Unipharm without legal representation, wins Interim Proceeding Against Novartis

February 22, 2018

galvusIsrael  Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION ” the patent application is a national phase of PCT/EP/2005/000400. It relates to a pharmaceutical used in the treatment for diabetes known as Vildagliptin (previously LAF237, trade names Galvus, Zomelis,) which is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1[2][3] and GIP[3] by DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.

Unipharm has opposed the patent issuing and, in an intermediate proceeding, Unipharm (not represented) submitted a disclosure request for:

  1. The specific testing referred to Appendix E of a the Applicant’s expert witness.
  2. All other tests relating to all the formulations that were performed where the particle size distribution was examined.

Unipharm

Alternatively, Unipharm requests that the part of the evidence that relates to the evidence submitted in the European Opposition proceeding from Dr Davis’ statement, including Appendix E, be struck.

The patent relates to tablets that are made by direct compaction and which include DPP-IV, (s)-1-[(3-hydroxy-1-adamantyl)amino]acetyl-2-cyanopyrrolidin (Vildagliptin) in free radical form or as a salt, wherein at least 80% of the particles compressed into the tablet are in size range of 10 microns to 250 microns.

novartis

In their Statement of Case, Novartis explains that use of direct compression was not obvious to persons of the art wishing to produce vildagliptin formulations, and the distribution and size of the particles affects the character of the tablet in a manner that determines the efficacy of the formulation. The chosen distribution enables tablets to be produced by direct compaction which have high quality, acceptable stability and good physical properties.

With respect to this, Novartis’ expert witness, Dr Davis, explains in his expert opinion as follows:

“There is no prior art suggesting that tablets of vildagliptin can be made using direct compression with this size range or any size range. This particle size range and percentage of the active agent is not disclosed in the prior art. It should be noted that the particle size distribution is important to achieving good physical properties in the tablet (e.g. good hardness). Evidence filed in a technical annex for the corresponding European Patent Application No.15199440.7 (available on-line from the EPO at https://register.epo.org/application?documentId=EZQR8ZQ06757DSU&number=EP15199440&lng=en&npl=false),  comparing 88% PSD of 10-250 micron (within the claim) versus 79% PSD of 10-250 micron (outside the claim) shows that the use of a particle size distribution as claimed is important in providing directly compressed tablets with good hardness (Appendix E).”

The Expert witness related to the technical appendixes that were submitted by the Applicant to the European Patent Office which compares tablets that fall within the ambit of claim 1 to those that do not, and this is the basis of the discovery request that Unipharm submitted.

Claims of the Parties

disclosureUnipharm’s opposition to this evidence is that Professor Davis relied on test results from tests that he himself did not conduct, and they express wonderment that Novartis did not produce the drug developers to be cross-examined. In response, the Applicants claim that the disclosure process should be allowed in cases where it is proven that the documents in question are relative to the proceeding in general and to the point of contention between the parties, and in this instance the Opposer did not justify his request for disclosure of documents and did not explain how the disclosure would help clarify the question under debate.

grain size

Novartis further allege that the request for disclosure is wide and general, in that it relates to all testing and formulations made, where particle size was examined. The Applicant further asserts that Dr Davis referred to Appendix E merely to show that it was published and not as evidence that the data therein is true (!?).

As to Unipharm’s alternative request, Novartis claims that the Opposer did not base this allegation, and that we are referring to an expert opinion based on data provided to him and his relying on the publication is equivalent to any expert relying on a professional publication such as a paper in a scientific journal or a patent application in a relevant field.

file-wrapperIn response, Unipharm claims that the Applicant’s expert, Professor Davis, did not merely testify that the document was included in the file wrapper of the European Patent Application, but also reached conclusions in his expert opinion that were based thereon. As far as anything connected to the scope of the disclosure, Unipharm focuses their request and asks to receive the documents relating to the experimentation with the particle distributions and efficacy of formulations made with the specific distributions.

Unipharm claims that the documents will reveal that the tests conducted, if indeed conducted, do not provide sufficient instruction to persons of the art to produce the invention successfully without additional experimentation and thus the patent application should be rejected as not enabled under Section 12 of the Israel Patent Law 1967.

