that or be a restatement of existing practice. 

If section 10 is meant to be a deviation from existing practice, then on what basis has the ILPTO arrogated to itself the authority to ignore court rulings?  Well, there’s a possible answer to that: the AZT case the case where the question of the validity of “Swiss” claims per se came closest to being front-and-center.  But that was a district court case which wasn’t appealed, and the ILPTO is only bound by district court decisions in the particular matter hand; district court decisions don’t create binding precedent on the ILPTO.  Only Supreme Court decisions do that.

But if that’s so, then the ILPTO is being pretty selective about when it chooses to ignore district court instructions as being limited to the particular case, and when it enshrines such rulings as if they’re Torah-mi-Sinai.  Because that same district court decision was the one where the judge said an applicant can’t have “overlap” between two applications, and the ILPTO, as we’ve noted several times on this blog, has turned that particular molehill into a large mountain that needlessly consumes significant amounts of examiner and applicant time. 

Why the inconsistency?  I don’t know.  Maybe there isn’t any, and section 10 of the circular cited above really doesn’t change anything.  But if section 10 is now viewed by the ILPTO as requiring the recitation of process steps in Swiss claims, then the ILPTO is being intellectually dishonest.

It's Good To Be The King! (Google Gets Patent on Parent of Young Child - And Her Name Ain't Alice)

That's a famous line from Mel Brooks' "History of the World", ostensibly uttered by Louis XVI, but on the basis of recently-issued US 9,119,029, it would seem to true of Google the Patent Applicant as well. Here's claim 1:

1. A system for finding friends near a friend, comprising: a memory, housed within a mobile device, for storing a contact list comprising records for a plurality of a user's friends, each record comprising a name of a friend of the user, and a location of the friend; and a locator for receiving as input, from the user, the name of a designated friend of the user in the contact list, the designated friend of the user not being the user himself, and for generating as output a list of at least one proximal friend, each proximal friend comprising the name of a friend of the user also in the contact list, other than the designated friend, whose location is close to the designated friend's location.

Now, my first reaction on reading this claim is, How the @#$% was this claim allowed?  This is a claim on a parent of a young child! The parent's brain is stored in the parent's head, and since the parent is mobile, the parent is a mobile device with a memory. The parent's brain stores names of its child's friends. At the park, the child - i.e., the user - asks the parent, "Is friend X here?" The parent looks around and says, "I see X over there by the swings, and your friend Y is with him."  In short this claim is anticipated by generations of parents. And if you want to say that somehow it's limited to a non-living device, then generations of parents have made this claimed system obvious.

My second reaction on reading this claim is, How the @#$% was this claim allowed? Under Alice, this isn't patent-eligible! And yet, it turns out that 101 was never raised during prosecution: a non-final rejection issued in May 2014, with an obviousness-type double-patenting rejection and exactly three references cited for an obviousness rejection. A terminal disclaimer and amendments were filed in July 2014, leading to a Final rejection in August 2014 which cited one new reference, which was combined with the already-cited references in an obviousness rejection. An RCE was filed in December 2014, and a non-final rejection issued in January 2015 citing yet one more new reference in an obviousness rejection. This was followed by an amendment, a telephone interview, and allowance of the claims in April 2015.  But Alice issued in June 2014, with PTO guidance following. Why no 101 rejection of these claims?

My third reaction on reading this claim is, How the @#$% was this claim allowed? There's no definition in the specification of "close" or "near". The claim fails 112 miserably for being indefinite. So why wasn't a 112 rejection raised? 

I'm not a conspiracy theorist, so I don't believe that having Michelle Lee as Director leads to preferential treatment for her former client. But cases like this make one wonder if it isn't good to be the king. Interestingly, Google is listed as the assignee on the ADS and on the front page of the patent, but according to PAIR, no assignment data is available, and there's no assignment info in the Assignment Search page either - meaning no assignment has yet been filed for this patent.  Maybe the inventors just listed Google as the applicant to make it look as if they work for Google, and to derive any benefits that may accrue from that.

Angiomax Patents: They’re Dead, Jim

It’s been a while since we wrote about Angiomax (the API of which is bivalirudin).  The hiatus was because, in the wake of the “Dog Ate My Homework Act” which was part of the so-called America Invents Act in 2011, The Medicines Company was given a reprieve from its attorneys’ mistake (they missed the deadline for filing for a patent term extension because the person docketing the action listed the deadline as two months from FDA approval instead of 60 days) and its basic patent covering the active ingredient of this drug, US 5196404, was extended from July 2010 until December 2014.   

TMO actually had some additional protection: it obtained two additional US patents, 7582727 and 7598343 (discussed here and here), prior to the nominal expiration of the ‘404 patent, and listed these in the FDA Orange Book.  Unlike the ‘404 patent, the ‘727 and ‘343 patents were involved in ANDA litigation.  Now the Federal Circuit has laid those two patents to rest, apparently clearing the road for generic bivalirudin.  In a decision issued last Thursday (The Medicines Company v Hospira, Inc.), the CAFC reversed the District Court and said that the asserted claims were invalid because of the on-sale bar: more than a year before the patent application was filed, TMO had purchased the product having the requisite purity from a supplier which had used the recited process to make the product. 

