Verbosity in summaries

February 15, 2015

Lord Chesterfield once wrote to a friend. “I’m sorry that I have written you a five-page letter; I didn’t have time to write a one page letter.

In Opposition to Israel Patent No. 16800 to PMS Armor LTD Opposed by DSM IP Assets, Ms Yaara Shoshani Caspi requested that the summaries be submitted on no more than 45 pages with standard margins and font.

For those who have lost the thread in this exciting opposition, and a parallel one between the two parties, see here , here and here.

Adv. Mati Barsam, representing PMS Armor LTD seemed to misunderstand the cap of 45 pages and filed 52 pages. Also, since he did not use double-spacing, the summary submitted was much wordier than it should have been.

Ms Shoshani Caspi considered that it was well-known that standard format was double spacing, David font at 12 point with margins of at least 2 cm on all sides. She ruled that in consequence of the over-long submission by PMS Armor LTD, DSM IP Assets could file up to 50 pages.

Citing the relevant case-law 16840/06 P .A. N. vs. Public Guardian, 20 Apr 2007, it is stated that:

“inter alia, limiting the amount of summary material is designed to ensure equality between the litigants in their access to the courts, the use of a smaller font is an attempt to overcome the limitation imposed by the court and to obtain an advantage over opposing counsel thereby”

So as to be absolutely clear, although the respondent was allowed to submit 50 pages, they were required to do so in double spacing, David font at 12 point with margins of at least 2 cm on all sides. PMS Armor LTD was ordered to pay 1200 Shekels + VAT to DSM IP.

COMMENT

If I was sitting in judgment on this case, I’d have been tempted to send the summary back and asked for it to be shortened, giving maybe 3 days, with the alternative that only the first 45 pages would be considered. If the summary is in single spacing, would reformat in double spacing and accept the first 45 pages only.

That said, Ms Shoshani Caspi’s approach is, of course, both reasonable and in line with Israel Patent Office policy to charge excess fees for filing long applications, and with WIPO’s policy of charging per page for PCT applications with more than 30 pages (including forms).

45 pages seems to me to more than enough to summarize just about anything. Particularly in Hebrew which generally requires only about 65% of the space taken by the same material in English. Once arguments are constructed and written up, it should be possible to cut down verbage and to edit down at least 20%. When I recycled reedited IP Factor blog entries for columns in various magazines such as WIPR, MIP and IAM, each one had its own word allowance, and by careful editing, it was always possible to cut articles down to size. It’s a question of being succinct and focused. Writing a 400 word précis of an article was a standard requirement to matriculate in English Language ‘O’ levels in the UK. It is a useful skill.

Since the advert of word processing, patent applications have become longer. Whilst it is not always possible to submit PCT applications in 30 pages, avoiding excess claim fees, for many inventions, this is more than adequate.

It seems to be easy to fall for the temptation to copy-and-paste and to write more, than to use the available editing facilities to shorten one’s work. I suppose when one employed scribes and wrote on expensive material like vellum, things were different.

Some clients and attorneys seem think that the longer the submission, the better. However, the opposite is usually the case. It is unlikely that a 50 page summary can be read in one sitting and for the adjudicator to work from a submission this long, the adjudicator really needs to summarize the summarize, and this is ridiculous. It is not just summaries of course. There are some IP firms that seem to file telephone directories for every application. This is generally unnecessary.

As an aside, as someone who regularly wades through IP decisions, I think that it would be nice if IP adjudicators and judges tried to cut their rulings down by 20% as well. Then again, no doubt my blogging could be focused and succinct.


A Request for a Patent Term Extension for IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck

February 10, 2015

gardasil

IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. was filed on 13 March 1996, and is due to expire on 13 March 2016.

Back in August 2007 a Request for Patent Term Extension was filed based on the commercially available preparation Gardasil. The pharmaceutical preparation contains four active ingredients: Protein L1, types 6, 11, 16 and 18.

The patent claims the Protein L1 type 18 as a product of genetic engineering. The patent relates to the other types of Protein L1 except for HPV 6 L1 for which no patent applications were submitted anywhere. The protein HPV 16 L1 was not claimed in any patent application filed in Israel. HPV 11 L1 was claimed in IL 117591 and expires on 21 March 2016. However, no applications for patent term extensions were filed for this protein.

