recent, The Regional Court in The Hague ruled that the German company Grantland (Grünenthal) Won against the Indian company Teva (Teva) Preliminary injunction on testosterone medication, And found that the former patent is valid and infringed. merely, German and British courts hearing the dispute ruled that the patents in question were invalid. The case is likely to continue in the coming months.

As mentioned above, In Holland, Grantland is known as Nebeto for its products (Nebido) A long-acting testosterone drug filed a request for preliminary relief against Teva, And it was successful. The active ingredient in this drug is testosterone undecanoate. Generally speaking, Doctors prescribe the drug primarily to treat chronic testosterone deficiency, or hypogonadism, in men. Patients need to be every10to14It's given once a week by intramuscular injection.

Granta buys Bayer (Bayer) Patent for

Summary from product features (SmPC) Come to see, Nebedo is packaged in ampoules or injection bottles, built-in4Milliliter solution. As an important part of marketing authorization, aboveSmPCThe specific characteristics and applications of Nebedol are described.

Nebedol was originally developed by Bayer. 2022Nian Yu, Grantland took over the production and distribution of the drug. Since the2023years2Since October, The Dutch Patent Office registered Granta, a German company, asEP1457208, The theme is "Methods and pharmaceutical compositions for reliably achieving acceptable serum testosterone levels" The owner of the patent. besides, Granta also holds marketing authorisation for Nebeto in the Netherlands. The above patent will be in2024years3Monthly expiration.

Beware of generic drug launches

2022years12month, Teva won the right to sell generic versions of Nebedol in the Netherlands. namely "Testosterone Teva (Teva testosterone) " Permission of. however, Grantland is a Teva based companySmPCVery similar to the reason, Allegations that Teva plans to launch generic drugs in the Netherlands have been violatedEP1457208Patent No. In response, Teva asked that the lawsuit be dismissed, And asked Granta to be responsible for paying the relevant litigation costs. meanwhile, The company also argues, Reference was made to parallel judgments in England and Germany, The Dutch courts will have it in future proceedings "Large and not negligible probability" To determineEP1457208Patent No. 1 is invalid.

however, The Dutch court ultimately sided with the plaintiffs, Ruled that Teva infringed the patents in question, And dismissed Teva's lack of creativity in the patent, Reasonableness and an invalid plea for reasons not sufficiently disclosed. In addition, Teva also argued, In preliminary injunction proceedings, The court cannot request an injunction based on limited rights. however, Granta has completed the registration of these claims in the Netherlands Patent Registry, Therefore, Teva's defense was not accepted by the court. For the above judgment, Teva plans to continue to appeal.

In this2023years9month13In the interim procedure initiated on the day, The interim relief judge also ordered Teva to remove its products from2023years10Monthly online drug databaseG-Standaardcensoring. Of course, In order to maintain the validity of this summary judgment procedure, The plaintiff must6File a substantive lawsuit within months. however, By that time, The patents involved will face the risk of expiration.

The patents in question have been invalidated elsewhere

It should be pointed out that, This is not the only recent ruling by national courts in disputes between two companies. 2023years2month, The Federal Patent Court in Munich, GermanyEP1457208Patent No. 1 is invalid in Germany, And denied several of Granta's requests for relief. The court held that, Based onVon EckardsteinPrior art, The patents in question lack creativity.

2023years7month, The first instance judgment of the British High Court also statedEP1457208Patent No. 1 should be considered invalid for lack of reasonableness, It also confirms the non-obviousness of the patent.

merely, The dispute between Granta and Teva has not been formally heard in Dutch courts, So from a case law point of view, In future, the court may also look to Germany and Britain for examples.

One of the arguments put forward by the defendant is that, Since there is already2The courts all ruled that Grantland's patent was invalid, The Dutch court should therefore dismiss the infringement suit.

however, The Dutch court retorted, This view is irrelevant, This is because patent claims registered in the Netherlands have a narrower scope of protection than those that appear in German and British lawsuits. In addition, The judge also held that, The issues discussed in the Netherlands are different from those in other jurisdictions, moreover, The court also considered the European Patent Office (EPO) Recently inG2/21The conclusions given in the case.

G2/21Legal case

With the appeals court recently over Bristol-Myers (Bristol-Myers Squibb) With generic drug company Sandoz (Sandoz) , Studd (Stada) Similar to the ruling in the Teva dispute, The District Court in The Hague also made referenceEPORecently inG2/21Made in the case "It is specious" The decision of. In this case, the antithrombotic drug Apixaban was involved (apixaban) In the case file, The Court of Appeal in The Hague issued a preliminary ruling, Right whenEPOThe appeal board decidedG2/21After the conclusion of the case, Number asEP1427415The likelihood of the patent in question being found valid in the pending proceedings is very high. therefore, The Court of Appeal granted the appeal against3A preliminary injunction from a generic drug company.

same, In the case of Granta v. Teva, Presiding Judge Margot．Cork (Margot Kokke) Also indicate: "In useG2/21Test results to assess the creativity of claims that do not feature technical effects, The patent owner is not required to provide evidence, Or in a simplified procedure to give confidence that the technical effect is effective at least in most of the compositions for which protection is requested. "

At present, Grantler has appealed the German verdict. merely, The latest developments in the case in Britain are unclear. (Be compiled fromwww. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Wang Dan



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