IL 136294 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.

 


Astrologist Successfully Sued for Copyright Infringement of New Card Designs – She didn’t see it coming

October 20, 2014

Astrological cards

Zur-Klein is  an astrologist. Tal Rinkov is an artist who created 37 cards for the Astrologist in accordance with an agreement between them which, inter alia, related to the copyright ownership.  (Ms Rinkov was also the kindergarten teacher of Ms Zur Klein’s daughter, which is how they met (some would say it was fate).

Ms Zur-Klein ordered 40 card designs for a payment  of 5000 Shekels.  The cards were to be mass-produced and distributed with an instruction manual and a teaching movie. The parties entered an agreement on 5 September 2014 that established several principles:

  1. The original artwork and the copyright of the artwork was to remain that of the artist.
  2. The artist would not be entitled to royalties for packs of cards and other goods itemized in the agreement
  3. The Astrologist would only be entitled to use the images on specific listed items
  4. All internet images  would be reproduced at a low resolution only
  5. All pictures would carry Ms Rinkov,’s signature, her name, website and contact details

Ms Rinkov was hospitalized in November of that year and only delivered 37 designs, and the last three were completed by another artist. (For reasons not apparent, the medium missed this eventuality). The images were transferred to a graphic artist who made various graphical changes to make the images more suitable for printing.

After various commercial entities expressed interest in the images, Ms Zur-Klein contacted Ms Rinkov to try to negotiate a transfer of copyright but due to a difference of opinion, no agreement to transfer the copyright issued.

Ms Zur-Klein  publicized the images in various internet sites including her own and other people’s, in her blog, Facebook page and elsewhere.  In all reproductions of the cards on the Internet, the artist’s signature appeared, but her name and contact details were not given. Indeed, on some websites, Ms Zur-Klein presented herself as the creator of the card (the term יוצרת הקלפים is used, which is both creator and manufacturer so the term is somewhat ambiguous). Furthermore, Ms Zur-Klein allowed other astrologists to use the designs without giving any credit to Ms Rinkov. There was also a newspaper article featuringMs Zur-Klein that was illustrated with one of the card designs that was also not credited.

On 6 June 2012, Ms Rinkov sent Ms Zur Klein a Cease & Desist letter.

The basis of the ensuing court case was the agreement signed by the parties. It is translated below:

Tal prepares for Carni 39 pictures, which together with the picture already executed, provides a set of 40 pictures for cards and other purposes – payment 5000 Shekels.

Apart from the payment for the work, there will be no other royalties for selling packs of cards, books, CDs and other astrological items depicting the images of Tal Rinkov.

The astrological products that Karni is allowed to use the pictures on are: packs of cards, books, audio CDs, video for watching, a banner for a website, business cards and other articles on authorization from the creator. Karni may not manufacture or distribute artistic works such as pictures, mugs, key-rings and the like.

All material displayed on the Internet are at low pixel count.

The name, website and contact details of Tal Rinkov will appear on all products, including future products.

The pictures on the cards and elsewhere will include the artist’s signature.

The original artwork and copyright remains the exclusive property of Tal Rinkov.

Pictures and associated artistic products (that are not astrological) will be produced and distributed exclusively by Tal Rinkov.

Any deal that Karni creates for Tal will generate a 20% commission for Karni.

When Tal sells a product (book, CD, cards and the like) she will profit 20%. Tal will receive a present of a pack of cards.

 According to the plaintiff, the defendant wrote the contract after the negotiations. The defendant claims, however, that the contract was the plaintiff’s idea, and that the plaintiff had written most of the clauses to the detriment of the defendant, such as her not getting benefit from sale of the cards. However, the defendant agreed that she had printed out the agreement.

The defendant claimed that she was entitled to the status of co-creator in the cards as although Ms Rinkov executed the artwork, it was to her, Ms Zur Klein’s specification regarding the symbolism, colors and charms. The plaintiff considered this a change of direction in the defence and objected to it on principle.  The judge ruled that the claim that the defendant hand guided the artist appears in clause 31 of the defence, but is more a factual than a legal defence and so she was willing to contemplate it. The plaintiff countered that Carni Zur-Klein had not, in fact, instructed her, but that she herself had researched the elements and colours.  Both sides supported their contentions with emails and other evidence. It does seem that the astrologer gave guidelines for the design, but these are by way of astrological knowledge rather than artistic input.

RULING

In this instance, Judge Lemelstrich  did not consider that under section 1 of the Copyright Law 2007, the two parties could be considered co-owners of a joint creation. Section 64 creates a rebuttable assumption that the artist is the creator and each card design was signed by Ms Ronkov as the artist.

