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.

 


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.


IPR Swimming with the Big Fish

October 7, 2014

O-fishallyfish schoolgive a man a fish

Kim Lindy’s IPR  which offers training courses is advertising their advanced patent prosecution workshop 2014.

One might think that this discusses patent prosecution. far from it. the title of the workshop is “Claim and Specification Drafting for USPTO with an Eye toward Enforcement”.

The program will be held on November 3 2014 and is designed for private or corporate practitioners with patent experience who wish to improve their general claim drafting and amendment writing skills with an eye towards ultimate enforcement.
“In this advanced one-day program, you will have a unique opportunity to receive hands-on drafting experience under the guidance of a globally recognized patent practitioner. You will receive individualized feedback on claim drafting and amendment writing skills. “
The course is being given by Michael Rosen who is an intellectual property attorney and a Principal at Fish & Richardson. that works in Israel on behalf of Fish.
According to Kim’s blurb, Michael Rosen is fluent in Hebrew and began working in Israel on behalf of Fish in August 2014. He specializes in all aspects of patent litigation and strategic counseling in technology areas ranging from the life sciences to computer software and hardware to consumer electronics, and he has experience at the trial, appellate, and Supreme Court levels.  This program is designed for private or corporate practitioners with patent experience, especially in the computer hardware, software, and electromechanical fields, who wish to improve their general claim drafting and amendment writing skills, especially in areas where enforcement is critical.
COMMENT
I believe strongly in on-going education. I practice what I preach to the extent  have read and continue to read books on patent drafting despite having written several hundred applications. I also try to attend lectures and programs in Israel and abroad.
I don’t know Michael Rosen, at least not this one. (I knew a few, including a Rabbi with intellectual and hippy tendencies who has now passed on). Whether this particular Michael Rosen is indeed globally recognized (or indeed what that means) is not something I can comment on.
I recently collaborated with Dr Ben Spungin on writing a patent application, and despite each of us having a lot of experience, we both learned something from each other. I can’t comment on whether this particular course is worth attending, but strongly endorse attending training seminars. The wise man learns from everyone.
Kim is also interested in attracting attendees from outside Israel. For more details regarding this particular program, click here.

 


On Ethics and Legal Ethics

October 6, 2014

legal ethics

It was Groucho Marx who quipped that military intelligence is a contradiction in terms. I don’t know who it was that first pointed out that the dictionary lists human intelligence, animal intelligence and military intelligence in that order. I heard it from an uncle.

Similar remarks could be applied to legal ethics.

There is a lot of discussion by philosophers on the difference between law and ethics. There is a concept called Legal Ethics. This is really a type of law applying to lawyers. It should be considered as minimum legal standard of behaviour not as the standard at which the lawyer is behaving ethically.

I got to think about this following Professor Phillips lecture “A time to sow and a time to reap” that he generously gave at our PCTea Party last week. Jeremy quoted  Mr Justice Birss’ ruling in a UK case where a patent attorney was sued for giving poor advice. In the case in question, Baillie & Others v Bromhead & Co (a Firm) & Others [2014] EWHC 2149 (Ch), 2 July 2014, at para [333], Judge Birss stated:

“Although I find for the defendants in this action, [the defendant patent attorney] should not regard this as a vindication of his professionalism. A number of the claimants’ criticisms … were well founded. The action has exposed inexplicable and negligent advice given by him. …”

What the judge is doing is stating that one can avoid legal culpability but still behave unethically. This concept is also discussed in the Talmud, where the concept of being a נבל ברשות התורה is discussed. Over and above specific regulations and commandments, Judaism has a catch all obligation to ‘be holy’, because the Lord is holy.

For a good paper on legal ethics, see “Moral Philosophy’s Standard Misconception of Legal Ethics1984 Wis. L. Rev. 1529 (1984) Schneyer, Ted

In this country, the Israel Law Bar seems to be mostly concerned with appropriate forms of advertising and dress. These issues are to separate the lawyer from the layman and to create a hallowed aura around lawyers. There is little that addresses professional ethics.

