America-Israel Patent Law

Look What They've Done To My CAFC Web Site

The CAFC's web site has a new look, and in that department it's definitely an improvement over the old CAFC site - the new look is much classier.    It also appears to me that it provides more information than the old site, though I haven't accessed an archived version to compare.  I'm not yet sold on the new format for displaying decisions, but I may yet come around to it.  You used to be able to pull a list with 6 months' or a year's worth of decisions at a time, based on the year the decision was given, as well search by party name or case number.  You can still search by name or case number, but you can't search by year – you can go back a day, a week, a month, three months, six months, a year, or list every decision since October 2004.  But you can't list, say, only decisions from the first half of 2005.  Moreover, with the new format, there are at most 50 decisions per page – that's 122 pages (and counting) to possibly sift through.  On the other hand, the new search engine doesn't need to be told to look for partial words – when I plugged in "Fuji" in the hopes of finding a series of cases involving Fujifilm and reconstructed cameras, all the decisions I was looking for (since 2004) came up.  So maybe the new format will prove easier to use than the old one.

Pedantic Patent Offices, Persistent Pro Se 'pellants…Puh-leez!

I

Some readers may recall last summer's CAFC decision in Taylor v USPTO.  That was the case where Mr. Taylor, acting on advice given by the USPTO over the phone, paid a maintenance fee for his US 5,1787,701 with a check that was $10 short of the requisite amount.  The USPTO cashed the check, never informed Mr. Taylor about the shortfall, then deemed the patent to have lapsed for failure to pay the maintenance fee.

Mr. Taylor only discovered this several years later, when he went to pay the next maintenance fee.  His efforts to have the patent reinstated were rebuffed, as were his efforts to get his money back, in part on the grounds that he didn't pay the $200 petition fee, a fee he said he couldn't pay because he was indigent.   So he sued the USPTO pro se, asserting it had misappropriated the $1030 had paid and seeking $1,000,000,000 in damages for the patent he no longer had. 

 The district court dismissed the case for failure to state a claim upon which relief could be granted.  On appeal, the CAFC politely told the USPTO to quit being a bunch of anally retentive weenies, and remanded the case to the district court with instructions to "enter judgment in accordance with this opinion", including ordering reinstatement of the patent upon payment of all outstanding maintenance fees.  

But there's more to the story.  In December 2009, on remand, per the CAFC's instructions, the District Court ordered the USPTO to refund the $1030 and to reinstate the patent upon payment of all outstanding maintenance fees.  That didn't satisfy Mr. Taylor, who wanted the billion dollars he'd asked for.  So he again appealed to the CAFC, asking it to reopen the proceedings regarding his claim for $1B in monetary relief.

But whereas in the previous round, the CAFC had been indulgent toward the indigent Mr. Taylor, this time it unsurprisingly showed no such leniency.  In a decision issued last week, the CAFC ruled that since Taylor had failed to raise the damages claim in his appeal of the original District Court decision, he had forfeited that claim.  

Interestingly, Mr. Taylor apparently still hasn't paid the maintenance fees, and the USPTO still hasn't refunded his $1030.  PAIR lists the patent as still being involved in court proceedings, and the maintenance fee page lists the patent as having lapsed in 2001.  Do you think the USPTO will refund the money with interest?  Or credit the interest toward whatever Taylor still needs to pay?  

II

The Israel PTO imposes a fee for making changes in the Patents Register.  This includes not only changes in the identity of the applicant/patentee, but also changes in the address of the applicant or the attorney.  Seems a little ridiculous to make an applicant pay for changing counsel.  It takes the ILPTO secretary a few minutes at most to record the change.  The requirement seems especially silly when one realizes that until the patent is granted, it's not in the Register.  

Be that as it may, a colleague reported to me that he took over representation of an application and paid the requisite 227 shekel fee online on June 16.  (Current exchange rate is about 3.88 shekels/dollar.)    But unlike in the USPTO's online filing and payment system, such payments aren't recorded at the ILPTO until the receipt is actually mailed by the applicant or attorney to the ILPTO.  In this case, the inventor only signed the power of attorney on June 30.  By the time the POA and payment receipt had arrived at the ILPTO in July, the fee had gone up.

By a shekel.  

That's an increase of less than 25 cents in people money.

So the ILPTO mailed a letter to my colleague, telling him that his payment was a shekel short.

The stamp alone cost 1.7 shekels.  I don’t know what the secretary's time and envelope cost.  I do know that my colleague's time to pay the outstanding shekel and send the receipt to the ILPTO will be worth somewhat more than a shekel.

 

III

I guess it's comforting, in a perverse way, to know that patent offices on both sides of the Atlantic can be pedantic.  It's confirmation that when they send an unnecessary OA because they're being overly formalistic, they're not picking on me or my client.  That's just the way they are. 

The denouement of the Taylor case also shows that just because the USPTO is wrong doesn't necessarily mean that a solo inventor is right.  Sort of the patent world corollary to "Just because you're paranoid doesn't mean they're not out to get you."

New Proposed Prior Art Reporting Requirements in Israel – Part II (This Post Isn’t About That Dead Horse Bilski Either)

In the previous post on this blog, I discussed the Commissioner’s proposal to increase the burden on patent applicants, by requiring them to provide not only copies of prior art cited during the examination of corresponding cases elsewhere, but also copies of the foreign office actions citing that art and the applicants’ responses to those OAs.  I noted that there is no legal basis under which the Commissioner can impose such a requirement.

This post ignores the lack of legal basis for the Commissioner’s proposed requirement, and deals with some of the policy deficiencies of the Commissioner’s proposal. 

Ostensibly, the proposed requirement will make substantive examination more efficient.  That, at least, is the reason proffered by the Commissioner for imposing the requirement.  But it’s not clear to me how that’s so, for several reasons.

First, as it is, the law currently imposes a duty of candor on applicants.  Israel examiners are capable of reading prior art publications for themselves and drawing their own conclusions.  Moreover, all EPO prosecution files and most US prosecution files are currently viewable online.  Thus Examiners can access corresponding search reports and OAs if they so choose.

Second, the law varies across jurisdictions.  Non-obviousness in the USA, while generally paralleling the EPO’s inventive step requirement, is not exactly the same.  There are situations in which publications that can be cited against both novelty and non-obviousness in the USA may only be cited against novelty in Europe, and aren’t citable at all in Israel. 