Section 5 of the Copyright Law notes that the idea, way to implement and facts are not copyright protected, only the  artwork itself is. According to Section 35a of the Copyright Law, a work for hire is the property of the artist in the first instance, unless otherwise agreed implicitly or explicitly. In this instance, both the Copyright Law and the contract  support the artist as owner of the copyright.

In the packs of cards, Ms Rinkov is acknowledged as the artist and Ms Zur-Klein is credited as an astrologer.

The parties agree that Ms Zur-Klein conceived the project, but the copyright in the images remain the property of Ms Rinkov.

Ms Zur-Klein apparently sold some 80 packs at 190 Shekels a pack.

the main issue sees to be the internet reproductions which do not provide the details of Ms Zur-Klein.

The ruling now relates to various astrological websites. Since I find this subject matter morally, ethically and religiously abhorrent, I am refraining from reproducing the links.

The important thing is that Judge Lemelstrich considers that the artist’s moral and financial rights were compromised in numerous infringements in various websites and internet campaigns. That said, the pictures on the Internet were not reproduced at a quality to enable them to be printed and used as playing quality cards.

The changes to the designs for subsequent printing by a graphic artist under the direction of Ms Zur-Klein were minor. These were considered insufficient to create a change to the copyright, in that the original work could not be considered defaced or the artist’s moral rights compromised. Nor did the amendments constitute a copyright protectable creation.

Ms Rinkov claimed 100,000 Shekels in statutory damages for copyright infringement and a further 100,000 Shekels for moral rights infringement, particularly noting the long and arduous legal proceedings and the multiple infringements.

Judge Lemelstrich noted that despite entering a clear contractual relationship to the contrary, Ms Zur-Klein acted as if the creations were hers to do what she liked with. She ruled 35,000 Shekels damages for infringing the moral rights, 15000 Shekels for infringing the material rights and a further 5000 Shekels for an article published after the Cease and Desist letter.

Judge Lemelstrich of the Haifa District Court ruled a permanent injunction against Ms Zur-Klein, her delegates, substitutes and others from performing any action that violates the September 2011 agreement or other rights as per the statement of case.

Ms Zur Klein will compensate Ms Rinkov 55,000 Shekels for copyright infringement, an also will pay 15000 Shekels legal fees. The money will be paid within 30 days.

Civil Ruling 15824-10-12 Tal Rinkov vs. Carni Zur-Klein, Haifa Court before Judge R. Lemelstrich, Ruling 13 October 2014

 

 


Laches in Amending Claims During a Patent Opposition Procedure

October 19, 2014

Zometa

Novartis Pharma filed Israel Patent Number 153229 titled “Use of 1-Hydroxy – 2 – (Imadazol-1-YL) Ethane – 1, 1 – Diphosphonic Acid in the Preparation of A Medicament for the Treatment of Conditions of Abnormally Increased Bone Turnover”.

The Application was allowed and published for Opposition purposes on 24 July 2007, and Teva filed an opposition on 23 October 2007.

After the Opposer filed their statement of case, the Applicant requested to correct the specification. The Opposer did not oppose the amendment, but following it, filed an amended statement of case. During 2011 and 2012 the opposition proceeded. On 10 April 2014 the applicant requested to amend the specification a second time. The amendment consisted of canceling claim 1 and dependent claims 2-5 and amending claims 6 and 7. The basis for the amendment was that the UK court had voided the corresponding patent, allegedly on formalistic and technical grounds, but to forward the discussion in Israel, the Applicant wanted to  amend the specification by canceling these claims.

Teva opposed the amendment, arguing laches and inequitable behavior since it was years since they’d filed their statement of case. They further claimed that the UK court had voided the patent due to the priority date and not on formalistic grounds. The UK Court of First Instance had issued their ruling over a year earlier, and this should be taken into account when considering the request to amend the application. This consideration was strengthened by the Opposition to Israel Patent 324844 Gradstan LTD vs Bristol Myers Squibb (6 March 1979). Furthermore, the request to amend the claims was not supported by an affidavit, and this was further grounds for refusing the request.

Novartis counter-claimed that the Appeal to the UK Supreme Court had only issued on 10 July 2014 and therefore there were no laches or inequitable behavior. Furthermore, if an affidavit was required, the applicant would be happy to provide one.

Teva countered that the flaws requiring correction were stated in the statement of case and Novartis should have corrected their application at the first opportunity which was over four years earlier.

THE RULING

The main argument is whether there is a statute of limitations or laches for amending a specification after allowance and before grant. The Opposer cited a very old case from 1979 to argue that this couldn’t be allowed, whereas the applicant cited the more recent Opposition to IL 101537 Merck and Co. vs. Unipharm Inc. (30 April 2003).