Discussion and Ruling

legal fishing expedition

There is no doubt that the Commissioner of Patents can request disclosure and access to documents in opposition proceedings. The disclosure is efficient in that it provides documents to the Patent Office that are not covered by Section 18 of the Law (Duty of Disclosure) and which can help clarify if an application is patent worthy. However, disclosure is performed in a manner to prevent the Applicant going on an illegal fishing expedition in the Applicant’s filing cabinets.

The considerations to be weighed up prior to giving a disclosure order are detailed in Opposition to 60312 Biotechnology General Corp vs. Genentech Inc and in Opposition to 143977 AstraZeneca AB vs. Unipharm ltd, and these are the stage of the opposition reached; the amount of documents and their content; the weight of the claim that the Applicants are attempting to prove with the documents asked disclosure of, their evidential weight, the possibility of the Applicant to obtain the documents themselves, and the burden it will cause the opposing party.

In these rulings it was also determined that disclosure could damage the property rights of the opposing party by forcing revelation of trade-secrets. However, the possibility of such damage being caused does not remove the authority of the Patent Office to demand such a disclosure, but obliges consideration of the legitimate property rights of the party when applying that authority.

In the opinion of Commissioner Alon Ofir, Novartis is correct that the experimental results will have no effect on the average person of the art’s ability to implement the invention. The answer to this question is found in what is revealed and not in what is not revealed in the patent application.

Nevertheless, Unipharm is correct with regard to everything related to the tests described in Appendix E, since the Applicant himself relied upon this in his statement. In this regard the Commissioner does not accept that this evidence can be considered as external evidence that their Expert Witness relied on. The document was prepared by Novartis themselves, with data they control, and their expert witness relied on it in his Opinion.

tablet-compression-machine

The particle size distribution is claimed by Novartis themselves as being a central element of their invention, and the claims of the Application itself limits the requested patent to one wherein 80% of the particles are in the 10 micron to 250 micron range. The Applicants themselves state in their Statement of Case, that the choice of particle size and distribution is what enables the fabrication of tablets of an acceptable quality by direct compression. Their Expert Witness finds support for this claim in Appendix E which compares tablets having this particle distribution with tablets that do not.

In these circumstances, one should consider the documents as relating to the central question being debated by the parties. Thus the documents relating to Appendix E are ruled relevant and Novartis are required to provide not just those relied upon but other documents summarizing experiments done with the intention of producing Appendix E, even if not included therein.

Novartis is given 30 days to produce an Affidavit of Disclosure with the relevant documents describing test results obtained in the experimentation leading to Appendix E, whether or not included in the Appendix, but relating to the hardness of tablets made from different particle distribution.

As an after-note, the Opposer is chastised for using language that does not show respect for the proceedings which was inappropriate.

No costs are awarded.

Ruling on Interim Proceeding regarding disclosure, by Commissioner Ofir Alon, 3 January 2018.

COMMENT

trawlingIn court proceedings in the United States there is wide discovery and the parties effectively go on fishing expeditions with trawlers and haul up everything and then have to wade through the bycatch.  This is not the case in Israel. One can ask for specific documents, but have to justify the request. Thus I have used the term disclosure and not discovery.

self representation

In this instance, Unipharm is not-represented, or to be more accurate Dr Zebulun Tomer is representing himself. No doubt if he runs into trouble he will call on his attorney Adi Levit to represent them. It is unlikely that the inappropriate language lost Unipharm a costs award as, since they have not used legal counsel, they are not entitled to costs anyway.

We strongly discourage industrialists to represent themselves in Opposition proceedings. The Tomers, however, have so much experience of killing pharma patent applications that there are very few lawyers that have handled so many cases.


Amending the Specification of an Opposed Patent Application

July 7, 2016

abbvie.png

Under Israel Law, allowed patent applications publish for opposition purposes for three months prior to issuing. If an opposition is filed, the issuance may be delayed for rather longer, if the patent issues at all.

