Totachi

July 6, 2017

277424Totachi Kougyo Co ltd submitted Israel Trademark Application Number 277424. The Application was in classes 4, 7, 9, 11 and 12 and is shown alongside. The Application is the national phase of an International Trademark under the Madrid Protocol. On 6 December 2016, the mark was allowed and under Section 56vi of the Trademark Ordinance, the International Bureau was notified with details about the deadline for Oppositions.

On 27 March 2017, Total SA filed an Opposition in accordance with Section 24(a) of the Trademark Ordinance 19722 and regulation 35 of the 1940 regulations. Consequently, on 29 March 2017, the International Office was informed, together with the deadline for responding.

The Applicant had two months, until 29 May 2017 to respond to the Opposition. However, until the date of this decision, 18 June 2017, no response was received from the Applicant. On 11 June 2017, the Opposer requested that the Israel Patent and Trademark Office note that the since no timely response was received, the Opposition should be accepted and the mark considered cancelled.

The Adjudicator of Intellectual Property, Ms Shoshani Caspi, accepted this request. Consequently the mark is considered withdrawn and the International Bureau will be duly informed. No costs are awarded.

Decision re Israel Trademark Application 277424 to Totachi Kougyo Co ltd, 18 June 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.


Unipharm Awarded 200,000 Shekels Costs

July 3, 2017

UnipharmIn the past we reported the ruling concerning Unipharm’s Opposition to IL 195087 to Novartis. On winning the Opposition, Unipharm filed a request for costs.

OVERVIEW OF OPPOSITION

The patent published for opposition purposes on 31 October 2012, and Unipharm submitted their Opposition on 3 January 2013, and a statement of case on 26 February 2013. The Applicant amended the application on 26 June 2013, and as no opposition to the amendments were submitted by Unipharm or by the public, the amendments were allowed. There was an intermediate attempt to have the case thrown out that Novartis lost, where costs of 5000 Shekels were awarded to Unipharm on 24 February 2014.

On 24 February 2017, an oral proceeding took place. The Opposer submitted their summation on 24 August 2016, and the Applicant submitted their summation on 30 November 2016; response to which was filed on 20 December 2016.

In a ruling of 21 February 2017, the Opposition was accepted and the application was rejected.

Following Unipharm winning the Opposition proceeding, they submitted a request for costs, asking for 311,217 Shekels as follows:

  1. Refund of 2000 Shekels filing fee for filing opposition
  2. 5000 Shekels previously ruled against Unipharm for unsuccessful interim proceeding consisting of trying to get the Opposition thrown out
  3. 5000 Shekels awarded against Opposer in decision of 28 July 2015 regarding getting some of the evidence struck from the record
  4. 34,392 Shekels for interim proceedings
  5. 72,549 Shekels for preparing for cross-examination and attending hearing
  6. 108,980 Shekels for summation
  7. 48,296 Shekels for analyzing and responding to Applicant’s summation
  8. 35,000 Shekels for preparing the request for costs

The request for costs was supported by an Affidavit from CEO Mr Zebulun Tomer.

In the early stages of the Opposition, Unipharm was not represented. Mr Zebulun Tomer filed the Opposition himself and only after filing a statement of case, was Adv. Adi Levit employed. Mr Tomer additionally requested costs for his own time, but did not elaborate.

The Applicant alleged that the costs requested were not justified and were exaggerated. Applicant also alleged that a lot of the costs, such as costs incurred in trying to get evidence struck from the record, were not refundable.

The Ruling

The Commissioner’s authority to rule costs is based on Section 162b of the Israel Law of Patents 1967:

The Commissioner has the authority to rule reasonable costs and to decide which of the parties will pay the costs and how they will be paid.

rulingAs ruled by the Supreme Court in Bagatz 9891/05 Tnuva vs. The Authority for Imports pd. 60(1) 600, 615 30 June 2005, the costs award considers circumstances, the amount of work performed, particularly in submissions and preparing evidence, complexity, stage reached, equitable behavior of the parties, and so on.

Costs are not intended to be refund of all expenses laid out, so that, for the winning party, it would be as if they never laid out money. Sometimes a party does NOT receive full costs: See IL 13433 Smithkline Beecham Corporation (SKB) vs. Teva Pharmaceuticals ltd., 30 May 2005.

Furthermore, to the extent that costs appear extraordinary, the amount of details required to substantiate the claim for costs that is required is more. See Opposition to IL 153109 Unipharm vs. Mercke Sharp & Dohme Corp., 29 March 2011.

