Top 20% of Students completing a Recognized MA or LLM in IP Law will receive Dispensation from the Oral Patent Attorney Exam

October 30, 2014
Oral hygene - brush with Circular motions

Oral hygene – brush with Circular motions

In a circular (30/2014) of 30 October, the Commissioner of Patents and Trademarks, Asa Kling, announced that under authority divestd to him by the Minister of Justice, the top 20% of graduating students from a recognized masters’ program in intelectual property law will not have to sit the Oral exam to qualify as an Israel patent attorney, provided that the syllabus of the degree program covers all aspects of IP Law. Candidates will still have to gain practical experience working under a licensed practioner and will have to pass the written exam which tests patent drafting ability.

COMMENT

I am a little unhappy with a decision to recognize a percentage of candidates. I believe that the qualification should be based on objective standards and not on relative ability.  That said, I am sure that a dedicated academic course covering the material will be better preparation for the profession than ad hoc study. One wonders if in the past, oral examiners have worked to unwritten guidelines to allow only the top 20% of candidates. This seems to be about the pass rate. One hopes not.

I suspect this decision may be more effective in promoting such masters programs than in changing the knowledge and ability of new practitioners.


Alternative Dispute Resolution – a seminar on mediating trademark disputes

October 30, 2014

200px-Success_as_a_Mediator_For_Dummies           Solomon

WIPO’s Arbitration and Mediation Center, the Israel Patent and Trademark Office, the Israel Ministry of Justice and the Tel Aviv and Central Region Chamber of Commerce are hosting a one day seminar on trademark mediation.

The event is directed to lawyers with an Intellectual Property leaning. Most of the lectures will be in English.

Proceedings before the Patent Office or the Courts are generally time-consuming and expensive. Often the parties in a trademark conflict can find sufficient common ground to reach an amicable or at least mutually acceptable solution. The event looks like a valuable seminar for those of us who are less interested in negotiating conflict resolution.

The event will be held on Wednesday 11 December 2014 between 9 am and 5 PM at the Chamber of Commerce, Hashmonaim 88, Tel Aviv. Registration is via phoning *8111.


Israeli and Canadian Patent Offices to Cooperate via the Global PPH instead of via a Special Dedicated PPH

October 29, 2014

israel canada

The Israel Patent Office has announced that since November 1, 2012, the Israel Patent Office (ILPO) has conducted a Patent Prosecution Highway (PPH) pilot program with the Canadian Intellectual Property Office (CIPO) in order to improve patent examination procedures in these countries and make them more efficient.

On January 6, 2014, the ILPO and the CIPO joined the GPPH (Global Patent Prosecution Highway) pilot arrangement, aimed to simplify and improve the existing PPH programs, and coordinate between all the countries participating in the program through a single arrangement.  The GPPH pilot allows patent applicants to request accelerated examination at any of the offices involved in the pilot, if their claims have been found to be allowable/patentable by any one of the other offices involved in the pilot.

Under the GPPH pilot, a request for accelerated processing can be based on work products, including PCT work products, providing the eligibility criteria of Framework Provisions for the GPPH are met. Since the guidelines of the GPPH pilot take precedence over those of the existing bilateral arrangements, and since both countries are participants in the GPPH pilot, the ILPO and the CIPO have decided to continue their cooperation through the GPPH pilot arrangement.

COMMENT

Obviously the Israel  Patent Office has to publicize these agreements.  I try to publicize Israel related IP news, which this clearly is. However, I really don’t know if this is significant. Does it matter if applications are accelerated as the result of a global or a local agreement? Will applications be subjected to more or less screening as a result? Will prosecution be more efficient? I really don’t know.

One thing is certain, the metaphor of highway is singularly inappropriate when considering the scale of Canadian roads when compared with those in Israel.


Making a Big Deal out of Contents of Affidavit

October 22, 2014

ynet big-deal

Israel Trademark No. 234855 is a graphic mark for Y-Net Big Deal that was filed by Yidiot Internet. (Yidiot is Israel’s most widely read daily tabloid. Y-Net is their Internet site).

