Teva Challenges Gilead Patent Application for HIV Treatment

May 8, 2017

drug cocktailThis ruling relates to a treatment for HIV consisting of a single once-a-day dosage that includes a combination of two or three different active ingredients.

Israel Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. Gilead purchased Triangle so that they would have the capability of producing both  FTC and TDF and in a press release in Bioworld in 2002 which quoted Gilead’s Chairman and CEO, they announced their intention to develop a single dosage formulation that included TDF and FTC, referring to the chemicals by their trade names of Viread and Coviracil. This announcement preceded the priority date and since they announced that they did not anticipate difficulties in formulating the combination, their announcement undermined claims 1 and 12 directed to the combination of TDF and FTC in the standard dosages of Viread and Coviracil. There were additional independent claims for FTC and TDF together with an additional active ingredient – either Reyataz, Kaltera or Sustiva. However, that combination was used in a clinical trial for treating Hepatitis B that was also prior art. This ruling addresses and clarifies the requirements for prior art to be anticipating and what is required to provide an inventive step. It also relates to the issues of claim support, enablement and utility.

History

GileadIsrael Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. On allowance the Application published for opposition purposes and Teva filed an opposition on 26 March 2009 and four months later submitted a detailed statement of case. On 1 February 2010, the Applicant requested permission to correct the application, and on 21 April 2010, Teva requested that the proposed amendments to the claims be refused. There was an intermediate ruling on this by the Commissioner on 22 June 2010, and on 27 June 2010 Teva withdrew their challenge to the amendments and the opposition continued with the amended claim-set. On 8 May 2011, the Opposer submitted an amended statement of case and Gilad submitted their response on 1 January 2012. On 23 September 2012, the Opposer’s evidence was submitted in the form of two affidavits, by Professor Richard Novak and by Professor Joseph Fortunak. On 24 July 2013, Gilad submitted their response in the form of Affidavits by Professor Robert Redfield and Professor G Stahly, and on 10 April 2014 further affidavits were submitted in response to points raised. Read the rest of this entry »


Wet-wipes, The Issue of Inventorship and the Responsibilities of the Patent Attorney

September 22, 2016

wetnap-were-ready-for-any-messThis ruling concerns a product that resulting from the contributions of two people who were formerly friends. A patent application was filed that named both people as both inventors and applicants. Later, after powers-of-attorney signed by each of the named inventor – applicants had been filed, there was an attempt to ‘correct an office error’, to list one of them as an inventor only. The corresponding PCT application and the national phase entry applications, including two issued patents in the United States only bore the name of one inventor and applicant. In an Opposition ruling the Israel Patent Office has now accepted that the second named inventor is indeed an inventor and also an owner.

Apart from emphasizing the need to determine who is the inventor and who is the owner of an invention when the patent is filed, the need to put everything into writing, and the dangers of working with friends, the case raises interesting questions regarding what contribution to reducing a patent to practice entitles someone to recognition as an inventor and whether this standard is the same in all jurisdictions. It also raises interesting questions regarding the duties and responsibilities of the patent attorney to ascertain the facts, or at least to avoid signing on contradictory statements regarding ownership and invention in different jurisdictions.

BACKGROUND

IL 152867 titled “Tissue Container With Auxiliary Compartment”is a patent application for a package of wet-wipes
rc-chairswith an adjacent container for nappy cream. The Application was filed back in November 2002 and listed Boaz Krystal and Liat De-Vries as inventors and owners. The patent application was allowed at the end of June 2010.