The (voluntary) code of conduct of Israel patent attorneys that was drawn up by Dr Kfir Luzzatto has a lot of good in it, regarding not criticizing colleagues, but only specific work products, and not taking over a case without checking that there are no open debts to previous representatives. These issues are important, but also only part of it. There is a need to treat clients and workers properly and to explain to clients what future costs are likely to be incurred.

I’d like to arrange a conference on business ethics for patent professionals. Anyone interested in attending such an event, please let me know.

Another of Jeremy’s slides had the following text:

  • Whatever you do with your IP – and this includes doing nothing – is a business decision and should be based on the same criteria as any other business choice
  • The vast majority of IP practitioners have insufficient and/or inadequate training and experience to equip them to give or evaluate the sort of business advice their clients need
  • Those IP practitioners who fall into that category are often in a state of denial

I wonder how many of us agree with these sentiments? I wonder how many of us refrain from giving business advice as: (a) we are not competent to, and (b) we have an invested interest in clients filing applications and paying maintenance fees as we charge for these services.


Sowing and Reaping, An insightful Look at the IP World by Professor Jeremy Phillips

October 3, 2014

sewing kats   grim reaper cat

I was very honoured that Professor Jeremy Phillips agreed to give a keynote lecture at my PCTea Party earlier this week. Jeremy is not just arguably the foremost trademark expert in the world and certainly the foremost IP blogmeister, but is also an excellent speaker. Having a panoramic perspective of the industry, his talks are not merely entertaining, but thought-provoking as well. Jeremy teased me somewhat, but then again, I teased him when introducing him. It was light-hearted banter that the audience appreciated, and neither of us were offensive or offended.

Taking his theme from the book of Koheleth (Ecclesiastes), Professor Jeremy Phillips looked at sowing and reaping in the IP world.  Jeremy noted that Koheleth (Ecclesiastes 1:4-11announced that there was nothing new under the Sun. In Diamond v. Chakrabarty :: 447 U.S. 303 (1980), MR. Chief Justice Burger ruled that patentable subject matter should “include anything under the sun that is made by man”. By combining these axioms he concluded that nothing was patentable!

More seriously, Jeremy’s main message seemed to be that most patents are an expensive waste of resources, as are most trademarks. Most copyright material has no commercial value either. He calculated that the likelihood of a UK company being struck by lightening was far larger than it was that they would be sued for patent infringement, and so he considered infringement liability insurance as a bit of a scam.

 Whilst well aware that less than 1o% of patents generate sufficient income to cover the filing and prosecution costs, he noted that the very small number of valuable patents generated sufficient wealth to justify the system.

Whilst owners of valueless Intellectual Property have a high level of protection, once patents, trademarks or designs are of commercial interest, there were various fair use, research and personal use exceptions and successful patents could be subjected to compulsory licenses and their owners could be threatened with fair trade and anti-monopoly litigation, so it seemed that worthless IP rights are over-protected, but the valuable ones are under-protected.

The main issue that Professor Phillips raised was whether anyone was educating the clients that they are essentially playing a type of roulette? He looked into who made money from IP and, noted that the patent office didn’t, courts didn’t, the owners didn’t and nor generally did pets! Whilst avoiding the big elephant in the room, I think there was implied criticism of the profession for making money by selling pipe dreams to gullible inventors. In the spirit of the Days of Repentance, it seems to me that it was more than appropriate to have the various IP professionals present contemplate their actions and to what extent we were really furthering innovation and to what extent we were feathering our nests at the expense of delusional wannabee entrepreneurs.

In Defense

My regular spiel at initial meetings with entrepreneurs is to the effect that I can help the prey client obtain protection for his invention/design/brand which is my specialty. Being a physicist and engineer I may even comment a little on the feasibility of an invention, but I do emphasize that I am totally unqualified to comment on the commercial viability of product based on a new idea and whether it will succeed in the market-place. Essentially I tell the client that I can help him (almost always a male)  predict the costs of IP protection, but have no idea of the income it will generate. I do warn him that statistically 80-90% of inventions I do a preliminary search for are knocked out as unpatentable, or as likely to receive only a very narrow patent in a crowded field and consequently to have little value in stopping competitors by generating a monopoly. I charge separately for searching and ask the client if her is interested in a preliminary search. I will file an application based on novelty to the best of our knowledge if I can make a case for non-obviousness and if the subject matter is arguably patentable – I do get 101 type rejections occasionally, but can generally deal with them. The boundaries keep changing and the goal-posts keep moving, so I am prepared to accept border-line cases and to fight for them. I do warn the clients that patenting is rarely profitable and is o easy money. I usually ask the entrepreneur if he has discussed the idea with his significant other and if he shouldn’t take care of mortgages, his pension, etc. first. I regularly suggest that I send him a written quotation and that he thinks about it and lets me know the following week. Thankfully enough of such inventors don’t listen that I have a steady stream of income from writing up patent applications of this nature.

