Revival of IL 211245 to Neurovision Imaging Inc.

August 17, 2016

he's dead jimIL 211245 to Neurovision Imaging Inc. issued on 1 December 2014 but the Applicant failed to pay the first renewal that was due within three months, by 1 March 2015. After the grace period passed the patent lapsed on 1 September 2015, the patent lapsed and the fact that it had lapsed published in the October 2015 Journal.

On 12 July 2016 a request for reinstatement was submitted. An affidavit from Steven Verdooner, the CEO of the company was appended. According to the Affidavit, back in May 2014, the US patent attorney who handled their portfolio informed them that the patent had issued and requested payment of issue fees and service charges. The issue fees were paid in June 2014.  In January 2016, after the patent had lapsed, the Applicant received a second letter from the same attorney informing them again that the patent had issued(!?). From examination of the section of the email notification appended, Deputy Commissioner Ms Jacqueline Bracha could not determine that the appended notification related to the Israel application, although the corresponding PCT application number was mentioned. Nowhere in the section of the email appended was a specific jurisdiction mentioned. From this there is no indication that the email related to Israel, where the patent had issued a year and a half earlier.

The Affidavit further stated that at some stage, the patent portfolio was transferred to a different US firm. On 2 May 2016, the second US firm informed the Applicant that the patent had lapsed due to failure to pay the Renewal. The request for reinstatement was filed two months later.

In the circumstances described, the Deputy Commissioner was not persuaded that the conditions for reinstatement detailed in Section 60 of the Law were fulfilled. Firstly, more than two months passed from when the Applicant was aware of the patent lapsing and their request to reinstate it. The Applicant made no effort to justify this amount of time passing and to explain what steps had been taken in the meantime. It is not clear that they acted promptly to restate the patent once they were aware that it had lapsed.

The Affidavit did not clarify if the Applicant had received the Patent Certificate and if the Associate (Shilon Zuckerstein) had reported the obligation of paying the first renewal. Even if the Applicant did not receive the Certificate, it is not clear why they did not ask for it once they were informed that the certificate had issued.

The Applicant was represented locally at that time (Shilon Zuckerstein) but not evidence was presented by the attorneys. It is not clear if the Applicants (now represented by Colb) had contacted them prior to producing their affidavit, if they didn’t have information or were not contacted. Thus the Applicant has failed to show that the renewal fee was not paid for reasons that may be considered ‘reasonable’ as required under Section 60 of the Israel Patent Law 1967.

Consequently, the application for reinstatement is rejected.

Request for Reinstatement of IL 211245; ruling by Ms J Bracha, 14 July 2016


Is Evidence Submitted in Response to Evidence Inadmissible?

August 16, 2016

 

inadmissible evidenceThis ruling relates to an interim skirmish regarding the admissibility or otherwise of certain evidence. Specifically, the Opposer is entitled to the last word consisting of a rebuttal of the evidence presented by the Applicant. At that stage the Opposer is not supposed to raise new issues. The grounds for opposition in the evidence should not exceed those in the statement of case. During the period of Opposition, the allowed but opposed patent is unenforceable. The regulations attempt to referee the opposition proceedings so that it moves forwards at a reasonable pace and there are deadlines for each stage. However, the deadlines have some flexibility…

The timeline

IL 169358 is the National Phase Entry of PCT/JP2003/016724 to Otsuka Pharmaceutical Co. Ltd. On 20 April 2013 the Application was allowed and published for opposition purposes. On 29 July 2013 Teva Pharmaceutical Industries Ltd. opposed the patent, submitting their statement of case on 1 December 2013. The Applicant responded on 26 March 2014 and the parties then submitted their evidence.

On 22 December 2014 the Opposer (TEVA) submitted an Opinion by Professor Paul Harrison. On 29 June 2015, OTSUKA submitted an Opinion by Professor Michael Thase. and one by Professor Abraham Weizmann. A counter-response for the Opposer (TEVA) comprising a second Opinion by Professor Paul Harrison was submitted on 13 December 2015.