Subsequently, an Opposition was filed by WET-NAPS LTD and Liat De-Vries on 4 October 2010 under Section 31(3) of the Israel Patent Law 1967 on the grounds that Boaz Krystal was not in fact an owner, and that the patent was exclusively owned by Ms Liat De-Vries.
affidavitsMr Boaz Krystal and his wife Mrs Dorit Krystal each submitted affidavits. Mrs Liat De-Vries submitted a primary affidavit and a supplementary one in response to Mr Boaz Krystal’s affidavit. Wet-Naps Ltd. is owned by Mr Ilan De-Vries, who is Mrs Liat De-Vries’ husband. He also submitted an affidavit on behalf of the company.  Mr David De-Vries, a patent attorney at Reinhold Cohn & Partners who drafted and filed the application and is a cousin of Mr Ilan De-Vries, Ms Ronit Tal who is an acquaintance of Liat De-Vries and Mr Yoram Hadar who is an industrial designer, also submitted affidavits. A hearing was held and the parties submitted their summaries.

wetnapWet-Nap Ltd manufactures, exports and markets wet-wipes. The company had a business relationship with Packtop Ltd., a company directed by Mr Boaz Krystal that distributes wet-wipes amongst other things.   At the time of filing, both the Krystals and the De-Vries couple were good friends.

roobarbs-shedThere is no argument that Mr Boaz Krystal and Mrs Liat De-Vries met at the Wet-Nap Ltd factory, where Mr Boaz Krystal heard the idea of including baby ointment together with a package of wet-wipes from Mrs Liat De-Vries. There is also no argument that Mr Boaz Krystal and Mrs Liat De-Vries had some kind of collaboration, to develop and improve this invention and to file a patent application for it. Eventually a joint application was filed in both Mr Boaz Krystal and Mrs Liat De-Vries names. However, the parties disagree regarding Mr Krystal’s contribution to the development of the invention and consequently disagree regarding whether he is to be considered an inventor and owner of the patent.

The Main Documents in the Prosecution File Wrapper

roobard-and-custard-friendsThe Application was filed in November 2002 by Reinhold Cohn Patent Attorneys. The Application form lists both Mr Boaz Krystal and Mrs Liat De-Vries as joint owners due to them being inventions. Both parties filed Powers of Attorney, and the Filing Certificate gives both names.

On 10 December 2002, Adv. David De-Vries of Reinhold Cohn Patent Attorneys submitted a notice stating:

office-error“Due to an office error, the name of the inventor, Mr Boaz Krystal was inserted as an Applicant. With our apologies for this, we are submitting a new cover sheet and application form in duplicate, listing Mr Boaz Krystal and Mrs Liat De-Vries as joint inventors, but Mrs Liat De-Vries as the sole owner.”

On 10 December 2002, Adv. Edna Haruti, now Mr Krystal’s representative, submitted a letter in which it was stated that Mr Krystal was a joint owner together with Mrs Liat De-Vries as he had invented the tissue container with auxiliary compartment together with her.  Adv. Edna Haruti also noted that registration of the patent in the name of Mrs Liat De-Vries only was contrary to the agreement between the parties.

shimon-shalitOn 2 February 2003 Patent Attorney Shimon Shalit, then Senior Examiner in charge of formalities at the Israel Patent Office, responded to both Reinhold Cohn and to Mr Krystal that Mr Krystal could not be removed as an owner in the application as filed, since there was no indication that he had assigned his invention to Mrs Liat De-Vries prior to the application being filed. In absence of such proof, since Mr Krystal was not an employee of Mrs De-Vries, by virtue of being a co-inventor, he was also a co-owner.

(As an aside – On 12 March 2006 Mrs De-Vries submitted a divisional application of IL 152867 for certain applications of the invention. This divisional application (IL 174309) was examined, allowed and issued as a patent. On 1 December 2010 IL 174309 lapsed due to failure to pay the renewal fees. That patent is not directly relevant to this Opposition, but Wet-Naps Ltd and Liat De-Vries related to it in their claims).

procrastinateIn the protocol of a hearing held on 5 February 2007 before then Deputy Commissioner Noah Smulevezh it was decided to defer the issue of ownership until the examination of the application was completed. It was further ruled that Reinhold Cohn would be address of record, but would update Mr Krystal or his representative regarding actions taken to get his input before responding to office actions. The patent application was eventually allowed and published for opposition purposes, resulting in this opposition proceeding.

