IL 136294 Pharmacia and Upjohn Successfully Opposed by Teva

October 20, 2014

Pharmacia

Pharmacia and Upjohn filed IL 136294, titled “Use of tolterodine, its 5-hydroxymethyl metabolite or racemate thereof in the preparation of medicaments for treating unstable or overactive urinary bladder”. On 6 May 2004, Teva filed an opposition.

The Application was a national phase entry of PCT/SE99/01463 which claimed priority from SE 9802864-0 and SE 9802871-4 filed on 27 August and 11 November 1998 respectively.

On 11 June 2003, a Divisional Application (IL 156414) was filed. Following the publication of patent office circular M.N. 23, the Opposition was frozen pending Examination of the Divisional Application. On 20 March 2006 the Divisional Application was abandoned and the file closed, and the Opposition procedure in the parent application was restarted.

On 19 June 2006, Teva submitted a detailed Opposition and Upjohn filed a counterclaim on 13 November 2006. Following submission of evidence, counter-evidence and responses, a hearing was held on 1 and 2 April 2009 before then Commissioner, Dr Meir Noam.

After the hearing, the parties submitted their concluding remarks between 21 April 2010 and 26 January 2012, after Dr Noam’s term of office finished. The Present Commissioner, Asa Kling, ruled on the case under regulation 202a, on the basis of the material in the file.

According to the Commissioner, the Opposition is two-fold. The Opposers argue that there is no inventive step in contravention to Section 5 of the Patent Law, and that the claimed invention is a method of treatment of Man and thus contrary to Section 7.

The Opposer, Teva, submitted their evidence via an opinion of Professor Danon. The applicant, Upjohn, submitted their evidence via an Opinion from Professor Abrams and a statement of Dr Wood. Teva submitted counter-claims via a second affidavit of Prof. Danon and an opinion by Professor Mor.

The patent relates to a treatment for sufferers of unstable or overactive urinary bladder. The problem is caused by a lack of control of smooth muscles around the bladder that receive electronic stimulation. The standard treatment at the time of filing involved desensitizing the nerves with tolterodine or oxybotynin. Both desensitizers had various adverse side effects including dryness of mouth. In minimizing this side effect, tolterodine was preferable to oxybotynin. Tolterodine is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine, where R indicates the Right handed enantiomer, and S, the sinister, or left handed enantiomer which does not work. The two desensitizers and the enantiomers are discussed in the specification.

The Application as allowed had 17 claims, of which claims 1, 8, 16 and 17 are independent.

Claim 1 is as follows:

  1. Use of tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, in a pharmaceutically effective amount thereof through a controlled release formulation capable of maintaining a substantially constant serum level of the active moiety or moieties for at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h, for the manufacture of a therapeutical formulation for treating unstable or overactive urinary bladder, substantially as described in the specification.

Claim 16 is similar, but includes the following limiting feature:

… with reduced undesirable side effects and with no reduction in the efficiency of the tolterodine compound…

Claim 8 is as follows:

  1. A pharmaceutical formulation containing tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, which formulation when administered to patient provides controlled release of said tolterodine its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, such that a substantially constant serum level of the active moiety or moieties is maintained foe at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h.

Claim 17 follows claim 8 , but includes the following limiting feature:

…for efficacious therapy with reduced undesirable side effects…

In order to ascertain inventive step or non-obviousness, the standard is that of a person of the art. Professor Danon and Dr Wood are pharmacologists. Professor Mor and Professor Abrams are urologists. Both sides argued whether in this case the person of the art to determine non-obviousness would need to be would need to be a pharmacologist, a urologist or a team including both skills. Accroding tot he Commissioner, this question may be answered by reference to Former Supreme Court President Shamgar in 345/87 Hughes Aircraft vs. State of Israel P.D. 44(4) 45 (1990) as including a person or team with knowledge of relevant subject matter but no creative ability. The Opposer (Teva) considers the person of the art to be a pharmacologist specializing in the relationship between active ingredients and the human body. The Applicant considers that persons of the art may be a team including pharmacologists and doctors of the relevant speciality, which in this case includes urologists.

The Applicants distinguish between the pharmacological and the pharmo-kinetical aspects of the invention, which in their words, are directed to a pharmacologist or formulator, and the medicinal aspects of the drug which are directed to a urologist. Professor Abram’s opinion follows this distinction.