After the round of submissions as defined in the Patent Regulations 1968 was over, the mutually acceptable dates of 8-10 November 2016 were set aside for a hearing in consultation with the parties and the various expert witnesses.

On 14 January 2016, Applicant (OTSUKA) filed for deletion of paragraphs 78-84  and 86, and appendices 22-26 of Professor Harrison’s opinion as submitted in the second opinion in the response of 13 December 2015. As an alternative submission, OTSUKA requested permission to respond to the issues raised.

On 15 February 2016, the Opposer (TEVA) submitted their response to the deletion request arguing that it was to be rejected. As an alternative, they requested permission to correct their statement of case to relate to the issues in the evidence in dispute. On 7 March 2016, the Applicant counter-responded to the response.

The case

The Application describes pharmaceutical formulations for treating moodiness. MoodinessParticularly depression. The applications includes 9 examples, of which examples 3 and 9 describe clinical trials on mice with serotonin reabsorption inhibitors and with Aripiprezol to test anti-depression effects.

 

During the Examination of the patent, the Applicant submitted a letter of 6 April 2011 with examples detailing the additional combinations of serotonin reabsorption inhibitors and aripiprezol in order to overcome prior art rejections by the Examiner and to show, as they put it, “…that the combination as presently claimed in the Application, has an excellent therapeutic effect for treating mood disturbances”.

Mouse in wonderlandIn Example 3 of the Application and supplementary experimental evidence, use was made of the so-called Forced Swimming Test (FST). In Example 9, use was made of the so-called Tail Suspension Test (TST).

In Section H of the second opinion submitted in response to the Applicant’s evidence, Professor Harrison responded to Professor Weizmann’s claims that what was allegedly surprisingly found in combining aripipre or dihydro-aripiprezol with serotonin reabsorption inhibitors resulting in an enhanced symbiotic effect was fairly obvious.

The Applicant does not deny that Professor Weizmann said this. They claim that the synergistic effect appeared in the statement of claims and that the Opposer could have related to it as they saw fit in their first evidence filing rather than by way of response.

In response to the synergy claim, Professor Harrison raised three points in his second expert opinion as filed in response:

  1. The claims of the patent application are not restricted to formulations having a synergistic effect and the clinical trials described in the application do not demonstrate any synergetic effect between ariprezol / hydro-aripiprezol and the serotonin reabsorption inhibitors. In this regard, Professor Harrison went on to state his finding that examples 5-8 of the application, which related to the combinations, do not provide evidence to any synergy.
  2. The examples described in the clinical trials do not include any relevant control groups that  can enable deriving the conclusion that there is a synergistic effect. In his second opinion, Professor Harrison refers to the first opinion and explains that there is no evidence that any improvement in patients being treated by the combination can be attributed to a synergetic effect of the combination.
  3. The examples allegedly showing a synergistic effect do not necessarily show this. One cannot determine a synergetic effect from the Tail Suspension Test.

Appendices 22-26 are references that are cited by Professor Harrison to demonstrate and to provide a basis for that claimed in paragraphs 78-86 of his second opinion. From the above, one can regard the challenged evidence as evidence submitted in response to the synergistic effect raised by Professor Weizmann in his submission of evidence.

The Applicant does not see this as evidence submitted in response. In the Statement of Case, paragraph 46 relates to the tests performed in examples 3 and 9 and stresses that there is no evidence of a surprising synergy:

The tests described in the Application relate to the combination of ariprezol / hydro-aripiprezol and serotonin reabsorption inhibitors selected from a specific group of chemicals for treating depression and major depression. There is nothing in these tests that demonstrates, even implicitly that the combination has an advantageous or surprising effect over that previously known which describes combining neurolifts with SRI. Specifically, these tests do not prove an advantage in the claimed combination over any combination of ariprezol with SRI.

Section 46 relates to the combinatory effect or synergy between two materials. The things were stated with respect to the examples described in the Application and not specifically with respect to the additional examples.