The Deputy Commissioner noted that she had ruled on the grounds for post allowance amendments under Sections 29, 65 and 66 f the Law in Reva vs. Astellas Pharma and in Rafael vs. Elta, both from May 2014.

The ability to amend the claims provides an advantage to the applicant, but it also results in side skirmishes that hold up the issuance of the patent, to the advantage of the opposer and to the detriment of the applicant.

In this instance, the request to amend the claims comes after the submission of evidence, at the stage of the hearing. However, this was justified by the UK ruling only now being made final.

Nevertheless, the request could have been made some months ago and wasn’t. No explanation was given. Although the ongoing Opposition prevents a patent from issuing (and being enforceable), it also provides uncertainty to competitors and the awarding costs only partially mitigates this.

The Gradstan case was exceptional in that five years had passed from when the applicant knew that the specification should be amended and, according to the then commissioner (Yoel Tsur?) the proposed amendment did not achieve its purpose.

In Merck vs. Unipharm the then commissioner (presumably Dr Meir Noam) ruled that even where there is a delay, the applicant should be able to amend the specification unless there is inequitable behavior or the applicant had previously fought tooth and nail for the wider claim set.

The Applicant’s reason for the delay (pending final ruling in the UK) is prima facie justification to wait until now. Hence, the delay is a matter of months, not four years and awarding costs is a fair way to compensate the Opposer.

There is no argument that the amendment is one that narrows the scope of protection since claims 1-5 are canceled and claims 6 and 7 are also narrowed since they specify a range of doses for menopausal women and the amended ranges are within the original ranges. The amended claims are also both fully supported by the specification.

As to the requirement for an affidavit, Ms Bracha ruled that this is required to support a factual matter about which there is some dispute. In this matter, that is not the case. Both sides agree when the original UK ruling was and when the Appeal ruling made it final.

CONCLUSION

The requested amendment is allowed and will publish for third-party oppositions. Absent such oppositions, the Opposer may file a corrected statement of claims within one month. If he does not wish to correct the statement of claims, he should alert the patent office of this within that month, and a hearing will be scheduled to examine the evidence.

Since this is the second request to correct the application and was filed some months after it transpired that there was a need to amend the claims, the Deputy Commissioner ruled costs of 3000 Shekels and attorneys fees of 30,000 Shekels + VAT. Furthermore, should the Opposer choose to amend their statement of case and to correct their evidence, they will be entitled to further costs regardless of the ultimate outcome of the proceedings

COMMENT

The active ingredient seems to be Zoledronic acid and the drug in question appears to be Zometa®.

This ruling seems fair.

Refusing to allow a patent to be amended due to the request not being supported by an affidavit seems to me to be formalistic. I would not consider a problem with the priority date as merely formalistic though.


Calculation of costs re Israel Trademark Number 242574 for “OSIS”

October 19, 2014

OSIS

AG & Co. KGaA applied for Israel Trademark Number 242574 for “OSIS”

The mark was applied for perfumery goods, essential oils, cosmetics, preparations for treating, washing, dyeing, bleaching, styling and perming hair, soaps in Class 3, and for mechanical implements for body and beauty care (included in this class), sponges, brushes (except paint brushes), apparatus and receptacles for applying hair dyes in class 21.

Ein Gedi Cosmetics opposed the registration.  After several extensions, Henkel abandoned the mark. On 13 July 2014 Ein Gedi requested costs of 12,000 Shekels. On 18 August 2014, Henkel responded to the request for costs.

The Adjudicator of IP issues, Ms Shoshani-Caspi, accepted that in general, the party prevailing in a proceeding is entitled to costs. In this instance, the Applicant did not detail his requests for costs which therefore have to be considered as an estimate only.

In Bagatz 891/05 Tnuva vs. Department of Industry it is stated that to obtain real costs, the applicant should detail the basis of calculating legal fees, the amount of work, and whether it was actually paid. After this is done, the opposing party should explain why the requested costs are inappropriate.

furthermore, Section 69 of the Trademark Ordinance gives the Commissioner (or whoever rules on the case on his behalf) discretion to award costs considered realistic.

In this case, since there was no basis to award actual costs, the adjudicator considered the complexity of the case, the amount of work, the professionalism of the parties, equitable behavior of the parties and with reference to Regulation 46 of the Trademark Regulations 1940, whether the case could be avoided were the Opposer to provide the applicant with sufficient notice.

Apparently the Opposer had not contacted the Applicant before filing the Opposition, but the Applicant had filed three extensions, indicating that they were originally considering and intending to respond. This was not considered as sufficient indication of inequitable behavior though.