To give an example, suppose X files a U.S. provisional application on January 1, 2001, disclosing and claiming ABC, and files a PCT claiming priority from the provisional on January 1, 2002.  X’s PCT publishes on July 1, 2002, and eventually he files national phase applications in the USA and Europe, but not in Israel.  Meanwhile, on July 1, 2001, Y files a PCT application also disclosing and claiming ABC, but without a priority claim.  Y eventually files national phase applications in Israel, the USA and Europe. 

In the USA, X’s PCT may be cited as prior art in assessing both the novelty and non-obviousness of Y’s application.  The fact that X’s PCT was published after Y’s filing date doesn’t matter  – see 35 U.S.C. §102(e) and last week’s CAFC decision in In re Giacomini.  But in Europe, the fact that Y’s filing date precedes the publication of X’s PCT means that X’s PCT can be cited only against the novelty of Y’s application, and not inventive step.  In Israel, X’s PCT is not citable at all against Y’s application: since X’s PCT published after Y’s filing date, X’s PCT doesn’t count as prior art under Israel law; and since X didn’t file a national phase application in Israel, there’s no basis to say that X has a prior right under Section 9 of the Israel statute (which basically says “first-come, first-served” with regard to rights in claimed inventions).

In such circumstances, how could it possibly make Israel prosecution more efficient to IL examiners with copies of OAs from the USA and Europe? 

Third, by creating an additional reporting requirement, the Commissioner would also be creating more opportunities for applicants to make innocent mistakes, and for adverse parties – which as often as not in Israel are free-loaders looking to capitalize on Israel’s liberal pre-grant opposition regime – to jump on those mistakes and assert bad faith prosecution and the like.  Given the ILPTO’s propensity for occasionally falling for such arguments, that doesn’t bode well for applicants. 

Moreover, the increased possibility of making a mistake engendered by the proposed reporting requirement is likely to lead to applicants deciding to err on the side of caution in what they report.  Think of the McKesson decision in the USA, which has led to the absurd situation of applicants providing the USPTO with copies of OAs issued by the USPTO in other related cases – even when it’s the same examiner examining both cases!  That doesn’t add to prosecution efficiency, it bogs it down, for both applicants and examiners.  Just because the US has gotten this wrong doesn’t mean Israel has to follow the USA’s lead.

Finally, not only is the proposed reporting requirement unnecessary and detrimental for the reasons explained above, but it is likely to also impose enough of a burden on applicants that some will rethink filing in Israel.  The new reporting requirement will require more paralegal and attorney time on their end, as well as the costs imposed by local patent practitioners.  Suppose a large company presently files 50 patent applications in Israel annually.  That’s a significant amount of additional cost to impose on such a company.  But contrary to what some locals seem to think, the patent budgets of large foreign corporations, to say nothing of smaller companies, are not elastic and infinite.  Israel is generally not important enough to them that they are willing to spend whatever it takes to get a patent in Israel.  So if the cost of patenting in Israel is raised sufficiently high, those applicants will simply reduce their number of Israel filings, or stop filing here altogether. 

In sum, aside from the ultra vires nature of the proposed reporting requirement, even if the Commissioner was empowered to impose such a requirement, he would be ill-advised to do so.  It’s unnecessary and instead of leading to prosecution efficiency will lead to inefficiency or even a reduction in patent filings in Israel.

What Part of “May” Doesn’t the Commissioner Get? (This Post Does NOT Pertain to Bilski)

If you’re looking for comments on the much-anticipated U.S. Supreme Court decision in In re Bilski, which is expected to be released this morning, you’ve come to the wrong place.  If you want a non-Bilski post, keep reading.

 

As in US law, the Israel patent statute imposes a duty of candor on applicants for patents.  The law also empowers the Commissioner to ask applicants to provide certain information, in order to assist the examining corps in examining applications.  Hitherto, in accordance with the relevant statutory and regulatory provisions, the practice has been for the ILPTO to send a letter to applicants a few months before examination commences, asking them provide lists of prior art cited against corresponding applications elsewhere.  In the case of X- and Y-level references from PCT search reports, applicants have also been asked to provide copies of such references on a CD-ROM.

 

Several months ago, the Israel Commissioner of Patents published a notice which stated that, beginning July 1, 2010, applicants would be required not only to submit lists of prior art cited elsewhere, but also (a) copies of office actions from other countries, and (b) copies of the applicants’ responses to those OAs.  Failure to comply, the notice stated, would be deemed a failure to respond to the pre-examination letter (an omission that will eventually result in the application going abandoned).

 

The imposition of this requirement was ostensibly to help the ILPTO do its job and to reduce redundant work efforts.  Nevertheless, the requirement caused consternation among local patent practitioners, in that, as worded, it would have significantly raised the costs of patent prosecution in Israel, at least for those applicants with large numbers of corresponding applications (such as multinational companies).  Moreover, as I’ve mentioned in an earlier post or two, the Commissioner isn’t empowered to make such a requirement.  But more on that below.

 

Yesterday, for reasons unstated but apparently in response to comments from different quarters, the Commissioner backtracked a bit.  He announced that the new requirement would not come into force on July 1.  Instead, he published a revised version of the notice, which he called a draft, and asked that comments on the draft notice be sent by July 11 to MitmahePatents@justice.gov.il.  It is hoped that the ILPTO will publish the comments it receives.  Translated into English, the revised draft notice reads as follows:

 

1. Section 18 of the Patents Act allows an examiner to use for assistance the search and examination reports of foreign patent authorities that examined patent applications for the same invention.

 

2. Rule 36(2) of the Patents Regulations states that the applicant “may append to its answer the documents submitted by it or by its predecessor in ownership rights, to the same authority in reply to the objections raised against the application filed there”. 

 

3. The goal of these legislative instructions is, inter alia, to save office resources, to improve the efficiency of examination and to reduce pendency.

 

4. In many cases, this goal is not fully realized, as the Israel examiner is compelled to raise anew objections that were raised by foreign patent examiners and replied to by the applicant, by way of amendment of the claims or by dealing with the objection in another manner.

 

5. In order to increase the efficiency of examination to benefit the general public, beginning with the coming into force of this notice the applicant shall append to his answer to the demand per Section 18 of the Act his comments on references cited against the novelty or inventive step in the corresponding application or the PCT application, as follows:

 

A. The applicant shall transmit to the office his answer to the international search report, if he submitted such an answer to the international search and preliminary examination authority.

