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 »


Patent to Astrazeneca  Successfully Opposed by Teva

April 20, 2017

Rosuvastatin_structure.svgRosuvastatin is a member of the statin class of drugs that is used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.

Israel Patent IL 166626 to Astrazeneca is the National Phase of PCT/GB2003/003463 filed in August 2003 and titled ” Process for preparing the calcium salt of rosuvastatin 

The Application was allowed and published for opposition in September 20011 and Teva filed an Opposition. A hearing was held in July 2015, and by June 2016 both sides had finished submitting their summaries and counter summaries.

The patent covers a process for obtaining (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt. The application included 27 claims of which the first, independent claim is as follows: Read the rest of this entry »


Unipharm Successfully Opposes Novartis Patent for Panobinostat Lactate Salts

March 26, 2017

PanobinostatThis ruling relates to an opposition against a patent application by Novartis for Panobinostat  which is a hydroxamic acid  that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor).  On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.

The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.

Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.

Background

NovartisNovartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.

UnipharmUnipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.

The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »


Exforge Patent Successfully Opposed in Israel, despite surviving an Opposition based on similar citations in Europe

November 7, 2016

Exforge is a blockbuster drug sold by Novartis for lowering blood pressure that combiexforgenes two medications in a film-coated tablet It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist (ARB or A2RA); typically formulated as the benzenesulfonate salt.

Israel Patent Application No. IL 140665 titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” relates to the drug.

In an Opposition to the Patent Application issuing, the Deputy Commissioner, Ms Jacqueline Bracha, has ruled that the combination of two active ingredients, each individually known for treating high blood pressure, into one pill for ease of dosage is not inherently inventive where the separate efficacy of the active ingredients is known, as are other two component pills for treating hypertension. Though claimed by applicants, there is no evidence of a synergy between the active ingredients.  The Patent Application is therefore ruled not patentable in Israel and significant costs were awarded to Teva and Unipharm. We expect that the decision will be appealed. This decision may have a knock on effect regarding patents for the same drug abroad and may encourage Teva to proceed with at-risk launches of generic competitors in other jurisdictions.

A translation of the ruling follows:

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 »


Orbotech’s Patent Application Remains Rejected, Despite Appeals

April 10, 2016

Rejected

Despite Appeals to the District Court and the Supreme Court and a compromise reached by the parties upholding the patent, the Deputy Commissioner refuses to allow IL 179995.

Orbotech is the Applicant of Israel Patent Application IL 179995. In a decision from back in July 2014 , the Deputy Commissioner Ms Jacqueline Bracha accepted Camtek’s arguments filed in an Opposition and refused the patent application.

Orbotech appealed to the District Court against the decision, and the District Court accepted the Appeal and ordered the case returned to the Deputy Commissioner to give the Applicant a chance to prove their assertion that the prior art patent ‘405 and the control system were insufficient to render the alleged invention unpatentable.

Not to be outdone, Camtek requested permission to appeal the District Court decision.However, then both sides agreed to a compromise which was ratified by the Court, under which the patentee would be awarded the patents but no costs would be awarded.

Consequently, Camtek may be considered as an Opponent who has retracted the Opposition and the court’s options are detailed in Section 34 of the Israel Patent Law 1967 which states:

34. If opposition was duly submitted under section 30 and was subsequently cancelled, then Registrar may refuse to grant the patent applied for if, in the course of the opposition, he discovered material according to which the application should not have been accepted in the first place. 

Thus this is a rare case where an Opposition was accepted. That decision was cancelled but the Court of Appeal did not positively allow the patent. Rather, the District Court considered the decision to accept the opposition was deficient and the Applicant was deprived of a fair opportunity to show that the prior art does not render the claimed invention non-patentable. However, the District Court did not, itself, analyze the references and conclude that they are insufficient to anticipate of render obvious the claimed invention.

Furthermore, the Supreme Court that authorized the Opposition being canceled also did not address the patentability issue or discuss Section 34.

In these circumstances, having analyzed the case and concluded that the claimed invention is not patentable, the Deputy Commissioner saw no reason to reconsider this decision and informs Amitech that with reference to the Decision of 20 July 2014, does not see fit to allow the patent. In paragraph 64 of that decision, the Deputy Commissioner had concluded that the patent was anticipated by the ‘450 patent and any additional functionality of the control system that was not claimed are not pat of the claimed invention.

Therefore, the patent remains rejected. Under regulation 74b of the Patent Regulations, the Applicant has 30 days to Appeal this decision.

 


Opposition to IL 178249 Dropped After Claim Amendment, but then Rejected Due to Lack of Novelty

March 8, 2016

solifenacin

Il 178249 to Astellas Pharma Inc is a patent application titled “PHARMACEUTICAL COMPOSITION FOR USE IN SOLID FORMULATION CRYSTALLINE SOLIFENACIN OR SALT THEREOF AND A PROCESS FOR ITS PREPARATION”. On allowance, back in 2012, it was opposed.

Following the Statement of Claims, Astellas requested various claim amendments, some of which were allowed and some were opposed. The Applicant requested a further amendment and the Opposer did not object, so the amended claims published for Opposition purposes.

This amended claims set (version 5) is now subject to a judicial decision under Section 34. Based on her analysis, the Deputy Commissioner, Ms Jacqueline Bracha considers the claimed invention as lacking novelty and inventive step, and therefore provisionally refuses it under Sections 4 and 5 of the Israel Patent Law 1967. The Applicant has 30 days to appeal this decision.

The claimed invention is a pharmaceutical preparation that includes solid formulation crystalline solifenacin or a salt thereof in a concentration of up to 77% as measured by NMR. The relevant date is the filing date of the priority document which is 25 March 2004.

The specification itself states that this preparation was known, as was its crystalline state and its method of manufacture, and its effectiveness in treating urinary diseases.  The amorphous state was present in tablets on sale prior to the priority date, and the Applicant is requested to answer whether this amorphous phase is indeed inherently present and if so,how and why it affects the novelty of the invention as claimed.

The Applicant claims that the percentage amorphous material in the tablet affects the efficacy and moisture during manufacture affects  the amount of amorphous material in the pills. PEG is used as a binder but this is not claimed and so is not part of the claimed preparation.  Apendix IX of the Statement of Opposition shows that exposure of pharmaceuticals to moisture degrades them, and this occurs more in amorphous regions. as stated in reference:

“What we can conclude from this analysis is that medium effects due to residual water in the amorphous state can be significant, but that the direction and extent of this effect will depend on the nature (e.g., polarity, specific solvation) of the transition state for the particular reaction causing degradation.”

Reference 10 states that wet granulation affects the degradation rate.

From the above, it is clear that persons of the art would expect the amount of amorphous active material to affect the rate of degradation, the extent of degradation over time and to reduce degradation  one should protect from moisture. Consequently the claimed invention is obvious.

The Statement of Opposition shows that the pill was on sale before the priority date.

 

The Application is therefore provisionally refused, and the Applicant has 30 days to respond.