Taking into account the amount of work done and that the opposer had to request costs,the Arbitrator of intellectual Property Ms Shoshani-Caspi ruled costs of 3000 Shekels including VAT.

Ein Gedi vs. Henkel re Israel Trademark Number 242574, ruling on costs by Ms Yaara Shoshani -, 17 September 2014

 


Israel Patent revived over seven years after it lapsed

October 16, 2014

carry on screaming   living dead

Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri was allowed on 11 July 2006, but the first renewal was never paid. Consequently as of 11 April 2007, the end of the six month grace period, it was considered as having lapsed as of 11 October 2006, and in the May 2007 a notice of the patent having lapsed published.

A mere seven years later on 21 May 2015, Yigal Tsabri, the patentee requested the patent be restored. In the request he detailed that around the time the patent issued his financial situation deteriorated and the connection between him and his agent of record was broken. The agent of record did not inform him of the requirement to pay the renewal fee and instead, opened a file with the government collection agency (Hozlap). On 19 December 2011 a bankruptcy order issued but the receiver had agreed to allow attempts to restore the patent.

On 25 May 2014 the Deputy Commissioner noted the long time that had passed and expressed concern that the case could not be considered reasonable. Although the applicant had described difficult circumstances he had not presented any evidence of having done anything to keep the patent alive. The applicant for restoration had not detailed when he learned that the patent had lapsed and why he’d needed a District Court authorization to file a request for restoration.

In the circumstances the Deputy Commissioner gave the Applicant an opportunity to appear before her on 22 June 2014. During this hearing it transpired that the lapsed patent was a source of income as it was being licensed! – this despite the fact the license was not registered with the Patent Office, the patent had lapsed as of October 2006 and apparently the licensee was unaware that the patent had lapsed! The income from the patent license was being used to pay off the bankruptcy debts.

The patentee declared that he’d learned about the patent lapsing about eight months prior to the request for restoration being filed. As soon as he’d learned of it lapsing he’d turned to the manager of the bankrupt estate (presumably the receiver – MF) and had got District Court Authorization to file the request for restoration as the fee for so doing came out of the bankruptcy estate.

The Applicant provided reasons from May 2006 until today, for not having been able to clarify the status of the patent which provides grounds for leniency, despite the patent being to some extent abandoned. These reasons were not published in the decision as they are of a personal nature.

The Court had apparently provided a public defender to represent the patentee, but he had failed to show up for the hearing so the patentee had represented himself.

The Deputy Commissioner ruled that the patent could be restored on payment of the various fees, but this decision publishes for opposition purposes. As the patentee is not represented, the decision is sent to him directly and also to the public attorney’s office.

Decision re restoration of 139892 to Yigal Tsabri. Ruling by Deputy Commissioner Ms Jacqueline Bracha, 9 September 2014.

COMMENTS

It does seem nice that a week and a half before Rosh Hashana, the Deputy Commissioner is showing clemency לפני משורת הדין.

However, 6 years is indeed a long time. It appears from the decision that the receiver had authorized the reinstatement back in 19 December 2011. From a first reading I assumed that this is one of the things that Ms Bracha wanted clarifying and is not actually the case. It also appears as if the patent attorneys had instituted the bankruptcy proceedings. Whilst this is certainly their right, I would be surprised if this is indeed the case. I also find it difficult to imagine that the agent of record didn’t forward the certificate. It seems more likely that they would warn regarding the first renewal and request all bills settled first.

The requirement for clarifying whether or not a patent is in force is to enter the Israel Patent Office website. The details are on line. The staff at the patent office are also fairly helpful over the phone. Indeed, if someone had come in to my office off the street wanting to know if a patent was in force, I would have told them , and suspect that this is true of many other patent offices.

The licensee has been paying money without minimal due diligence to check if there is a patent that is in force. This is surprising but not unbelievable.

Clients are odd things. I had a client who drafted his own application by copying someone else’s issued patent which he cited in the background. The basis of his claim to a patent was that he’d made the device smaller. Not surprisingly, the prior art was cited against him and that was when he came to me. I actually managed to make fairly drastic rewrites based on the figures and to obtain a patent. That inventor made the conscious decision to not to bother paying the first renewal fee since he was licensing the patent anyway!