Distinguishing from cases where the experimental use exception to the on-sale bar applies, the CAFC noted that these were commercially usable batches worth about $10 million apiece, and that there is no “supplier” exception to the on-sale bar, so the fact that the sale was made to TMO itself was of no avail.  Thus, said the CAFC, the claimed product was on sale more than one year before the patent applications were filed.  As Dr. McCoy would say, “He’s dead, Jim.” 

Of more interest to this reader, but not elaborated on by the court, was the characterization of the claims as product-by-process claims.  One usually thinks of product-by-process claims as being worded, “A product X which is prepared by the process of mixing A with B and heating at temperature C.”  Claim 1 of the ‘343 patent, the only independent claim of that patent at issue, certainly qualifies a p-b-p claim:

1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier, for use as an anticoagulant in a subject in need thereof, said batches prepared by a compounding process comprising:

(i) dissolving bivalirudin in a solvent to form a first solution;

(ii) efficiently mixing a pH-adjusting solution with the first solution to form a second solution, wherein the pH-adjusting solution comprises a pH-adjusting solution solvent; and

(iii) removing the solvent and pH-adjusting solution solvent from the second solution;

wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp⁹-bivalirudin that does not exceed about 0.6% as measured by HPLC. [emphasis added]

Claim 1 of the ‘727 patent, however, reads:

1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp⁹-bivalirudin that does not exceed about 0.6% as measured by HPLC.

Where's the process?  Initially the court stated that the two patents “include product-by-process claims describing” the discovery of the process that led to the claimed invention.  But later in the decision the court seems not to distinguish between the two patents in this regard:

“We find no principled distinction between the commercial sale of products prepared by the patented method at issue in D.L. Auld Co. and the commercial sale of services that result in the patented product-by-process here. The Medicines Company paid Ben Venue for performing services that resulted in the patented product-by-process, and thus a “sale” of services occurred.” 

“Accordingly, we find that the district court clearly erred in finding the Ben Venue sale of services did not constitute a commercial sale. To find otherwise would allow The Medicines Company to circumvent the on-sale bar simply because its contracts happened to only cover the processes that produced the patented product-by-process.”

Was the CAFC construing the statement “wherein the batches have a pH adjusted by a base” in the claim 1 of the ‘727 patent as evincing a p-b-p claim?  Or was characterizing this claim as a p-b-p claim just an oversight?  The court didn’t say, and it doesn’t appear that the question is germane for the on-sale bar determination – i.e., it’s dictum.  But today’s dictum sometimes has a way of becoming tomorrow’s holding...

Comments on USPTO patent eligibility guidelines under Myriad and Mayo

As of last night a fair number of comments had been submitted to the USPTO about its examination guidelines under Myriad.  My two cents are here Download Comments on Myriad guidelines, even though I don't think I can say it better than Nancy Linck, and I don't have her gravitas.

Don't Try This At Home (Unless Home Doesn't Have Rule 11)

If you're going to sue someone for infringement, it's a good idea before filing suit to make sure that you've got at least a colorable argument that your claims cover the allegedly infringing product.  Not only will you increase the odds that you (or your client) will prevail, but you can avoid those nasty Rule 11 sanctions.  As the CAFC just explained to some Israeli expats who were playing New York lawyer.

Amendment of the Israel Patent Statute: No More Abstracts

A substantive post on the more notable aspects of last week’s amendments to the Israel patent statute is in progress, but at least one point bears separate discussion: the abolishment of the requirement for the publication of an abstract. 

Section 26(b) of the statute says that upon conclusion of substantive examination and payment of the publication fee, the Registrar is to publish certain particulars concerning the application.  Until now, subsection 26(b)(5) specifically said that one of these particulars was “a description of the essence of the invention, in the Registrar’s view” – in other words, an abstract – and section 27 said that this description “shall not serve the court or the Registrar as evidence when they come to construe the specification [which includes the claims – DJF] in any legal proceeding”.   

In practice, until 2009 the Registrar simply published the first claim to fulfill his duty under 26(b)(5); as discussed in an earlier post, in 2009 the Registrar, acting ultra vires (as usual), decided to require applicants to submit such abstracts. 

Both the pre- and post-2009 practices have now been mooted, as sections 26(b)(5) and 27 were removed from the statute as part of last week’s amendments.  (Show of hands: how many of you think the ILPTO will continue to exceed its authority and demand the submission of an abstract despite the lack of statutory authority for such a requirement?) 

