Changing of the Guard

July 11, 2017

changingThe various professional organizations representing the IP profession in Israel (LES, AIPPI and IPAA) cosponsored a reception to honour outgoing Commissioner Asa Kling and incoming commissioner Alon Ophir.

The event was held on Sunday in the Israel Yaffe conference center just North of Tel Aviv.

As an IP blogger, I felt obliged to attend and to write about the event. However, it was singularly non-memorable.

About 90 practitioners turned up, including some of the senior members of the profession that rarely patronize IP events. Other senior members were absent. This could, however, be due to vacations and the like.

dinosaurNachman Cohen-Zedek, as the last of the dinosaurs, spoke some words of introduction. I could not tell what he said, and nor could the other participants sitting in my area. The acoustics were poor and most of the speakers forgot to talk into the microphone. Asa used a projector to show a power-point presentation, however, it was out of focus and poorly illuminated, so apart from noting that the talk was illustrated with a steady increase in pink clouds with writing on them, I can’t actually report what he spoke about.

TOMERAs he is wont to do at various events, Dr Zebulum Tomer took the microphone, ostensibly to ask a question but in practice to give a little speech. He clearly believes that his one man crusade against poor pharmaceutical patents is a public service, which it is. However, those developing drugs are also serving a public interest. I don’t think anyone needed reminding that he is not an attorney but an industrialist. He reminds everyone at all events. The lawyers present generally look down on industrialists, and are certainly jealous of his competence in opposing patents which outshone that of anyone present.  The patent attorneys probably were a little jealous, still half wishing we actually made something instead of pushing paper.

Alon OphirThe person compering the event noted that Alon Ophir is the second commissioner named Ophir and that we will have to relate to him as Ophir the Second or some such to avoid confusion. This was a reference to former Commissioner Martin Oppenheimer who Hebracised his name to Michael Ophir. Commissioner Ophir seemed very young. He is a Kippa wearing practitioner which fueled speculation about whether his appointment reflected activism in Bayit Yehudi, the political party that the Minister of Justice represents. The press releases about Commissioner Ophir’s appointment mentioned how impressed the committee was regarding his vision. I was disappointed that he did not explain what his vision was. He noted that obviously outgoing Commisioner Kling did a great job, what does seem to be his focus is in decreasing pendencies and making the patent office ever more efficient. He expressed surprise and disappointment that more Israeli applicants were not first filing in Israel and accelerating examination to get an opinion before having to file abroad and applying the discount when filing PCT applications. He attributed the failure to ‘probably inertia’. Whilst accepting that some practitioners do use time-honoured strategies without consideration of changes, I don’t think this is the whole answer, and hope that the commissioner tries to listen and discuss with the profession instead of assuming that they are all lazy. I had to leave early as I had a ride with another attorney, who on leaving the hall early told me that we would be stuck in traffic. I suggested that perhaps we should go back in and leave later. He thought for a minute and said that he’d prefer to be stuck in traffic. I think this says it all.

With the attraction of introducing a new commissioner and thanking his predecessor, and with July being generally a quiet month, this was an opportunity to hold a stimulating event with the participation of some of the senior practitioners. The organizers chose to invite paid up members instead of reaching out to potential members, and did not consider how to make the event fun or intellectually stimulating. I think this is a shame and a lost opportunity.  It was however, correct and proper that an event happened.

I went on to a Bat Mitzva party. The 12 year-old girl celebrated by completing a tractate of the Talmud. it was the type of event where friends of the parents are Western immigrants with higher degrees and there were a number of patent attorneys present. One noted that his clients filed patent applications in Israel but did not want to speed up examination, and he thought that the changes in recent years whereby one cannot simply suspend examination indefinitely and cannot suspend at all without paying to do so, were commissioner efficiency drives that served no purpose. Readers in the know will not be surprised to learn that the practitioner was ex Fenster & Fenster. This approach, which enabled amending the spec and claims in light of infringers and deferring prosecution and allowance unless a patent was needed, was, though legal, nevertheless an abuse of the system. However, it does emphasize that practitioners are supposed to work the system for the benefit of their clients. Commissioners are supposed to ensure that the system works efficiently and such abuses don’t take place. We are on different sides of the fence.


Reviving an Inflatable Refrigerator…

July 6, 2017

renewIsrael Patent Number 190365 to Abraham Klanss titled “Inflatable Refrigerator and Freezer” lapsed due to failure to pay the second renewal. The Application was submitted on 23 March 2008, and so the deadline for paying the second renewal for years 6-10 was 23 March 2014.

When both the deadline for paying the renewal and the six month grace period passed, the Application was considered lapsed and a notification to that effect published in the November 2014 Israel Patent Office Journal.

From the Affidavit submitted with a request to reinstate the Application it transpired that Applicant had transferred the issue to Advocate Dror Matityahu, but the address of record in the Israel Patent Office was that of Patent Attorney Yoram Tzavyon.

From correspondence between Advocate Dror Matityahu and Patent Attorney Yoram Tzavyon it appears that the Advocate had paid the fee, despite the previous arrangement being that Tzavyon would handle the renewal.

The Applicant received no updates from his lawyer. In January 2017, after trying in vain to contact the lawyer, the Applicant received a status update from the Israel Patent Office and learned that the patent had lapsed.  The first attempt at reinstatement was submitted on paper in April. The current regulations require such requests to be submitted electronically and this happened the following month.

The circumstances described above are extreme. If Attorney Matityahu did indeed pay the renewal fee, he certainly did not send proof of payment to the patent office so the renewal was not registered in a timely manner. The Applicant for restoration has affirmed that he is unable to make contact with his lawyer so cannot clarify if the renewal was indeed paid as stated.

Section 60 provides for restoration if a request to restore a patent is submitted in a timely manner. The time that had passed since learning of the problem in January and first attempting to reinstate in April was considered by the Deputy Commissioner as being just about timely, it being noted that all the information was available from the database published on Israel Patent Office website, without requiring contacting the secretariat. The Applicant stated that he did not want the patent to become abandoned.

All things considered, despite the doubt, the Applicant can be considered as having fulfilled the requirements of Section 60 and so the Application for reinstatement is published for Opposition purposes provided the missing Renewal is paid.

Decision by Deputy Commissioner Bracha re Reinstatement of Israel Patent IL 19035, 26 January 2017.