In light of the above, Commissioner Kling could not conclude that there is no argument with respect to the synergistic effect itself. Furthermore, since the Applicant himself referred to the examples and a claimed synergetic effect, it seems that this point requires clarification and analysis in the framework of the hearing. Thus one cannot conclude that the issue is moot in light of the exchange of statements of case.

The question remains if reference to the supplementary examples is not by way of response. As the Applicant emphasized, these materials were included in the prosecution file and therefore were presumably before the Opposer when the Statement of Case and the evidence submissions were written.

That said, examination of the Applicant’s statement of case does not testify as to which specific examples were considered, and if they limited themselves to examples specified in the application or if they widened their case to include the examples within the prosecution file that were before the Examiner.

To the extent that the alleged synergy effect relates to the supplementary examples, the Opposer reasoned that the Applicant cannot give these much weight in the framework of their evidence. With respect to the supplementary examples, the Opposer stresses that the results were submitted in the evidence stage only, and reference to these in the statement of case itself was merely in a general manner. The Opposer explains that since it was not clear if the supplementary examples, that are not within the application itself, but were only submitted during the examination, would be referred to in the opposition proceedings, they did not relate to them prior to the Applicant introducing them in Professor Weizmann’s Opinion. Consequently, the Opposer claims that relating to these examples in the evidence stage is essentially by way of response.

The nature of evidence submitted in response is defined in Regulation 62:

The opposer is allowed, within three months from when evidence is submitted on behalf of the Applicant, as per regulation 59(b) or regulation 61, to submit counter-evidence that relates to the facts specifically denied by the Applicant in his evidence or to issues first raised in that evidence.

The criterion relevant to our case is the question of facts first raised in the Applicant’s submission of evidence.

The Opposer cannot grab the rope from both ends. The Opposition is a continuation of and a part of the Examination process. See Civil Appeal Shechter vs. Abmatz ltd, p.d. 44(2) 846 and Appeal 665/84 Sanofi vs. Unipharm p.d. 41(4) 729. The material within the prosecution file is available to the parties. Nevertheless, during the opposition procedure, by virtue of the issues raised during the proceedings, the parties are required to identify the material to be discussed in the hearing. Since even from the Opposer’s perspective, the supplementary examples were available in the file wrapper, one cannot relate to this evidence as facts first brought up in the Applicant’s submission of evidence. Since these are supplementary examples, one cannot consider them as evidence suddenly presented for the first time in the Applicant’s submission of evidence.

Nevertheless, in light of the discussion of the synergistic effect in examples 3 and 9, and in view of the not insignificant reference to the supplementary examples by Professor Weizmann in his expert opinion, one cannot consider the supplementary examples irrelevant. The synergetic effect as discussed by Professor Harrison is not a widening of the statement of case.

In several instances the case-law has concluded that the rules of submitting evidence before the Commissioner of Patents are more flexible than the rules governing the submission of evidence to the court. See for examples Appeal 5041/13 Einat Gabai vs. Aminach Furniture and Mattress Industries Ltd, 21 January 2014, where the court discussed the period for submitting evidence and concluded that in legal proceedings before the Patent Office, the test for accepting evidence are more flexible (see paragraph 4 of Judge Hendel’s ruling). The District Court recently reached a similar conclusion in 34039-01-14 Mifalei P.M.S. Migun Ltd cs DSM IP Assets B.V. (12 August 2014) where the court allowed new evidence to be filed during the Appeal as the desire to reach the truth and fair justice was considered over-riding the procedural issues. in that instance, the Court concluded that patents, as opposed to civil law, the rules for allowing new evidence to be submitted were even more flexible. See also 5307-10-14 Orbotech Ltd vs. Camtek Ltd, 8 December 2015.