“Obviously, once the pharmaceutical invention is made… pharmacokinetic and pharmacologic considerations become relevant. However, unless the pharmaceutical invention is made first, the pharmacologist is not a relevant person.”

According to the Applicant, the motivation to develop a drug is based on medical needs and so the application is primarily directed to the urologist, and other professionals, such as pharmacologists are consulted only once the drug is being developed to answer a specific medical need.

The Opposer considers that the medical need is the problem to be solved, and the person to be consulted to solve the problem is the person the art. Support for this position is found in “Patents for Inventions” by T.A. Blanco White, 5th Edition page 90:

“In principle, it would seem clear that the proper people to think of in judging obviousness are those who would in practice be called upon to solve problems of the sort concerned.”

Furthermore, the Expert for the Applicant Professor Abrams himself stated that the urologist might identify the clinical condition and would describe it to the pharmacologist, which strengthens the position that the person of the art is, in fact, the pharmacologist.

The Commissioner ruled that the person of the art is indeed the pharmacologist, although the urologist might well initiate the process of developing a drug.

Support for this was found in Alza Corporation vs. Mylan, a US ruling concerning urine leakage, where it was stated that:

“In their post-trial memoranda, the parties do not directly dispute the level of ordinary skill in the art at the time of the ‘355 patent’s filing. Thus, based on the testimony of Dr. Amidon and Dr. Peppas, the Court finds that a person of ordinary skill in the art has either an advanced degree in pharmacy, biology, chemistry or chemical engineering and has at least two years of experience with controlled-release drug technologies, or possesses a bachelor’s degree in one (or more) of the same fields and has at least five years of experience with controlled-release drug technologies.”

Consequently, the Commissioner ruled that whilst a urologist could be included in the team, the persons of the art defining obvious would include a pharmacologist.

As far as inventive step is concerned, the issue in question boils down to whether something would have been considered obvious by a pharmacologist, or by a team consisting of a pharmacologist and a urologist.

Both sides agreed that:

  1. As of the priority date both tolterodine or oxybotynin in instant release form were being used to treat unsteady or over-active bladders. Furthermore, oxybotynin was also being used in a controlled release form.
  2. It was understood that oxybotynin caused more serious side effects of dry-mouth and thus tolterodine was the preferred treatment.
  3. Dry mouth symptoms of tolterodine were most prevalent when tolterodine was at its highest concentration in the blood.
  4. It was already established that tolterodine had a positive effect on unsteady or over-active bladders after its effect on saliva forming and the symptoms of dry-mouth had disappeared.
  5. Moving from instant release to slow release formulations may not be successful for treatment of unsteady or over-active bladders and the efficacy required clinical trials.
  6. The Applicants considered that the minimal problems of dry mouth associated with tolterodine in quick release form were such that there was no motivation to develop a slow release version of the drug. Furthermore, slow release Oxybotynin did not have less slide effects than the quick release version so the urologist would be likely to conclude that slow release tolterodine would behave in a similar fashion.

Finally, according to the Applicants, it transpires that the slow release tolderine is actually more effective. This is not supported by the specification and is first raised as a consideration in the Applicant’s statement of claims. There is no evidence that Applicant was previously aware of this point.

The Applicant does not claim that this fact is relevant to the issue of inventiveness, but the commissioner nevertheless emphasizes that such post filing revelations are irrelevant to the issue of inventive step (non-obviousness) and the Applicant can’t turn the clock back. There has to be an inventive step at the time of the priority filing (albeit, possibly one discovered by accident).

The parties now debated a very interesting point. Regardless of the surprising improvement of the not particularly serious dry mouth side effect, according to Teva there was a drive towards creating a slow release version of the treatment since this would enable taking a pill once a day instead of twice a day. They consider this fact self-evident and not requiring scientific proof.

Upjohn countered that this advantage of merely reducing the dosing frequency would not have warranted a switch to a controlled release treatment. They considered that the frequency of dosage was a minor issue for chronically ill patients and thus with the anticipation of increased side-effects, the drug developer would have no drive to develop a controlled release version. Citing Goldstein and Kalman:

“Certainly the oral ingestion of a drug 3 or 4 times daily presents no hardship to the patient; the substitution of a single daily dose of a sustained-release preparation would not be warranted unless some advantage other than convenience had been demonstrated.”