The Commissioner does not consider that Unipharm’s submission was sufficiently detailed with regards to attorney fees incurred. Submitting invoices that do not detail the work done is insufficient. There is no detail regarding the attorney’s hourly rate and the number of hours worked. The Commissioner also does not consider the costs requested were reasonable when considering the specific case.

calculationHowever, the winning party is entitled to recoup costs. Since the applied for costs were insufficiently detailed, the Commissioner estimated costs, basing himself on the Tnuva and other rulings.

 

After doing his calculations and estimations, etc., the Commissioner ruled 200,000 Shekels + VAT as appropriate costs for the legal work undertaken.

 

Dr Tomer’s Costs

Citing the appropriate precedents, including Opposition IL 173788 Unipharm vs. Lundbeck, IL 166621 Unipharm vs. Neurocrine Biosciences Inc., etc., the Commissioner ruled that Unipharm’s CEO’s time could not be charged to the Applicant.

Refunding costs of Opposer for Application to have Evidence Struck from Record

It has been established that one does not charge a party for costs that opposing party incurred in interim procedures that were rejected – See Opposition to IL 141762 Unipharm vs. Novartis, 21 June 2013.

Conclusion

As to the previous issued ruling of 25 April 2014 that Novartis should pay 5000 Shekels costs to Unipharm for failed attempt to have opposition thrown out, the Commissioner considered this sum as outstanding, but that there was no need to readdress the issues.

The Commissioner thus ruled that Novartis should pay 2000 Shekels legal fees and 200,000 Shekels + VAT costs to Unipharm.

Opposition by Unipharm against ILL 195087 to Novartis, Ruling re Costs by Asa Kling 7 May 2017


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.


Unipharm Successfully Opposes Novartis Patent for Panobinostat Lactate Salts

March 26, 2017

PanobinostatThis ruling relates to an opposition against a patent application by Novartis for Panobinostat  which is a hydroxamic acid  that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor).  On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.

The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.

Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.

Background

NovartisNovartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.

UnipharmUnipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.

The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »


K -KOSHER – Looking for contributions to Oppose Indian Trademark Application

January 16, 2017

k-kosher

India has the world’s second largest population, its third largest economy and is the second largest producer of food after China.

India is a ‘global hotspot’ for food manufacturers, food producers, and food ingredient professionals. The country is now becoming an integral part of the global food ingredient network and supply chain. Given this trend, India has become one of the most important destinations for food investment, with the food industry growing at an annual rate of 17%. As food exports continue to increase in India, many Indian food manufacturers are required to certify that their products and ingredients are kosher.

In April 2016, Indian trademark Application Number 3243779 was filed by Mrs. Suchi Agarwal trading as AMRIT EXCLUSIF. The mark covers beverages including wine, spirits, liquors, whisky, brandy, rum, vodka, gin and Scotch all included in class 33. Ms Agarwal already has the word mark for leather goods.

Veteran Israel Trademark Attorney Neil Wilkof brought this application to my attention.

 

Wine is a key element in the rituals that mark the onset and end of the Jewish Sabbath and festivals, and features in life cycle events such as circumcision and wedding ceremonies. Perhaps due to its centrality, over the millenia, very stringent manufacturing and storage requirements have been developed that must be met for wine and brandy to be considered Kosher.

Neil’s problem is that the 3243779 mark is misleading in that if applied to the beverages listed, consumers would assume that the beverages are Kosher. On the other hand, no one organization should be able to prevent other manufacturers from using the work Kosher on wines that are manufactured in accordance with Jewish Law, and under bona fide Rabbinical supervision. There are a number of Indian trademarks for Halal marks including 1131733 (wordmark) and 1131732 and 1493214 which are each slightly stylized. A Moslem purchasing meat labeled as Halal would expect it to be from a clean animal that is slaughtered with a knife in accordance with Moslem practice and beverages labeled as Halal to be free from Alcohol. Similarly Jews should be able to expect wine or meat labeled as Kosher to be manufactured and stored in accordance with Jewish Law.

Neil and I have discussed the case with retired trademark expert Professor Jeremy Phillips as well as with the local Indian trademark counsel who brought the application to Neil’s attention. We all believe that there are grounds to oppose this registration under the Indian Trademark Law. The deadline for filing an Opposition is in mid-February 2017. We are happy to donate are time to this cause and I’ve reached out to the officer who handles fraud in matters of Kosher food for the Israel government.

None of us knows any Jewish licensed trademark Attorneys in India, and whilst we believe that Buddhists and Moslems will be sympathetic to the cause, we cannot expect a non-Jewish practitioner to work Pro Bono on this matter. Neil has consulted with the firm in India and it is estimated that the cost of fighting this opposition  could amount to $2000 – $3000. Neil and I are willing to assist the firm pro bono as needed.  If we can now find 20-30 practitioners who will each put $100 in the pot, we will have a budget for fighting this. Neil and I have agreed to put in the first couple of hundred. Please contact either of us if you’d be prepared to help.