Handling Drug Patent Opposition Proceedings

Handling drug patent opposition proceedings is a crucial step in ensuring the quality and validity of granted patents in the pharmaceutical industry. Opposition procedures are closely related to the patent granting procedure and provide a mechanism for third parties to challenge the grant of a patent before or after it is granted.

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The Importance of Opposition Proceedings

Opposition proceedings are essential in maintaining the integrity of the patent system. They ensure that patents are granted only to genuine inventions that meet all the requirements under the applicable law. This not only benefits the patentees but also the public by providing a reliable and enforceable patent system.

Pre-Grant and Post-Grant Oppositions

There are two types of oppositions: pre-grant and post-grant. Pre-grant oppositions occur before the grant of a patent, typically within a certain period after the publication of the application. Post-grant oppositions occur after the grant of a patent, usually within nine months following the mention of grant in the European Patent Bulletin.

Grounds for Opposition

The grounds for opposition vary from country to country but typically include lack of novelty, inventive step, or industrial applicability, as well as non-compliance with the requirement of sufficient disclosure. In Europe, added subject-matter is a common ground for opposition, which is assessed very strictly.

Filing an Opposition

To file an opposition, a notice of opposition must be submitted within the specified time period, accompanied by the opposition fee. The notice must state the extent to which the patent is opposed, the grounds for opposition, and the supporting facts and evidence.

The Opposition Process

The opposition process involves several stages. The opponent files a notice of opposition, which is then examined by the patent office for admissibility. If admissible, the opponent must state the grounds for opposition and submit evidence. The patent proprietor is given the opportunity to reply to the raised grounds and make observations. The opposition division then makes a decision based on the submissions from both parties.

Acceleration of Opposition Proceedings

In cases where parallel court actions are pending, the EPO accelerates the opposition proceedings to ensure timely resolution. This is particularly important in the pharmaceutical industry where patent disputes can have significant commercial implications.

Costs and Benefits

The costs associated with opposition proceedings vary widely, ranging from £10,000 to £40,000 (approximately $12,000 to $50,000) depending on the complexity of the case. However, the benefits of opposition proceedings are significant, as they ensure the quality and validity of granted patents, which in turn protect the public interest and the interests of patentees.

Conclusion

Handling drug patent opposition proceedings is a critical step in maintaining the integrity of the patent system. By understanding the grounds for opposition, the opposition process, and the costs involved, pharmaceutical companies can effectively protect their patents and ensure the quality of granted patents.

“Opposition proceedings are essential in maintaining the integrity of the patent system. They ensure that patents are granted only to genuine inventions that meet all the requirements under the applicable law.” – WIPO