It appears that in this instance, where the material is anyway in the prosecution file, there is room to be flexible and to allow the parties to contribute to the public interests of the register being correct (i.e. allowing or disallowing patents on the basis of the evidence, not on procedural reasons preventing relevant evidence from being submitted) and further in the interest of efficiency (see Appeal 217/86 Schechter vs. Ambatz ltd. p.d. 44(2) 846, 857) by allowing the additional examples to be considered.

in light of the above, Professor Harrison’s second opinion as submitted in response to the Applicant’s evidence is allowed to remain in the opposition proceeding file as it was originally submitted, and the Applicant is given 30 days to submit short evidence relating to the supplementary examples as discussed in the paragraphs whose deletion was sought – paragraphs 78-84 and 86 of the opinion.

Costs for this interim ruling will be awarded as part of the main ruling.

Asa Kling: intermediate ruling re submission of evidence in Opposition to IL 169358 to Otsuka, 10 July 2016.


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

In an odd development, but not one that without precedent – see here and here – Dr Shlomo Cohen Law Offices has asked the Israel Patent Office to reconsider a judicial ruling.

In this instance, the original ruling relates to the Patent Term Extension (PTE) of IL 169693 to “Bristol Myers Squibb” and Pfizer that issued under section 64(v)5 of the Israel Patent Law. The original ruling issued in September 2015, and granted a patent term extension of 974 days until 18 May 2025. That ruling followed a challenge by the patentees to Examiner’s decision of 5 March 2015.

The way that Patent Term Extensions (PTEs) are calculated in Israel is detailed in Read the rest of this entry »


Lapsed Patent for Monitoring Flow of Sewage Reinstated

July 25, 2016

renew

Israel Patent Number IL 214216 titled “SEWAGE FLOW METERING METHOD”to Roberto Cymmerman lapsed due to failure to pay the first renewal. The patent issued on 1 July 2015 and so the deadline for renewal was 1 October 2015. The payment was not paid on time. Nor was it paid during the six month grace period under Section 57 of the Israel Patent Law 1967. The fact that the patent had lapsed had not published.

On 30 May 2016 the Applicant requested reinstatement via legal counsel but a Power of Attorney appointing the legal counsel was only submitted after a ruin from 6 June 2016.

An affidavit from Patent Attorney Yoram Savyon who had previously represented the Applicant was submitted. From the Affidavit it transpired that the firm uses a computerized renewal system that was updated on receipt of the notice of allowance; with a calculation of the anticipated date of grant. Based on this, the final deadline for paying the forthcoming renewal was entered. (Further renewals are derived from the filing date and are entered with the filing of the application).

In this instance, the worker who manages the database did not enter the first renewal (which is based on the issue date), but did enter the subsequent renewal date. That the patent issued was reported by the office manager to the relevant worker and it is not clear why he failed to enter the information.

According to the Affidavit, some two months before the final deadline for paying the second renewal, i.e. in May 2016, the Applicants were informed of the deadline and then it transpired that the first renewal was not paid as the deadline was not entered into the system. The Affidavit also noted that for mistakes of this kind, the worker had already been fired.

Deputy Commissioner Ms Bracha noted that the patent itself was filed on 20 July 2011 and so the deadline for the second renewal (years 6 to 10) was 20 July 2017 and not 2016 as claimed in the Affidavit. This mistake raises eyebrows to some extent with regards to the facts detailed in the Affidavit as to how the mistake was discovered. Nevertheless, the mistake for not paying the fee in a timely manner that was detailed in the Affidavit does fit in with the requirements of Section 60 of the Law and so (intent and due care – MF) and so, provided the fee is paid in a timely manner, Deputy Commissioner Ms Jacqueline Bracha saw fit to allow reinstatement, together with an opportunity to the public to oppose.

Ruling by Ms Jacqueline Bracha concerning reinstatement of IL214216, lapsed due to failure to pay renewal fee, 20 June 2016.