The mark covers promoting the goods of others, namely, providing coupons, rebates and vouchers for the goods of others; included in class 35. H.U.B. Trading LTD opposed the mark.

On 14 August 2014 the Opposer requested the striking from the record of large swathes of an affidavit by a Mr Hochman that was filed by the Applicant. The Opposer claimed that some of the objected to sections of the affidavit included hearsay beyond the knowledge of the applicant and other sections were legal claims that did not belong in an affidavit. The Applicant did not respond.

On consideration, the Adjudicator, Ms Shoshani-Caspi did not consider that the extreme sanction of striking from the record was warranted. At best, there was grounds to give a low significance to certain parts of the affidavit. Furthermore, she was unhappy with damaging the Applicant’s evidence without a careful analysis of what was known by the witness and why certain things found therir way into the affidavit, presumably following legal advice. In conclusion, Ms Shoshani-Caspi rejected the action to strike the parts of the affidavit. She ruled that after an evidentiary hearing and cross-examination of Mr Hochman by opposing counsel and in summing up, the Opposer could make these claims again, and Costs would be awarded in the framework of the main ruling.

Israel Trademark No. 234855 “Y-Net Big Deal” H.U.B. Trading LTD vs. Y-Net, intermediate ruling of 11 September 2014.


Arab Lorry with Fake Sports Shoes Stopped At Border Crossing

October 22, 2014

fakes

An East Jerusalem Arab lorry driver carrying 5000 pairs of Nike and Adidas sports shoes was stopped at the Al Zaim border crossing (near Maaleh Adumim, East of Jerusalem) yesterday. The shoes and the paperwork were fake. See here and here. It transpires that the fakes were manufactured in Hebron and the attempt to enter Jerusalem from Maaleh Adumim was to give the impression that the shoes were made in the industrial park at Mishor Adumim.

The lorry driver was stopped as the result of information obtained by Customs and Excise.

Hebron is a hub of fake goods manufacturing. In the past, fakes originating there have included electrical fittings, sunscreen, baby food and CDs and DVDs. Another popular scam is to steal new Israeli cars, drive them to Hebron, dismantle them and then feed the parts into car repair garages. Aparently parts are sometimes stolen to order.


Israel Patent Opposition Suspended Pending Examination of a Divisional Application

October 22, 2014

boehringer       procrastinate

In another Patent Opposition, Teva Pharmaceutical Industries opposed Israel Patent Number 195030 titled “DPP IV INHIBITOR FORMULATIONS” to Boehringer Ingelheim International GMBH.

The patent published for opposition purposes on 30 September 2013 and an opposition was filed on 29 December 2013 and there is a pending Divisional application – IL 212841.

On 22 January 2014, the Opposer requested to suspend the Opposition process under Israel Patent Office Circular 020/2012 which allows suspension of Opposition processes whilst related applications are examined, provided that a detailed request to do is filed. The Opposer considers the claimed subject matter of the two cases as very similar. Although there are differences, these are minor. The Applicant accepts the similarity but does not consider this as in and of itself being a prima facie justification for suspending examination, and that at best this is grounds for a detailed request. Until such a request is filed, there is no basis to suspend the Opposition proceedings (which leaves the allowed patent in suspense, such that it cannot be enforced).

In ruling on this matter, the Commissioner (who drafted the original Circular) ruled that the existence of the Divisional Application was not, of itself, sufficient grounds to suspend the opposition. It is, in his opinion, too early to identify the claimed invention. However, under Section 24, the specification of a Divisional Application will invariably be very similar to that of the Parent Application, and this is the basis of the Opposer’s assumption that similar issues will arise in the Divisional application if it is allowed, and so suspension until that time to hear both cases together makes sense. The consideration as to whether or not to suspend the opposition is efficiency and the case is similar to other cases where an ongoing proceeding is suspended until another is decided. There is a Supreme Court precedent that relates to this issue: Appeal by authorization 3765/01 “HaPhoenix HaYisralei Insurance Company vs. Alexander Kaplan et al. (28 Jan 2002), where, in paragraph 3, it is stated that in the name of efficiency courts have the discretion to combine hearings, even where the parties are different. In the Opposition to IL 82910 Unipharm vs. Anktielofaget Hassle (1996) this principle is applied to patent cases; justification being Reg. 520 of the Civil Law Procedure. The purpose of suspension is thus to allow the apparently similar / related cases to be combined. The Opposer is correct that the currently pending claims of the Divisional Application are somewhat similar to those in the opposed patent.