The Commissioner rejected this argument, preferring Glaxo group LTD’s Patent [2004] R. P. C. 843:

“That salmeterol would be the obvious substitution for salbutamol follows from the most basic consideration, that a drug that only needs to be taken twice a day will encourage compliance.”

And

“…the patent must be invalid, because I consider that the problem of compliance has, on the evidence, always been a problem.”

The Opposer considered that despite possible problems in achieving, it is obvious to try to reduce the dosage frequency, and thus a mere change in dosage frequency achieved by a coating is not inventive.

The Applicant countered that the development of a slow-release version warranted a patent since there were many cases where controlled release was less than successful, and they brought three examples of this.

The Opposer showed why the three examples were all exceptions to the rule and the commissioner felt that the onus was on the Applicant to show why this instance should be considered inventive.

Both parties accepted that tolterodine was preferable because of its lesser severe side effect of dry mouth. The Applicant considered that this being reduced further by controlled release dosages was patentable.

“According to the present invention it is now surprisingly been found that contrary to the case of oxybutynin, the substantial elimination of peak serum levels of tolterodine and its active metabolite through controlled release of tolterodine for an extended period of time, such as through a once-daily administration form, while maintaining the desired effect on the bladder, indeed gives a significant reduction of the (already low) side effects, particularly dry mouth, compared with those obtained for the same total dosage of immediate release tablets over same period.”

The commissioner noted that Upjohn had stated that this was a surprising discovery, but that they had not actually explained why this was the case. He noted that the Opposers reasoned that if regular tolterodine has lower dry mouth side effects than oxybutynin, this would remain the case with quick release versions.

The commissioner felt that the Applicants had not explained why, despite the fact that occasionally slow-release preparations might have unwarranted side effects or efficacy issues, it would not have been obvious to try to reduce the frequency of the dosage to once a day only.

Furthermore, earlier patent WO098/03067 notes that the S-enantiomer is preferable to the R-enantiomer and suggests a more frequent dosage or a controlled release. On this point, the Applicant tried to argue that since the current application relates to the S-enantiomer only, the earlier patent was irrelevant. Furthermore, the earlier patent suggests multiple frequent dosages which teaches away from the present invention. The commissioner did not find these arguments persuasive and still considered it would be have been obvious to try.

The Opposer considered the experimental evidence as totally anticipated by persons of the art and that there was nothing surprising in it.

The cut and thrust of the parties is reported in depth, but the general tendency of the Commissioner is to uphold the ruling in IL109059 F. Hoffmann-La Roche AG vs. AGIS Industries (1983) LTD from 17.10.2004 that it would have been obvious -to-try.

“First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile.” (Brugger v. Medic-Aid Ltd., [1996] R.P.C 635 at 661)

“… Whether the subject matter was obvious may depend upon whether it was obvious to try in the circumstances of that particular case and in those circumstances it will be necessary to take into account the expectation of achieving a good result. But that does not mean that in every case the decision whether a claimed invention was obvious can be determined by deciding whether there was reasonable expectation that a person might get a good result from trying a particular avenue research. Each case depends upon the invention and the surrounding facts. No formula should be substituted for the words of the statute. In every case the court has to weight up the evidence and decide whether the invention was obvious. This is the statutory task.” (Norton Healthcare v. Beecham Group Plc, CA, (1997)) ([2004] R.P.C. 43 at para 42)

Consequently, the claimed invention was found to be obvious and the Opposition was accepted.

Opposition by Teva to IL 136294 Pharmacia and Upjohn, Assa Kling, 30 September 2014.

COMMENTS

I am neither a pharmacologist nor an urologist, (although I do enjoy taking the $%*& against poor decisions occasionally). It is established that the standard of inventiveness of obvious to try. Both sides accept (at least tacitly) that when taking tolterodine, once the problem of dry mouth is addressed, it would be obvious to try a slow release formulation, so the solution is fairly obvious. The question remains whether identification of the problem as a problem is worthy of a patent. Here the pro-pharma lobby will stand on their chairs and wave banners that of course this is patentable, whereas the generic side of the industry will have serious reservations. This may not just be a question of who pays one’s bills. It is at least possible that attorneys and scientists with different philosophies get drawn to the different market sectors that reflect their look on life.