 

B. The applicant shall submit one answer only to each citation, in English or Hebrew, as he chooses. 

 

C. Per section 18A of the Act, during examination the applicant must update the office regarding any additional citation made in a foreign patent office.  To the extent the prior art was cited against the novelty or inventive step, the applicant must provide a copy of his answer to the citation, as submitted to the foreign patent office, if the answer is in English.

 

6. Non-submission of comments as recited in the preceding paragraph 5 is as if no reply to a Section 18 demand was filed. 

 

7. The wording of the section 18 demand will be revised in accordance with this notice.

 

8. This notice shall come into force on __ (three months the final version of the notice is published on the office’s web site).

 

There are a number of difficulties with this proposal, from both a legal and a policy perspective.  Today I’m going to discuss the legal perspective; observations on the policy issues will follow in a subsequent post. 

 

For starters, the proposed notice relies on Rule 36(2) of the implementing regulations.  Unlike the Patent Rules in the USA, which are promulgated by the USPTO itself (in accordance with the Administrative Procedures Act), the regulations in Israel are established by the Justice Minister, and thus, unlike the USPTO, the ILPTO is not afforded deference in its interpretation of the rules.  Rule 36 reads as follows (again, translated from the original Hebrew):

 

Demand of References

 

36.       The following rules will apply to a demand per §18(a)(2) of the statute:

 

(1)     Approximately four months before examination of the application will commence, the Commissioner will send a notice to the applicant in which he will demand of the applicant the following particulars:

 

(a) The lands [should probably say “countries” per (b) following – DJF] in which protection for the invention which is the subject of the application was sought by the applicant or its predecessor in ownership rights;

 

(b) The references upon which the authority relied in the aforementioned country in which the application was examined;

 

(2)    The applicant must answer the demand within four months from being asked to do so, and may append to its answer the documents submitted by it or by its predecessor in ownership rights, to the same authority in reply to the objections raised against the application filed there; if said documents are written in a language which is not an official language, the applicant will append to them a translation into an official language;

 

(3)    If in the applicant’s answer per paragraph (2) there were mentioned references which are specifications of patents, designs, or utility models or other documents which have not been offered for sale to the public, the Commissioner may demand a copy of them if they are not in the possession of the office.

 

As explained in its first line, Rule 36 comes to set forth the implementation of Section 18(a) of the statute.  There’s just one problem with that: there is no section 18(a) in the statute!  Huh?! 

 

Well, Rule 36(2) was enacted in 1968, following the adoption of the statute itself in 1967.  As enacted, the statute indeed contained a section 18(a), which in translation read as follows:

 

18. (a)   In applications of certain classes which will be prescribed, the Commissioner or an examiner may utilize for the examination the following additional means:

 

(1)   To transmit the application to an international institution with which the state has contracted for the sake of searching for material that enables said examination;

 

(2)  To demand that the applicant provide the list of references upon which a foreign patent office relied during examination of an application for the same invention which was filed in that country by the applicant or its predecessor in ownership right in the invention. * * *

 

But in 1995, §18 was amended, and §§18A, 18B and 18C were inserted.  These are written in Hebrew and in translation read as follows:

 

18. Additional Means of Examination (Amendment: 1995)

 

The examiner will utilize at least one of the following additional means of examination:

 

(1)    The list of references upon which any foreign patent authority relied in examining a patent application for the same invention which was filed in the foreign country by the applicant or the applicant’s predecessor in ownership rights in the invention;

 

(2)    A list of publications which were published before the application date, known to the applicant and directly touching upon [alternative translation: pertaining to] the invention;

 

(3)    Copies of publications and references that the applicant is required to list [for the ILPTO] in accordance with this section, if the examiner requests such copies;

 

(4)        Copies of publications and references that are mentioned in publications and references that the applicant is required to list [for the ILPTO] in accordance with this section, if the examiner requests such copies;

 

(5)        Transfer of a copy of the application, for purposes of searching for material that will enable the office to examine, to an institution in Israel or abroad, with which the office has contracted in accordance with any statute in a contract drafted by the Commissioner and that includes a section pertaining to the maintenance of secrecy of patent applications and non-disclosure of information, in accordance with §165 [of the patent statute];

 

and to this end he may do one or more of the following:

 

(1)     demand that the applicant to produce any of the documents listed in paragraphs (1) to (4) above;

 

(2)    transfer the application for the sake of searching as stated in paragraph (5).

 

18A. Obligation of the Application to Update the Office (Amendment: 1995)

 

Until the application is accepted [i.e. allowed and published for purposes of pre-grant opposition - DJF], the application is obligated to update the office regarding any change that occurs in the list of references or publications enumerated in Section 18, if the changes were brought to its attention or the attention of its attorney.

 

18B. Notice of the Institutions Assisting in Examination (Amendment: 1995)

 

The Commissioner shall publish in the official publications journal [the equivalent of the Federal Register – DJF] a notice of the institutions with which the office has contracted per §18(3) and the types of applications with regard to which he plans to use the [search] means enumerated in said section.

 

18C.  Means of Enforcement With Regard to The Examination Process (Amendment: 1995)

 

If a misleading particular was transmitted in the applicant’s answer to a demand per §18, or if the applicant knowingly did not update the office regarding any substantive change in the list of documents or the publications that he is required to update per §18A, and a patent was granted on the application, or the application was accepted [i.e. allowed and published for purposes of pre-grant opposition - DJF] –

 

(1)     The Court or the Commissioner, in a proceeding before them, may do one or more of the following:

(a) cancel the patent or not grant a patent;

(b)    grant a license to exploit the patent to anyone who desires such, as if the Court or Commissioner comes in the stead of the patentee, under conditions agreed upon by the parties, and in the absence of such agreement, by the hand of the Court or Commissioner, in accordance with the matter;

(c)   order a shortening of the term of the patent.

 

(2)   The Court may impose on the transmittor of the misleading particular or the person who knowingly did not update the list of documents or publications, in accordance with the matter, a fine as set forth in section 61(a)(1) of the Penal Statute, 5737-1977.

 

While the amended §18 is in some ways similar to the old §18, it is nevertheless different (otherwise why bother to amend the statute at all?).  And it doesn’t contain a subsection (a). 

 

To people used to Israeli bureaucracy, it’s not terribly surprising that in the 15 years since section 18 was amended, the Justice Ministry hasn’t managed to update the regulations accordingly.  Nevertheless, from a strictly technical standpoint, Rule 36 has no legal force, as it comes to implement a statutory provision that no longer exists.  So from a legal standpoint, the Commissioner’s using Rule 36 as basis for his new proposed policy isn’t tenable.