I also had a Russian inventor who came to me with a portfolio of six patent applications, three of which had lapsed. He’d drafted the applications himself, and I suspect he’d written them in Russian and used a computer to translate the specification. I am always happy to take on a challenge, and managed to restore two of the cases that had lapsed within less than 12 months. I extensively rewrote the specifications without adding new material and got five of the six cases to issue. The earliest application had lapsed over three years earlier and I was unable to revive it, despite the applicant providing some evidence of periodic hospitalization and problems with a previous agent of record. He was unable to adequately demonstrate to the satisfaction of the Deputy Commissioner that he’d taken action promptly on first learning that the patent had lapsed, since I was taken on over a year later. It was a shame, since the patent was for a significant invention. The client wanted to appeal to the Courts, but did not instruct me on time. The Deputy Commissioner’s main concern was that third parties could have learned of the first application from a corresponding US case (published and allowed, however the issue fees were never paid). The rights of such third parties practicing the invention would have been compromised if the patent application was reinstated. I had actually tried to preempt this by offering an unconditional free license to any such third parties in the request for reinstatement itself. In the ruling refusing to all reinstatement, the issue of prejudicing unknown third parties and the need to strike a balance between the applicant’s rights and theirs was extensively discussed. My suggestion of an unconditional license wasn’t. Thisraised grounds for an Appeal to the Court, but the client didn’t instruct me on time and didn’t pay the fees. The main difference between that case and this is (a) that the Russian case was a lapsed application and this is a lapsed patent, and (b) specific health issues of each inventor, where the details of this case have not published. I jumped through all the legal hoops and related to every precedent to no avail. Presumably the patentee in this case did not, as he was unrepresented. What is interesting however, is that in the present case there is clearly a third-party who has not needed to pay licensing fees and was being defrauded, albeit possibly unintentionally. Now, by reinstating the patent, this actual and real licensee will have to continue paying fees hereinafter, possibly until November 2000. Go figure.

This ruling will publish for appeal purposes. The law granting the patent office discretion to revive long dead patents is clear. The question is whether the discretion was used wisely and whether the serious of events described by the patentee to justify the revival were true. We do not know what they are. The decision as published is heavily censored to protect the patentee’s privacy. Unless third parties can access the details, how can they challenge them? Can the former agents of record produce evidence against their ex-client who apparently did not settle his bills, to show that he did receive details of the deadline for renewal? Would this be a considered unethical? What about the hapless licensee who has being paying royalties to use a lapsed patent? It is unlikely that someone not involved would oppose a case with virtually no chance of recovering costs as the patentee is apparently bankrupt.


Claim Reconstruction – Israel style

October 14, 2014

One of the problems with the written word is that word and phrase may have slight ambiguities in meaning that are clarified by context and be dictionary definitions.

The’ metes and bounds’, i.e. the perimeter of the monopoly of a patent is defined by the claims. In the US, virtually every patent infringement proceeding includes a preliminary Marksman hearing where the parties argue as to how the claims should be construed. Once the scope of the patent is determined, the parties can argue about whether an allegedly infringing product or method actually infringes and appropriate damages.

Janssen

Israel Patent Application No. 181650 to Janssen Pharmaceutica titled “SOLID PHARMACEUTICAL COMPOSITION COMPRISING A PHARMACEUTICALLY ACCEPTABLE CARRIER AND HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE AND USE THEREOF IN THE MANUFACTURE OF A MEDICAMENT FOR TREATING OR PREVENTING HIV INFECTION” was allowed and published for opposition purposes. Teva Pharmaceuticals, Israel’s largest pharmaceutical company and the world’s largest generic drug manufacturer opposed the patent.

Somewhat unusually for Israel patent office practice, following submission of claims and counter-claims, Teva noted a large discrepancy between the parties as to the scale of the monopoly covered, and requested a preliminary ruling on the scope of the claims. Teva argued that a preliminary ruling on the scope of the claims could expedite the opposition proceedings.

The application was filed in Israel on 2 September 2005 and was allowed and published for opposition purposes in the August 2012 journal on 30 August 2012. The application for a preliminary ruling was submitted by Teva on 21 January 2014. Janssen filed their counter-claims on 20 February 2014 and Teva responded on 11 March 2014.

Both sides concur that the claimed invention relates to a solid medicinal preparation that includes a therapeutically effective amount of the hydrochloride salt of rilpivirine  as an anti-viral agent by itself or with others.

The argument between the parties is whether the preparation includes Amtrisitivan (FTC) and tanofoyer Diazonbrocsil fomrate (TDF). Teva claims that the claimed invention does not include the combination of rilpivirine, Amtrisitivan (FTC) and tanofoyer Diazonbrocsil fomrate (TDF), whereas Janssen rejects this interpretation and argues that the invention includes this combination.

Teva alleges that a preliminary ruling on this issue would accelerate the opposition process and save judicial time. Specifically, should the patent office rule that the three-way combination is not included, they would retract their opposition, which by nature of the complexity fo the application is likely to be a protracted affair. On the other hand, if the correct claim interpretation is found to include the three-way combination, the opposition will be focused on other issues and will be less complex.