The legal question that this decision addresses is whether a patent term extension can be requested for a patent that protects only one active ingredient of a pharmaceutical preparation.

The claims of IL 117459 cover a gene sequence of Protein L1 type 18, a vector including the gene sequence, a cell embodying the vector a process of expressing the gene sequence and a preparation that causes a vaccination to the protein including the gene sequence.

The senior examiner considers that Gardasil includes four proteins and any changes in any of them or preparations of three or less will result in a different medicament. Consequently, she considered that there is an inconsistency between the medicine and the claimed invention, in that not all the active ingredients of the claimed invention are in the basic patent.

The Applicant countered that claim 12 of IL 117459  covers a composition that includes (inter alia) HPV 18 L1 and thus the patent does not limit itself to this substance. Consequently, Applicant claims that IL 117459 is a basic patent as defined in Section 64a of the Israel Patent Law 1967 and as referenced in Section 64d. The Law does not require that a basic patent should include all active ingredients of a commercial product, and only one such active ingredient need be listed. Support for this interpretation was argued based on the wording of 64h(d) which relates to an active ingredient included in a preparation and claimed in the basic patent

The Applicant alleged that interpretations that a basic patent should include all active ingredients of the commercially available preparation is contrary to the underlying logic of the legislation and it is unreasonable to include such a limitation by judicial interpretation.

The senior examiner rejected these arguments and the Applicant requested an oral hearing which was held on 28 October 2014 and the Applicant was granted until 10 December 2014 to submit a summary of his arguments.

Section 64d states:

The Commissioner should not grant a patent term extension unless all the following apply:

  • the composition, process for its preparation and usage thereof, medical preparation including the composition, its process for preparation and medical equipment are claimed in a basic latent that is in force.

Section 64a defines the terms ‘composition, ‘medical preparation’ and ‘basic patent’ as follows:

  • Medical preparation – any form of medical drug that has been processed, including preparations for veterinarian applications and those having nutritional value that are injected intravenously.
  • Composition – the active ingredient or salts, esters, hydrates or crystals of the composition.
  • Basic Patent – a patent protecting any composition, production method, use, medical preparation including the composition, or any medical equipment requiring regulatory approval in Israel.

Based on the court ruling concerning the Appeal to patent term extension for IL 97219 to Novartis (26/12/2005) the term composition means a single active ingredient.

In Novartis, then Commissioner Dr Meir Noam (himself a chemist) ruled that the term basic patent in both Section 64a and 64d relates to the first patent that protects an active ingredient and that the term composition is in the singular, implying that one new ingredient is sufficient and that novel combinations of known ingredients cannot be considered as a basic patent.  A preparation that includes one new ingredient that requires regulatory approval may be protected by extending a basic patent. Combinations, aggregations and synergies of known ingredients may be patentable but such patents are not basic patents.

In this instance, the issue is the regulatory approval of a combination of active ingredients, not the basic patent. Gardasil includes four active ingredients. Each one provides a parallel vaccination effect and maintains its pharmaceutical character. The four proteins are separately synthesized by fermentation in recombinant Saccharomyces cerevisiae (a species of yeast) but are combined into one treatment for economical reasons and due to ease of use.

(HPV Type 16 L1 and HPV type 18 L1 are also components of the registered drug Cervarix registered to a third party, and the proteins are each separately active.  However, Cervarix was registered after Gardasil).

Since the drug Gardasil comprises four separately active ingredients that each has an independent effect and do not work as a synergy, the Commissioner accepted that Gardasil could serve as the first regulatory approval of HPV type 18 L1. He found support in the ruling fo Judge Dotan in the Novartis case. He noted that Merck could have requested regulatory approval for the four proteins separately and the discussion would be moot. Finally, citing the Neurim ruling (13281-06-12 based on the ECJ ruling that Melatonin for treating insomnia was not obvious in light of veterinary treatment for causing sheep to rut earlier), it is clear that the purpose of the Law is to provide patent term extensions for new types of treatment, and there was no reason why the Applicant should have had to register each active ingredient separately.