Teva Abandons Opposition but Application Ruled Invalid Anyway

July 5, 2017

 

AstellasAstella Pharma filed Israel Patent Application No. 178249 titled “Pharmaceutical Composition for use in Solid Formulation Crystalline Solifenacin or Salt Thereof and a Process for its Preparation”. The Application was the national phase of PCT/JP/2005/005377 which was filed on 24 March 2005 and claimed priority from a couple of earlier US provisional applications.

The Application relates to a solid pharmaceutical containing Solifenacin or Solifenacin Succinate that is up to 77% amorphous as determined using NMR.

solef moleculeThe Application was allowed, and on 27 February 2002 Teva Pharmaceuticals submitted an Opposition. On 26 June 2013, Astella requested permission to amend the specification. Teva opposed some of the amendments and in an interim ruling of 19 May 2014 Ms Jacqueline Bracha approved some of the amendments, which were then published for Opposition purposes, and since no oppositions were submitted, were then allowed. This ruling relates to the amended specification.

On 29 July 2015, instead of submitting an amended statement of case, Teva abandoned the Opposition. Nevertheless, on 27 March 2016, in a detailed ruling, Ms Bracha explained to Astella that under the Authority granted by Section 34 of the Law, she was refusing to grant the patent. The ruling was based on two publications that Teva had submitted in the Original statement of case that showed that persons of the art would expect the rate and degree of solubility to increase with increased amorphousness of a tablet. On 22 May 2016 the Applicant requested an oral hearing which was held on 4 January 2017 and this ruling follows that hearing.

Applicant’s Claims

Astella, represented by Gilat Bareket, claimed that in a Section 34 proceeding, the burden of proof is on the Commissioner. The claim that since the Opposition was abandoned and following allowance by the Examiner, there is an assumption of validity. Therefore, the Commissioner has to overcome this rebuttable assumption.

The Applicant claims that the prior art describes a process for fabricating Solifenacin hydrochloride crystals. It did not relate to amorphous Solifenacin or to degradation of the amorphous Solifenacin or to medical formulations comprising Solifenacin Succinate.

The Applicant claims that there is a continuous decrease of the active ingredient due to degradation which they determined to be due to the amorphous Solifenacin that is produced in when preparing the tablets.

The Applicant clarified that restricting the amount of the amorphous Solifenacin to no more than 77% increases the stability and reduces degradation to rates tolerable in Japan. Furthermore, the Applicant found that when the fabrication process is wet granulation they can control the amount of amorphous material by controlling the moisture levels. They also claim that using PEG as a binder also lowers the degradation, however the Deputy Commissioner notes that this was not claimed and is thus not part of the invention.

As stated, the invention is intended to provide a stable formulation with less than 0.4% degradation of Solifenacin Succinate in the total amount.

The discussion related to the following publications:

  • Ahlneck and G. Zografi., The Molecular Basis of Moisture Effects on the Physical and Chemical Stability of Drugs in the Solid State,Int. J. PHARM., vol. 62(2-3) (1990) – “Appendix 10”;
  • Y.Shalaev and G. Zografi., How Does Residual Water Affect the Solid-State Degradation of Drugs in the Amorphous State?, J. PHARM. SCI., vol. 85(11) (1996) –  “Appendix 9”;
  • C. Hancock and G. Zografi., Characteristics and Significance of the Amorphous State in Pharmaceutical Systems, J. PHARM. SCI., vol. 86(1)(1997) – “Appendix 11”.

The Burden of Proof

The Applicant alleges that the burden of proof resides with the Commissioner. In Y Kedmi “On Evidence”, 4th Edition 2009, it is stated that the burden of evidence depends on the substantive law:

The determination regarding which side bears the burden of proof depends on two basic principles:

  • “The one seeking redress has the burden of proof” [Baba Kama 46a] and this may be plaintiff or the defendant, depending on circumstances.
  • “Evidence follows the Substantive Law” – both when establishing the basis of the legal claim / defense, and when overcoming presumptions.

burden of proofAs a general rule, the burden of proof that a patent application is registerable is on the Applicant see 665/84 Sanofi ltd. vs Unipharm ltd. p.d. 41(4) 729 and Appeal 645-06-13 Unipharm vs. Lilly Icos, 26 January 2014.

The Opposition is considered as a completion of the Examination, and the allowability is reconsidered. It serves to protect the integrity of the register and the executive examination, see Opposition of IL 136482 Bromium Compounds ltd vs. Albermarle Corporation USA, 7 November 2010:

It appears that the attitude of the court has changed since then. Now the Supreme Court sees the Opposition process as a completion of the executive examination that is designed to ensure the public interest and the integrity of the register.

The public interest that the Opposition proceedings serves is detailed in 2826/04 Commissioner of Patents vs. Recordati Ireland Ltd. p.d. 59(2) 85.

The purpose of the Section 34 proceeding is identical to that of Oppositions, i.e. to maintain the integrity of the register, see the Section 34 ruling concerning IL 156034 Serguei Borisovish Sivolovenko vs. Diamcad NV, 25 January 2015:

The Section 34 proceeding is another hurdle that the Applicant may have to negotiate before receiving a patent. During this proceeding, the Commissioner is allowed to consider all the material before him from the Opposition proceeding, and to decide whether to uphold the Examiner’s decision or to change it. The purpose is no different from that of Examination or Oppositions, and is to protect the integrity of the register and the public interest to not issue patents contrary to Section 3 of the Law. Successful negotiation of the Examination stage does not bestow a right to a patent.

The patentee’s right to a monopoly for the patented invention is in rem. Consequently he has to show that the invention fulfils all the requirements of patentability under the Law. The burden of proof only changes once a patent issues. This was clarified by Commissioner Kling in IL 142896 and IL 179379 Medice Arzneimittel GmbH & Co.KG Alkermes Pharma Ireland Ltd, 4 April 2017.

In a cancellation proceeding, the burden of proof that a patent is invalid is on the Requester for cancellation. For example, this was established in Appeal 8802/06 Unipharm ltd. vs. Smithkline Beecham PLC, 18 May 2011:

Section 37 of the Law completes this idea by establishing that Examination and granting of a patent do not guarantee it has validity. So the issuance of a patent by the Commissioner does not create a non-rebuttable assumption of validity. It merely establishes that the Commissioner considered it issuable. (appeal 47/87 Hasam Systems for Defence of Trustworthiness ltd. vs. Bahari, p.d. 45(5) 194, 201-202 (1991). However, the burden of proof that an issued patent is invalid is on the party claiming invalidity (See Appeal 665/84 Sanofi vs. Unipharm ltd. p.d. 41(4) 729, 736 (1987), Appeal 700/78 Isisco International Company for Solar Energy Systems ltd. vs. Banit, p.d. 34(1) 757, 763 (1979).
Thus, before a patent issues, the burden of proof is on the Applicant.

