Key takeaways 

• The scope of the Bolar exemption will be clearer.
• Defendants in infringement suits will be entitled to submit revocation counterclaims. This will shorten and simplify infringement suits in which the validity of the patent is also challenged. However, defendants will still be entitled to begin revocation procedures separately from these suits.
• When assessing a request for a preliminary injunction ("PI"), the court must consider the evidence submitted in the revocation counterclaim.
• Defendants will obtain stronger rights in respect of PIs. Under certain circumstances, at the defendant's request, the court must repeal the PI or order the plaintiff to compensate the defendant for damages caused by the PI. 

In more detail 

Clarification of the Bolar exemption's scope

• Currently, the Patent Act treats the Bolar exemption as a subclass of the experimental use exemption.
• Pursuant to the amendment, the Patent Act will clearly distinguish between:
  • experimental use, i.e., activities with an experimental purpose relative to the subject of the invention; and
  • the Bolar exemption, i.e., experiments, examinations and ancillary activities required to obtain the marketing authorization required to market a medicinal product.
• The amended Bolar exemption will apply only to "medicinal products". The amendment also clarifies that the exemption applies regardless of whether (i) the applicant or a person having an economic relationship with the applicant conducts the activities to which the Bolar exemption applies and (ii) the product is placed on the market in the European Economic Area or outside of it.

Faster and simpler infringement suits

• Under the Patent Act, the Metropolitan Court has jurisdiction over patent infringement suits while the Hungarian Intellectual Property Office ("HIPO") has jurisdiction over revocation procedures. This means that if the defendant challenges the patent's validity in an infringement suit, the Metropolitan Court must stay the proceeding and wait for the final and binding decision regarding patent validity in the revocation procedure commenced before the HIPO. This solution, also known as "bifurcation", has been criticized as being slow (generally needing 17 months to obtain HIPO’s decision), inefficient and unnecessarily complicated.
• Under the amendment, defendants in infringement suits will be entitled to submit a "revocation counterclaim" if:
  • the defendant argues that one of the grounds for revocation under the Patent Act or the European Patent Convention applies to the patent; and
  • the HIPO does not conduct a revocation procedure and has not adopted a final and binding decision regarding the same patent based on the same facts.
• Submitting a revocation counterclaim will shorten and simplify the infringement suit because the Metropolitan Court will deal with it as a matter of urgency.
• Defendants must note that, after the submission of a counterclaim, neither party will be entitled to engage private experts.
• The amendment does not repeal the bifurcation system. Thus, if the defendant has initiated a HIPO revocation procedure before the infringement suit, the Metropolitan Court must still stay the suit and wait for the final and binding decision regarding patent validity in the revocation procedure commenced before the HIPO. As an exception, if the defendant submits an opposition against a European patent in force in Hungary, the court will be entitled in particularly justified cases to stay the suit but will not be obliged to do so.

Significant changes affecting PIs

• When assessing a request for a PI, the Metropolitan Court must consider the evidence submitted by the defendant in the revocation counterclaim.
• At the defendant's request, the Metropolitan Court must repeal the PI ordered during or before the infringement suit if:
  • the patent has lapsed;
  • the European patent in force in Hungary has been revoked; or
  • the HIPO or the Metropolitan Court has revoked the patent or the part thereof on which the infringement is based.
• At the defendant's request, if the Metropolitan Court establishes that the request for a PI is unfounded, it must order the plaintiff to compensate the defendant for all damages caused by the PI. The request for a PI is unfounded, in particular, if:
  • the patent or the European patent in force in Hungary has been revoked;
  • the PI loses its effect by the plaintiff's act or omission; or
  • the court establishes that there was no infringement and, based on the evidence available to it, no imminent threat thereof either.