COMMENT
In this case, a human error resulted in failure to insert a date into a spreadsheet or dedicated program by a poorly trained and incompetent clerk who was subsequently fired. In the Colb ruling, hand-written renewal records and a more excusable error were considered a lack of due care. I argued that even computerized systems required data to be correctly entered and extracted. In this case, there seems to be a bug in the system for calculating subsequent renewals in that five years and not six is hard wired into the system (or perhaps the filing date was typed in a year early by mistake?!). There is a second error blamed on the office junior who was righteously fired, but was he/she at fault? The main thing justifying this case being considered due care seems to be the use of a computer system, despite it having a bug and being operated by someone incapable of data entry. I consider this standard of due care to be overly reliant on there being a computerized renewal system in place. Objectively, there were apparently two errors here and no indication that there was any intention to pay the first renewal in a timely manner whereas in the Colb case there was one error.


Shabbat Lifts Not for the Public Good

July 18, 2016

 

shabbat liftG.L. Glatt Lift Company Ltd. filed a patent application for a Shabbat Lift; an elevator that may be used on the Jewish Sabbath without transgression of the holy day. (The term Glatt relates to a standard for Kosher beef that the generally accepted Ashkenazi authorities consider a stringency. By transference, the term implies super-Kosher, or something similar. Many Jewish authorities allow usage of a lift that stops automatically, or riding in a lift in a hospital or similar if someone assumed to be non-Jewish operates it for their benefit. Other authorities are stricter. More discussion on this is given at the end of this article).

Maalit ShabbatIn this instance, the Applicants have filed a patent for a technological Hallachic solution that is allegedly novel and inventive and that is claimed to overcome the reservations of those Hallachic authorities that do not allow usage of the type of ‘Shabbat Lifts’ that are common in apartment blocks with religious residents.

Israel Patent Application No. IL 221842 titled “Shabbat Lift” was submitted on 9 September 2012. The application claims priority from a US provisional application number 61/533,244 that was filed on 11 September 2011, and a corresponding PCT application, No PCT/IB2012/054604 was also filed.

On 13 October 2015, the Applicants received a Notice Prior to Examination to which they responded on 1 February 2016 with a list of prior art. The submission of a response to the Notice Prior to Examination creates a state of affairs by which the application is ready for examination (see section 5.3 of the Examination Procedure for Examiners).

On 1 February 2016 the Applicant also submitted a request for accelerated examination, which is a petition to make special. The justification for the request was that awarding the patent was in the public interest.

The Applicant claimed that the lack of appropriate Shabbat lifts prevented high-rise accommodation for the Ultra-Orthodox and the proposed solution would overcome this barrier. The Applicant considered that his invention would facilitate high-rise Ultra-Orthodox accommodation and thereby minimize land usage (by increasing the population density) and would thereby lower building costs.The solution would also make life easier for the ill, the elderly and children who could not use elevators on Shabbat. Various articles regarding the lack of accommodation for the Ultra-Orthodox were appended.

The statement was not specific, but it appears that the legal support was claimed from Section 19a (v) and (vi) that state that:

An applicant for accelerated examination with reasonable arguments may submit a reasoned request, together with a statement supporting the facts; all of the following, inter alia, may be considered reasonable justification:

(5) common good;

(6) special justifying circumstances.

Generally patents are examined in turn so ‘first come, first served’ as per Section 9 of the Patent Law:

If more than one applicant request a patent for the same invention, he that first applied will prevail. 

The order of examination is generally on a ‘first come, first served’ basis as per Section 34a of the regulations:

34a the applications will be allocated to each internal classification group and within each classification group, will be examined in turn. 

Examination in turn both facilitates Section 9 and also ensures that relevant prior art is available to the Examiner. The first come, first served regime is itself in the public interest – See ruling re Petition to make special Israel Patent Application no. IL 216870 to Cimas Limited, 24 March 2014.

The possibility for making an application special is an exception to the general rule. It undermines the principle of ‘first come first served’, makes the examination more difficult and arguably damages the quality of the examination.  For example, a queue-jumping application may be examined and allowed without realizing that an earlier filed application that was not examined challenges the novelty or inventiveness of the claims. Any fast-tracking results in other applications being delayed and is thus against the public interest.