I don’t think I am a rarity in showing this altruism. I suspect that very many colleagues and competitors are equally candid. I know that my ex-partner Jeremy Ben-David is speaking at an event later this month on the title of the wrong reasons for filing patent applications. Sending away potential clients with some good advice often has a pay back when the same client comes back, perhaps years later, with a better invention or recommends one to his associates.  The clients looking for a quick route to easy money are more likely to be the ones that leave one with unpaid bills.

I enjoy meeting the inventors and so long as meetings don’t go on for more than an hour, am generally happy to do so without charging. Surprisingly often they offer to pay me anyway, realizing that they’ve received valuable advice. In the past I’ve charged for first meetings but offset the fee against future work. It discourages wannabee inventors from doing the mail round and wasting the time of several patent attorneys. If I get the impression on the phone that the inventor is a time-waster or if he tells me that he’s been to see a few other firms and wants a further opinion, I generally charge for the first meeting. It is a good selection mechanism.

We may think that we should be educating the client and can charge for so doing, but clients often don’t want advice. They want a patent application. They don’t pay for advice. Free advice is something you can’t earn a living from giving but can still be sued for.

The interesting thing is that occasionally gimmicky patents do fly. Some kitchen gadgety things that I’ve patented that seemed quite superfluous to mankind have been successfully licensed to my surprise and astonishment. I was confident about the likelihood of the patent issuing but was quite open about my skepticism as to the commercial value of the invention.

Some corporate technologies I’ve patented have been licensed for 8 and 9 figure sums. It does happen. Just not very often.

I have corporate clients that are well aware that some patent applications I draft for then are unlikely to issue but if there is novelty and I can make a case for inventive step., i.e. some sort of argument against obviousness, I am prepared to do so, so long as the client understands the issues.  There are companies that file applications knowing that the resultant patent will be difficult to enforce but who have sound commercial reasons to file the applications anyway. Some companies need to show new features at each annual trade convention and want patent applications for these features. Often we are able to successfully prosecute the applications and patents issue. That said, with corporate clients, I may meet with and interact with the inventor of the head of R&D. Sometimes I meet the CEO or the CTO. I rarely meet the shareholders or investors and these sometimes include international R&D funds, etc. Am I aiding and abetting the managers of a company to defraud the investors or the share-holders if we file something because it helps the manager’s status within the company? Who are we responsible to? What are responsible for.

I think that contemplating these issues is valuable for patent attorneys as we approach Yom Kippur, the Day of Judgement.

The party celebrated 10 years of this blog. The packed auditorium was mostly filled by patent professionals and I received a lot of positive feedback about the event which consisted of an hour’s mingling with free beer, wine, tea and coffee, ice-cream, soft drinks and both savoury and sweet party foods, followed by Jeremy’s talk. I suspect that the professionals who like my blog came along and those that are less enamoured by my reporting style stayed away. It is a shame as I am happy to receive feedback and generally post comments submitted to this blog, unless they are clearly spam.

Most of the attendees came from smaller firms. It could be that the larger firms do enough internal events and have educational programs so that their staff feel less of a need to socialize with their contemporaries and to attend thought provoking presentations. Those that did attend seemed to enjoy themselves and there seems to be interest in doing this type of thing more regularly.
We wish aךl our Jewish readers a spiritually uplifting Yom Kippur, and םור Moslem readers a spiritually uplifted Day of Sacrifice – יום הקורבן.

 


Israel Patent Office Requests Submissions Regarding Patentable Subject Matter

September 12, 2014

 

The postage stamp - a great idea, but probably not patentable

The postage stamp – a great idea, but probably not patentable

Section 3 of the Israel Patent Law states:

. אמצאה, בין שהיא מוצר ובין שהיא תהליך בכל תחום טכנולוגי, שהיא חדשה, מועילה, ניתנת לשימוש תעשייתי ויש בה התקדמות המצאתית – היא אמצאה כשירת פטנט.