An interesting question arises, however, as to the current effect of previously-published abstracts: does now-cancelled section 27 continue to apply to abstracts that were published under section 26(b)(5), or can such abstracts - to say nothing of abstracts submitted by applicants themselves in the past, even if never published - now be used in claim construction?  I’m not going to speculate on the answer to that question, but I am going to advise my clients henceforth to not submit an abstract with patent applications filed in Israel. 

Snatching Defeat From the Jaws of Victory

As reported in the previous post, the Knesset’s Constitution, Statute and Law Committee met on January 22 to discuss the bill to enable 18-month publication of Israel patent applications.  Reports from someone in attendance (sadly, yours truly couldn’t be there, although that didn’t stop the official minutes from stating that I was in attendance) were that progress continued to be slow, with discussion focusing on what information and documents would become publicly available at 18 months and how that information would be accessible – would the entire file history become available online, as in the USA and Europe, or would only certain pieces of information be available online, with persons interested in the contents of the files needing to either come to the ILPTO to inspect the files or ordering copies of their contents? 

However, the most entertaining (or, depending on your point of view, sad) part was apparently one trade group’s approach backfiring with respect to the question of third party submissions.  In particular, while the wording of the draft legislation isn’t absolutely clear about what kinds of communications third parties would be allowed to have with examiners concerning pending applications, the Justice Ministry’s view is that the amendment would permit third parties to bring to the attention of examiners information that the applicant already had an obligation to disclose, without additional comments from the third party itself.  

According to both the minutes and eyewitness account, the issue was brought up by one of the trade groups opposed to broad third-party involvement, despite the fact that the proceedings had not yet reached the point of discussing this issue.  Not only did this this approach fail to convince the committee chairman of the correctness of the narrow-involvement position, but it actually piqued the chairman’s interest in allowing broader third-party submissions, while effectively precluding the Justice Ministry from arguing the case for narrow involvement.  The issue has not yet been settled, but it seems that in this case, the group’s hired guns scored what the British would call an own goal (or, in Yankee-speak, shot themselves in the foot).

According to the committee’s web page, the committee is scheduled to resume its deliberations on this bill on February 13 and 26.

Salvador Dali Visits the Knesset

A few minutes from now, the Knesset’s Constitution, Statute and Law Committee will continue its consideration of the bill to enable 18-month publication of patent applications. The Committee’s first hearing on this bill took place on December 7, and consisted primarily of grandiose, grandstanding statements by socialist-leaning members of Knesset (who generally made statements about “social justice” which weren’t germane to the issue of 18-month publication) and lawyers for innovator and generic pharmaceutical companies (who also included irrelevant statements), although there were also a few statements from ostensibly neutral people, viz. representatives of the Israel Bar Association (an organization to which all lawyers in Israel must belong) and a volunteer group called the Association of Patent Attorneys in Israel. A colleague who works in-house for the local branch of a global innovator drug company characterized the proceedings as “surreal”.

Very little headway on the substantive provisions was made at the first meeting; presumably such headway will be made today, accompanied by fireworks as the local generic drug industry (which has been lobbying heavily to amend this bill so as to strip the statute of teeth) attempts to impose its will. If the past is any indication, no other industries or even individuals are interested in the goings-on regarding this bill, which is a shame, since, as a law school professor of mine put it, politics is played by those who show up.

A fuller accounting of the bill and the proceedings will follow in future post. However, there is one subtle aspect in which the December 7 proceedings were more surreal than my colleague may have appreciated. That has to with the way in which Supreme Court decisions are used in political discourse in Israel. Specifically, it’s not unusual for politicians to point to statements by the Israel Supreme Court as providing moral grounding for their proposals. (Perhaps in a future post I’ll go into what I see as the sociology of this phenomenon, but in a nutshell it related in part to the fact that the same court sits as the land’s highest appellate court as well as a court of first instance in certain administrative or constitutional law proceedings.) This was certainly the case at the December 7 hearings, in which several of the speakers pointed to statements by the ILSC regarding the need to balance incentives to innovate with the public’s need for cheap drugs.

What I found ironic was that one of the recent Supreme Court cases that contains language to similar effect (Unipharm v Smithkline Beecham, Civil Appeal No. 8802/06) itself support its position by quoting an earlier Supreme Court decision (Civil Appeal By Leave 5768/94, the so-called “AShIR decision”) that the present bill seeks to overturn. AShIR is a 1998 decision in which, under a theory of unjust enrichment based in Israel’s Unjust Enrichment statute, the Court recognized intellectual property rights in certain manufactured goods for which statutory IP rights (patent or design) were not available, either because the manufacturers did not seek such rights, such rights had been obtained but expired, or the items were already known and therefore not susceptible of patent or design protection. The bill currently under consideration would preclude suits such as AShIR from being brought again in the future.

If you’re going to quote someone in support of your position, you probably shouldn’t simultaneously be trying to undermine that person with the very legislation for which you seek support. But memories in the Knesset don’t seem to be very persistent.