As a general rule, the Applicant may amend ‘scribal errors’ i.e., typos in the specification and may narrow the scope of coverage of the claims, but cannot add material or widen the claims to cover something not previously within their ambit. In practice, applicants often request amendments that are allegedly permissible but which the opposer considers as somehow adding material or widening the monopoly sought. Sometimes amendments are opposed as a delaying tactic as until a patent issues, it cannot be enforced.

In the present instance, the application in question is IL 122546 to Abbvie Inc. titled “COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME”, which was filed two decades ago on 28 June 1996 by Abbot Laboratories as the national phase of PCT/US1996/0011015 which itself claims priority from a US provisional application (no 60/000654) filed on 29 June 1995. The case was transferred to Abbvie in June 2013.

The case was allowed and published for opposition purposes on 31 January 2012, and on 29 April 2012 oppositions were filed by Vertex Pharmaceuticals and by Teva Pharmaceutical Industries LTD.

Abbvie petitioned to amend the claims and this interim ruling relates to the proposed amendment and examines whether it is supported and whether it is indeed a narrowing of the scope of the claims.

last minuteIn his ruling of 2 May 2016, the Commissioner Asa Kling allowed the amendments to the claims but this is an interim ruling anyway and the patent, if eventually granted, will lapse anyway 20 years from filing on 29th June 2016. This begs the question as to the point of continuing with the opposition?!

The ruling has been carefully translated and is reproduced below but I have added a break as it may not be of interest to everyone…

Read the rest of this entry »


Long Division

January 24, 2016

Herceptin

IL 234696 to Genentech relates to the antibody that is the active ingredient in its blockbuster drug Herceptin.

The Application is a divisional application of IL 214084 which is itself a
divisional application of 136201.

Section 24 of the Israel Patent 1967 states that: (a) As long as the application has not been accepted, the applicant is entitled to demand that it be divided into several applications.”  (b) If the application includes more than one invention, then the Registrar may, as long as he has not accepted the application, direct the applicant to divide his application.”

Back in February 2010, in Circular MN 81, then Israel Commissioner Dr Meir Noam creatively interpreted this statute to mean that although a first filing into Israel may be divided into divisional applications, those divisional applications could not be further divided once the parent application had published. This new interpretation was a departure to 40 years of established practice and did not seem compatible with the wording of the Law.

As we noted back then, the logic for the new interpretation of the statute was that Israel was getting ready to automatically publish applications 18 months from priority and not just make allowed patents open to inspection. Nevertheless, the new interpretation issued in an Israel Patent Office circular and overturned common practice dating back to when the statutes were legislated. Back then I commented that

With the proposed amendment allowing for 18 month publication, this measure is clearly required. Nevertheless, I am not convinced that this is interpretation of the law, but rather amendment thereof.Arguably this measure requires a formal amendment to the Law by the Knesset and goes beyond the authority of the Commissioner. It should be included in the proposed amendment for 18 month publication (second reading) and it would be fun if someone challenges this Circular on procedural grounds.

It was a different and also timely circular, not to require publication of printed journals, but to rely on on-line publication, and subsequent Knesset criticism of this as beyond the legal competence of the commissioner, that caused Dr Noam to retire.

The current commissioner Asa Kling seems to be more wary about changing substantive law by creative interpretation and prefers to rely on the Knesset and Ministry of Justice.

After IL 234696 to Genentech was filed, Genentech challenged the circular and in January 2015 an ex parte hearing before the Current Commissioner of Patents and Trademarks was held. Genentech noted that the Circular did not institute a new law or regulation but merely provided a new interpretation to an old law.  Genentech argued that the new interpretation in the Circular was based on an untenable reading of Section 24a and was thus ultra vires.  If this was indeed interpretation of the Statute, it should apply retroactively and invalidate a number of issued divisional-of-divisional applications. If, however, the Circular was to be considered as new law, it was ultra-vires and thus void. Notably, the former commissioner himself postponed application of the Circular which was odd if it is to be considered as interpretation. Without needing to force the issue of the validity or otherwise of the Circular, Genentech asked for at least an exception to be made for their case, i.e. that their divisional be considered as a legitimate application despite being a divisional of a divisional.  In a ruling that issued in January of this year, the present Commissioner noted that in the U.S., In re Ernest Johan Jens Henriksen, 55 C.C.P.A. 1384; 399 F.2d 253; 1968 CCPA LEXIS 273; 158 U.S.P.Q. (BNA) 224 the Court of Customs and Patent Appeals found somewhat similar guidelines of the USPTO unlawful. The EPO who also initially banned secondary divisional applications, has changed its practice and reinstated the possibility of filing secondary divisional applications. Filing secondary applications is also allowed in Australia and Japan.