Fast-tracking risks unfairness, but the legislators allow it under circumstances detailed in Section 19a of the Law where there is an over-riding public interest or special circumstances. Section 19a was legislated in the 10th amendment to the patent law that came into effect on 12 July 2012. From examination of the discussion at the committee state it is clear that the Commissioner has the discretion to explain the law. It is clear that the type of justification that is acceptable is extreme circumstances. For example: there could be circumstances that a dramatic discovery is like an earthquake and is positive for the State of Israel. Isaak Herzog, Knesset legislative committee discussion of 13 March 2012.

The justifications listed in Section 19a were actually those for third parties to request an application be fast-tracked but there is no reason to suppose that they are not applicable to requests by the Applicant himself. Nevertheless it appears that what the legislators intended was something of interest to the entire population as of national interest for the whole population and not for micro-economic interests of one sector or another. There is an underlying assumption of public interest in all patents. The only justification for ever granting a patent (i.e. a monopoly, albeit limited in time and geographical application) is that there is a national interest in micro-economic profits and technological progress.

No-one challenges the fact that each patent provides a different public interest depending on the type of invention and its application. There is no clear economic or social scale that can be used to rank different patents. However the same term is generally understood in the same manner in different legislation to provide coherency (see Aharon Barak, Volume 2, Legislative Interpretation, Nevo 1993 pages 313 and 321. Thus the term “common good” in Section 19a of the patent law is a priori similar to the term in Section 122 which discusses forced licenses. Section 122 states:

The Commissioner, where he comes to consider the request for a compulsory license under Section 117 should consider, inter alia:….

….

(2) the common good generally obliges that all inventions should provide the protected goods by manufacturing or import, so enable widest possible supply in the circumstances, without delay.. 

The District Court ruled in 881/94 Eli Lilly and Company vs. TEVA Pharmaceuticals LTD 25 November 1998:

In the field of patents, the common interest is the main and dominant cause for determining balances and rights. There may be a specific basis for worrying for private interest of the specific owners, and a patent an be considered as a reward that the legislators bestows on the entrepreneur. But the main justification of the patent system is the public considerations of utility and profit that affect the community taken as a whole. Whilst it is true that a patent provides protection to an individual, the existence of the right and its extent are determined by how much they fulfill the public interest. In this regard a patent is like a compulsory license. In both cases a personal right is provided to an individual but the underlying rationale for granting the rights is the common good. Just as the compulsory license is not granted for the benefit of the applicant, similarly a patent is only granted to the owners because it is in the public interest. It is not a balance between private rights and the public interest, but rather a balance between different public interests that together define the common good.

Thus the common good in this instance, as with compulsory licenses, is the result of balancing different public interests. Where the Applicant desires to depart from the general balance of interests including the principle of ‘first come first served’, the justification for jumping the queue has to be something weighty of significance to the wider public or a positive macro economic effect.

Furthermore, from when the application is filed until it eventually issues as a patent, there is nothing preventing the applicant from implementing the invention described in the patent application, enabling the public to benefit immediately. The enforcement of a patent is of economic interest to the patentee only. First tracking is not in the public interest at all. It only serves the applicant.

Without addressing the issue of patentability at all at this stage, the Commissioner does not thing that the present invention is more ‘public good’ than other inventions and, as the applicant himself testified, it serves a specific population segment only. The petition to make special did not include any economic calculation to show why it was justified.

Although the above arguments relate to the ‘public good’ they are equally applicable to the ‘special reasons justifying advancing the examination’. Consequently the application for fast-tracking is rejected and the application will be examined in turn.

Ruling by Commissioner Asa Kling Concerning Making Special Israel Patent Application Number IL 221842 to Glatt Lifts LTD., 14 June 2016 

COMMENTS

Very few inventions positively affect everyone. If something could help 10% of the population, it seems to me that it should be considered of significance, whether the population is women, AIDS sufferers, people living near the Gazan border, parents of small children or the Ultra-Orthodox. I don’t see any reason why common good should be interpreted as of value to people across the population without regard to race, age, religion, religiosity or sexual orientation.