 

Interestingly, one wonders if the Commissioner isn’t aware of this difficulty: in the nearly 15 years since amended §18 and new §§18A-18C came into force, the ILPTO has continued to send out demand letters as described in Rule 36, but those letters don’t refer to Rule 36.  Rather, they refer directly to amended section 18, which clearly states that the Commissioner has the power to require applicants to provide him with lists of prior art cited in corresponding cases in foreign jurisdictions.  So perhaps the Commissioner realizes that Rule 36 is dead – which raises the question, why does he now refer to a dead rule in support of his attempt to impose new reporting requirements on applicants?

 

Nevertheless, for the sake of argument, let’s assume that Rule 36 didn’t die that day in July 1995 when amended §18 and new §§18A-18C took hold.  Rule 36(2) states that the applicant MAY provide copies of its arguments submitted in response to foreign OAs.  There’s no ambiguity in the Hebrew term used, “reshai” (רשאי) – it means may, as in, is at liberty to.  It’s at the APPLICANT’S discretion to submit such documents.  What part of “may” doesn’t the Commissioner understand? 

 

There is nothing in Rule 36 that gives the Commissioner the power to require that applicants submit copies of foreign OAs, let alone their replies to such foreign OAs.  And there’s nothing in §§18-18C that gives the Commissioner such power, or that empower the Justice Minister to give the Commissioner such power.  In this respect, the new version of this notice – the third one circulated by the Commissioner – is just as defective as its previous incarnations.  If the Commissioner wants to impose such a requirement on applicants, he’s going to require new legislation from the Knesset.  This isn’t a change that can come about via a bureaucrat’s fiat.

 

At least in this draft, the requirement only applies to English-language responses.  The two earlier versions of the notice, had they come into force, would have required the submission of all responses worldwide; presumably it would have been necessary to translate non-English language responses into English or Hebrew.  Even in this regard, the present draft is wanting: as discussed in an earlier post, Arabic is an official language in Israel, so the requirement in draft paragraph 5B that responses be submitted in English or Hebrew – and by implication, not Arabic – is also ultra vires.

 

(As a minor aside, I’d also mention that there is what appears to be a typo in the official Hebrew version of Rule 36 that renders it difficult if not impossible to understand; I’m not going into that particular detail here, and have translated the rule as it appears it was intended to be written.)

Plaese Poorf Raed: Patent Attorney Trainee Sought; Knowledge of English Spelling and Grammar Not Necessary

 

Recently the following advertisement was posted on one of the English-language “help wanted” bulletin boards in Israel.  I’ve decided to spare the guilty parties further embarrassment and redacted their names:

 

Patent Attorney Intern Needed

 

We are looking for a patent attorney intern.

 

XYZ is a mid-size UK-Israeli firm with a fun atmosphere. We draft and prosecute patent applications for fortune 500 companies and universities, and we need help.

 

Relevent fields are software, electornics, and electro-optics.

 

We are looking for candidates who are after a career at the patent industry and therefore, candidates should be willing to work hard for an intern wage in order to get good training.

 

English should be at native-tongue level. Candidates will be expected to write a short paper to prove their English level.

 

Please send CVs by email only to XXX@__.com. Thank you!

 

Well, if this advertisement is any indication of the quality of their patent applications, then yes, they most certainly need some help!  So in the interest of collegiality, I offer a few suggestions for how the members of this firm might ensure that they identify the best candidate.

 

They should begin by asking candidates to spell “relevant” and “electronics”.  Inasmuch as their web site also contains the statement that “Israeli PTO circulars will become affective 3 months after publication on the PTO’s website”, they should probably ask candidates to write essays that use both “affective” and “effective”. 

 

Similarly, candidates should be asked to explain the meaning of the term “conflicating”, which appears in the following sentence on the firm’s website: “We are pleased to try to help conflicating parties resolve their conflicts in peaceful manners, as an alternative to litigation proceedings.”  (The paragraph goes on to conclude, “Our managing partner is well-known for his mediation skills.”  As well as his gift for lexicographical creativity, no doubt.)

 

The partners should also ask candidates to explain the difference between “[being] after a career at the patent industry” versus “seeking a career in the patent industry”.  For that matter, they should ask candidates to explain the differences between the patent industry and the field of patent law and practice.  I’m not sure I know myself - I haven’t yet seen a patent factory, but then there are many parts of the world I haven’t visited.

 

In addition, candidates should be asked to identify at least two errors in following sentence, taken from the firm’s web site:  “Our double-check procedure makes sure that many professional and experienced eyes review each application before it leaves the office to make sure that it describes the invention well, as broad as reasonably possible, and design to fly through the examiners as easily as possible.”

 

In any case, full credit to this firm for its adherence to truth-in-advertising strictures.  Not everyone would be so bold as to tell job candidates of whom perfect English is demanded that they should be prepared to work long hours for low wages, for professionals whose own English skills are wanting.  Low pay and a boss you don’t respect – that’s always a winning combination.  I’m sure many excellent candidates have already beaten a path to this firm’s door.

Wishful thinking? Dubai-Based IP Services Portal Leaves Israel Off Its Site

I belong to several IP-related groups on LinkedIn.  This past week I received notices from two of them about a new portal to put potential users of IP-related legal services in touch with purveyors of those services.  Looking at the site, I saw that at the bottom of the home page is a division of the world into geographical areas, with the notation “Select a Country to Send Inquiries”.  I wanted to see what firms from Israel were listed.  So I scrolled over the “Middle East and North Africa” map, but Israel wasn’t in that list.  Thinking maybe they’d put Israel with Europe, I scrolled over Europe.  Nope, not there either.  How about Asia?  Nada.  Then I looked in the alphabetical list of countries.  Hungary, Iceland, India Indonesia, Iran, Iraq, Ireland, Italy, Jamaica…notice anything missing? 

 

Turns out this particular operation is based in Dubai.  Apparently the Arab predilection for ignoring the facts and engaging in wishful thinking extends to the IP sphere.  Newsflash for the guys running the site: Israel exists.  Or was that flap a few months ago about some terrorist getting killed in a hotel in Dubai just a case of you guys getting worked up over what some ghosts did?   

 

Not only does Israel exist, the PCT database lists 21590 published PCT applications having an Israeli applicant.  That’s over 200 times more than the 104 such applications for the whole UAE.  The disparity may partly explain why Israel weathered the financial crisis of 2008 and 2009 so much better than Dubai did. 

