Combining Similar Proceedings

November 19, 2014

combining hearings

C.T.S. LTD filed Israel trademark application numbers 2253382 and 253359 “Lactofil” and לקטופיל. The Mark covers Cosmetic preparations namely lotions, creams, mousses and soaps for nourishment and cleaning of the skin and face all in Class 3. “” Laboratorios Genesse, S.L. opposes the marks

Meanwhile, Laboratorios Genesse, SL. has filed Israel trademark application number 249389 for Lactivit for Soaps, gels, perfumery, essential oils, cosmetics, lotions for hair and skin care, creams for hair and skin care, and dentifrices also in Class 3. C.T. S. LTD are opposing this registration.

Both parties propose combining the hearings. The Lactofil hearing was scheduled for 29 October 2014.

The legal issue in both cases is likelihood of confusion with the similar product of the other party. The parties and the issues in both cases is the same. Combining the cases saves the parties time and expense, and saves judicial resources. In one case there are additional claims of inequitable behavior, but this is not seen as sufficient justification to hear the cases separately.

As both parties have equal rights, Ms Yaara Shoshani, Adjudicator at the Israel Patent and Trademark Office ruled the cases are to be combined, however in each case, at the combined hearing, the Opposer has the right to cross-examine the applicant’s witnesses and only then may the Opposer’s witnesses be cross-examined.

In the circumstances, no costs were awarded.

Decision to Combine Similar Trademark Proceedings, Yaara Shoshani Caspi 6 October 2014. 

COMMENT

Apart from the parties in question, there is a third party of importance, i.e. the public. It seems to me that combining the proceedings is not only economical for the parties and for the public purse in terms of judicial expense, but also is most likely to result in a sensible ruling.


Wyeth’s Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination

November 10, 2014
Rocking the boat...

Rocking the boat…

There was an amendment to the Israel Patent Law earlier this year. This amendment (11th amendment) relates to patent term extensions. The amendment was announced, but did not go into immediate effect.

Wyeth filed a request to correct a mistake in the Patent Extension Order concerning Israel Patent Number 120701. The extension Order was given on 23 February 2014, and extends the basic patent for Bazedoxifene which, without the extension, would have lapsed on 18 April 2017.  The intention to grant an extension until 26 August 2019 was given in October 2013 and published back then. The calculation was based on the Law prior to the eleventh amendment.

On 18 September 2014, Wyeth submitted a request to correct the Extension Order to provide protection according to the regime after the eleventh amendment.

Section 16 of the Amendment states:

16(a) this Law will apply to Extension Order requests that are pending before the Commissioner of Patents on the day that this Law comes into effect, and for future requests for patent term extension.

Wyeth’s contention is that the amendment to the Law came into effect on 27 January 2014 and due to the publication for opposition purposes, the period for opposition finished on 31 January 2014, so, at the time the Law came into affect no Patent Term Extension had been granted and the request for patent term extension for IL 120701 must, therefore, be considered as pending at the time the amendment came into effect.

The amendment narrowed down the list of countries that could be relied upon for Israel to grant a corresponding extension. Instead of anywhere in Europe that grants an extension, only Italy, UK, Germany, Spain and France could be taken into account. Significantly, Japan was no longer considered a relevant country in regards to patent term extensions. Wyeth’s patent was extended on the basis of the extension of the corresponding Japanese patent. By ignoring Japan, a longer term could be requested.

There is an interesting twist here. In October 2013, the FDA issued approval for Bazedoxifene together with conjugated estrogens as Duavee. This fact was not taken into account in calculating the Patent term Extension and could act against Wyeth. The Commissioner ruled that it would be improper to apply some sections of the amendment and not others, and that the Israel Patent Office should consider the ramifications of this FDA approval as well. In consequence, the Commissioner did not amend the ruling, but rather canceled it as a wrongfully given bureaucratic decision. He ruled that the published patent term extension was null and void and that the Application would be subjected to accelerated re-examination under the amended Law with the ramifications, if any, of the FDA approval of Duavee also considered.

Various legal precedents were given to support this contention and the solution it offered. The Commissioner noted that Patent Term Extensions are not final and could be reconsidered, even previous to the eleventh amendment.  He related to previous rulings concerning Teva vs. Abbott, Neurim, Lundbeck vs. Unipharm and Roche.

In addition to being able to oppose any subsequent patent term extension, the cancellation of the existing patent term extension may also be opposed by third parties.

Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.


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.

 


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.


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.


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