The underlying presumption of the Applicant is that conventional elevators do more electrical work for each passenger riding in the elevator and that this is against the laws of Shabbat to rely on Shabbat settings on lists. If this assumption is true, it affects all Jews and most of Israel’s population is Jewish. Even if many Jews are not Observant, and many more are not persuaded that using currently available Shabbat lifts are not acceptable I suspect that from the Applicant’s perspective, Shabbat observance is of value and desecration is problematic regardless of the religious philosophy of the Jew in question. It may be what’s preventing the Messiah from coming. Furthermore, the State of Israel accepts the principle of Shabbat observance as being of national interest by not allowing trading on Shabbat and by not having Shabbat desecration by the Head of State, ambassadors, etc. and by requiring Shabbat observance on army bases apart from where security considerations take precedence.

For more details of the ruling (wrongly???) attributed to Rav Elyashiv, see here. See also a report in the Yeshiva World (sic) and one from the UK’s Daily Telegraph. Rabbi Yisrael Rozen’s ruling allowing both ascending and descending in Shabbat Elevators and listing what modifications are required to enable an elevator to be used on Shabbat may be found here (Tchumin 5, 75; see also article by Professor Lev in same volume, page 58).

I took the liberty of reviewing IL 221842 to Glatt Lifts LTD and its claims. If I was examining it for patentability, I would disallow it as not being enabled. It may be enabled from the perspective of the Hallachic problem it is trying to solve, but in my opinion, it does not provide a solution that enables a person of the art to go away and build a working lift without undue experimentation which is the standard for which patent applications are judged.


Amending the Specification of an Opposed Patent Application

July 7, 2016

abbvie.png

Under Israel Law, allowed patent applications publish for opposition purposes for three months prior to issuing. If an opposition is filed, the issuance may be delayed for rather longer, if the patent issues at all.

As a general rule, the Applicant may amend ‘scribal errors’ i.e., typos in the specification and may narrow the scope of coverage of the claims, but cannot add material or widen the claims to cover something not previously within their ambit. In practice, applicants often request amendments that are allegedly permissible but which the opposer considers as somehow adding material or widening the monopoly sought. Sometimes amendments are opposed as a delaying tactic as until a patent issues, it cannot be enforced.

In the present instance, the application in question is IL 122546 to Abbvie Inc. titled “COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME”, which was filed two decades ago on 28 June 1996 by Abbot Laboratories as the national phase of PCT/US1996/0011015 which itself claims priority from a US provisional application (no 60/000654) filed on 29 June 1995. The case was transferred to Abbvie in June 2013.

The case was allowed and published for opposition purposes on 31 January 2012, and on 29 April 2012 oppositions were filed by Vertex Pharmaceuticals and by Teva Pharmaceutical Industries LTD.

Abbvie petitioned to amend the claims and this interim ruling relates to the proposed amendment and examines whether it is supported and whether it is indeed a narrowing of the scope of the claims.

last minuteIn his ruling of 2 May 2016, the Commissioner Asa Kling allowed the amendments to the claims but this is an interim ruling anyway and the patent, if eventually granted, will lapse anyway 20 years from filing on 29th June 2016. This begs the question as to the point of continuing with the opposition?!

The ruling has been carefully translated and is reproduced below but I have added a break as it may not be of interest to everyone…

Read the rest of this entry »


Israel Commissioner Vindicated by Supreme Court

June 22, 2016

appealMerck & Co. LTD is the exclusive licensee of IL 110956 for Ezetimibe owned by Schering Corporation. The patent protects the active agent Ezetimibe as found in the pharmaceutical Ezetrol, or Zetia, which reduces the amount of cholesterol in the human body. The original 20 month patent term lapsed on 13 September 2014. However, on 22 September 2005 the patentee received a patent term extension until 23 June 2017. Later however, in September 2014, following a submission by the Association of Industrialists in Israel, the Commissioner of Patents, Assa Kling, ruled that the patent term extension for IL 110956 for Ezetimibe be shortened until 22 January 2016 on the basis of the subsequently issued, shorter patent term extension of the corresponding US patent, and awarded costs of 40,000 Shekels from Merk to the Association of Industrialists.

constitutionalMerck, represented by Liad Whatstein, appealed the ruling, using arguments that failed to persuade the Commissioner, including that the law itself was unconstitutional since it destroyed property rights which were recognized in basic laws (section 8 of the Basic Law of Human Dignity and Freedom. 1980. Furthermore, the fact that the subsequent amendment to this section is not retroactive supports the allegation of lack of constitutionality.