 

Keep up your delusions, Dubai.  It’s a great way to move from doing whatever it is you do with your camels into the 21st century.

 

By the way, if anyone’s looking for an IP pro in “Palestine” – because we all know that when the PA/Hamas aren’t trying to lob missiles or homicide bombers at Israel, they’re at the vanguard of the granting and enforcement of IP rights – the site includes “Palestine”, but doesn’t list any firms.

The Israel PTO as a PCT Search Authority: Making it Work

Much hay was made in Israel last fall when WIPO decided to allow the Israel PTO to try to become a PCT search and examination authority.  At the time, the Commissioner of Patents sent out a letter in Hebrew to the ILPTO email list (click here for translation by yours truly) explaining the goings-on that occurred in Geneva leading up to the decision.  The local press picked up the story as well, in most cases inaccurately reporting that this meant that Israelis could now file PCT applications.  (Actually, the Israel PTO has been a PCT receiving office since 1996.)  One firm whose partners are known to be publicity hounds even finagled an interview on one of the television news programs to explain the importance of WIPO’s decision.

 

Other than that instance of shameless self-promotion, I suspect that much of the hullabaloo was less self-aggrandizement and more of the Sally Field “You like me, you really like me” variety: given the hypocrisy and immorality to which Israel is constantly subjected to at the UN and other international fora, it was nice to receive some positive recognition for a change, from a UN body no less.

 

Even then, with the decision there was a reminder that politics always plays a role in these sorts of decisions.  As explained in the Commissioner’s letter to the Israel patent community, part of the quid quo pro for extending the invitation to Israel was that Egypt would also be given the opportunity to become an ISA. 

 

Egypt?

 

What a joke.  Comparing the Egyptian Patent Office to the ILPTO is like comparing a 1971 Dodge Dart to a 2010 Cadillac.  As statistics available on the Egypt PO and the ILPTO websites attest, the Israel PTO has far more examination experience, fielding roughly 3.5 times more applications annually than the Egyptian PO.   The just-published PCT Yearly Review also has some interesting statistics in this regard as well.  But the Egyptian PO is, evidently, the best the Arab world has to offer, and the Arab world wasn’t going to acquiesce to Israel’s entry into the ranks of PCT search authorities without one of its own being afforded the same opportunity.   

 

Setting the politics of the decision aside, the WIPO decision represents several opportunities for the ILPTO.  First, it’s an opportunity for the ILPTO to move into ranks of the world’s first-rate patent offices, instead of continuing to operate, as one local practitioner puts it, as a 19th century patent office in a country with 21st century technology.  Israel’s greatest natural resource is it brainpower, and in that regard the examining corps at the ILPTO has the potential to be one of the best in the world.  It’s much harder to gain university admission in Israel than it is in, say, the USA, and as a consequence Israeli university graduates tend to be better educated, on average, than their American counterparts.  Because many Israelis were themselves born abroad, or are the children of immigrants, particularly from the former Soviet Union, many Israeli examiners have facility in English and Russian or other European languages, which can enhance their search abilities. 

 

But in addition, if the ILPTO becomes and ISA/IPEA, it could simultaneously contribute to the reduction in the backlog at the USPTO and elsewhere, reduce costs for applicants, and increase its own revenues.  How so?

 

First, the ILPTO allows the filing of applications in English, which opens up the possibility of becoming a search authority for PCT applications filed in other jurisdictions, most notably the USA and the EPO.  Couple that with the fact that ILPTO examiners cost less to employ than their counterparts at the USPTO or the EPO, and the ILPTO could potentially be an attractive search option for applicants from other countries, just as US applicants have in recent years begun using the Korean Patent Office to conduct PCT searches, partly because of the lower cost vis-à-vis the USPTO, and partly because of the timeliness with which KPO searches are delivered (as opposed PCT searches conducted in the USA, which are generally of low quality and not infrequently delivered after the 30-month national phase deadline has passed). 

 

There are two steps the ILPTO needs to take to make this happen.  First, it needs to improve the quality of its examination and reporting.  Some ILPTO examiners are already world-class.  They find the most relevant art, and they clearly explain how it applies to the claims.  But there are still a significant number who continue to practice, or worse, are being trained, to do a poor job: they don’t find the best prior art, or they mis-apply the art that they find, or rather than explain how the art they’ve found applies to each claim, they produce a one-liner along the lines of, “The claims are obvious in view of publication X”.  This has to be remedied, so that all of the examiners consistently produce first-rate work.  Fortunately, it’s an attainable goal.

 

The second step involves getting other patent offices to recognize the searches done at the ILPTO.  This is where politics re-enters the picture.  Because no one, not even an Israeli applicant, is going to want to use the ILPTO to search if that search doesn’t have some cachet outside of Israel.  Israel needs to get on board with the US patent prosecution highway, and with other countries that have similar arrangements.  While the PPH leaves much to be desired, these days anything that can help an applicant for a US patent decrease application pendency and increase the likelihood of allowance is going to warrant a close look from US-based applicants, particularly if it can help the applicant reduce its costs. 

 

I believe that the current Commissioner appreciates, at least in some respects, the need to make nice with the decision-makers in other patent offices and to come to agreements with them regarding searches and examinations done in Israel.  He said as much in his letter referred to above.  In the six months or so he has left in office, this would be a good thing for him to concentrate on, and his successor would also do well to make it a priority. 

I Know A Dependent Claim When I See It! (What Does a Dependent Claim Look Like Again?)

One of the first things any patent practitioner (or inventor filing a patent application) learns is the difference between independent and dependent claims.  The former read something like,

 

“1. A device comprising an X, a Y and a Z connecting the X to the Y”, or

 

“2. A method for doing/making A comprising doing X, Y and then Z”. 

 

The hallmark of a dependent claim is that it necessarily incorporates all the limitations of the claim from which it depends, and further specifies some additional limitation(s).  In the U.S., this is codified in 35 U.S.C. §112, fourth paragraph, which reads,

 

Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limita­tion of the subject matter claimed. A claim in depen­dent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

 

Thus dependent claims usually read something like,

 

“3. The device of claim 1 wherein the X is shaped like a doughnut”, or

 

“4. A method according to claim 2 wherein X is conducted at a temperature above 60ºC.”  

 

Sometimes, though, a claim will be worded, e.g.,

 

“6. A method for treating cancer, comprising administering to a patient in need thereof a compound as recited in claim 5.” 