Furthermore, in Appeal 223/07 Lundbeck vs. Unipharm it was ruled that patent term extensions should be analyzed from an IP perspective and not from a pharmaceutical perspective. The Supreme Court upheld this ruling.

Furthermore, in the medical register, Gardasil is listed as including four active ingredients, including HPV 18 L1, and this is, indeed, the first medical registration of this ingredient in Israel.

Consequently, based on the extension awarded in the UK for EP 1359156, the Israel patent was extended 493 days to 19 July 2017.

Ex Partes ruling concerning patent term extensions to IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. by Commissioner Asa Kling, 11 January 2015.

COMMENT

This is a publication of an ex-partes ruling. It is possible that local generic manufacturers such as Teva or Unipharm may challenge this.


On Blood Pressure and Diabetes. Can citations post-dating the effective Filing Date be used as evidence of what was known at the time of filing?

February 10, 2015

 

blood pressure

Israel Patent Application No. 140665 to Novartis relates to preparations including Valsartan and Amlodipine for treating high blood pressure and diabetes. The application is a national phase of PCT/EP/1999/004842 and claims priority from an earlier US patent application.

The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two references that were published after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and espunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicated the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

Comment

Although not allowed to be added to the record, as it could have been submitted earlier, this ruling does seem to indicate that such post priority publications may indeed be used to show what was prior art.


Can post priority-date publications that describe clinical practice be considered prior art?

February 5, 2015

exforce

Israel Patent Application No. 140665 to Novartis tited “Use of Combiantion Compositions comprising Valsartan and Amlodipine n the preparation of medicaments for the treatment and prevention of diabetes related hypertension” relates to preparations including  Valsartan and Amlodipine for treating high blood pressure and diabetes.

The application was a national phase of PCT/EP1999/004842 from 9 July 199 and claims priority from an earlier US patent application.  The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two publications from after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and expunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known.

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicate the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

The Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

In this case, the additional information is not prior art in the public domain, or it would not have been accepted for publication. It post-dates the application and is, therefore, not prior art. The Deputy Commissioner did not consider this material as indicating what was widely known prior to the priority date. The Opposers are trying to use the citations of Lip to show what was known prior to the priority date, and to do this, they should have submitted these citations in their statement of case.

Whilst not wishing to rule out using a paper that provides history of what was known earlier, the Deputy Commissioner warns against the danger of a hindsight bias and of reading the authors conclusions into the prior art.

As to the Opposers argument that the Applicant should have submitted an affidavit to support the evidence, Ms Bracha rejected this as the dates are not contested and so an affidavit is unnecessary.

In conclusion, Ms Bracha ruled that Sections 25-26 and 86-88 of the second opinion should be deleted. Legal costs of 5000 Shekels were ruled against the opposers.

COMMENT

In the DSM  vs. Mifalei Migun case, Judge Judith Schitzer of the District Court correctly ruled that one does not have to submit an affidavit with every piece of evidence or statement, so the Deputy Commissioner is correct on this account.

As to the late submission of evidence however, I think that the Opposers can fairly be penalized for not timely submitting these papers by having interim costs awarded against them for not submitting the evidence earlier, but the evidence should be related to substantively if it testifies to what was practiced prior to the patent being filed and not thrown out on procedural grounds. Ultimately the purpose of the Opposition proceeding is to clarify novelty and inventiveness to protect the public interest. If a drug becomes patented and should not be, the public will pay monopoly prices. Sure, the opposers have to answer as to why these papers were submitted late. Maybe the applicant should be given a second chance to respond and compensated for delays, but I disagree with this decision to throw out what could be key evidence.


Plasson

January 25, 2015

PLasson

Plasson manufactures pipe couplings. Unidelta launched a competing product and Plasson claimed patent infringement of their patents IL 125899 and IL 127327 and passing off and requested an injunction. The District Court accepted the charges that the “main point of the patent” was infringed and issued an injunction preventing the manufacture, import or sale of Unidelta’s pipe connections in Israel as they are a copy of Plasson’s product. On Appeal, the Supreme Court overturned the finding of patent infringement and referred the case back to the District Court. The Supreme Court ruled that where the similarities between the allegedly infringing product and the patented invention lie in features that are in the public domain, there can be no case of infringement.