The Opposers’ (Wet-Naps Ltd and Mrs Liat De-Vries) Main Claims
wetnap

Mrs De-Vries and Wet-Naps Ltd claimed to have thought of the idea and developed the invention whereas Mr Krystal had merely provided technical drawings and a business plan for commercializing the product. They alleged that during the period in question, Mr Krystal provided technical and consultancy services to the company as almost an in-house service provider and as such, was exposed to the invention. They further claimed that Mr Yoram Hadar (industrial designer) and Patent Attorney David De-Vries provided sketches for the product that eventually evolved into the patent application. They further alleged that Mr Krystal had suggested a specific implementation (embodiment?) – storing the cream in a blister pack or sachets, which developed into  Read the rest of this entry »


Shabbat Lifts Not for the Public Good

July 18, 2016

 

shabbat liftG.L. Glatt Lift Company Ltd. filed a patent application for a Shabbat Lift; an elevator that may be used on the Jewish Sabbath without transgression of the holy day. (The term Glatt relates to a standard for Kosher beef that the generally accepted Ashkenazi authorities consider a stringency. By transference, the term implies super-Kosher, or something similar. Many Jewish authorities allow usage of a lift that stops automatically, or riding in a lift in a hospital or similar if someone assumed to be non-Jewish operates it for their benefit. Other authorities are stricter. More discussion on this is given at the end of this article).

Maalit ShabbatIn this instance, the Applicants have filed a patent for a technological Hallachic solution that is allegedly novel and inventive and that is claimed to overcome the reservations of those Hallachic authorities that do not allow usage of the type of ‘Shabbat Lifts’ that are common in apartment blocks with religious residents.

Israel Patent Application No. IL 221842 titled “Shabbat Lift” was submitted on 9 September 2012. The application claims priority from a US provisional application number 61/533,244 that was filed on 11 September 2011, and a corresponding PCT application, No PCT/IB2012/054604 was also filed.

On 13 October 2015, the Applicants received a Notice Prior to Examination to which they responded on 1 February 2016 with a list of prior art. The submission of a response to the Notice Prior to Examination creates a state of affairs by which the application is ready for examination (see section 5.3 of the Examination Procedure for Examiners).

On 1 February 2016 the Applicant also submitted a request for accelerated examination, which is a petition to make special. The justification for the request was that awarding the patent was in the public interest.

The Applicant claimed that the lack of appropriate Shabbat lifts prevented high-rise accommodation for the Ultra-Orthodox and the proposed solution would overcome this barrier. The Applicant considered that his invention would facilitate high-rise Ultra-Orthodox accommodation and thereby minimize land usage (by increasing the population density) and would thereby lower building costs.The solution would also make life easier for the ill, the elderly and children who could not use elevators on Shabbat. Various articles regarding the lack of accommodation for the Ultra-Orthodox were appended.

The statement was not specific, but it appears that the legal support was claimed from Section 19a (v) and (vi) that state that:

An applicant for accelerated examination with reasonable arguments may submit a reasoned request, together with a statement supporting the facts; all of the following, inter alia, may be considered reasonable justification:

(5) common good;

(6) special justifying circumstances.

Generally patents are examined in turn so ‘first come, first served’ as per Section 9 of the Patent Law:

If more than one applicant request a patent for the same invention, he that first applied will prevail. 

The order of examination is generally on a ‘first come, first served’ basis as per Section 34a of the regulations:

34a the applications will be allocated to each internal classification group and within each classification group, will be examined in turn. 

Examination in turn both facilitates Section 9 and also ensures that relevant prior art is available to the Examiner. The first come, first served regime is itself in the public interest – See ruling re Petition to make special Israel Patent Application no. IL 216870 to Cimas Limited, 24 March 2014.

The possibility for making an application special is an exception to the general rule. It undermines the principle of ‘first come first served’, makes the examination more difficult and arguably damages the quality of the examination.  For example, a queue-jumping application may be examined and allowed without realizing that an earlier filed application that was not examined challenges the novelty or inventiveness of the claims. Any fast-tracking results in other applications being delayed and is thus against the public interest.