(we assume that it is in the interest of the applicant for the Opposition to proceed quickly as a patent cannot be enforced until all oppositions are dropped or ruled on, and clearly the faster the process, the cheaper it is likely to be).

The Opposition procedure is acknowledged by section 30 of the Israel Patent Law 1967. Grounds for Opposition are given in Section 31 and these include: (i) a reason why the Commissioner may reject the application; (ii) that the invention is not patentable under Section 4(2) (lacking novelty); and (iii) the oppose and not the applicant is the true owner of the patent.

The Opposer considers the request for a preliminary ruling as a kind of division of the proceedings that will save time and could render further aspects superfluous and cites the opposition to Israel Patent Application 75934 Merkaz Argazim LTD. vs. Levy (1992) as a precedent for such a preliminary hearing. The Applicant considers the request as a delaying tactic designed to result in the Opposition including multiple proceedings.

The Commissioner accepts that the opposition to Israel Patent Application 75934 Merkaz Argazim LTD. vs. Levy (1992) provides a precedent to splitting up an opposition, and that this is acceptable as long as doing so does not prejudice the rights of either party, but notes that the current case is not identical in that it is a preliminary hearing (that the Opposer claims could settle the issues.

The commissioner ruled that he had the authority to make preliminary and intermediate rulings, but was not obliged to do so. From review of the claims and counter-claims he considered that there were differences that could best be clarified by allowing the presentation of evidence.

The Commissioner considers that the issue behind Teva’s opposition was an allegation that the Applicants were claiming more than they were entitled to and that the so-called correct interpretation is a wide construction. In other words, Teva’s issue is Section 13a of the Patent Law and regulation 20. This interpretation (which opens the claimed invention to challenges on novelty and inventiveness grounds) is allegedly supported by the specification and how a person of the art would read the patent specification and claims.

The Commissioner ruled that the Applicant should make an alleged interpretation for the Opposer to oppose, and without this it would be improper to rule on the scope of the claims based on so called internal evidence.  Essentially Section 31  of the law is precisely to determine the scope of the claim protection and there was no justification to preempt this.

The Commissioner referred to Hughes Aircraft and to Zuk Ohr vs. Car Security LTD and considered that in the opposition the Commissioner should rule on the scope of the claims taking the prior art into account, and that one cannot interpret an application without consider the inventive step therein, He then stated that the scope of the prior art before the Commissioner required gathering evidence and this was especially the case where there was an apparent dispute between the parties.

The Commissioner considers that Teva wishes to clarify the scope of the claims based on internal evidence only, ignoring external evidence and expert witness testimony. Specifically the Commissioner noted that TEVA argued that claims 4, 5 and 10 of another Janssen patent, Israel Patent No. IL 173438 included the three-way combination of rilpivirine, Amtrisitivan (FTC) and tanofoyer Diazonbrocsil fomrate (TDF), and to allow the patent would result in two patents for the same combination.

Without ruling on whether another patent of the same applicant is internal or external evidence, the Commissioner noted that there is a rebuttable presumption that the examiner was aware of the second patent. The commissioner considered that an Opposition required bringing something that the Examiner was unaware of, or a problem in the Examination, and does not consider that to be the case.

In light of the above, the Commissioner considers that there are factual differences between the parties and the correct way to proceed is with a full-fledged opposition. Furthermore, the Commissioner argued that a preliminary ruling on the issue of patent scope might give one party an advantage in subsequent proceedings. He also expressed concern that this could open the flood gates to other preliminary ruling that could put a strain on the patent office. (this reminds me of a cartoon in MAD MAGAZINE where the wife wanted a washing machine to save on laundry bills, a car to save on bus fares and a coffee machine to save on restaurant bills, and the husband declared that he could not afford to economise). The Commissioner considered that preliminary hearings should be reserved for clear-cut cases where everything could be cleared up, and not for relatively complex issues.

marlsmen

Finally, as an after-word, the Commissioner related to the so called Marksman hearings in the US, that TEVA suggested was a similar model. The Commissioner noted that Janssen did not see this US style preliminary ruling by the courts in infringement cases as parallel to the Opposition Proceeding before the Israel Patent Office.

In conclusion, Commissioner Kling rejected the request for a preliminary ruling on the scope of the claims (ruling of 24 July 2014) and gave the Opposer until 30 October 2014 to submit their evidence. Costs for this interim ruling will be awarded together with costs for the main decision.

Opposition to IL 181650 Teva vs. Janssen Pharmaceutica, preliminary ruling of 11 September 2014.