It is important to consider the rights of third parties and other considerations than simply efficiency of combining from the perspective of the patent office. In this case, it is likely that the Opposer (TEVA) will oppose the divisional application, should it issue. In conclusion, the Commissioner agreed  to suspend the Opposition for 18 months and to then reconsider in light of developments concerning the divisional application.

COMMENT

There are certainly similarities between court cases and oppositions. There are, however, some pertinent differences. One does not suspend a court case pending a possible filing of a related case, only to wait for an ongoing case to issue.

Oppositions are complicated proceedings that take time. Indeed, a primary purpose of filing them is to prevent a patent from being enforceable. Suspending an opposition to claims that have been examined and allowed on the basis that some additional claims may eventually be allowed seems to be a punishment to the Applicant. It seems to me that the opposition to the allowed patent should be allowed to proceed, with statements in the Opposition filed by both the Applicant and the Opposer serving as estoppel in possible future oppositions of the divisional. Factual issues that are determined should be binding on the future hearing. If and when the divisional patent is allowed, and an opposition is filed, overlapping grounds could be co-joined to this opposition and new grounds could be heard separately. I therefore consider this ruling to be wrong.

I have thus somewhat surprised myself by coming out in favour of the pharma Applicant and against the generic Opposer.  I console myself in that in this case the issue is one of legal principle and not one of novelty or inventiveness / obviousness. I am against evergreening, but I am also against misuse of the patent opposition system to prevent patents from issuing by uneccessary time-wasting.  Comments, anyone?


IL 136294 to Pharmacia and Upjohn Successfully Opposed by Teva

October 20, 2014

Pharmacia

Pharmacia and Upjohn filed IL 136294, titled “Use of tolterodine, its 5-hydroxymethyl metabolite or racemate thereof in the preparation of medicaments for treating unstable or overactive urinary bladder”. On 6 May 2004, Teva filed an opposition.

The Application was a national phase entry of PCT/SE99/01463 which claimed priority from SE 9802864-0 and SE 9802871-4 filed on 27 August and 11 November 1998 respectively.

On 11 June 2003, a Divisional Application (IL 156414) was filed. Following the publication of patent office circular M.N. 23, the Opposition was frozen pending Examination of the Divisional Application. On 20 March 2006 the Divisional Application was abandoned and the file closed, and the Opposition procedure in the parent application was restarted.

On 19 June 2006, Teva submitted a detailed Opposition and Upjohn filed a counterclaim on 13 November 2006. Following submission of evidence, counter-evidence and responses, a hearing was held on 1 and 2 April 2009 before then Commissioner, Dr Meir Noam.

After the hearing, the parties submitted their concluding remarks between 21 April 2010 and 26 January 2012, after Dr Noam’s term of office finished. The Present Commissioner, Asa Kling, ruled on the case under regulation 202a, on the basis of the material in the file.

According to the Commissioner, the Opposition is two-fold. The Opposers argue that there is no inventive step in contravention to Section 5 of the Patent Law, and that the claimed invention is a method of treatment of Man and thus contrary to Section 7.

The Opposer, Teva, submitted their evidence via an opinion of Professor Danon. The applicant, Upjohn, submitted their evidence via an Opinion from Professor Abrams and a statement of Dr Wood. Teva submitted counter-claims via a second affidavit of Prof. Danon and an opinion by Professor Mor.