Fast-tracking risks unfairness, but the legislators allow it under circumstances detailed in Section 19a of the Law where there is an over-riding public interest or special circumstances. Section 19a was legislated in the 10th amendment to the patent law that came into effect on 12 July 2012. From examination of the discussion at the committee state it is clear that the Commissioner has the discretion to explain the law. It is clear that the type of justification that is acceptable is extreme circumstances. For example: there could be circumstances that a dramatic discovery is like an earthquake and is positive for the State of Israel. Isaak Herzog, Knesset legislative committee discussion of 13 March 2012.

The justifications listed in Section 19a were actually those for third parties to request an application be fast-tracked but there is no reason to suppose that they are not applicable to requests by the Applicant himself. Nevertheless it appears that what the legislators intended was something of interest to the entire population as of national interest for the whole population and not for micro-economic interests of one sector or another. There is an underlying assumption of public interest in all patents. The only justification for ever granting a patent (i.e. a monopoly, albeit limited in time and geographical application) is that there is a national interest in micro-economic profits and technological progress.

No-one challenges the fact that each patent provides a different public interest depending on the type of invention and its application. There is no clear economic or social scale that can be used to rank different patents. However the same term is generally understood in the same manner in different legislation to provide coherency (see Aharon Barak, Volume 2, Legislative Interpretation, Nevo 1993 pages 313 and 321. Thus the term “common good” in Section 19a of the patent law is a priori similar to the term in Section 122 which discusses forced licenses. Section 122 states:

The Commissioner, where he comes to consider the request for a compulsory license under Section 117 should consider, inter alia:….

….

(2) the common good generally obliges that all inventions should provide the protected goods by manufacturing or import, so enable widest possible supply in the circumstances, without delay.. 

The District Court ruled in 881/94 Eli Lilly and Company vs. TEVA Pharmaceuticals LTD 25 November 1998:

In the field of patents, the common interest is the main and dominant cause for determining balances and rights. There may be a specific basis for worrying for private interest of the specific owners, and a patent an be considered as a reward that the legislators bestows on the entrepreneur. But the main justification of the patent system is the public considerations of utility and profit that affect the community taken as a whole. Whilst it is true that a patent provides protection to an individual, the existence of the right and its extent are determined by how much they fulfill the public interest. In this regard a patent is like a compulsory license. In both cases a personal right is provided to an individual but the underlying rationale for granting the rights is the common good. Just as the compulsory license is not granted for the benefit of the applicant, similarly a patent is only granted to the owners because it is in the public interest. It is not a balance between private rights and the public interest, but rather a balance between different public interests that together define the common good.

Thus the common good in this instance, as with compulsory licenses, is the result of balancing different public interests. Where the Applicant desires to depart from the general balance of interests including the principle of ‘first come first served’, the justification for jumping the queue has to be something weighty of significance to the wider public or a positive macro economic effect.

Furthermore, from when the application is filed until it eventually issues as a patent, there is nothing preventing the applicant from implementing the invention described in the patent application, enabling the public to benefit immediately. The enforcement of a patent is of economic interest to the patentee only. First tracking is not in the public interest at all. It only serves the applicant.

Without addressing the issue of patentability at all at this stage, the Commissioner does not thing that the present invention is more ‘public good’ than other inventions and, as the applicant himself testified, it serves a specific population segment only. The petition to make special did not include any economic calculation to show why it was justified.

Although the above arguments relate to the ‘public good’ they are equally applicable to the ‘special reasons justifying advancing the examination’. Consequently the application for fast-tracking is rejected and the application will be examined in turn.

Ruling by Commissioner Asa Kling Concerning Making Special Israel Patent Application Number IL 221842 to Glatt Lifts LTD., 14 June 2016 

COMMENTS

Very few inventions positively affect everyone. If something could help 10% of the population, it seems to me that it should be considered of significance, whether the population is women, AIDS sufferers, people living near the Gazan border, parents of small children or the Ultra-Orthodox. I don’t see any reason why common good should be interpreted as of value to people across the population without regard to race, age, religion, religiosity or sexual orientation.