Validity of Patent Application

On page 2 of the Application, the Applicant notes that solifenacin was known as was its efficacy for treating diseases of the urinary tract, salts of solifenacin and the crystalline state of solifenacin hydrochloride and methods of manufacture.

VesicareSolifenacin Succinate was used in Vesicare, see accompanying flyer which was published in December 2004, before the priority date of the present application. The synthesis of Solifenacin Succinate is also described in the prior art (Appendix 3 of the Opposer’s Statement).

The Applicant claims that during development of the formulation they discovered that there is degradation where the amorphous state is present. The Applicant claims that the prior art was unaware of this phenomenon and thus did not address it.

Appendix 9 page 1137 teaches that exposure of solid pharmaceuticals to high moisture results in degradation:

“It is widely recognized in the pharmaceutical field that exposure of solid drugs (small molecules or proteins) to high relative humidity and the resulting association of water vapor with the solid generally accelerate the rate of chemical degradation.”

Further on it is mentioned that the instability typically occurs in the amorphous part of the formulation:

“…most instabilities observed for drugs occur in solution much more readily than in the solid state; when they do occur over practical time scales in the solid state, it is very likely that the reaction is taking place in the more disordered amorphous regions of the solid. Indeed, it has been shown in a number of cases that under otherwise identical conditions reactivity of a particular substance in the amorphous state is greater than that in the crystalline state.”

Appendix 11 teaches that in cases where the active ingredient is found in an amorphous form, this is likely to accelerate the degradation. However, sometimes, the amorphous form spontaneously crystallizes:

“The high internal energy and specific volume of the amorphous state relative to the crystalline state can lead to enhanced dissolution and bioavailability, but can also create the possibility that during processing or storage the amorphous state may spontaneously convert back to the crystalline state.

… In the first, a material may exist intrinsically in the main amorphous state or it may be purposefully rendered amorphous and we would like to take advantage of its unique physical chemical properties. Under these circumstances we usually want to develop strategies to prevent physical and chemical instability of the amorphous sample. In the second case, we may be dealing with a crystalline material that has been inadvertently rendered amorphous during processing. This type of amorphous character usually exists predominantly at surfaces at levels not easily detected and has the potential to produce unwanted changes in the physical and chemical properties of the system. In this situation we usually want to process the system so that the amorphous portions of the solid are converted back to the most thermodynamically stable crystalline state.”

amorphousThe Application describes attempts by the applicant to prove that there is a connection between the amorphous state and the results of degradation F1 (table 2 on page 38 of the Application.

The Applicant compared the stabilities of samples 1-4 that included 63%, 73%, 715 and 7% amorphous material, with samples 1-3 that contained 92%, 90% and 92% amorphous material. However, the results of table 2 do not show a clear correlation between the amount of amorphous material and the F1 decomposition product. For example, example 1 had 63% amorphous material but only 0.31% F1, whereas example 2 had 73% amorphous material but only 0.29% F1, and in comparative sample 1 with 92% amorphous material  there was 0.48% F1, and in comparative sample 3 with 92% amorphous material  there was 0.4% F1.

Furthermore, as can be seen from table 2, the moisture of the granulate influences the F1 breakdown product, and can at least partially explain the difference between the results of comparison samples 1 and 3. The Applicant claims that there is some correlation between the water content of the granulate and the amount of amorphous material but it is not certain that the amorphous material content influences the amount of F1 degradation product.

japaneseFurthermore, it appears that the 0.4% limit that the Applicant set was based on the Japanese Health Ministry requirements and was not empirically determined. The Applicant admits that the Japanese acceptable limit was 0.5% and 0.4% is preferable. Table 2 shows that even where the amorphous quantity exceeded 77%, less than 0.5% of F1 was obtained.

Even if we assume that the Japanese Ministry of Health limits are desirable, the applicant has not established that there is a problem attaining these limits that the invention overcomes, due to the stability of the salt. The 77% amorphous material limit is also not empirically established. The Applicant was not able to produce Solifenacin Succinate with more than 0.5% F1 degradation product, and there is no linear connection between moisture content and amorphous material content.

Applicant does not deny that amorphous Solifenacin Succinate can spontaneously crystallize (see Appendix 2 and letter of 5 December 2012 and “Analysis of Appeal in European examination file from 17 April 2012 that the Applicant submitted in the corresponding European application. The slight differences in F1 product are even less significant due to this spontaneous crystallization.

There are a few more paragraphs regarding the various compositions and the binder (that wasn’t claimed and then, the Deputy Commissioner states that) from another angle, Appendix 9 teaches that there is a close connection between moisture and the amount of amorphous material present – page 113:

“Generally, for reactions occurring in the amorphous solid state, the rate of reactivity increases with increasing water content, and this can be attributed to the ability of the amorphous solid to absorb water vapor into its bulk structure, forming an amorphous solution. In a few cases it has been reported that a certain amount of water must be present to ensure chemical stability, e.g., lipid peroxidation rates decrease with the addition of small amounts of water; however, a destabilizing effect of absorbed water is more generally the case for the major types of drug degradations, e.g., hydrolysis, oxidation, or deamidation.”

So it seems that average persons of the art at the time in question would conclude that limiting moisture would limit the amorphous material in the formulation and this would, in turn, limit degradation. Consequently, this has no inventive step whatsoever.

CONCLUSION

The invention is wholly lacking in inventive step and so the IL 178249 Application is rejected.

COMMENTS

I am not a pharmacist, but have a fairly strong background in chemistry. It seems to me to be fairly obvious how to control the crystallization rate and extent, and how this will affect solubility. Possibly high school thermodynamics in inadequate, but a basic undergraduate course of chemical thermodynamics is more than adequate to predict this invention, so it seems to me that the Deputy Commissioner was correct to refuse the patent.

Formally, the Opposer is wrong to claim that the onus of proof is on the Commissioner. The case-law considers the Opposition proceeding as part of Examination and does not assume that the Examiner concluding that an invention is patentable establishes a presumption of validity. TEVA’s withdrawal of their Opposition may have been a commercial decision. In practice, although formally Israel requires an inventive step, an Examiner has to show anticipation or obviousness not to grant a patent. TEVA made some of the scientific literature of record, and the Deputy Commissioner was correct to relate to it.