COMMENTS

I don’t think that the Commissioner needs to do more to reject a request for a preliminary ruling on one issue than to state that he does not feel it was the most efficient way to proceed. I can’t see one party appealing such a statement. Instead, the Commissioner has waffled over 5 1/2 pages. That is his right of course. However, I found this ruling poorly structured. What disturbs me  more is that the Commissioner seems to consider that the scope of the claimed invention is somehow dependent on the prior art and on expert testimony. I disagree. I think the claims should be sufficiently clear without reference to prior art. The correct interpretation may depend on the specification and on dictionary definitions. It does not depend on prior art. The scope of what is actually patentable does depend on prior art of course. After clarifying what the prior art is, it may be justifiable to narrow the scope of the claims. I am familiar with various decisions that strike patents for claiming more than they are entitled to. I disagree with this approach. I think that it is justifiable to narrow the scope of the claims in light of prior art, and relying on dependent claims is one way to do this. I don’t consider double patenting per se. to be problematic. It may be the basis of a terminal disclaimer limiting the term of the second patent to the expiry date of the first patent, but there is nothing wrong with multiple protection of the same formulation with differently worded claims that protects different aspects. What is of relevance, of course, is whether Janssen’s earlier patent is novelty destroying prior art, or raises issues of obviousness.

I do not agree that an Opposition proceeding needs to rely on a piece of art not before the Examiner. I think that it is sufficient for the Opposer to claim that the Examiner did not give sufficient weight to a piece of art or misinterpreted it to have the right to file an opposition, giving judicial review of the Examiner’s work.

I note that in contradiction to the Commissioner’s approach (and, indeed, to Supreme Court precedent, Judge Binyamini of the Tel Aviv District Court who seems to be one of the better judges on IP issues, actually uses preliminary hearings to try to isolate the real bone of contention and to try to rule on this, making further hearings redundant. This does not imply that the Commissioner is wrong to prefer to have all evidence before him and to follow standard procedure. It is however interesting to note the difference in approaches.

I also note that Janssen is represented by Gilat Bareket of the RCIP group which was where the Commissioner Asa Kling worked prior to becoming commissioner. As Reinhold Cohen is the largest local IP group this is not a surprising state of affairs and it is also true that the Commissioner has been in office for a reasonable period of time. I don’t know whether it is practicable for the Commissioner to excuse himself from all cases where RCIP represents one party or the other. Nevertheless I don’t think this looks good. It may be an additional reason for TEVA (represented by Shin Horowitz) to appeal the eventual ruling.

Finally, I had a quick look at the claims of this application and consider them to be fairly clear. I don’t think that a Marksman type hearing would fairly address the issues that according to the preliminary ruling are those of concern to TEVA. I did not review the specification carefully, but did scan it, and could not find correct spellings in English for the chemical terms I’ve transliterated. Corrections and other comments, are, as always appreciated.


Israel Patent Office Shortens Patent term Extension for Ezetimibe

October 12, 2014

Ezetimibe  molecule

Israel Patent Number 110956 titled “HYDROXY-SUBSTITUTED AZETIDINONE COMPOUNDS, HYPOCHOLESTEROLEMIC PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, AND PROCESSES FOR PREPARING THEM”

The patent protects the active agent Ezetimibe as found in the pharmaceutical Ezetrol or Zetia, that reduces the amount of cholesterol in human body. The patent is owned by Schering Corporation and is licensed exclusively to Merck & Co. LTD. The original 20 month patent term will lapse on 13 September 2014. However, on 22 September 2005 the patentee received a patent term extension until 23 June 2017.

On 7 January 2013, the Association of Industrialists in Israel filed a request to cancel or shorten the patent term extension. Grounds for the request for cancellation were Section 64(xi) of the Patent Law 1967 (current version) which states that “Following a request from any third party, other than the patentee or a sole licensee, the commissioner can cancel a patent term extension or change its duration if it transpires that there were grounds for opposing the extension or the patent; there is no statute of limitations to filing a cancellation request under this Section.” The Association of Industrialists in Israel requested that the patent extension term be shortened so that it terminated on 22 January 2016.

On 23 December 2013, the Commissioner of Patents allowed the parties to submit their arguments in writing, avoiding a hearing, but refused to allow the parties to widen the grounds of their attack. The original patent term extension request was based on the first commercial authorization being from Germany on 17 October 2002. However, during the proceedings, the applicant requested to be allowed to delay selection of the country until the US and Australian patent term extensions issued, following the ruling of the then Deputy Commissioner Axelrod in Novartis (Israel patents 79336, 84901 and 105264) and the 7th amendment to the Israel Patent Law 1967, from 2006. On 22 August 2004, the Applicant requested that the extension be calculated on the basis of the Australian patent (AU 681,445) which is what happened. Since that time, under US pressure, the relevant section of the Israel Patent Law has again been amended (11th amendment) but this is amendment is not retroactive.