In conclusion, the present Commissioner has allowed Genentech’s 234696 filing as being a legitimate divisional application despite being a divisional of a divisional.

COMMENT

There was some justification in Dr Noam’s attempt to prevent parties from leaving a divisional application pending to claim around competition in cases of generic competition not literally infringing. I think that preventing this type of activity does indeed require primary legislation. However, what the Commissioner has apparently not done is to rescind Circular M.N. 81. It remains unclear whether Genentech is an exception to the rule, and why this should be so, or whether Patent Office Circular M.N. 81 is now void.

Either way, as the validity of both parent application (IL 214084) and grandparent application (IL 136201) were challenged in Opposition proceedings, we suspect that if the case is allowed, the claims will likely be challenged in a further Opposition and the correct interpretation of Section 24 and whether divisional applications of divisional applications are allowable will be challenged directly. If such an opposer remains unhappy, he may take it up with the courts.  Although I was wary of the original Circular, I consider a situation under which the Commissioner has the discretion to allow or reject the filing of a divisional of a divisional on a case by case basis even more problematic.

 


PCT Filing Fees to Drop in January 2016

December 17, 2015

wipo_pct_logo270

Israel applicants of the PCT can select the USPTO, the EPO or the ILPO for conducting International Searches and preliminary examinations, i.e. for generating the ISR and IPER and chapter 2.

As of January 1, 2016, most of the PCT prices will drop. For example, the International filing fee will drop from $1384 to $1363. That price is good for applications of up to 30 pages including forms and Figures. Additional pages currently cost a further $16, but this will drop $1 a page to $15 a page.

The International Search fees via the EPO will drop from the current $2125 to $2097. Preliminary Examination fees (for the IPER) will drop from $208 to $205 if the USPTO is used. The IPER fee via EPO will drop from 191 Euros to a mere 183 Euros.Backing the trend however, the Israel Patent Office (ILPO) will now charge 794 Shekels instead of 766 Shekels.

Users of PCT Safe save $205 per application, and if they file electronically, the discount is $307.

PC Tea

PC Tea

Extraordinary value for money is our PCTea bags which take away the stress of international filing. These are a blend of organic green tea and organic spearmint (nana) and are worth about $10 a box. Clients using our stress free PCT services are welcome to a free box.


US Patent Law for European Patent Professionals

November 26, 2015

nemeth

I was given a copy of US Patent Law for European Patent Professionals, by Audrey Nemeth to review, read it quite quickly and forgot to publish something. Now that the IPKAT has published a review, it has spurred be to get around to this myself.

The IPKAT’s review is here.

The book was written by a European patent attorney whilst preparing for the US patent agent license. It looks at US Patent Law from a European perspective.

Bibliographic data: hardback, xxviii + 215 pages. ISBN 9789041160447. Book’s web page hereAudrey Nemeth’s blogpost introducing this book on the Kluwer Patent Blog is here.

One of the most interesting points that it raised is the different histories behind the patent laws and the different basic philosophies that affect terminology, prosecution and patentable subject matter.

In Europe, for a patent claim to be valid it must describe an invention having novelty, utility and inventive step. In the US one requires novelty, utility and non-obviousness. I expect that most practitioners are aware of this, but haven’t necessarily thought about the difference in any depth.

