A few days ago, A senior adviser to the European Court of Justice has ruled against Astrazeneca for blocking the antacid drug Losec (Omeprazole) An opinion on the entry of generic drugs into the market, Said Astrazeneca should be punished. In view of this, Drugmakers may well need to reassess their intellectual property rights in the European market in the future. The Astrazeneca case will prompt the commission to investigate further, Pay more attention to anti-monopoly issues.

Inadvertent misnomer Although the case has yet to reach a final conclusion, But the general Counsel of the European Court of Justice JanMazak Rejected all of Astrazeneca's claims, Subject to court approval, It could be a case against Astrazeneca 5250 Ten thousand euros (about 6600 Ten thousand dollars) fine, And drug manufacturers must take concrete action to ensure they are not misdirecting their patents, Even if it was unintentionally misleading.

Mazak The statement will encourage companies to restructure to ensure some integration between their regulatory and legal departments. This is also to ensure that when applying for intellectual property protection, Companies' representatives at the EU Patent Office must be fully informed of the regulatory status of medicines, Especially when it first gained EU listing status. But the biggest problem for drug companies may be this, If the manufacturer is dominant in the market, Now, even if you inadvertently misrepresent what you own IP Rights can also be punished.

Pinsent Masons International (PinsentMasons) A partner in a law firm NatashaPearman explain: "The essence of exclusivity is to exclude other products from entering the market. " For the original drug manufacturers, It may face even greater constraints in the future, The case echoes the European Commission's inquiry into the pharmaceutical industry, The commission is also preparing to uncover potential abuse of competition among these companies. The ongoing investigation and ongoing cases involve Lundbeck, ServierSA, Johnson & Johnson and Novartis and their Dutch subsidiaries Janssen and Sandoz. The starting and ending date of management rights is controversial The Astrazeneca case is a long one, What's involved are proton pump inhibitors (PPI) Losek.

in 2 After a generic drugmaker filed a complaint against Astrazeneca, The Commission concluded: Astrazeneca misled Germany, Belgium, Denmark, Norway, Dutch and British patent offices, It was given incorrect information about when Losecor first gained listing status in the EU, Thus, the company obtained a supplementary protection certificate which should not have been granted, Or excessively extended the protection period of its intellectual property rights. The supplemental protection certificate extended the term of protection of Losecor's patent 5 For years (Under certain circumstances 5 Years and a half) .

The Commission also concluded, Astrazeneca withdrew its presence in Denmark, Norwegian and Swedish licenses, The omeprazole capsules were also withdrawn, Instead, a multi-unit pellet system was introduced to prevent generic drug makers from obtaining marketing approval in these countries through a brief approval mechanism.

The General Chamber of the European Court of Justice also supported the Commission's opinion, The court's senior advisers have now also rejected Astrazeneca's request to cancel the fine. Astrazeneca argues, The commission did not clearly define the market scope of the products in question, The firm did not abuse its dominant position in two ways.

Innovation is another obstacle?

European Federation of pharmaceutical Industries and Associations (EFPIA) The case was brought on behalf of Astrazeneca, For fear of a narrow definition of the market by the European Commission and the court (Only for PPI, And ignored the vast market for antacids) It is easy to identify companies as market leaders.

EFPIA representation: "This will have a significant negative impact on business practices that promote competition, Ultimately, it will affect innovation across the European market. " EFPIA I was very disappointed with the result, But it is still to be hoped that the opinion of the court's senior counsel will be solely on this case, Without having a broad impact.

Although the opinions of the court's senior counsel do not carry the force of law, But courts usually follow its advice, Moreover, all of Astrazeneca's claims were rejected with sufficient justification, So it looks like the court will uphold the original decision, Astrazeneca will face fines. In addition, EFPIA Hope is based only on AG Public statement, Not the conclusion of the final judgment.

(author: FarazKermani)

source: Zhinan needle