The current dispute is based on whether or not Schering / Mercke filed details of the US case as required in the 7th amendment. An affidavit from a Dr Volman on behalf off the patentees implies that they did, but this is not supported with any appended evidence. Apparently there is no copy of such a submission and there is no reference to the US case in the file. Whether or not details of the US extension were submitted, under the Law, the maximum extension should have been until 22 January 2016 which is a 597 day extension of the US case (US Re 377721). Furthermore, even without the US case, the maximum extension should have been 14 years after the pharmaceutical preparation was first allowed in the US, i.e.. 17 October 2016 and not until June 2017. The parties also disputed whether the Seventh amendment should be applied retroactively. The patentee argued that this could shorten the lifespan of an extended patent and created uncertainty and although Although the wording of the seventh amendment states clearly that it could be applied retroactively, was argued as being unconstitutional since it destroyed property rights which were recognized in basic laws (section 8 of the Basic Law of Human Dignity and Freedom. 1980. Furthermore, the fact that the subsequent amendment to this section is not retroactive supports this allegation of lack of constitutionality.

The purpose behind the Seventh amendment was to ensure that Israeli generic drug manufacturers would not be disadvantaged when compared to overseas generic drug manufacturers from other countries recognizing patent term extensions. Dr Gil Tomer (Director of Israel Generic Drug Manufacturer and distributor Unipharm) argued on behalf of the Association of Israel Industrialists that regarding the seventh Amendment to the Israel Patent Law, the position of the State of Israel, as clear from negotiations with the US, was that any patent extension term granted was subject to be shortened due to other shorter patent terms. The respondents (Mercke Schering) argued that the correct interpretation of the application of Section 7 retroactively to pending cases was only for cases that did not yet have a published extension period, since this would adversely affect rights already assigned. The respondents claimed support for their interpretation from the ruling of previous Commissioner, Dr Meir Noam, in IL 97612 to Sanofi Synthelabo (July 2005), who argued that after Novartis, changing the duration of issued patents would lead to uncertainty. In addition to claiming that the retroactive application of the seventh amendment was unconstitutional, respondents noted that the amendment was poorly worded and argued that these defects adversely affected its applicability.

In his ruling, the Commissioner referred to a recent ruling concerning IL 94634 of Israel Industrialists vs. Sir Roy Calne from 13 July 2014 which related to similar issues and where the constitutionality was discussed and the constitutional arguments were rejected.  Following previous Commissioner Meir Noam in the patent term extension case concerning IL 83148 to Roche, Commissioner Kling notes that any interpretation of the Law regarding the interim period other than that it affects published patent term extensions effectively renders the relevant Sections as having no application. Essentially the Commissioner reiterated his reasoning from the Calne case and cited the Lundbeck vs. Unipharm, Novartis vs. Commissioner of Patents and Neurim vs. Commissioner of Patents.

Commissioner Kling noted that In 3734/11 Dodian vs. State of Israel (concerning taxing gas wells), Judge Fogelman accepted that in certain cases legislation could have retroactive affect with financial consequences yet still remain constitutional. The Supreme court affirmed this approach in Bahat vs. Ministry of Health, that retroactive legislation could only be considered unconstitutional if it unjust and unfair to the extreme. The Commissioner felt that judicial interference in legislation, particularly regarding the economy, should be considered most carefully and with restraint. Furthermore, any interim arrangement was by nature short-termed and therefore presumably considered by the legislature.

The patentee suggested that the Knesset be invited to defend themselves regarding the amendment. In Bahat the Supreme Court ruled that calling on the Knesset to justify itself was not something that the courts could do after a time lapse. Since in this instance, the Seventh amendment was 8 years since legislated and since then had been amended yet again, it was moot. Furthermore, the Commissioner noted that if it were justified to invite the Kneset to explain itself, this should have been requested at the first opportunity and not now, some 10 months later. Also, the pharmaceutical industry was represented in Knesset debates leading to the legislation.

The commissioner therefore felt that it would be improper for him to interfere with the balance of interests reflected in the Law as legislated. In conclusion, the Commissioner reduced the extension period to 22 January 2016 based on the US patent, and after noting that the parties had waived the right for a hearing, but that there was a lot of material to wade through, awarded costs of 40,000 Shekels from Merke to the Association of Industrialists.

Re 110956 Association of Israel Industrialists vs. Schering and Mercke, Asa Kling, 18 September 2014.


Follow

Get every new post delivered to your Inbox.

Join 286 other followers