This decision seems to be correct. However Astella, may appeal it to the courts.


Dummy Targets and Decoys

June 29, 2017

This ruling relates to claim construction and permissible amendments.

IAIIsrael Aircraft Industries submitted Israel Patent Application Number 190197 titled “Method for Performing Exo-Atmospheric Missile’s Interception Trial”  back in March 2008.  The application was first filed in Israel and does not claim priority from foreign applications. On allowance, the application published for opposition purposes and Rafael Advanced Military Systems Ltd filed an opposition.

The independent Claims  1 and 15 of the application are as follows:

“1. A method for facilitating exo-atmospheric ground to ground (GTG) missile’s interception trial, comprising:
Launching a carrier accommodating at least one inflatable dummy target, said carrier being configured to release an inflatable dummy target therefrom; said dummy target or portion thereof is configured to be inflated and has characteristics that resemble a GTG missile characteristics; said dummy target is configured to re-route its flight trajectory during its release from the carrier for at least (i) facilitate sensing of interception during the END GAME, (ii) assuring that the carrier being substantially out of the field of view of the interceptor during the END-GAME, or assuring that the carrier being substantially in the field of view of the interceptor during the END-GAME at the pre-defined location relative to the dummy target;
Launching an interceptor for exo-atmospheric interception of the dummy target; and
Receiving communication of data sensed during the interception process.”

“15. A method for simplifying exo-atmospheric ground-to-ground (GTG) missile’s interception trial, comprising:
Providing at least one inflatable dummy target that is manufacturable in considerable simpler manufacturing process than a GTG missile, and capable of manifesting characteristics that resemble characteristics of the GTG missile and wherein use of said inflatable dummy target prevents near and far safety problems;
Providing a common carrier missile capable of accommodating at least one dummy target irrespective of the characteristics thereof;
Whereby said common carrier missile is capable of being launched and being configured to release the at least one inflatable dummy target at selected exo-atmospheric location, for testing the ability of an interceptor missile to intercept said dummy target at exo-atmospheric interception point, thereby testing the interceptor’s operational feasibility to destroy the GTG missile.”

Rafael based their Opposition on the following publications:

  1. Development of Coherent Laser Radar at Lincoln Laboratory, 2 Nov 2000
  2. An Internet page from The Federation of American Scientists (FAS) 22 Nov 2002
  3. Explanation of why the sensor in the exo-atmospheric kill vehicle (EKV) Cannot reliably discriminate decoys from warheads from 2000
  4. US 3,290,681 from 6 December 1966
  5. US 3,411,778 from 19 November 1968
  6. US 3,212,730 from 19 October 1965
  7. US 2002/0149996 from 17 October 2002

rafael.pngRafael considered that the claimed invention lacked novelty contrary to Section 4, and lacked  inventive step contrary to Section 5. Furthermore, the specification was allegedly not enabling contrary to Section 12a of the Law. Rafael further alleged that a major amendment during the Examination process required that the application be post-dated and thus the PCT application based on the Israel application anticipated the claims as issued. Read the rest of this entry »


Isscar Opposes Hanita Patent for Milling Tool

June 15, 2017

Hanita Metal Factory ltd. applied for Israel Patent Application No. 177336 and, on allowance, it published for opposition purposes. Isscar opposed the patent issuing.  The applicant requested to amend the specification and neither Isscar, nor the public opposed, so the opposition concerns the amended specification.

The parties submitted their statements of case and evidence and then a hearing was held on 10 January 2017. The parties then submitted summaries and the Opposer filed their response to the summary.

The Application in question is titled “Chatter resistant end mill” and has one independent claim with seven dependent claims. The independent Claim 1 of the Application is as follows:

“A chatter-resistant end mill or shell mill or burr, comprising a shank portion and at least one cutting portion divided into a plurality of teeth by flutes disposed between said teeth, each tooth having at least one cutting edge,
Wherein a first angle separating said cutting edge of a first tooth from the cutting edge of a second tooth adjacent to said first tooth in a first direction is different from a second angle separating second cutting edge of said first tooth from the cutting edge of a third tooth adjacent to said first tooth in a second direction opposite the first direction,
Wherein a third angle separating the cutting edge of said second tooth from the cutting edge of a fourth tooth adjacent to said second tooth in said first direction is equal to an equal spacing angle defined by a value of 360 degrees divided by the number of said plurality of teeth,
Wherein one flute of the flutes is disposed between two adjacent teeth which are spaced apart at an angle exceeding said equal spacing angle, the one flute being wider and deeper than another one of the flutes.”

Thus the claimed invention includes a shank portion, a cutting portion, flutes, a tooth, a cutting edge, and various spaced apart cutting elements having angles defined in the dependent claims which are fairly clear when read together with the figures shown below.

Milling toolThe basis of the Opposition was various patents, catalogues and Russian metalworking standards. The claims were considered as claiming more than the disclosure deserved and that they were insufficiently supported. The Opposers also claimed that the effective date of the Application should be post-dated to the date of the claim amendment and then the claims could be disqualified by the Applicant’s own prior art.

The cutting tools claimed were carbides and the Russian standards were for Stainless steel cutting tools. The Applicant considered the standards were therefore irrelevant.

RULING

The burden of proof in patent opposition procedures is initially on the Applicant, see 665/84 Sanofi vs. Unipharm ltd. and 645-06-13 Unipharm vs. lilly Icos 25 January 2014. The Opposer does have to bring evidence to support their challenge (see Il 143977 Astra Zeneca vs. Unipharm, but then the Applicant has to prove that the claims are patentable.

In this instance, the grounds of the Opposition are lack of novelty, lack of inventive step, and insufficient disclosure as required by Sections 4, 5 and 13 respectively.

Novelty

Section 4 defines the novelty requirement as follows.

  1. An invention is deemed new if it was not published, in Israel or abroad, before the application date—
    (1) by written, visual, audible or any other description, in a manner that enables a skilled person to make it according to the particulars of the description;
    (2) by exploitation or exhibition, in a manner that enables a skilled person to make it according to the particulars thus made known.

To cancel the Novelty of an Application a single piece of prior art has to fully describe the elements of the invention in a manner that enables persons of the art to make the invention. See Appeal 345/87 Hughes Aircraft vs. State of Israel p. d. 44(4) 45 (page 105 of the ruling).

