BIOGARAN is a French pharmaceutical company specializing in generic drugs.

DAIICHI is a Japanese company engaged in pharmaceutical research and development company, as well as manufacturing molecules and drugs.

DAIICHI held a patent No. FR 2483 912, filed on June 5, 1981, for a cholesterol-lowering drug whose active ingredient is pravastatin (hereinafter the Patent).

On May 19,1992, through its patent and trademark firm Lavoix, DAIICHI filed an application for a supplementary protection certificate to extend the rights conferred by the patent, under No. 92C0224.

The SPC was granted on August 26, 1992 and was due to expire on August 10, 2006, according to the provisions of article L.611-2, 3° of the French Intellectual Property Code.

DAIICHI, through its new patent and trademark firm, the Weinstein firm, timely paid the six renewal fees required to maintain the validity of the SPC between May 2001 and June 2006.

The French National Institute of Industrial Property (hereinafter INPI) received full payment of these renewal fees and issued receipts confirming these payments to the Weinstein firm.

However, due to a computer malfunction, the Director of the INPI issued a decision on January 26, 2005 against DAIICHI, stating the lapse of its rights to SCP No. 92C0224 due to the lack of payment of the fourth renewal fee.

This decision was notified to the Lavoix firm by registered letter with acknowledgement of receipt received on January 27, 2005 and was published in the Official Bulletin of Industrial Property (hereinafter BOPI) on March 25, 2005.

The revocation decision was entered in the National Register of Patents in June 2006.

On June 28, 2006, DAIICHI filed a gracious appeal with the Director General of the INPI requesting to cancel the revocation decision of the SCP dated January 26, 2005, arguing that it was unfounded.

On July 3, 2006, the Director General of the INPI rejected DAIICHI’s request.

DAIICHI appealed this decision and the Teva company intervened in the appeal proceedings.

Considering the decision declaring the lapse of DAIICHI’s rights to the SPC, BIOGARAN began marketing a generic pravastatin drug in July 2006.

In a decision dated March 14, 2007, the Paris Court of Appeal rescinded:

the decision issued by the Director General of the INPI of July 3, 2006 rejecting DAIICHI’s gracious appeal,
the decision declaring the lapse of the SPC of January 26, 2005.

The Director General of the INPI and the Teva company appealed this decision to the French Supreme Court.

The French Supreme Court dismissed the appeals filed by the INPI and the Teva company on July 1, 2008.

On July 7, 2008, DAIICHI registered this decision of the French Supreme Court, confirming the retroactive invalidity of the revocation decision of the Director General of the INPI concerning the SPC.

Following this decision on April 14, 2009 DAIICHI summoned BIOGARAN before the Paris Court of First Instance, claiming infringement of its SPC No. 92C0224 and, in the alternative, unfair competition.

In this action, DAIICHI criticized BIOGARAN for having marketed its generic pravastatin, following the INPI decisions of January 26, 2005 and July 3, 2006, before the SPC fell within the public domain, i.e. before August 10, 2006.

Concurrently, BIOGARAN summoned DAIICHI before the Paris Court of Appeal on February 11, 2011, forming third-party opposition against the decision of March 14, 2007, which had rescinded the two decisions taken by the INPI on January 26, 2005 and July 3, 2006.

In its decision of February 29, 2012, the Paris Court of Appeal, ruling on the third-party opposition appeal of BIOGARAN and other generic manufacturers, declared the third-party opposition filed by BIOGARAN admissible, but dismissed its request to set aside the decision of March 14, 2007.

BIOGARAN therefore appealed to the French Supreme Court.

In a decision issued on June 25, 2013, the French Supreme Court quashed all the provisions of the Court of Appeal’s ruling of February 29, 2012.

In a decision dated October 27, 2017, the referring Court of Appeal retracted a ground of the judgment issued on March 14, 2007 by the Paris Court of Appeal.

The parties appealed this judgment and by decision of December 4, 2019, the French Supreme Court partially set aside the judgment of October 27, 2017, notably in that it retracted not the formal judgement but a ground of the judgment of March 14, 2007.

Following this judgment, BIOGARAN seized the referring Court of Appeal.

In three rulings rendered on May 21, 2021, the Paris Court of Appeal:

reversed the formal judgement of the Paris Court of Appeal of March 14, 2007
dismissed the appeal filed by DAIICHI against the decisions of the Director General of the INPI dated January 26, 2005 and July 3, 2006,
dismissed the subsidiary claim of DAIICHI that it be held that only [the companies BIOGARAN, Arrow Génériques and Mylan], as third party opponents, benefit from the effects of the retraction of the judgment of the Paris Court of Appeal of March 14, 2007,
dismissed all other claims of the Parties contrary to the grounds [...].

DAIICHI appealed this ruling, notably reproaching the Court of Appeal for holding that the notification made to the first representative, the Lavoix firm, was valid and thus started the appeal periods, even though the annuities had been paid by a second representative, the Weinstein firm.

According to DAIICHI, the notification of forfeiture should have been made to this second representative.

By judgement of September 6, 2023, the French Supreme Court dismissed DAIICHI’s appeal considering that the Court of Appeal had established:

that in accordance with the applicable regulations, DAIICCHI was bound to appoint a representative domiciled, based, or established in France;
that DAIICHI had appointed the Lavoix firm as its representative through a power of attorney, containing no express contrary stipulation, according to which it would not have been extended to the receipt of notifications from the INPI;
that on the day of payment of the 4th annuity, DAIICHI was still bound to appoint a representative located in France, regardless of the exemption, for French patent and trademark attorneys to provide evidence of authorization;
that the mere payment of annuities by another patent and trademark firm does not constitute the appointment of a new representative;
that, in this case, no information had been provided to the INPI regarding a change in the representative appointed, noting that the receipts for fees, issued until May 2005, did not mention the Weinstein firm’s status as representative.

The French Supreme Court therefore concludes that the Court of Appeal correctly deduced that since no appointment of a new representative has been made, the Lavoix firm remained the only appointed representative in France on the day of the notification of the decision of forfeiture on behalf of DAIICHI.