Having a general background in chemistry but no background in pharmacology I tend to side with the generic industry. I suspect that most impartial patent attorneys with backgrounds in computing or engineering would find the Applicant’s arguments tortuous and unconvincing.

One question not addressed is why they chose to try to develop a controlled release version if there was no a priori assumption of it being preferable? (If the answer is ever-greening, is this acceptable, or is it obvious to try to keep a drug patent protected indefinitely?

Arguably the standard of obvious to try is to high, but it is the standard that Dr Meir Noam, the previous commissioner set. He was a chemist.

The present commissioner, Asa Kling is an aeronautical engineer.  He is no more a person of the art than I am. Nevertheless, his position as commissioner requires him to decide who the person of the art is, what is the standard for inventiveness and particularly whether identifying the issue of this side effect is in and of itself an inventive step. Really the issue is one of policy. The drug development industry will no doubt cry out that the Israeli standard is too high, whilst the generic industry will be more supportive of this ruling. If this ruling is appealed to the courts, the Commissioner’s determination will be scrutinized.

 


Laches in Amending Claims During a Patent Opposition Procedure

October 19, 2014

Zometa

Novartis Pharma filed Israel Patent Number 153229 titled “Use of 1-Hydroxy – 2 – (Imadazol-1-YL) Ethane – 1, 1 – Diphosphonic Acid in the Preparation of A Medicament for the Treatment of Conditions of Abnormally Increased Bone Turnover”.

The Application was allowed and published for Opposition purposes on 24 July 2007, and Teva filed an opposition on 23 October 2007.

After the Opposer filed their statement of case, the Applicant requested to correct the specification. The Opposer did not oppose the amendment, but following it, filed an amended statement of case. During 2011 and 2012 the opposition proceeded. On 10 April 2014 the applicant requested to amend the specification a second time. The amendment consisted of canceling claim 1 and dependent claims 2-5 and amending claims 6 and 7. The basis for the amendment was that the UK court had voided the corresponding patent, allegedly on formalistic and technical grounds, but to forward the discussion in Israel, the Applicant wanted to  amend the specification by canceling these claims.

Teva opposed the amendment, arguing laches and inequitable behavior since it was years since they’d filed their statement of case. They further claimed that the UK court had voided the patent due to the priority date and not on formalistic grounds. The UK Court of First Instance had issued their ruling over a year earlier, and this should be taken into account when considering the request to amend the application. This consideration was strengthened by the Opposition to Israel Patent 324844 Gradstan LTD vs Bristol Myers Squibb (6 March 1979). Furthermore, the request to amend the claims was not supported by an affidavit, and this was further grounds for refusing the request.

Novartis counter-claimed that the Appeal to the UK Supreme Court had only issued on 10 July 2014 and therefore there were no laches or inequitable behavior. Furthermore, if an affidavit was required, the applicant would be happy to provide one.

Teva countered that the flaws requiring correction were stated in the statement of case and Novartis should have corrected their application at the first opportunity which was over four years earlier.

THE RULING

The main argument is whether there is a statute of limitations or laches for amending a specification after allowance and before grant. The Opposer cited a very old case from 1979 to argue that this couldn’t be allowed, whereas the applicant cited the more recent Opposition to IL 101537 Merck and Co. vs. Unipharm Inc. (30 April 2003).

The Deputy Commissioner noted that she had ruled on the grounds for post allowance amendments under Sections 29, 65 and 66 f the Law in Reva vs. Astellas Pharma and in Rafael vs. Elta, both from May 2014.

The ability to amend the claims provides an advantage to the applicant, but it also results in side skirmishes that hold up the issuance of the patent, to the advantage of the opposer and to the detriment of the applicant.

In this instance, the request to amend the claims comes after the submission of evidence, at the stage of the hearing. However, this was justified by the UK ruling only now being made final.

Nevertheless, the request could have been made some months ago and wasn’t. No explanation was given. Although the ongoing Opposition prevents a patent from issuing (and being enforceable), it also provides uncertainty to competitors and the awarding costs only partially mitigates this.

The Gradstan case was exceptional in that five years had passed from when the applicant knew that the specification should be amended and, according to the then commissioner (Yoel Tsur?) the proposed amendment did not achieve its purpose.