 

Is that an independent or dependent claim?  I don’t know any practitioners who would say it’s a dependent claim: although claim 6 has incorporated the limitations of claim 5, it has done so simply as a form of shorthand.  Claim 6 hasn’t added any further limitations regarding the compound recited claim 5.  And most importantly, whereas claim 5 is directed to a compound, claim 6 is directed to a different statutory class of patent-eligible subject matter, a method of treatment.  So claim 6 must be independent. 

 

Curiously, under US practice, there is at least one situation in which claim 6 would be regarded as dependent.  When counting the number of independent claims for purposes of calculating the filing fee due (each independent claim beyond the first 3 costing the applicant big bucks), the USPTO regards a claim like claim 6 above as dependent, thus saving applicants filing fees.  At least, that’s been my experience and the experience of other practitioners with whom I’ve spoken.  However, for purposes of unity of invention, it’s possible that an examiner would regard claims 5 and 6 as being directed to different inventions that necessitate separate searches, and thus force an applicant to choose between the two, in so doing implicitly finding that claim 6 is an independent claim.  In Israel, claim 6 would be regarded as an independent claim (although in Israel, there are no excess fees for excess independent claims per se, only for the 51st claim and up, period).

 

Why discuss such a basic notion as the difference between independent and dependent claims?  Because it arose two weeks ago in a decision from the Board of Patent Appeals and Interferences (BPAI) at the USPTO.  The decision was handed down in an old interference (declared in October 1996!) between Abbott GMBH & Co. KG and Yeda Research and Development Co. Ltd., the tech transfer arm of the Weizmann Institute.  At issue was the ownership of patent rights over proteins that bind another protein known as tumor necrosis factor alpha (TNFα).  The crux of the dispute between the two parties was whether or not Abbott’s US 5,344,915 was entitled to the benefit of Paris Convention priority to a German application filed in 1989.  The BPAI ruled it was, hence Abbott had rights in the one count over Yeda’s USSN 07/930,443. 

 

The interesting part of the decision, however, concerns Yeda’s contention that claim 2 of the ‘915 patent was in improper form for a dependent claim, as set forth in 35 U.S.C. §112, ¶4.  These claims read as follows:

 

1.     A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence

 

Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu

 

where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

 

2.     A protein as claimed in claim 1 in deglycosylated form.

 

Yeda argued that since the deglycosylated protein recited in claim 2 had molecular weight that, according to Example 6 of the ‘915 patent, was about 3000 Daltons less than that of the claimed TNFα-binding protein, claim 2 did not include all of the limitations of claim 1, and did not contain a further limitation on the protein of claim 1.  Hence, said Yeda, claim 2 was in improper dependent form.  In support of its argument, Yeda cited to MPEP ¶ 608.01(n), which sets forth an infringement test for determining compliance with 35 U.S.C. §112, paragraph 4:

 

The test as to whether a claim is a proper dependent claim is that it shall include every limitation of the claim from which it depends (35 USC 112, fourth paragraph) or in other words that it shall not conceivably be infringed by anything which would not also infringe the basic claim.

 

Argued Yeda, since the lower molecular weight deglycosylated protein of claim 2 could not conceivably infringe Claim 1, the recitation therein was not a “further limitation” on the subject matter of that claim.

 

The BPAI majority disposed of this argument by saying that Yeda bore the burden of proof, and had failed to show that a person of ordinary skill in the art would not regard the deglycosylated protein of claim 2 as being “about 42,000 Daltons” as recited in claim 1, and therefore

 

Yeda has failed to show that the deglycosylated protein of Claim 2 is completely outside the scope of the “about 42,000 dalton” requirement of Claim 1 (Pfizer, 457 F.3d at 1292) or that the deglycosylated form would not be understood to infringe Claim 1. Yeda has not established, prima facie, that Abbott’s Claim 2 does not provide a “further limitation” of the Claim 1 subject matter.

 

Yeda’s argument was a creative and intriguing one, and the majority’s disposing of it on grounds that 39,000 Daltons is close enough to 42,000 Daltons isn’t really satisfying.  Suppose that claim 2 had instead read, “2. The protein of claim 1 having a molecular weight of 39,000 Daltons”.  In that case, Yeda’s argument might have been stronger – if a claim specifies a molecular weight if 42 kDa, and the patent itself doesn’t explicitly that 39 kDa is to be considered as 42 kDa, it’s not clear that a 3000 Dalton difference is minor.

 

One Administrative Patent Judge, however, while concurring in this part of the judgment, did so on different grounds.  The first paragraph of his two paragraph concurrence is unremarkable:

 

While I join the majority in its denial of Yeda’s motion for unpatentability based on 35 U.S.C. 112(4), I do so for a different reason.  Paragraph 4 of §112 requires an express reference to the claim from which it depends and an incorporation by reference of the limitations of that claim.  It does not follow, however, that the converse is true: reference to another claim does not mean that the claim is intended to be dependent. For at least a generation the Office has permitted such cross references in claims that cannot possibly be dependent.  For example, “A widget made by the method of claim 3.” The widget cannot be within the scope of the method. The cross reference simply incorporates the limitations of the cited claim without creating a dependency. Under this practice, the principal effect is that the non-dependent, cross-referencing claim is itself independent and thus the applicant might owe an additional fee if there are more than three independent claims. 35 U.S.C. 41(a)(2)(A).  In an age of word processors, one could question whether the convenience of cross referencing is outweighed by the confusion it causes.  The question, however, is beyond our purview.

 

That’s just as discussed above: different statutory classes = no dependency, even if another claim is referenced.  Having (in baseball terms) set up the non-dependence of claim 2, the concurrence closes:

 

I conclude that Abbott's claim 2 is an independent claim. The claim states in its entirety “A protein as claimed in claim 1 in deglycosylated form.”  Significantly, the claim does not use the typical dependent form of “The protein of claim 1, wherein the protein is deglycosylated.” The use of “A protein” rather than “The protein” is telling since it deliberately avoids making the protein of Abbott claim 1 a literal antecedent.  Since the patent has only three claims, we cannot infer anything from the fees paid.  Abbott claim 2 is an independent claim and thus cannot be unpatentable for failing to comply with the statute governing claim dependency. 

 

It’s hard to argue with this APJ’s logic, which also explains why the majority’s view doesn’t sit quite right: claim 2 is not an improperly dependent claim because 42,000 can mean 39,000.  It’s not an improperly dependent claim because it’s not a dependent claim at all! 