Background

In addition to literal infringement of the claims of a patent, Section 49 provides grounds for legal remedies where the kernel of the patent is copied. This is rather like the “pith and marrow” doctrine in the UK. Essentially, the Law provides remedies where claim infringement is avoided by a technicality, and may be seen as similar to the doctrine of equivalents. Arguably contributory infringement and inducement to infringe may be considered as judicial extensions of this doctrine. It is important to allow general inventing around, but to avoid situations where poor claim drafting can result in no literal infringement of the claims.  What the Supreme Court has done is to clarify the extent of application of Section 49.

Ruling

Judge Meltzer of the Israel Supreme Court ruled that Section 49 provides monopolistic powers to the patentee to prevent literal infringement of the claims defining the invention and also similar products / processes that infringe the kernel of the invention. In this instance, both parties accept that there is no literal infringement so the only issue is the kernel of the patent. The kernel cannot be wider than that described in the Specification and, where the patent is for a device or system comprising a combination of known parts, the kernel of the patent cannot include the parts themselves. In this instance, the District Court did not address the question of what the kernel of the patent is, and without identifying the kernel of the patent, it is impossible to establish that this is infringed by Unidelta’s product. Once the kernel is established, the court must consider whether the infringing product operates in a similar way to achieve similar results.

The Supreme Court ruled that the patent issued because of a limiting feature added to the other components.

The main claim recites:

“1. A pipe coupling comprising a tubular housing having an axial bore adapted to receive a pipe end to be coupled and having an externally threaded housing portion and an inner housing abutment; a pipe gripping sleeve having formed therein a plurality of substantially equiangularly distributed, axially directed slits extending from a first end thereof to a region adjacent to but spaced from a second and opposite end thereof thereby defining an integrally formed, axially distortable, ring-like sleeve end portion, a first axial portion of said sleeve, through which said slits extend, tapering externally from a peripheral, outwardly directed flanged portion towards said first end and being formed with a plurality of inwardly directed, axially spaced apart serrations; a tubular collar having a first inner axial portion tapering from an inner collar abutment to a first end of said collar and a second inner axial threaded portion extending from said collar abutment to a second and opposite end of said collar; and a flexible sealing ring; the arrangment of said coupling being such that with said pipe end extending through said collar, sleeve, sealing ring and housing, said collar is screw fitted on said housing, said sleeve is located in said housing and said collar with said flanged portion located between said collar abutment and an adjacent end of said housing and said sealing ring is located between said sleeve ring and said housing abutment; screw tightening of said collar on said housing causes the respective tapering portions of the collar and sleeve to be mutually displaced with the gripping contraction of said sleeve about said pipe end and the axial compression of said sealing ring about said pipe end”.

Plasson’s patent is for a ring fitting that includes a wide and flexible ring that enables different sized pipes to be attached together in one smooth motion without dismantling the connector. Since Unidelta’s system did not include this limiting feature, but merely combined pre-existing components to create an alternative pipe fitting, there was no infringement of the kernel of the patent.

Quoting from the specification:

Pipe couplings of the type herein described, which are presently in wide-spread use, normally require pushing the pipe through the seal (typically an O-ring) in the bore of the body member in order to achieve compression of the O-ring on the pipe, and thus a leak free joint. However, for pipes of large diameters, the operation of pushing the pipe through the O-ring seal requires a large force, making the operation very difficult, and sometimes even necessitating an extra operation of chamfering the pipe end for this purpose.

A further disadvantage in the pipe couplings of the type herein described now in use is that such couplings do not tolerate substantial variations in the pipe diameter so that precise pipe diameter tolerances must be maintained, or a large number of different-size couplings must be produced for the different diameter pipes to assure good sealing and gripping actions”.

“…a pipe coupling constructed in accordance with the foregoing features provides a number of important advantages including: convenient assembly, since the particular seal, in its relaxed condition, introduces very little resistance to the forceful entry of the pipe during assembly; …increased diameter range of pipes capable of being coupled, since the two-ribbed (or three-ribbed) sealing ring can accommodate substantial differences in diameter sizes…”.

This emphasizes that Plasson did not invent the only pipe coupling for joining pipes of different diameters, and there patent was limited to one that is easy to seal due to little resistance.