In Merck vs. Unipharm the then commissioner (presumably Dr Meir Noam) ruled that even where there is a delay, the applicant should be able to amend the specification unless there is inequitable behavior or the applicant had previously fought tooth and nail for the wider claim set.

The Applicant’s reason for the delay (pending final ruling in the UK) is prima facie justification to wait until now. Hence, the delay is a matter of months, not four years and awarding costs is a fair way to compensate the Opposer.

There is no argument that the amendment is one that narrows the scope of protection since claims 1-5 are canceled and claims 6 and 7 are also narrowed since they specify a range of doses for menopausal women and the amended ranges are within the original ranges. The amended claims are also both fully supported by the specification.

As to the requirement for an affidavit, Ms Bracha ruled that this is required to support a factual matter about which there is some dispute. In this matter, that is not the case. Both sides agree when the original UK ruling was and when the Appeal ruling made it final.

CONCLUSION

The requested amendment is allowed and will publish for third-party oppositions. Absent such oppositions, the Opposer may file a corrected statement of claims within one month. If he does not wish to correct the statement of claims, he should alert the patent office of this within that month, and a hearing will be scheduled to examine the evidence.

Since this is the second request to correct the application and was filed some months after it transpired that there was a need to amend the claims, the Deputy Commissioner ruled costs of 3000 Shekels and attorneys fees of 30,000 Shekels + VAT. Furthermore, should the Opposer choose to amend their statement of case and to correct their evidence, they will be entitled to further costs regardless of the ultimate outcome of the proceedings

COMMENT

The active ingredient seems to be Zoledronic acid and the drug in question appears to be Zometa®.

This ruling seems fair.

Refusing to allow a patent to be amended due to the request not being supported by an affidavit seems to me to be formalistic. I would not consider a problem with the priority date as merely formalistic though.


Jerusalem Post Publishes Write-Up on Teva System for Better Prescribing

June 16, 2014

drug variability

Former Employee and patent attorney Dr Moshe Treitel sent me a link to an article in the Jerusalem Post that describes a technology that Teva has developed for better diagnosing. See here for more details.

Quoting Judy Itzkovich’s article:

“As the average Israeli 65 years and older now takes seven different medications for chronic illness, the danger of drug conflicts and complications is high.
In this country, adverse drug reactions (ADRs) are responsible for 4.1 percent of all hospital admissions, while it is 5.7% in Germany, 6.5% in Britain and a whopping 12% in Australia.”

The system, developed by Dr Ronni Shiloh, attempts to minimize adverse drug-drug interactions and to correct doses for specific patients by providing the doctor with a simple graphic interface or GUI on a smartphone or tablet, that summarizes a wealth of medical information in a simple and easy to comprehend graphical interface.

Drug interactions are a major cause of complications, particularly in the elderly. This product may save unneccessary hospitalization and expensive testing, to the benefit of patients, health funds and the Health Ministry alike.

 גילוי נאות – Full Disclosure

I drafted the patent application for Teva and am prosecuting it in various jurisdictions. They out-sourced to me, since despite being Israel’s largest IP firm (that’s Teva, not IP Factor!),  their extensive in-house patent capability is mostly pharmaceutical and molecular biology, whereas this is a computer based system.


Teva Announces Favorable European Patent Office Ruling in COPAXONE® Patent Proceeding

May 27, 2014

copaxone loepard spots

In a press release distributed by Business Wire, Teva Pharmaceutical Industries Ltd.  has announced that the European Patent Office issued a decision in favor of Teva in a patent opposition proceeding filed by Synthon BV, Mylan and an unidentified third party. On September 6, 2012, the three opponents commenced an opposition proceeding against European Patent EP 2 177 528, a patent for COPAXONE® (glatiramer acetate injection) that expires September 9, 2025.

In today’s hearing, the European Patent Office specifically determined that claims 1-12 of the ‘528 patent are valid. Therefore infringing follow-on glatiramer products would not be able to launch prior to patent expiry.


Teva’s at risk launch of a generic version of Atripla for treatment of AIDS withstands challenge in Canada

January 15, 2014

Atripla    atripla 3

On January 13, 2014, the Canada Federal Court dismissed an application by Bristol-Myers Squibb, Gilead Sciences, LLC and Merck Sharp & Dohme Corp.  under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance for Teva’s generic version of its Atripla® tablets (2014 FC 30).