The patent relates to a treatment for sufferers of unstable or overactive urinary bladder. The problem is caused by a lack of control of smooth muscles around the bladder that receive electronic stimulation. The standard treatment at the time of filing involved desensitizing the nerves with tolterodine or oxybotynin. Both desensitizers had various adverse side effects including dryness of mouth. In minimizing this side effect, tolterodine was preferable to oxybotynin. Tolterodine is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine, where R indicates the Right handed enantiomer, and S, the sinister, or left handed enantiomer which does not work. The two desensitizers and the enantiomers are discussed in the specification.

The Application as allowed had 17 claims, of which claims 1, 8, 16 and 17 are independent.

Claim 1 is as follows:

  1. Use of tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, in a pharmaceutically effective amount thereof through a controlled release formulation capable of maintaining a substantially constant serum level of the active moiety or moieties for at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h, for the manufacture of a therapeutical formulation for treating unstable or overactive urinary bladder, substantially as described in the specification.

Claim 16 is similar, but includes the following limiting feature:

… with reduced undesirable side effects and with no reduction in the efficiency of the tolterodine compound…

Claim 8 is as follows:

  1. A pharmaceutical formulation containing tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, which formulation when administered to patient provides controlled release of said tolterodine its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, such that a substantially constant serum level of the active moiety or moieties is maintained foe at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h.

Claim 17 follows claim 8 , but includes the following limiting feature:

…for efficacious therapy with reduced undesirable side effects…

In order to ascertain inventive step or non-obviousness, the standard is that of a person of the art. Professor Danon and Dr Wood are pharmacologists. Professor Mor and Professor Abrams are urologists. Both sides argued whether in this case the person of the art to determine non-obviousness would need to be would need to be a pharmacologist, a urologist or a team including both skills. Accroding tot he Commissioner, this question may be answered by reference to Former Supreme Court President Shamgar in 345/87 Hughes Aircraft vs. State of Israel P.D. 44(4) 45 (1990) as including a person or team with knowledge of relevant subject matter but no creative ability. The Opposer (Teva) considers the person of the art to be a pharmacologist specializing in the relationship between active ingredients and the human body. The Applicant considers that persons of the art may be a team including pharmacologists and doctors of the relevant speciality, which in this case includes urologists.

The Applicants distinguish between the pharmacological and the pharmo-kinetical aspects of the invention, which in their words, are directed to a pharmacologist or formulator, and the medicinal aspects of the drug which are directed to a urologist. Professor Abram’s opinion follows this distinction.

“Obviously, once the pharmaceutical invention is made… pharmacokinetic and pharmacologic considerations become relevant. However, unless the pharmaceutical invention is made first, the pharmacologist is not a relevant person.”

According to the Applicant, the motivation to develop a drug is based on medical needs and so the application is primarily directed to the urologist, and other professionals, such as pharmacologists are consulted only once the drug is being developed to answer a specific medical need.

The Opposer considers that the medical need is the problem to be solved, and the person to be consulted to solve the problem is the person the art. Support for this position is found in “Patents for Inventions” by T.A. Blanco White, 5th Edition page 90:

“In principle, it would seem clear that the proper people to think of in judging obviousness are those who would in practice be called upon to solve problems of the sort concerned.”

Furthermore, the Expert for the Applicant Professor Abrams himself stated that the urologist might identify the clinical condition and would describe it to the pharmacologist, which strengthens the position that the person of the art is, in fact, the pharmacologist.

The Commissioner ruled that the person of the art is indeed the pharmacologist, although the urologist might well initiate the process of developing a drug.

Support for this was found in Alza Corporation vs. Mylan, a US ruling concerning urine leakage, where it was stated that:

“In their post-trial memoranda, the parties do not directly dispute the level of ordinary skill in the art at the time of the ‘355 patent’s filing. Thus, based on the testimony of Dr. Amidon and Dr. Peppas, the Court finds that a person of ordinary skill in the art has either an advanced degree in pharmacy, biology, chemistry or chemical engineering and has at least two years of experience with controlled-release drug technologies, or possesses a bachelor’s degree in one (or more) of the same fields and has at least five years of experience with controlled-release drug technologies.”