The first rule is that to prove novelty destroying prior publication one has to identify a single document that describes the invention in its entirely and it is not sufficient to create a mosaic of different documents to create a general picture.

Hughes also states that:

A general description is insufficient to remove novelty if it is not enabling and does not provide enough signposts leading to the invention of the patent.

The requirement for showing the invention is explained in Appeal 4867/92 Sanitovsky vs. Tams ltd et al, p.d. 50(2), 509:

On one hand, the defense of a patent includes not just that described in the claims, but also the core of the invention [MF – what the British case-law refers to as the pith and marrow in a somewhat odd mixed metaphor] (section 49). On the other hand one can claim a lack of novelty when accused of infringement (section 4) not just when a piece of prior art describes all the elements of the invention, but also then the prior discloses the core of the invention.

The essence of the invention is that part that is central and essential to the workings of the invention in contradistinction to elements that can be substituted for or left out entirely. the main core will remain protected even if an essential element is switched for another that performs the identical function. 
Page 515-516.

See also See also Appeal 793/86 Michael Porat. vs. Z.M.L. Modern Medical Equipment, p.d. 44(4); 578 pages 583-584.

The Opposer considers that the claimed elements are described in the prior art. A brief summary of the art cited by the Opposers follow’s.

F10 is a “Drilling Groove Milling Cutter” that relates to a four-edged drilling groove milling cutter having end and peripheral cutting edges.”

F13 is titled “Roughing and Finishing Rotary Tool Apparatus and Method” and is described as follows:

“The rotary cutting tool of the present invention employs roughing and finishing blades on the same tool to produce roughing and finishing cuts in one cutting operation. The rotary cutting tool preferably has a roughing flute adjacent to each roughing blade and a finishing flute adjacent to each finishing blade. In highly preferred embodiments, the finishing flutes are smaller than the roughing flutes… The flutes are therefore preferably unequally spaced. In some highly preferred embodiments, the blades are unequally circumferentially spaced and are immediately behind the flutes. At least one finishing blade preferably extends radially farther than at least one roughing blade.”

Witness for the Applicant, Mr Hina admitted that element j of the application is mentioned in both F10 and F13:

Commissioner: … to the best of my understanding, we have just asked a very simple question, does F10  as translated into English in F10A show the 360 degree divided into sections, yes or no? If so, please refer to where it shown in this publication.

Mr Hina responded No.

Patent Attorney Luzzatto : you write that element j is not found in F13, correct?

Mr Hina: I repeat there is something not defined in the indices.

The test explained in Hughes Aircraft requires one publication to teach all elements. Since this is not the case, the claimed invention is novel.

Inventive Step

The second grounds for cancellation was a lack of inventive step contrary to Section 5 which states:

An inventive step is a step which does not, to an average skilled person, appear obvious in the light of information published before the application date in ways said in section 4.

Unlike Novelty which requires a single document to teach an invention, an Inventive Step can be disqualified by a number of citations that provide a picture of what was known at the Application date:

The basic question of inventive step is determined by considering the total professional knowledge in the relevant field, and to do so it is legitimate to join different publications into a general picture Appeal 3314/77 [1] page 209. However, one must always bear in mind that the joining together of the disparate documents must be obvious to persons of the art at the date in question; for if it requires an inventiveness to do so, particularly where scattered crumbs of knowledge are gathered together – the general picture obtained is not obvious and one cannot say that the patent has no inventive step.” –page 111.

See also Sanitovsky pages 515-516 and Appeal 793/86 Michael Porat vs. Tzamal Modern Medical Equipment, p.d. 44(4) 578, 585.

Thus unlike novelty where a single document is required to teach an invention, as far as Inventive Step is concerned, one can combine disparate documents so long as it would have been obvious to an average person of the art to do so.

Appeal 47/87 Hasam Reliable Defense Systems vs. Abraham Bahri, p.d. 45(5) 194 states that to show a lack of inventive step, one may cobble together different pieces of prior art.

The question of inventive step is determined by comparison to professional knowledge in the relevant field by combining disparate references without forgetting that their combination has to, itself, be obvious, so that if it requires an inventive step to combine the publications, particularly where disparate elements are collected from all over the place, the picture is not obvious and one cannot state that the invention lacks an inventive step. 

Thus one has to consider whether persons of the art would have a motivation to combine the publications at the relevant date. See Opposition to IL 138347 Sarin Technologies ltd. vs. Ugi Technologies, 14 January 2008.

The US case-law developed a thumb rule for inventive step by combining publications or known elements under which one has to consider the teaching, suggestion or motivation to make the combination (see Section 51 of the ruling).

Further on (paragraph 51):

The Board of Appeals of the European Patent Office takes an approach known as the “could/would approach” to consider if a combination includes an inventive step. A combination of known elements is not considered obvious merely because a person of the art could have combined them, unless he would have been motivated to combine them to achieve some advantage.

Mr Bulhov testified that when designing a new tool bit, persons of the art deal with two issues” judder and removal of the scrap. There is no dispute that cutting tools with different angles were known and that the angle separation could provide stability. Mr Bulhov testified admitted that prior to the filing date, milling at two different angles was known.

The first piece of prior art cited, which was a catalogue from 2003, shows that Applicants were marketing a four angled milling bit, where two of the angles were different.  The accompanying text stated “Chatter-free machining, avoids resonance vibration due to patent pending flute form design and constant, unequal flute spacing.”

Publications F18 and F19 are Russian standards titled “End Mills with Cylindrical Shank” and ” End Mills with Tapered Shank” respectively.

The Commissioner rejects Applicant’s claim that the standards merely recommend the invention but do not require it, since that is not sufficient to make the invention non-obvious, and establishes that the relevant features were known in the art. See Opposition to IL 166626 Teva Pharmaceuticals vs. Astra Zeneca LTD, 11 March 2017. https://blog.ipfactor.co.il/2017/04/20/patent-to-astrazeneca-successfully-opposed-by-teva/

F18 and F19 are Russian language documents that are difficult to date, but the most recent versions are 1996 which was 10 years before the filing date of the present invention. Although in Russian, the documents are directed to tool makers and are prior art in all respects Page 21 of F18 and page 4 of F18 states that “Mills shall be manufactured with non-uniform circumferential tooth pitch as shown in Fig. 3 and Table 3.”

Specific cutting angles are given for the various grooves.