As a result of this book showing the two systems side by side I realized that in Europe there is a basic philosophy employed by the Examiners during examination, that to deserve a patent, one needs to actively improve on the existing, by having an inventive step, whereas in the US, one is entitled to a patent for anything new under the sun made by man, unless it is obvious in light of the prior art.

Though similar, these concepts are not the same. In Europe, having dismissed the main claims as lacking novelty or inventive step, the Examiner may state that the dependent claims do not provide anything sufficiently significant to be considered as being an inventive step. In the US, however, the Examiner starts from the assumption that the invention is patentable and feels obliged to show how each and every claim is anticipated or obvious in light of prior art and established doctrine.

It is this fundamental difference in approaches which explains why the USPTO traditionally awarded the patent to the first to invent and even after the American Invents Act which further closes the gap between the two systems, will consider prior disclosure by the inventor as not necessarily preventing him from obtaining a patent.

Veteran Israel Practitioner David Gilat has said on many occasions that the Israel Patent Office’s job is to issue patents and there is an assumption of patentability that has to be overcome for an application to be refused. I was never convinced by that argument and on balance think that in this issue as in many others, Israel is closer to Europe and this is why during opposition proceedings, although the onus is on the opposer to show that the Examiner was wrong to allow the patent, nevertheless there is no assumption of validity. Putting aside the philosophical aspects, the book is helpful in understanding the procedural differences in both jurisdictions.

Audrey Nemeth suggests that it is sometimes justified having different parallel applications drafted for the US and Europe. I find this a little excessive and don’t imagine many clients would be willing to pay twice to have the same application drafted twice. I can, however see value in having licensed practitioners in both jurisdictions critiquing an application.

A personal note

I am not licensed in Europe or in the US, but for most of my clients, the US is the #1 patent jurisdiction. Funding and subject matter permitting, most clients see Europe as highly desirable for patent protection, although may largest client (in terms of patent work) only files in the US and the Far East, considering Europe too expensive for companies there to compete with him.

When I draft patents, I consider both the USPTO and EPO guidelines and am familiar with the differences in the maximum number of claims that don’t require excess claim fees, the different positions of the USPTO and EPO regarding multiple dependent claims, unity of invention, the two-part claim construction, preferred transition terms and annotations of the claims. I don’t prosecute directly in the US or EPO by generally provide very advanced draft responses so that the associate has little to do other than to review and put into his or her template. In most cases for the US, I use the associate’s template so that there is even less for the associate to do.

Despite 15 years of experience, and having drafted and prosecuted hundreds of patents, I found this book worth reading and useful reference to keep handy.

 

What about Japan, China and Korea?

The US and European mind-states, though not identical, reflect a Western Judeo-Christian heritage. I think that similar works covering the Korean, Japanese and Chinese patent laws would be very helpful.

I have a book in the same series that looks at IP in China. In Communist China, Intellectual Property Law preceded regular property law. I have a book on Chinese IP whose opening chapter quotes Confucius. Notably, that book has no footnotes or references to court rulings. It seems that whereas in the US and Europe, court rulings create precedent, this is not the case in China.

I know that claims that I draft are generally considered clear by European and US examiners, but often receive long lists of clarity objections in Korea.  Sometimes I can work out what the Examiner’s problem is. Sometimes I am completely flummoxed. The Examiner is, of course, looking at a translation of the English text I wrote and my copy of the Office Action is a translation of the Examiner’s comments. In this game of Chinese Whispers, I have to rely on the associate whereas in the US and Europe, we are all looking at the same English language documents.

 