In Appeal number 5407-11-14, the Jerusalem District Court upheld the constitutionality of the Law but recalculated the extension until October 2016 based on the duration of the corresponding German patent.  On 11 April 2014, a tribunal of Supreme Court Judges Danziger, Hendel and Shaham heard an Appeal by Merck on the constitution issue, and one by the Association of Industrialists in Israel wanting the shorter term calculated by the Commissioner to be restored. The Association of Industrialists in Israel were represented by Adv. Tal Band, and the Legal Counsel to the Govt. Ms Shimrit Golan joined the Appeal on behalf of the government.

On Appeal Judge Hendel of the Israel Supreme Court reviewed and justified the various amendments and ruled that shortening the period of a previously ruled Israel Patent Extension Order during the 20 year pendency of the original patent was constitutionally sound, as was doing it on the basis of a subsequently issued shorter protection period from a recognized country.  Judge Handel painstakingly but beautifully explained the background to the patent term extension legislation and why it was filling to link Israeli extension periods on those granted abroad. He jsutified the extension regime which is an exception to patent norms, and threw out Merck’s argument. The rigorous analysis was concluded by a section on comparative law where Judge Handel first related to Mishpat Ivri (Jewish Civil Law) and showed that there were echos of intellectual property rights in the Talmud, and that scholars of the 19th to 21st centuries related to patent law. He argued that the Jewish tradition recognises both quasi-property rights in inventions and creative activity but frowns upon tradesecrets, particularly with respect to pharmaceuticals, noting the case of Rabbi Yohanan a handsome scholar that lived in Zipporis in the Galilee who contracted scurvy, and then broke the trust of a roman matron that cured him, revealing the cure in his sermon, because of the public interest. The analysis of the Jewish sources was masterful. Then Judge Hendel briefly reviewed the US law and its developments, concluded that the US and Israel were both trying to create a fitting balance between the needs of the drug developers to benefit from a real period of protection after obtaining regulatory approval to enable them to sell their drugs at a premium and recoup their investment, and the needs of local generic drug companies to be able to compete with their foreign counterparts but them being able to conduct acts required to obtain regulatory approval during the extension period. Judge Handel noted that there was public interest in encouraging drug development by pharmaceutical companies who had to make enormous investments to bring new treatments to the market. However, there was also significant public interest in widespread and affordable drugs.

Merck’s appeal was rejected by Judge Handel and Judges Danziger and Shaham concurred without comment. Judge Handel noted that were Merck NOT to have appealed, the Appeal by the industrialists on the District Court’s actual calculation would not have been heard, so Merck’s second appeal actually resulted in a shorter patent term extension than they would have received otherwise.

I consider this ruling objectively important and very well written. Due to the significance of the issues raised, I have translated the entire ruling to make it available to non-Hebrew speakers, noting that computer translations were of little value. I have posted the full translation below the following page break as a public service. I have not used the term ‘ethical’ which Judge Handel used to refer to the drug developing countries, and occasionally have not translated idioms, or used an English language metaphor where it appears to be appropriate. The illustrations to the ruling are my contribution. I think they liven things up a bit. If you find them distracting, adjust your settings to view text only! Please note, translating this took a few days and I put billable work aside to the chagrin of various clients. I would appreciate that anyone using this translation has the decency to attribute and to link to this blog.

Read the rest of this entry »


Follow

Get every new post delivered to your Inbox.

Join 816 other followers