Consequently, the Commissioner ruled that whilst a urologist could be included in the team, the persons of the art defining obvious would include a pharmacologist.

As far as inventive step is concerned, the issue in question boils down to whether something would have been considered obvious by a pharmacologist, or by a team consisting of a pharmacologist and a urologist.

Both sides agreed that:

  1. As of the priority date both tolterodine or oxybotynin in instant release form were being used to treat unsteady or over-active bladders. Furthermore, oxybotynin was also being used in a controlled release form.
  2. It was understood that oxybotynin caused more serious side effects of dry-mouth and thus tolterodine was the preferred treatment.
  3. Dry mouth symptoms of tolterodine were most prevalent when tolterodine was at its highest concentration in the blood.
  4. It was already established that tolterodine had a positive effect on unsteady or over-active bladders after its effect on saliva forming and the symptoms of dry-mouth had disappeared.
  5. Moving from instant release to slow release formulations may not be successful for treatment of unsteady or over-active bladders and the efficacy required clinical trials.
  6. The Applicants considered that the minimal problems of dry mouth associated with tolterodine in quick release form were such that there was no motivation to develop a slow release version of the drug. Furthermore, slow release Oxybotynin did not have less slide effects than the quick release version so the urologist would be likely to conclude that slow release tolterodine would behave in a similar fashion.

Finally, according to the Applicants, it transpires that the slow release tolderine is actually more effective. This is not supported by the specification and is first raised as a consideration in the Applicant’s statement of claims. There is no evidence that Applicant was previously aware of this point.

The Applicant does not claim that this fact is relevant to the issue of inventiveness, but the commissioner nevertheless emphasizes that such post filing revelations are irrelevant to the issue of inventive step (non-obviousness) and the Applicant can’t turn the clock back. There has to be an inventive step at the time of the priority filing (albeit, possibly one discovered by accident).

The parties now debated a very interesting point. Regardless of the surprising improvement of the not particularly serious dry mouth side effect, according to Teva there was a drive towards creating a slow release version of the treatment since this would enable taking a pill once a day instead of twice a day. They consider this fact self-evident and not requiring scientific proof.

Upjohn countered that this advantage of merely reducing the dosing frequency would not have warranted a switch to a controlled release treatment. They considered that the frequency of dosage was a minor issue for chronically ill patients and thus with the anticipation of increased side-effects, the drug developer would have no drive to develop a controlled release version. Citing Goldstein and Kalman:

“Certainly the oral ingestion of a drug 3 or 4 times daily presents no hardship to the patient; the substitution of a single daily dose of a sustained-release preparation would not be warranted unless some advantage other than convenience had been demonstrated.”

The Commissioner rejected this argument, preferring Glaxo group LTD’s Patent [2004] R. P. C. 843:

“That salmeterol would be the obvious substitution for salbutamol follows from the most basic consideration, that a drug that only needs to be taken twice a day will encourage compliance.”

And

“…the patent must be invalid, because I consider that the problem of compliance has, on the evidence, always been a problem.”

The Opposer considered that despite possible problems in achieving, it is obvious to try to reduce the dosage frequency, and thus a mere change in dosage frequency achieved by a coating is not inventive.

The Applicant countered that the development of a slow-release version warranted a patent since there were many cases where controlled release was less than successful, and they brought three examples of this.

The Opposer showed why the three examples were all exceptions to the rule and the commissioner felt that the onus was on the Applicant to show why this instance should be considered inventive.

Both parties accepted that tolterodine was preferable because of its lesser severe side effect of dry mouth. The Applicant considered that this being reduced further by controlled release dosages was patentable.

“According to the present invention it is now surprisingly been found that contrary to the case of oxybutynin, the substantial elimination of peak serum levels of tolterodine and its active metabolite through controlled release of tolterodine for an extended period of time, such as through a once-daily administration form, while maintaining the desired effect on the bladder, indeed gives a significant reduction of the (already low) side effects, particularly dry mouth, compared with those obtained for the same total dosage of immediate release tablets over same period.”