An invention, whether a product or a process in any technological field, that is new, useful, may be used in industry and has an inventive step is a patentable invention.

Prior to 1995, the Law related to agricultural or industrial, but the term agricultural was dropped.

The Guidelines to Examiners follow TRIPS and patents are allowed for any technology invention. Unfortunately, this does not clarify what is and isn’t patentable.

There are exceptions. Natural organisms and methods of therapeutic treatment are specifically excluded by section 7 of the Law.

The courts in Israel have not clarified what is and what isn’t patentable subject matter.

Clause 5 of appendix b to the Guidelines for Israel Patent Attorneys 23/1 states that

את המונח “שימוש תעשייתי” ניתן לקרוא בהקשרו של התחום הטכנולוגי (הנדון להלן) ולאור היות האמצאה מועילה. בדרך כלל, אם ניתן לשייך את האמצאה לתחום טכנולוגי כלשהו ושיש בה את התועלת המובטחת על ידי המבקש הרי שגם ניתן לעשות בה שימוש תעשייתי

My best attempt to translate this is as follows:

The term ‘industrial use’ may be read with respect to technological fields, and the invention has to have utility, to be categorizable in a specific class and to have the required usage, and will thereby be deemed as having industrial applicability.

Of particular confusion to Examiners, are medical devices, surgical diagnostic and treatment; inventions that contradict the Laws of Nature (helpfully explained as patent applications claiming new physical theories without indication of their uses; genetic sequences and other biological material without use being discussed.

Perhaps not surprisingly, Examiners would like a little more clarity. Less surprisingly perhaps, the Israel Patent Office has solicited comments from the public. We welcome this initiative.

In addition to the above fields of endeavour, responses may relate to the meanings of industrial usage, utility, technology field, process or device, and also to other restrictions to granting patents, including on the basis of Section 17c, i.e. that some other recognised jurisdiction (typically USPTO) has ruled that the invention is patentable – and that the claims in Israel are identical to those granted.

Helpfully, the patent office has included links to Guidelines for European examiners and UK examiners:

http://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_ii_4_9.htm

http://www.ipo.gov.uk/practice-sec-004.pdf

http://www.ipo.gov.uk/medicalguidelines.pdf

http://www.ipo.gov.uk/biotech.pdf

Responses may be submitted to the Israel Patent Office up until 30 October 2014 – when presumably there will be a Halloween party.

COMMENTS

Back in 2009, I held an event titled “The boundaries of patentability”. We examined stem cell research, business methods, software and the like. The question keeps coming up.

In the US, in Diamond v. Chakrabarty, 447 U.S. 303 (1980), paraphrasing Koheleth (Ecclesiastes), Judge Burger ruled that anything under the sun made by man was considered patentable. Some US patent attorneys have tried to patent plots for films. Children, though man-made are also not considered patentable. Over the years, I’ve come across a range of clients wanting to patent cold fusion, directed Brownian motion motors (that client actually managed to obtain a patent in the US on an earlier version and had apparently been around to every patent firm). I’ve had clients wanting to patent games, including chess openings. One academic with feminist leanings has suggested that the technological industrial requirement discriminates against women who are less technical, and has suggested that patents become available for non-technical inventions.

It is about time that gene sequences per se are recognized as not patentable in Israel. The Circular on the subject is wrong.

As the issue has not been raised, I assume that the guidelines for examining computer inventions are clear to examiners. I don’t find them clear, and nor do other practitioners who’ve I’ve spoken to.

Despite the working of this call for comments, I don’t think that the patent office considers new Laws of nature as patentable subject matter. The question is whether devices that operate according to principles hitherto unknown to science, or rejected by mainstream science should be considered patentable. Should the applicant have to provide proof of utility?

It occurs to me that patent attorneys have an interest in the range of patentable subject matter being widened as this may translate into extra work. It would be nice if the Association of Israel Patent Attorneys sets up a working committee and petititions its membership for comments so as to be able to submit an official position.

 


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