 

Interestingly, most practitioners I know don’t really care how one begins a dependent claim, “A thing according to claim 1…” or “The thing according to claim 1…”; the particular wording usually comes down to personal preference.  It may be that the person who drafted claim 2 intended it to be an independent claim, but it may also be that in this case they got lucky.   

Fawning Over Francis?

As reported in an earlier post, last fall the Israel patent community was left scratching its head as a result of the Commissioner’s about-face regarding Australia.  Specifically, in December 2008 the Commissioner indicated that applicants would no longer be able to piggy-back on an allowance in Australia to obtain allowance of a corresponding patent application in Israel, because the ILPTO’s experience had shown that Australian examinations weren’t reliable.  In September 2009, the Commissioner reversed course and again recognized Australia for this purpose, announcing his decision in a tersely worded statement that provided no reasons for the change of heart.  At the time, some speculated, jokingly, that there had been a pay-off of some sort to the ILPTO, perhaps a junket to Australia.

 

The joke wasn’t far off the mark.  In late September, the WIPO general assembly decided to grant Israel the opportunity to become a PCT International Search and Examination Authority.  The reinstatement of Australia a few weeks earlier was done in anticipation of the WIPO meeting at which this decision was taken: Dr. Meir Noam, the Commissioner of Patents, reasoned that by reinstating Australia, he would curry favor with Francis Gurry, the head of WIPO and an Australian national.  While it’s impossible to know if the ruse worked without asking Mr. Gurry himself, it’s hard to believe that the head of WIPO would condition support for recognition of any particular country as an ISA on how that country regarded the WIPO head’s home country, rather than, say, that country’s competence at prior art searching and analysis.  It’s even more difficult to believe that Mr. Gurry actually pays attention to details of Israel patent practice such as whether or not one can piggy-back on Australia to gain allowance in Israel. 

 

While Dr. Noam has admitted that he was trying to get in Mr. Gurry’s good graces for purposes of having Israel named as a potential ISA, it’s hard not to wonder if, in reversing his position on Australia, Dr. Noam wasn’t also angling for a job at WIPO.  He has been pushing for stronger ties with WIPO, and during his tenure hired an Israeli national from WIPO’s administrative ranks to be an adjudicator at the ILPTO.  In February 2009 the Cabinet decided to limit the terms of high-ranking civil servants across the board, so by last September, it was probably clear to Dr. Noam that he would be out of a job at the end of 2010.  Maybe he was hoping that by placing politics, both ILPTO and personal, above substantive concerns about the quality of patent examination in Australia, Mr. Gurry would be more likely to offer him a job.

 

What is clear is that although during Dr. Noam’s tenure as Commissioner, the ILPTO has made progress on some fronts, in others it still lags behind, and in some ways things have gone precipitously downhill.  On the up side, many new examiners have been hired, and according to the ILPTO, as of April 2010 the backlog in patent examination had dropped in most areas to between about 2-3 years from national phase entry to the beginning of examination.  Similarly, the backlog in judicial decisions (e.g. patent and trademark oppositions; patent, trademark and design cancellation actions; ex parte appeals within the ILPTO) had dropped significantly – although given the fact that Dr. Noam’s predecessor had failed to render a single substantive patent decision in the over four years he was on the job, things couldn’t have gotten any worse in that regard.  And as discussed in a previous post, there is now a publicly-available online database that facilitates checking the status of Israel patent applications. 

 

Nevertheless, not all is rosy.  The quality of OAs remains spotty, with many examiners, even senior ones, still failing to explain how the art they cite applies to which claims.  In the 1990’s Israel was one of the first countries to introduce electronic filing of trademarks – credit Nurit Maoz, who is still head of the trademarks division, for that – but it still isn’t possible to file a patent application electronically in Israel, let alone to view patent file histories online.  Similarly, the quality of the judicial decisions has not always been on the mark.  Witness, for example, Dr. Noam’s decision in IL 100816, a case in which a patent containing 1 independent and five dependent claims was at issue.  After disposing of claim 1 as being obvious over the prior art, Dr. Noam concluded that the remaining claims, by virtue of being dependent from claim 1, were necessarily obvious and thus invalid – without actually analyzing the additional recitations in those dependent claims to see if they distinguished over the prior art.

 

Of greater concern is the observation that Dr. Noam has become increasingly authoritarian in his approach to the running of the ILPTO.  While it was traditional for Commissioner to circulate letters from time to time clarifying ILPTO policies, Dr. Noam has issued more such circulars, over 80, than any of his predecessors.  (One PTO employee I spoke with said that they no longer keep up with all the circulars because there are simply too many.)  In several cases, these circulars were so unclear that they necessitated subsequent letters of clarification – in some cases several such clarification letters. 

 

Furthermore, whereas in the past those circulars were issued with respect to questions that had arisen regarding interpretation of the Patent statute and regulations, or policies adopted for administrative convenience, Dr. Noam has in some cases tried to impose new policies that are substantive policy-making and thus properly the province the Knesset (the legislature), not a civil servant.  Placing limitations on the filings of divisionals-of-divisionals is one example.  Another, on tap for the beginning of July, is a requirement, newly imposed by the Commissioner without legal basis therefor, that applicants provide copies of OAs from corresponding applications in foreign jurisdictions and their responses to the points raised in those foreign OAs – even if the claims pending in Israel are different or the applicant has not yet filed a response to the original OA.  (American readers: echoes of the Dudas administration?)

 

Nor has the Commissioner made his administration a model of transparency.  The decision to reinstate Australia was done without explanation, as was the decision to attempt to require applicants to do the ILPTO’s work by imposing draconian reporting requirements.  (Curiously, earlier this month, in yet another circular, the Commissioner announced that in the future he would disseminate draft circulars and solicit comments before issuing new circulars.  Yet later in the same week, he issued more circulars without going through such a process; and to date, no draft circulars have been disseminated.)  Until March of this year, the ILPTO’s web site contained telephone listings of all examiners and many other ILPTO personnel; that list is now gone, replaced with a much more truncated list that doesn’t include examiner telephone numbers.  (Here is a copy of the list of ILPTO personnel from March 2009, organized by department.) In addition, in some cases information is sent via email, without being posted on the ILPTO’s web site.  And the web site itself doesn’t contain, for example, copies of all ILPTO judicial decisions.  

