Sanders (Sandoz) , Studd (Stada) And Teva (Teva) The company will not be able to sell the antithrombotic drug Apixaban in the Netherlands (apixaban) generic. The Court of Appeal in The Hague has ruled on the matter. After all, Even if it wasn't that long ago5month, Bristol-myers Squibb (Bristol-Myers Squibb) Still no gain against this3A preliminary injunction from a generic drug maker.

The blood thinner Altol (Eliquis) It is one of Bristol-Myers Squibb's most important best-selling products. 2Since these years, The controversy over whether generic drugs containing the active ingredient of Apixaban can enter the European market has never ceased.

In Holland, For the first time, the pharmaceutical company successfully transformed Sandoz, Copyrighted products sold by Studd and Teva were removed from the market. 8The middle of month, The Court of Appeal in The Hague ruled in a judgment, above3The generic drug manufacturer's products violated Bristol-Myers Squibb's foundationEP1427415Apixaban Supplemental protection certificate for patent No (SPC) .

Forced out of the market

As mentioned above, These companies will no longer be allowed to operate in the so-calledG-StandaardRegistered its generic Apixaban product. This amounts to a sales ban in the Netherlands, becauseG-StandaardIt is an online drug database, It lists all products dispensed or used in Dutch pharmacies.

If these generic drug manufacturers don't follow the rules, They are either going to face every day10A fine of 10, 000 euros, Either follow for each violationEP1427415No. Patent product payment1000Euro penalty standard to accept punishment. Sandoz and Teva have now stopped sales in the Netherlands. merely, It is unclear whether Mr. Studd is now doing the same.

Owned by Bristol-Myers SquibbEP1427415No. Patent and correspondingSPC (Valid until2026years) . The patent relates to the compound Apixaban. The company toEliquisMarketed as a trade name. By thinning the blood, This drug can be used to treat thromboembolic diseases, Especially after people have hip or knee surgery. It is reported, in2021years, One product alone, Apixaban, has created approximately70Billions of dollars in revenue. EP1427415Patent No. 1 was issued2022years9Month due.

Multiple attempts

Bristol-myers Squibb tried to force Sandoz out of the Dutch market last year. merely, 2022years5A ruling by the Hague District Court in October did not uphold the company's request for a preliminary injunction.

And at the European Patent Office (EPO) itG2/21 (rationality) After the decision of the case, Bristol-myers has filed a new request for a preliminary injunction against Sandoz. meanwhile, After Stard and Teva also entered the Dutch market, Bristol-myers Squibb has also requested a preliminary injunction against the two generic drug companies. merely, Those requests had not previously been upheld.

Because the judge of the Hague District Court at the time thoughtG2/21The outcome of the case does not change the scope of the concept of reasonableness, Therefore in2023years5A request for a preliminary injunction filed by Bristol-Myers Squibb was denied at the end of the month.

three-in-one

Bristol-myers Squibb has appealed the rulings. The Court of Appeal in The Hague decided to combine the three cases, And the verdict has now been delivered together. Preliminary decision of court, inEPOThe expansion of the Appeals boardG2/21After the verdict in the case, EP1427415There is a high probability that the patent will be found valid in a pending invalidation action, So the court approved the action3A preliminary injunction from a generic drug company.

this3The company can still appeal to the Dutch Supreme Court, In addition to "Procedural error" To present one's point of view. merely, The Dutch Supreme Court will not discuss it againEP1427415The validity and infringement of patent No. These companies are available in10A decision on whether to make the move has to be made by mid-October.

The ups and downs of Bristol-Myers Squibb

In this year's10month30day, The District Court in The Hague will hear the main case brought by Bristol-Myers against Sandoz. In response to the alleged infringement, Sandoz also filed a motion to dismiss the lawsuit. At the appointed time, If the district court finds the patent in question invalid, The decision of the Court of Appeal to grant a preliminary injunction would then be invalidated. however, If the district court judge rules in Bristol-Myers' favor on the infringement issue, Then Sandoz will be banned from the market, Up to correspondingSPCUp to date.

Bristol-myers has also filed an infringement lawsuit against Teva in the Netherlands, Teva has also filed a motion to dismiss the lawsuit. The court has temporarily suspended the proceedings, And probably will2024The case won't go to trial until next year.

recent, The original drug maker has also had some success in France. This year6month, The Paris Court of Justice rejected Teva's claimEP1427415No. Patent invalid request. But just a few weeks ago, The British Court of Appeal gave a very different answer, Confirm that Bristol-Myers Squibb's Apixaban patent is invalid.

At the same time, The Apixaban debate is also playing out in many other European countries, including Italy and Norway. (Be compiled fromwww. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Wang Dan



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