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


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


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.

Teva’s patent for Azilect Survives Challenge by Mylan

September 24, 2013


Teva Pharmaceutical Industries Ltd. announced on Monday that the U.S. District Court for the District of New Jersey has issued a favorable ruling in the Company’s patent infringement lawsuit against Mylan regarding an Azilect (rasagiline tablets) patent which covers methods of treating Parkinson’s disease. The Court has upheld the validity of Teva’s patent.

Teva’s patent expires in 2017, and they are hopeful that this development will result in an injunction against Mylan launching a generic equivalent before then.

Teva said it filed a lawsuit suit against Mylan in October 2010. Similar lawsuits were filed against Watson and Orchid in October 2010, Apotex in May 2011 and Sandoz in April 2012. Teva reached settlement agreements with Watson, Apotex and Orchid earlier this year. Sandoz has agreed to be bound by a final judgment in the case against Mylan.

Win some lose some. Teva loses Copaxone cases in US, but the European Patent for Copaxone Upheld in UK

August 1, 2013

Generic versions of Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone are to go on the US market a year earlier than expected, with major financial consequences expected for the company.

The news comes as the result of a ruling in the US Court of Appeals for the Federal Circuit on 26 July, which upheld only four of nine patent claims to Copaxone asserted by the company.

The four patents upheld have an expiry date in May 2014, whereas one of those dismissed had an expiry date in 2015.

The effect of the ruling is that generics producers—including Teva’s opponents in the dispute, Mylan Pharmaceuticals and Novartis subsidiary Sandoz—will be able to release rival versions of the drug a year earlier than many industry members had expected.

Mylan CEO Heather Bresch said in a statement: “We expect that it will allow Mylan to launch its generic version of Copaxone on May 25, 2014.”

Since Copaxone reportedly accounts for 20 percent of Teva’s sales and around 50 percent of its profit, the financial results of the decision may be substantial for the company.

US UK flag

A statement from Teva following the US decision to invalidate patents related to Copaxone read: “Teva is disappointed with the court’s decision with respect to four of the 2014 patents and the 2015 patent and will appeal today’s decision.”

Nevertheless, despite having several related patents invalidated in the US by Mylan, Yeda’s European patent EP0762888  for the multiple sclerosis drug Copaxone which is licensed exclusively to Teva has been upheld in the UK High Court, successfully shaking off a threat from Generics (UK) Limited which is the UK trading arm of Mylan, who challenged the patent on grounds of non-inventiveness and ambiguity.

On 29 July, Lords Justice Alan Moses, David Kitchin and Christopher Floyd in the High Court of Justice for England and Wales  ruled in Teva’s favour and held that the patent to be valid. They also refused to grant a non-infringement declaration to Mylan, since Mylan failed to demonstrate technical differences between their products and Copaxone. The ruling by the High Court affirms the conclusion of a 104-page ruling by Justice Richard Arnold in the UK Patents Court in July 2012.

Teva CEO said in a statement following the ruling: “Thousands of patients in the UK and elsewhere depend on Copaxone for relief in relapsing-remitting multiple sclerosis, and we are pleased that the English Court of Appeal has upheld the validity of the patent until its expiry in 2015.”

The UK ruling in favor of Teva upholds the patent in the UK, whereas in the US where Mylan managed to invalidate some of Teva’s patents, generic players such as Mylan will be able to market alternatives from May 2014.

Teva maintains that Copaxone is difficult to manufacture and so the generic equivalents should have to satisfy stringent FDA approval. They are considering appealing the US decision to the Supreme Court, but the chances of the appeal being heard are slim. Unless Mylan and TEVA coordinate their actions, which could be seen as delaying a generic launch, the discrepancy may lead to a price differential between the US and Europe and to smuggling of the generic equivalent.

Teva has Setback with Copaxone

July 17, 2013


Sandoz, based in Basel, Switzerland, and Canonsburg, Pennsylvania-based Mylan were sued in the U.S. District Court, Southern District of New York (Manhattan) by Teva after they filed with the U.S. Food and Drug Administration for approval of generic drugs to compete with Petach Tikva, Israel-based Teva’s Copaxone, which is prescribed to reduce the frequency of relapses in MS patients. i.

Mylan and Sandoz AG won the dismissal of the lawsuits.

U.S. District Judge Katherine Forrest in Manhattan, granted the drug companies’ motions to dismiss the cases in their entirety,  ruling that the generic competitors were using technology that is different from that protected in Teva’s patents.

“Any case or controversy that may have existed at the outset of these cases when filed has been mooted,” Forrest said in her opinion.

The cases are Teva Pharmaceuticals USA v. Sandoz, 09-10112, and Teva Pharmaceuticals v. Mylan Pharmaceuticals, 10-7246, U.S. District Court, Southern District of New York (Manhattan).

This report is based on a report by Bloomberg.

Teva to pay out $1.6 Billion to Pfizer and Takeda in Damages for Infringing Patent for Protonix.

June 12, 2013

protonix moleculeProtonix

Protonix is a heartburn treatment that was developed and patented by Nycomed which was later purchased by Japan’s Takeda Pharmaceutical Co.  Nycomed had licensed Protonix to Wyeth, which Pfizer subsequently  purchased.