The underlying presumption of the Applicant is that conventional elevators do more electrical work for each passenger riding in the elevator and that this is against the laws of Shabbat to rely on Shabbat settings on lists. If this assumption is true, it affects all Jews and most of Israel’s population is Jewish. Even if many Jews are not Observant, and many more are not persuaded that using currently available Shabbat lifts are not acceptable I suspect that from the Applicant’s perspective, Shabbat observance is of value and desecration is problematic regardless of the religious philosophy of the Jew in question. It may be what’s preventing the Messiah from coming. Furthermore, the State of Israel accepts the principle of Shabbat observance as being of national interest by not allowing trading on Shabbat and by not having Shabbat desecration by the Head of State, ambassadors, etc. and by requiring Shabbat observance on army bases apart from where security considerations take precedence.

For more details of the ruling (wrongly???) attributed to Rav Elyashiv, see here. See also a report in the Yeshiva World (sic) and one from the UK’s Daily Telegraph. Rabbi Yisrael Rozen’s ruling allowing both ascending and descending in Shabbat Elevators and listing what modifications are required to enable an elevator to be used on Shabbat may be found here (Tchumin 5, 75; see also article by Professor Lev in same volume, page 58).

I took the liberty of reviewing IL 221842 to Glatt Lifts LTD and its claims. If I was examining it for patentability, I would disallow it as not being enabled. It may be enabled from the perspective of the Hallachic problem it is trying to solve, but in my opinion, it does not provide a solution that enables a person of the art to go away and build a working lift without undue experimentation which is the standard for which patent applications are judged.


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 »


Oppositions – once the genie is out of the bottle…

February 17, 2014

diamond

Once a patent is allowed in Israel, it publishes for opposition purposes. Oppositions are usually filed by competitors, since they have a commercial interest in preventing the applicant from obtaining a patent. Sometimes there is little more than commercial interest. Usually, however, the opposer knows the field better than the Examiner and may be familiar with prior art published in the scientific literature, for example. The competitor may spend considerable resources to uncover prior art and to develop arguments showing that a patent should not have been allowed.

Sometimes competing companies merge or one takes over the other. In such cases, an opposition proceedings between the parties may be dropped. The arbitrator of an opposition proceedings is, however, entitled to put himself/herself into the opposers shoes, to review the arguments and evidence submitted, and to continue the opposition as an ex-partes proceeding.

Israel Patent Application Number 156034 relates to a method of locating flaws and inclusions in diamonds.

Their main claim is as follows:

A method for localizing inclusions in a diamond wherein said diamond is fixed on a holder, characterized in that: a scan is taken of the outer surface of the diamond at an arbitrary initial position; the inclusion in the diamond is observed in at least a first and a second direction of observation; wherein the translation and rotation for every direction of observation is registered with reference to the initial position; wherein the registered translations and rotations, the  scan of the outer surface and knowledge of the refractive index of the diamond are fed in a computer to calculate 3d image including the inclusion with respect to outer surface in order to localize the inclusion with respect to the outer surface of said diamond. 

Dia Expert filed an opposition and argued that their system and its user manual were close prior art. The differences between the two systems include using the refractive index in calculations and being able to translate the stone and not just rotate it.

Opponent argued that the refractive index is simply Snell’s Law, and that its use in similar equipment is found in a couple of cited references. Similarly, the translation is also discussed in the prior art.

The opposition was withdrawn, but the Deputy Commissioner, Ms Jacqueline Bracha, argued that the opposer had demonstrated that claims 1-3 were obvious and claim 4 was anticipated by the prior art. She also felt that the opposition had convincingly argued that the patent application was not enabled.

Invoking her prerogative to refuse the patent under Section 74b of the Law, she gave the applicants 30 days to show how the claimed invention was novel, inventive and supported.

Decision re IL 156,034 to DiamCAD N.V. by Jacqueline Bracha, 27 January 2014