The Applicant argues that since these specifications relate to high-speed steels and not carbides, they are not relevant. The Applicant considers that judder in carbides is a more serious problem. The Commissioner considers that the Applicant’s claim is weak as the claims and indeed the specification are not limited to carbides or indeed, to other specific materials. The Applicant has not explained why the choice of cutting tool material would lead to the assumption that the angles are different and the publications themselves, though directed to HSS do not teach away from other materials.

Thus element J is taught by F18 and F19 and persons of the art could be expected to combine this with other elements to reduce judder.

Publication F10

Publication 10 teaches a milling tool with two pairs of flutes, such that each pair of flutes has the same angle.  The Applicant alleges that this teaches against having three separate angles as claimed, and thus F10 cannot be combined with F18 and F19 and does not teach the claimed invention.

It appears that the invention described in F10 combines two properties: the cutting surfaces are of different lengths and the angles of the flutes. The invention claimed in F10 directs persons of the art to combine wide flutes with long cutting surfaces:

“Therefore, according to the invention, larger chip spaces are provided for the long cutting edges having the unfavorable chips than for the short cutting edges having the favorable chips… By the interaction of the two features, the invention provides the possibility of optimum coordination of cutting edge length and chip space on the drilling groove milling cutter.”

The large scraps created by the large cutting edges require large flutes. Thus flutes 10 and 11 in Figures 2 and 3 of F10 are larger than flute 12 and 13. Thus F10 teaches the additional element claimed:

“On account of their width, the chips produced by the main drilling cutting edges require larger chip grooves than the chips of the intermediate drilling cutting edges. For this reason, the pitches 10, 11, located in each case in front of the rake faces of the main drilling cutting edges, as far as the next intermediate drilling cutting edge are configured to be greater than the pitches 12, 13 in front of the rake faces of the intermediate drilling cutting edges.”

F133

A publication is considered as being prior art that may be combined with other publications if a person of the art would consider it obvious to do so. Citing R. Carl Moy, “Moy’s Walker on Patents”, 4th ed. 2009, p. 9-48 – 9-50 the Commissioner concludes that where the publications are trade publications in the field of interest one can assume that persons of the art would know about them, and the publication in question relates to milling tools with different sized flutes to minimize judder.

In light of the above, the Commissioner considers that the principles of reducing judder by different width flutes are known and together with F19 and F19, 4 and 5 fluted milling tools are known.

Furthermore, the dependent claims lack inventive step. These relate to difference cutting edge angles along the shank. Such variations are described in F13 and F13a and are referred to as unequal flute spacing. Thus the dependent claims are also not patentable. Claims 2and 4 claim standard ranges for the angles. Claim 4 claims different dimensions as described in F10 and claims 5 and 7 describe variations taught in F13 and F1a. Claim 8 relates to standard cutting edges.

Thus the Application lacks inventive step.

Adequate Disclosure

Section 13a of the Law states that:

the specifications shall end with a claim or claims that define the invention, on condition that each said claim reasonably arise out of the subject described in the specification.

This means that the claims define the scope of protection sought. The claims should be interpreted with respect to the specification taken as a whole, including the text and drawings. See Hughes 65.

In Appeal 8802/06 Unipharm vs. Smithkline Beecham from 18 May 2011 it is stated: that:

In accordance with Section 13 of the Patent Law, the protection of the invention is determined by the claims that define the invention, and not be the specification as understood in Section 12, which includes the title and description (see Hughes p. 68); however one can refer to the specification to explain the nature claims  (see Appeal 2972/95 Yosef Wolf and Partners, ltd. vs Beeri Press Limited Partnership,

A ‘Greedy’ claim is one that attempts to protect more than it discloses. The extent that this term can be used with reference to the requirements of Section 13(a) is given in Appeal 1008/58 American Cyanamid vs. Lepitit et al. page 261 from 4 April 1960. See also Opposition by Teva to IL 142809 to Pharmacia AB from 26 February 2015. .

The Opposer claims that claim 1 is greedy in that it has much wider scope than is supported by the specification. The Applicant disputes this and argues that following the voluntary amendment, flute B is defined as the longest and deepest flute:

“Wherein one flute of the flutes is disposed between two adjacent teeth which are spaced apart at an angle exceeding said equal spacing angle, the one flute being wider and deeper than another one of the flutes.”

Page 8 does state that flute B is deeper and wider than flute A

“The flute 32 relating to angle B is wider and deeper than the flute 34 relating to angle A, so as to improve coolant feed and facilitate chip clearance and removal when teeth work with higher feed per teeth compared to equal tooth space dividing (by angle A).”

The specification provides that the angle of flute B is large than the angle of flute A. Amended claim 1 requires that the angle of flute B is the largest angle. This is not supported in the specification which only compares flute B with flute A. So amended claim 1 is not fairly supported by the specification.

Conclusion

Claim 1 is not-inventive and also is not adequately supported. The Opposition is accepted and IL 177336 is rejected. Costs may be claimed in accordance with circular MN 80.

COMMENT

I accept that the claims encompass combinations of known elements to create a cutting tool that is new.  I also accept that unless one limits oneself to a specific tool design, the claims will always be wider than that demonstrated. My problem is that the type of features described are functional rather than aesthetic. At present, Israel design examiners consider functional features as non-patentable. We could even extend this and consider such cutting tool elements as replaceables and use public policy to restrict protection.  If, however, we wish to encourage research and development of better performing cutting tools, we should provide some sort of protection for them to prevent immediate copying. Israel does not have a petty patent system or protection for purely functional design. It seems to me, therefore, that combining elements from different publications for tool bits to create a novel bit, should be patentable. We could limit the protection to combinations described and maybe the claims are overly wide. Perhaps what is missing here is dependent claims for specific tried and tested drill bits.

By training, I am a materials scientist and engineer. My PhD research was in hard metals and coatings. I did not study milling and though I understand the purpose of the various elements, I am inclined to agree with the Commmissioner that there is a rebuttable assumption that a design element known for a HSS tool would not be appropriate for a carbide tool. However, carbides are much harder and hence more brittle. Optimizing a new tool is not intuitive and probably is the result of much experimentation, but I don’t know if the combination has an inventive step. Shamgar’s guidelines in Hughes Aircraft are fine and dandy, but one really needs experts on cutting and milling to determine whether the combination of known elements in a new product of this type does or does not include an inventive step.