As to passing off, the Supreme Court was critical of the District Court for finding this without explanation of why they considered that this was applicable. The Supreme Court referred the case back to the District Court for further consideration on this issue.

Judge Meltzer established costs against Plasson of 75000 Shekels.

Judge Miriam Naor (now president of the Supreme Court) commended Judge Melzer on reducing the issue to non-technical matters without technalese that regular people could understand.

Appeal 6750/10 Unidelta vs. Palson, Supreme Court 18 December 2014

COMMENT

One wonders who the non-technical people are in this case, plumbers or the President of the Supreme Court? Is the technical issue here flanges and pipes, gaskets and washers, or non-literal infringement, pith & marrow and other legalese?


Narrowing Claims During Oppositions

January 18, 2015

narrowing

IL 188066 to Elta “Gunshot Detection System and Method” is being opposed by Rafael.

During opposition proceedings, the Applicant is allowed to narrow the scope of protection by deleting claims or by adding restrictive features.

In addition to claim amendments that were specficially authorized, Elta deleted some additional claims and made further amendments. These amendments were clearly restricting the scope of the claims but Elta exceeded the amendments that were agreed between the parties and did not flag that they were making further amendments.

In the circumstances, the Commissioner Asa Kling accepted the amendments, gave Rafael two months to correct their statement of case and awarded costs of 7000 Shekels costs to Rafael.

 


Reviving Lapsed Patents in Israel

January 18, 2015

revival

The December crop of patent office decisions included a number of attempts to revive lapsed patents. The requirements for revival, broadly speaking, are that the patent lapsed unintentionally and that the patentee acted promptly to restore the lapsed patent. Three out of five requests for reinstatement were allowed. Two requests were refused due to tardiness in filing the request for revival.

IL 152965 to Shlomo Lavel unintentionally lapsed. Patentee claims to have paid the renewal fee on-line but could produce no evidence of this. He further claims to have made steps to commercialize the technology. When trying to pay the second renewal he discovered that the patent had lapsed. As Deputy Commissioner Ms Jacqueline Bracha was convinced that the patent lapsed unintentionally and that the patentee took steps to rectify the situation promptly on learning that the patent had lapsed, she has ruled that it may be revived and the decision will publish for opposition purposes.

IL 168588 to Sharine Polishing technologies LTD unintentionally lapsed. Patentee paid the renewal fee on-line but did not send the proof of payment to the patent office. Following a random check he discovered that the patent had lapsed. As Deputy Commissioner Ms Jacqueline Bracha was convinced that the patent lapsed unintentionally and that the patentee took steps to rectify the situation promptly on learning that the patent had lapsed, she has ruled that it may be revived and the decision will publish for opposition purposes.

IL 192499 to S. M. B. T. technologies issued on 25 June 2013. The first renewal should have been paid within three months, i.e. by 29 September 2013, and, when it was not paid within the subsequent six months, was deemed to have lapsed as of 29 September 2013. The current owners took possession on 3 September 2013 and responsibility was transferred to Zvi Ben Ari, Patent Attorney. Mr Ben Ari attempted to pay the next renewal on 3 June 2014 and learned that the patent had lapsed. He contacted the previous representatives for an explanation but was unsuccessful in this attempt. It seems that the patent was abandoned due to human error. The problem was that the request to reinstate was only submitted some four months later. In the circumstances, Deputy Commissioner Ms Jacqueline Bracha could not find that the patentee or his representative had acted promptly to reinstate as required by Section 60 of the Law, so reinstatement was not allowed. The patentee is entitled to a hearing under regulation 90.

IL 196017 to Microsoft lapsed due to failure to pay the second renewal which lapsed at the end of June 2013, and the fact that it had lapsed published in the February 2014 patent office journal. Microsoft filed for reinstatement, claiming that their foreign renewal service provider unintentionally noted the filing date as June 2008 instead of June 2007 and so docketed the renewal for 28 June 20014 instead of 28 June 2013. In April 2014 the local agents (Colb) were contacted and on 15 July 2014 they filed for revival with affidavits from the service provider. Although the reasons for the patent lapsing were explained, no explanation was provided for the nearly four months that passed before the reinstatement request was filed. In the circumstance, reinstatement was not allowed. The patentee is entitled to a hearing under regulation 90.


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