Atripla® tablets are a combination of three anti-retroviral medicines that is used to treat HIV/AIDS.  The three active ingredients are efavirenz, emtricitabine and tenofovir disoproxil fumarate.

Merck et al. sought an order prohibiting the Minister from issuing a Notice of Compliance to Teva until after the expiry of Canadian Patent No. 2,279,198  on February 2, 2018.  The 198 Patent disclosed and claimed novel processes for making a particular crystalline polymorphic form of efavirenz called “Form I”.  However, the only claims at issue were those that claimed Form I per se.

For Teva to infringe the patent, the patent has to be valid and Teva’s actions have to infringe.

Teva alleged that claims 1 to 3 of the Patent were invalid on several grounds, including obviousness, double patenting, claims broader than the invention made or disclosed, lack of utility and anticipation.

With respect to non-infringement, the central issue was whether the crystalline form of efavirenz in the Teva tablets (“Form Teva”) would convert to the claimed Form I during or after the manufacturing process.  As a preliminary point, Merck argued that an adverse inference ought to be drawn for Teva’s refusal to produce samples of its final tablets.  No adverse inference was warranted, however, since Form Teva could be made from a publicly available process and Teva had provided details of its manufacturing process.  With this information, Merck was able to perform experiments in an attempt to establish that Teva’s tablets contained Form I efavirenz.

Merck’s conversion experiments on Form Teva included grinding with a mortar and pestle, heating, and combined grinding and heating in an attempt to demonstrate conversion to Form I. 

Justice Barnes found that the experiments were irrelevant because they were not representative of the Teva manufacturing process.  Specifically, Merck’s expert did not grind the ingredients in a manner analogous to Teva’s manufacturing process. In the grinding experiments, the expert was unaware of the size of the samples that were ground, did not record the grinding pressure applied, and could not recall if he was present for the grinding.  As a result, the Court was unable to conclude that the energy applied during Merck’s grinding studies accurately approximated the forces applied during Teva’s manufacturing process.  Accordingly, the court found that Merck failed to meet its burden of proving that the Teva tablets will contain Form I efavirenz and the application was dismissed.

The Court declined to rule on Teva’s invalidity allegations, instead basing its judgment solely on Teva’s justified allegations of non-infringement.

In this respect, Justice Barnes noted that voluminous evidentiary record, the relatively short period of time remaining in the 24-month automatic stay period, and his finding with respect to non-infringement made it “unnecessary and probably unwise to attempt to resolve the validity issues.”  Nonetheless, Justice Barnes did observe that Teva presented a stronger obviousness case than was previously before him in the Mylan case which dealt with the same patent (2012 FC 1142).


Pfizer Settles Viagra Patent Litigation With Teva…Bit of a Letdown

December 17, 2013

Viagra

NEW YORK, Dec 17, 2013 (BUSINESS WIRE) — Pfizer Inc. announced that it has settled its litigation against Teva Pharmaceuticals, USA Inc., relating to Pfizer’s patent covering the use of Viagra(R) to treat erectile dysfunction (sildenafil citrate 25, 50, and 100 mg tablets), which expires in April 2020 (including pediatric exclusivity). As a result of the settlement, Teva will be allowed to launch a generic version of Viagra(R) in the United States on December 11, 2017, or earlier under certain circumstances. Teva will pay Pfizer a royalty for a license to produce its generic version. The terms of the settlement agreement are otherwise confidential. Teva has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Viagra(R).

Teva obtains a licence to launch before patent term runs out. Pediatiric exclusivity? What are kids taking this for?


Copaxone survives attack by Mylan in Dutch Court

October 7, 2013

Copaxone2

The District Court of the Hague (Netherlands) has rejected a patent revocation suit brought by Mylan B.V., a subsidiary of Mylan Laboratories Inc., against the patent covering Copaxone, a treatment for Multiple Schlorosis that is patented by Teva Pharmaceutical Industries Ltd. The Dutch court upheld the validity of Teva’s European Patent, which will remain in force until May 2015. The favorable ruling follows a similar ruling by the English Court of Appeal in July 2013, which also affirmed the validity of Teva’s patent.


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