Israel Patent Office Denies Request to Reinstate Abandoned Patent Application

June 14, 2017

When Israel patent applications are examined, not always a patent issues. Sometimes a final rejection issues where the Examiner is not persuaded that the Application has merit. More frequently, the Applicant loses interest or runs out of funds and does not respond to an office action. Some six months later, the Israel Patent Office issues a notice prior to closing the file and if no response is received within one month of that issuing, the file is closed.

Even after a patent application is abandoned and the file closed, it is possible to have the file reopened and the final rejection to be reconsidered under Section 21a of the Law.

Here, the time-line is critical. It is relatively straight forward to have a closed patent application reopened within 12 months of the application being considered abandoned. After that window, it is very difficult and one has to show circumstances to justify an exception being made.

Israel Patent Application No. IL 220137 to Skvirsky, Skvirsky and Monassevitch titled “Removable attachment to a Dental Prosthesis” was filed on 4 June 2012. On 2 December 2013, the Israel Patent Office reported that the file would be accessible to the public 18 months from publication unless the Applicants withdrew it. The Applicants did not respond, and so the application published.

On 21 January 2017 the Applicants received a Notice Prior to Examination which had a four-month period for responding. Extension fees for patent applications are payable retroactively but after the four months and a further six months had passed without a response being filed, a Notice of Imminent Abandonment was sent to the Applicants on 4 November 2014. This too was ignored and the Application was considered abandoned and the file closed on 21 December 2014.

On 8 August 2016 the Applicants requested that the file be reopened. No Affidavit was submitted with the request which stated that the Applicants had not received any of the letters from the Israel Patent Office and had contacted the Israel Patent Office on their own initiative on 7 August 2016 and discovered that the file had been closed.

In an interim ruling of 1 January 2017, the Deputy Commissioner Ms Bracha requested a signed Affidavit detailing the circumstances of the file closing to be submitted by 5 February 2017, a week before a hearing was scheduled. The Applicants did not submit an Affidavit but simply sent a further letter making the same claims that they had submitted with their request to have the file reopened.

On 12 February 2017 Mr Yaniv Skvirsky attended the hearing. He explained that the letter of December 2014 from the Israel Patent Office was delivered in August 2016. He also claimed not to have received the Deputy Commissioner’s order for an Affidavit to be submitted. As this was part of the communication that related to the hearing, it is not clear how he knew when to present himself.

After the hearing, the Deputy Commissioner requested that within 14 days, Skvirsky submit an Affidavit together with a copy of the  letter that he did receive in August 2016. This was also not submitted.

Section 21a of the Law provides a period of one year for the Applicant to request reexamination of a refused patent application. Section 164 of the Law allows this period to be extended “if the Commissioner considers it fitting to do so”.

The justification for applying the |Commissioner’s discretion under Section 164 of the Law depends on context, the conflicting interests being considered. In this regard, see 2826/04 Commissioner of Patents vs Recordati Ireland ltd, 26 September 2004.

The policy regarding different extensions that guides the Commissioner will change with the context and the nature of the proceeding for which an Extension is sought.

In this instance, one has to balance the Applicant’s interest with that of the public to know whether something is protected or abandoned in a reasonable time frame. Once the Section 21a period has passed, the public relies on the period of a year for appealing the final rejection and understands that there is no protection for the product in Israel. This relying increases over time, so as the 12 month period recedes in the distance of time, it becomes ever more difficult to revive an abandoned patent. See Opposition to IL 110548 Shmuel Sodovsky vs. Hugla Kimberly Marketing ltd. 12 August 2010 and Application IL 15763 to Icos Corporation, 21 October 2013.

Once the Application has published at 18 months from priority, it is more difficult to revive a patent that is more than 12 months after being considered abandoned. In this instance, the Applicants wish to revive the patent application 7 1/2 months after the 12 month period for revival, and there are significant discrepancies in the Applicants statement regarding the events that led up to the patent application becoming abandoned: the Applicants first claimed not to have received the letters from the patent office. Then they claimed to have received them a year and a half after they were posted, but despite being asked to reproduce the letters, they did not do so.

The Applicants claimed not to have received the invitation to the hearing, yet they knew to turn up for it. At the hearing, the Applicants acknowledged that the address of record was correct, and was the home address of one of the Applicant’s father. It is not reasonable that three separate letters sent over the course of a year went astray. Nor is it reasonable that one such letter arrived 18 months late.

The discrepancies in the chain of events and the Applicants ignoring of directives indicates that they were not really interested in obtaining a patent in Israel, and consequently the request for extension of the 12 month period to appeal final rejection is rejected. 

Decision re reviving IL 220137 given by Ms Jacqueline Bracha, 3 May 2017     


Extension of Israel Patent Extended

June 8, 2017

BSSIsrael Patent No. 164987 to Bristol-Myers  Squibb is titled ” PROLINE DERIVATIVES AND  PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME”. On 9 January 2017, the relevant Examiner calculated that the patent was entitled to a 479 day extension. The patentee has appealed this calculation.

The patentee’s representative submitted his calculation and a hearing was held on 28 May 2017. Following the hearing, the Deputy Commissioner accepted the arguments and ruled that the extension should be 679 days.

SunvepraThe patent term extension is for the active ingredient of Sunvepra which is asunaprevir. The Application for a patent term extension was under section 64(o) of the Israel Patent Law. The Applicant notes that the drug is not marketed in any of the relevant States as per section 64(a) and so the period of protection should be calculated on the basis of Section 64(i)(b) as follows:

If the registration is only requested in Israel, the patent term extension will be in force for a period equivalent to that from when the request for registration was submitted to when approval occurred, so long as the Applicant acted equitably and with appropriate efficiency.

The disagreement between the Examiner and the Applicant concerns the proper interpretation of the term approval as used to indicate the period of the extension. There is consensus that this period starts with the submission for regulatory approval, but the end of this period is disputed. The Examiner considered that this period terminates with the registration of the medication in the register of medical formulations as per section 47a of the Pharmaceutical Ordinance 1981. The patentee contends that the date should be the date on which approval for sale of the drug occurs.

In accordance with Section 64a of the Law, the term approval is defined in section (b)1 of the Law in the same manner as in section 54a as follows:

In this Section, ‘approval’ is authorization or permission or other document needed to sell the product.

The Legislative was aware of the difference between the term רישוי meaning approval and רישום meaning registration. The term רישום (registration) is used in sections 64(d)2 and 64(d)3. The meaning of the term רישום (registration) is registration in the Register of Medical Formulations under section 47a of the the Pharmaceutical Ordinance.