The commissioner noted that Upjohn had stated that this was a surprising discovery, but that they had not actually explained why this was the case. He noted that the Opposers reasoned that if regular tolterodine has lower dry mouth side effects than oxybutynin, this would remain the case with quick release versions.

The commissioner felt that the Applicants had not explained why, despite the fact that occasionally slow-release preparations might have unwarranted side effects or efficacy issues, it would not have been obvious to try to reduce the frequency of the dosage to once a day only.

Furthermore, earlier patent WO098/03067 notes that the S-enantiomer is preferable to the R-enantiomer and suggests a more frequent dosage or a controlled release. On this point, the Applicant tried to argue that since the current application relates to the S-enantiomer only, the earlier patent was irrelevant. Furthermore, the earlier patent suggests multiple frequent dosages which teaches away from the present invention. The commissioner did not find these arguments persuasive and still considered it would be have been obvious to try.

The Opposer considered the experimental evidence as totally anticipated by persons of the art and that there was nothing surprising in it.

The cut and thrust of the parties is reported in depth, but the general tendency of the Commissioner is to uphold the ruling in IL109059 F. Hoffmann-La Roche AG vs. AGIS Industries (1983) LTD from 17.10.2004 that it would have been obvious -to-try.

“First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile.” (Brugger v. Medic-Aid Ltd., [1996] R.P.C 635 at 661)

“… Whether the subject matter was obvious may depend upon whether it was obvious to try in the circumstances of that particular case and in those circumstances it will be necessary to take into account the expectation of achieving a good result. But that does not mean that in every case the decision whether a claimed invention was obvious can be determined by deciding whether there was reasonable expectation that a person might get a good result from trying a particular avenue research. Each case depends upon the invention and the surrounding facts. No formula should be substituted for the words of the statute. In every case the court has to weight up the evidence and decide whether the invention was obvious. This is the statutory task.” (Norton Healthcare v. Beecham Group Plc, CA, (1997)) ([2004] R.P.C. 43 at para 42)

Consequently, the claimed invention was found to be obvious and the Opposition was accepted.

Opposition by Teva to IL 136294 Pharmacia and Upjohn, Assa Kling, 30 September 2014.

COMMENTS

I am neither a pharmacologist nor an urologist, (although I do enjoy taking the $%*& against poor decisions occasionally). It is established that the standard of inventiveness of obvious to try. Both sides accept (at least tacitly) that when taking tolterodine, once the problem of dry mouth is addressed, it would be obvious to try a slow release formulation, so the solution is fairly obvious. The question remains whether identification of the problem as a problem is worthy of a patent. Here the pro-pharma lobby will stand on their chairs and wave banners that of course this is patentable, whereas the generic side of the industry will have serious reservations. This may not just be a question of who pays one’s bills. It is at least possible that attorneys and scientists with different philosophies get drawn to the different market sectors that reflect their look on life.

Having a general background in chemistry but no background in pharmacology I tend to side with the generic industry. I suspect that most impartial patent attorneys with backgrounds in computing or engineering would find the Applicant’s arguments tortuous and unconvincing.

One question not addressed is why they chose to try to develop a controlled release version if there was no a priori assumption of it being preferable? (If the answer is ever-greening, is this acceptable, or is it obvious to try to keep a drug patent protected indefinitely?

Arguably the standard of obvious to try is to high, but it is the standard that Dr Meir Noam, the previous commissioner set. He was a chemist.

The present commissioner, Asa Kling is an aeronautical engineer.  He is no more a person of the art than I am. Nevertheless, his position as commissioner requires him to decide who the person of the art is, what is the standard for inventiveness and particularly whether identifying the issue of this side effect is in and of itself an inventive step. Really the issue is one of policy. The drug development industry will no doubt cry out that the Israeli standard is too high, whilst the generic industry will be more supportive of this ruling. If this ruling is appealed to the courts, the Commissioner’s determination will be scrutinized.

 


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