 

Given some of his more recent actions, there will probably be many in the Israel patent community who will not mourn Dr. Noam’s exit as Commissioner.  As for his relationship with WIPO, we will have to wait and see if Dr. Noam ultimately lands a WIPO sinecure, and if he does secure such a post, we may never know if he actively pursued it.  One interesting tidbit, though: Mr. Gurry is in Israel this week, and a letter from the Association of Patent Attorneys in Israel (APAI) to its members stated that Dr. Noam urged that there be a “massive” turnout of patent practitioners at a reception for Mr. Gurry to be held tomorrow in Tel-Aviv.  So that we can show our collective obsequiousness?

Angiomax (Bivalirudin) – Another Day, Another Interim Extension and Another Patent

As discussed in earlier posts, back in early 2001 The Medicines Company (TMC) missed by one day the deadline to request a patent term extension (PTE) for US 5,196,404, which covers bivalrudin, the active ingredient in its flagship Angiomax^® drug product.  In March of this year, just days before the ‘404 patent was to expire, TMC convinced a federal judge in the Northern District of Virginia to order the USPTO to grant an interim PTE.  Per that order, the USPTO granted an interim extension until May 23, 2010. 

 

It’s now May 25, and inquiring minds are doubtlessly wondering, is the ‘404 patent in force or not?  Well, according to the Transaction History on PAIR, on Friday, May 21, 2010, the USPTO granted another interim PTE, although as of this writing that document does not appear in the Image File Wrapper; presumably it will be posted in the coming days.  Interestingly, neither the IFW nor the TH list a request for a second interim extension as having been filed, so it’s unclear from PAIR if such a request was filed by TMC or if the PTO itself docketed to issue an interim extension sua sponte in the absence of resolution of the district court proceedings in NDVa.  However, as reported by Kurt Karst at the FDA law blog, the second interim extension was granted by court order, upon an emergency motion filed by TMC.

 

Interestingly, apparently the PTO, in opposing an TMC’s emergency motion, said that it lacked the statutory authority to issue a second interim extension, and that the judge could not order the PTO to exceed its authority and in so doing violate an act of Congress, although it said it would comply with such an order if one issued.  It would have been fascinating to see what would have happened had the USPTO not obeyed the order and not issued the interim extension, thereby letting the patent expired.  The statute and rules provide for reinstatement of a patent that lapsed due to failure to pay a maintenance fee (see 35 U.S.C. §41(c) and 37 C.F.R. 1.378), with rights accruing to third parties who rely on the lapse during the intervening period.  And the statute provides for the PTO to issue interim extensions if the patent-protected product is still undergoing FDA review at the time the patent reaches the end of its natural life, at the request of the patentee (see 35 U.S.C. §156(d)(5)(B) and (C)).  But there’s nothing in the statute about reinstating a patent the term of which has expired.  Clearly, the drafters of §156 didn’t contemplate it taking over nine years from grant of FDA approval to determine whether or not a patentee was entitled to a patent term extension.  (I wonder why not?)

 

So had the USPTO had not issued a new interim PTE last Friday, and yesterday a competitor imported bivalirudin to the USA, would TMC have had any recourse?  Clearly the USPTO would disagree with the power of an Article III judge to order reinstatement of a patent in such a situation.  But even if the USPTO reinstated the patent under such circumstances, would the competitor now have acquired the right to sell the product imported while the patent was dead?

 

 

In a most definitely real and not hypothetical vein, TMC also recently acquired another patent to protect bivalirudin.  US 7,713,928, titled “Ready-to-use bivalirudin compositions”, issued on May 11, 2010 from USSN 12/563,821, filed in September 2009 as a continuation of 12/545,036, filed a month earlier.  (Curiously, PAIR does not link the issued patent to the earlier application.)  Like US 7,582,727 and US 7,598,343, both of which were filed in July 2008 and issued in the second half of 2009, the ‘928 patent was filed with both a non-publication request and a request for accelerated examination.  (Another case, USSN 12/180,550, also filed in July 2008, remains pending and unpublished, and from an IDS filed in during prosecution of the ‘928 patent, it appears there are two other related, still-pending applications, USSN 12/652,872 and 12/683,045, that have not yet come up for publication.)  However, the non-publication request was rescinded in January 2010, apparently to facilitate the filing of corresponding cases abroad. 

 

The independent claims of the ‘928 patent read as follows:

 

1.     A ready-to-use composition comprising (i) bivalirudin (SEQ ID NO: 1), or salts thereof; (ii) one or more pharmaceutically acceptable stabilizing agents, selected from the group consisting of buffering agents having a pK_a of about 2.5 to about 6.5, pH-adjusting agents, polymers, preservatives, antioxidants, sugars or polyols, and combinations thereof; and (iii) a pH of about 4 to less than 5, wherein total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215 nm after storage at 25ºC for 1 month.

 

19.    A ready-to-use composition comprising bivalirudin in an amount of about 5 mg/mL; (ii) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate; (iii) [9-10]-cycloimido bivalirudin; (iv) [11-12]-cycloimido bivalirudin; and (v) a pH of about 4.25, wherein after storage at 25ºC for one month, total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215.

 

20.    A ready-to-use composition comprising (i) bivalirudin in an amount of about 5 mg/mL; (ii) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate; (iii) sodium chloride; (iv) [9-10]-cycloimido bivalirudin; (v) [11-12]-cycloimido bivalirudin; and (vi) a pH of about 4.2, wherein after storage at 25ºC for one month, total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215 nm.

 

These claims will not present an impediment to companies wishing to copy Angiomax^®: that product is sold in lyophilized form and is reconstituted within 24 hours of use, whereas the specification of the ‘928 patent defines “ready-to-use composition” as excluding compositions which have been reconstituted within 24 hours of use.  This is in keeping with the goal, stated in the patent, of providing a bivalirudin composition that does not require reconstitution and which is stable for a long period of time in liquid form. 

 

Claims 19 and 20 are interesting in that they recite the presence of two impurities, viz. [9-10]-cycloimido bivalirudin and [11-12]-cycloimido bivalirudin.  The specification surmises that these impurities are intermediate structures involved in the formation of other, previously-identified impurities; the ‘727 and ‘343 patents are actually directed to compositions having low levels of these previously-identified impurities.  As there doesn’t appear to be any utility for the compositions containing the recited cycloimido bivalirudins, one wonders what would happen if the defense of claims 19 or 20 against the prior art came down to the presence of these two impurities.  An echo of the SKB-Apotex fight over crystalline paroxetine hydrochloride?