The term רישוי (approval) used by the legislative for calculating patent term extensions is wider and includes all approvals needed to market the product. Where the product is a medical device there is no disagreement that after registration in the register there are other approvals necessary before a product can be marketed to the public. These approvals are listed in regulations 14-18 of the Regulations or Pharmacists (formulations) 1986 and we are concerned with the first of these in regulation 14:

No one may market a formulation for the first time in Israel unless it is from a batch that receives marketing approval from the manager.

The Examiner himself was aware that to marketing approval was required in addition to registration as is clear from his letter of 6 September 2016. There is no doubt that this marketing approval was only signed on 4 September 2016 as is clear from the appendix to the Affidavit of Ms Talya Ben-David, Brostol-Myer Squibb’s regulatory manager in Israel. So although the formulation was registered from 18 February 2016, it was only approved for marketing some 200 days later.

The Applicant’s understanding of the Law is ‘technical’. As is clear from the Appeal to the Jerusalem District Court 223/09 Lundbeck vs. Unipharm (25 May 2009) regarding understanding terminology of the Law:

One can therefore say that the substantive scope of considerations that the Commissioner may use when determining the period of protection is different from that when considering a patent application. Deciding whether an invention is patentable is by nature discretionary in that it requires ascertaining novelty, inventiveness, utility, etc. In contradistinction, when determining the appropriate patent term extension, the Commissioner is limited to considering the formal requirements of the Law, without consideration of the way the invention works or the Applicant’s investment in inventing, developing and registering. This is what the legislative body decided was the appropriate way to balance the conflicting interests when providing patent term extensions. The burden on the Commissioner is technical and is designed to be objective.

It so happens that this technical calculation also corresponds to the purpose of the Law which is to compensate the Applicant for regulatory delays whilst enabling competitors to test and develop their generic equivalents without infringing the patent.

Section 54a of the Law, legislated as an amendment to the 1967 Law, cancels the de facto extension of products requiring approval (particularly drugs), by enabling generic competitors to prepare for and obtain regulatory approval whilst the patent is in force and to launch their products immediately on the patent lapsing. In compensation for this change, the patentees were allowed to obtain patent term extensions. The extension is not for the whole patent but only prevents manufacturing and sale of the medical formulation that includes the material covered by the patent (Section 64(h)d of the Law). Just as the de facto extension for regulatory approval is needed to market the drugs, so the compensation for the drug developers, by enabling patent term extensions, is tied to approvals. The patent term extension is needed to compensate the patentees for “the period that has passed until the patentee receives approval from the Israel Office”. See also the words of explanation for the fourth amendment to the Patent Law (use and patent term extension) 1997, Draft Law 2664 page 146 onwards.

Although the Israel Law is not identical to the arrangements reached in the US and in Europe, it seems that there also, the patent term extension is calculated from the time that all approvals are received. See for example Section 14 of the Medical REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL   concerning the supplementary protection certificate for medicinal products of 6 May 2009:

“The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.”

See also 35 USC 156 which deals with determining the “regulatory review period for the approved product” and also the words of explanation for the 13th amendment of the Patent Law 2012:

“The approval of the extension period for patents for medical formulations and medical devices of the type given in the US (Patent Term Extensions PTE) under Section 156 of Volume 35 of the US Code. This approval extends the US patent for delays in obtaining regulatory approval for marketing medical formulations and medical devices that occur after the patent issues, and half of the period for clinical trials for the same medical formulations and medical devices, with deductions from this period for tardiness by the patentee in obtaining such regulatory approval. The period of the Approval given in the US under the US Law cannot exceed five years and cannot extend beyond fourteen years from the first marketing approval of that medical formulation or medical device.

However, reference to foreign laws is not required since the term ‘approval’ in Section 64(i)2 is clear and unambiguous:.

The proceeding for considering the request for a patent term extension

extension

Section 64(o)b provides a very short period for examining requests for patent term extensions. This short period obligates fast examination and does not allow back and forth exchanges between the Examiner and the Applicant.

The examination of the patent term extension request commenced on 6 September 2016. In an Office Action the Examiner explained that the Application did not accord with Section 64(d)(3) of the Law since at the time of the Application, there was no regulatory approval in Israel, so he considered that the registration did not allow the formulation to be legally marketed.

The Applicant challenged this ruling before the Commissioner but this before this was substantively considered, an Affidavit was submitted that showed that marketing approval was given on 4 September 2016 and so the Commissioner ordered the request to be examined.

On 8 January 2017 the Examiner informed the Applicant that the Commissioner was willing to give a 783 day extension, and gave him a month to relate to this. The method of calculation was not detailed.

calculationThe following day, on 9 January 2017, the Applicant requested details of this calculation and established telephone contact with the Examiner. The contents of the conversation were not documented but the Applicant’s representative explained the main points discussed. [why the Examiner wasn’t interviewed is not discussed]. In the discussion, it was noted that an error had occurred in calculating the extension period which did not conform with either the Applicant’s or the Examiner’s interpretation of the Law. The Examiner considered that the extension period should be from when regulatory approval was requested until registration of the product. Consequently, that day, 9 January 2017, the Examiner issued a letter correcting the 783 days to 479 days, commencing on 27 October 2014, when regulatory approval was sought, and ending on 18 February 2016 when registration occurred. Due to an error, the Applicant was not given a month to appeal this decision. Instead, it was published in the January 2017 patent journal. Thus on 31 January 2017, a notice that an extension would be given under Section 64(e)c of the Law, despite the Applicant appealing the decision on 22 January 2017. It is emphasized that Section 64(e)c of the Law allows the Commissioner to publish the announcement within 60 days, thereby allowing the Applicant to appeal the examiner’s decision prior to it publishing, which is his right under section 161 of the Law.

There is no doubt that the publication is an error that should be corrected under Section 170 of the Law. The error is twofold: Firstly, it should not have published before the Applicants appeal was heard. Secondly, the publication did not accord with Section 64(i)b of the Law, as clarified in this ruling.

Therefore, a new announcement will publish in the June 2017 journal to the effect that the patent term extension is 679 days. Under section 170(c) the public may oppose this correction.

Ruling by Deputy Commissioner Bracha regarding Patent Term Extension to IL 164987.

COMMENT

I found this ruling convincing and concur that it seems to fit with the intent of the Law and not just with its literal wording. However, the corrected calculation may be opposed both substantively based on alternative interpretations and also due to third parties relying on the shortened term. We await further developments.