Israel’s Teva Pharmaceutical Industries Ltd. and India’s Sun Pharmaceutical Industries launched at-risk generic versions of Protonix. Teva started selling its generic version of Protonix in December 2007. Sun then launched its own version in early 2008, both before the U.S. patent covering the drug expired in 2011.

back in 2010, a jury decided that the patent protecting Protonix was valid, and the U.S. District Court for the District of New Jersey then upheld that decision. A settlement was reached shortly after the start of a federal trial to determine damages. Under the settlement, Teva Pharmaceutical Industries Ltd. will pay $1.6 billion while India’s Sun Pharmaceutical Industries Ltd. will pay $550 million in infringement damages, for selling their generic equivalents of Protonix before the expiry of the patent protecting the drug. According to Associated Press, Pfizer Inc. will apparently pocket 64% of the settlement.

Gives you heartburn, doesn’t it?

Teva to Produce Generic Drug for Attention Deficit and Hyperactivity Disorder

June 2, 2013

Shire Plc (SHP) has settled a patent lawsuit against Teva Pharmaceutical Industries Ltd. (TEVA). This paves the way for lower-cost generic versions of Intuniv, used to treat attention deficit hyperactivity disorder (ADHD).
Israel based Teva is the world’s largest generic-drug company. According to a statement from Shire, Teva will market a generic version of the Intuniv under license. The license will take effect once another generic-drug maker, Actavis Inc. (ACT), has sold the drug for six months starting in December 2014.
Shire sued Teva, based in Petach Tikva, Israel, in federal court in Wilmington, Delaware, in April 2010 alleging infringement of two patents for Intuniv. Shire previously settled with Parsippany, New Jersey-based Actavis over the patents. A trial of the litigation against Teva and Actavis was held in September.
The case is Shire LLC v. Teva Pharmaceuticals USA Inc., 10-cv-00329, U.S. District Court, District of Delaware (Wilmington).

Merck’s Appeal Against Unipharm and Teva Refused

May 3, 2013

fosamax once weekly

Mercke Sharp & Dohme Corp. developed a drug called Alendronate for treating osteoporosis which is marketed as Fosamax®.

Fosamax has annual worldwide sales of over one billion US dollars. The drug has a number of unpleasant side effects. Merk filed a patent application for reducing the side effects via a different dosage regime.  Specifically, Merck’s patent proposes a higher dosage taken less frequently. The patent in question is WO/1999/004773 titled “Method for Inhibiting Bone Resorption” and covers a once weekly oral dosage pill for alendronate and other bisphosphonates for the treatment of Paget’s disease and osteoporosis. It was filed in Israel as a national stage entry of the PCT as IL 153109.

The Israel Examiner allowed the patent, but when it published for opposition purposes, Unipharm opposed the patent claiming lack of novelty, obviousness and that it was essentially for a medical treatment and thus was directed to subject matter considered non-patentable under section 7 of the Israel Patent Law. An article summarizing the original decision by then Commissioner of Patents Dr Meir Noam may be found here.  Essentially, Dr Noam (who is a chemist by training) threw out the non-patentable subject matter objection and ruled that that clause was to protect doctors and pharmacists in prescribing and drugs, but the subject matter was patentable. However, he ruled that in light of the prior art, the claimed invention lacked inventive step as it was “obvious to try”. The district court upheld this decision and also the separate decision to award record costs of NIS 550,000 (which is about $150,000).

Merck appealed both the ruling of non-validity and the costs awarded to the Israel Supreme Court.

In a 12 page ruling, Judge N Handel rejected the second appeal, ruling that a further appeal is only justified in cases where there is an important legal principle or particular public interest. He noted that Dr Noam had held 12 days of hearings and had related to all the evidence in a reasoned decision so there was no reason to overturn it. He further noted that the separate decision for costs was based on a reasoned calculation and included NIS 150,000 in expenses and NIS 400,000  in legal fees, whereas the opposers has actually claimed NIS 1,402,854 in legal fees.   He rejected charges that were costs were punitive and, in the circumstances, he didn’t consider the costs awarded were unreasonable. He awarded a further NIS 35000 to the defendants for having to fight this additional appeal.

Appeal to Supreme Court 6837/12 Merck vs. Unipharm and Teva. re Fosamax

Patents and the Global Health Crisis

April 29, 2013

Professor William Fisher tel aviv university

Professor William Fisher of Harvard Law School is giving the Sixth Annual Cegla Lecture on Legal Theory, entitled “Infection: The Health Crisis in the Developing World and What We Should Do About It“. The lecture will take place on Thursday, May 2, 2013 between 6 PM and 8 PM (18:00 and 20:00 for those that prefer the 24 hour convention).

The event will take pace in Tel Aviv University, the Buchmann Faculty of Law, Trubowitz Building, Somia Kossoy Conference Room, Room 207 on the third floor.


Professor Michael Birnhack who is chairing the event refers to Professor William Fisher as Terry Fisher. He also claims that the lecture will deal with patents and the global health crisis.  The title and identity of the speaker therefore seem to be somewhat misleading!

That said, I have no doubt that Professors at Harvard Law School who get flown in to give an annual lecture are well worth listening to. I therefore hope that my readers on both sides of the patented medicine – generic debate (which, form feedback I receive seems to include many of the industrialists, patent attorneys and litigators) will come along to listen – and will behave themselves, i.e. polite heckling only, no rotten fruit.



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