A lack of uniformity in unity of invention

July 20, 2015
UNity
As Israel’s leading IP blogger, I regularly get emails and phone calls from students, inventors, academics and professionals, both from Israel and abroad, about various aspects of patent and trademark practice.
Most recently, I received an interesting question on what constitutes unity of invention. The question is rather better than the answer.
All regimes require unity of invention. One is entitled to protect one invention in a single patent. There are separate issues regarding double patenting, i.e. protecting the same invention with more than one patent, but, how is a single invention determined?
The practice relates to claims and differs in different jurisdictions.
In the US, unity seems to depend on the main class that the Examiner classifies the invention as and has to search when evaluating novelty and non-obviousness. One can file up to three independent claims (regardless of type) for the same basic price. However, there is no limit on the number of independent claims in the same class, since the searching requires trawling the same material.
US Examiners love to issue restriction orders due to multiple inventions, and sometimes do this based on the figures. They may require a restriction to a product or process, but may also require an election of a preferred species where different figures show different embodiments. However, once a structure is allowed, corresponding and withdrawn method claims can be allowed and rejoined so long as the method requires using the allowed apparatus.
In Europe, the theory relates to the inventive concept to be searched. In practice one is entitled to one independent method claim and one independent apparatus claim. Anything else and the claims will be reject as ambiguous.
It will be appreciated therefore, that the same claims may be considered as having unity in US but not in Europe and vice-versus.  Indeed, with two independent method claims and two independent structure claims each with minor differences, I’d expect the USPTO examiner to want inventor to elect either method claims or structure claims, and EPO examiner to want one of each.
In Israel (and there is no logic to this – it was a circular from Previous Commissioner, Meir Noam), one is entitled for up to two claims of each type. this can be method, product, system, gene sequence (now no longer patentable anywhere else).
Examiners will require restrictions on unity considerations, but there is no clear definition of unity. If a foreign patent office allows a set of claims one can request allowance under Section 17c and the issue of unity is not a grounds for objection by examiner or in opposition. What this means is that something acceptable in the US or in Europe (or in UK, Austria, Australia and other jurisdictions recognized in Appendix B for purposes of Section 17c) is acceptable in Israel. Since US and Europe have different standards, it will be clear that there is no clear standard in Israel.
See https://blog.ipfactor.co.il/2010/02/03/israel-patent-office-to-allow-no-more-than-two-independent-claims-of-each-type/ for more information.

 


Israel Patent Application Number 142789 – The European Patent Wrapper

January 15, 2015

file wrapper

DSM IP Assets owns Israel Patent Application Number 142789.

PMS Armory Factory LTD opposed the patent issuing. The opposer wished to enter the file wrapper of the corresponding European patent application into the evidence, but the Adjudicator of IP, Ms Shoshani Caspi refused to allow this as the request was submitted late in the proceedings. The opposition was rejected on 17 October 2013 and the Opposer appealed to the District Court.

On 12 August 2014 Judge Shitzer ruled that the file-wrapper of corresponding patent application EP 1137828 should be admitted as evidence. See here. The Applicant appealed this to the Supreme Court who ruled that the case was ongoing and so they were not yet prepared to get involved.

The Applicant therefore requested an expedited decision by the Patent Office regarding EP 1137828 so that they would be able to benefit from the application before it finally lapsed in 4 1/2 years. The Opposer rejected this request, claiming that it gave the impression that they were time-wasting. They requested due process including the right to cross-examine the witness. Applicant argued that the file wrapper did not need to be submitted by a witness that would be available for cross-examination. The District Court merely ruled that the evidence was admissible. Submitting via a witness who would be cross-examinable was a mere time-wasting exercise.

The Opposer argued that the European file wrapper raised technical issues that required clarification, and the applicant argued that this was widening the grounds for opposition. The sides each tried to get the other’s case thrown out on technicalities and argued as to who should be cross-examined first to avoid giving one side an advantage over the other.

Ms Yaara Shoshani Caspi ruled that as the European file wrapper was ruled as admissible by the courts, its relevance should be determined and now was not the time to try to stop it being considered by a technicality. She went on to rule that the European file wrapper should be submitted with a statement of its relevance to why the claimed invention is not patentable and the applicant could respond to the statement. There was a need to finish the opposition without further ado to provide legal clarity to the sides and to third parties regarding the validity or otherwise of the patent.

The Opposer should submit the European file wrapper in full within 14 days with no moe than six sides of arguments and the applicant would have 14 days to respond. The opposer would then have 7 days to sum up in three sides. That would be the time to decide whether a witness should be available for cross-examination. Should there be a hearing the sides would be required to sum up orally, and a final ruling would issue soon after the summary / hearing. No costs were awarded at this time.