Raltegravir (BGH, X ZB 2/17, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Federal Court of Justice (BGH) dismissed the patentee’s appeal against the decision of the Federal Patent Court (BPatG) provisionally permitting, in compulsory licence proceedings, the continued distribution of the HIV medicine Isentress, containing raltegravir (Rn. 7 and operative part). It held that the applicants had made sufficient efforts to obtain a licence on reasonable commercial terms, although their offers fell far short of the patentee’s expectations, since the validity of the patent was uncertain (Rn. 21 to 23). The public interest was established by the risks that stopping distribution would pose to several patient groups, including infants, pregnant women and patients forced to switch therapy (Rn. 40 to 71). The decision clarifies, for the pharmaceutical industry, the conditions for provisional permission under Sections 24 and 85 of the Patent Act (PatG).

Facts and procedure

The parties are not named in the published text. The applicants have distributed Isentress in Germany since 2008 (Rn. 1). The respondent owns European patent EP 1 422 218, maintained in amended form by the EPO after opposition, with an appeal pending (Rn. 2). Following a letter of 3 June 2014 asserting a Japanese patent of the same family, talks on a worldwide licence failed (Rn. 3). The patentee sued for infringement before the Düsseldorf Regional Court on 17 August 2015; the action was stayed pending the EPO appeal (Rn. 4). The applicants brought a compulsory licence action from 5 January 2016 and on 7 June 2016 applied for provisional permission to use the invention (Rn. 5 and 6). On 31 August 2016 the BPatG (3 LiQ 1/16 (EP)) rejected the main request and, on the auxiliary request, permitted distribution of Isentress in the four forms already marketed for the treatment of HIV and AIDS patients (Rn. 7).

The applicable law

Section 24(1) PatG requires unsuccessful efforts, over a reasonable period, to obtain the patentee’s consent on reasonable commercial terms, and a public interest (Rn. 18 and 38). Since 1 November 1998 a mere declaration of willingness is no longer sufficient (Rn. 17 to 19). Under Interferon-gamma, the public interest cannot be defined in general terms: it requires special circumstances, for instance a medicine which treats a serious disease better or avoids side effects, and is generally lacking where equivalent alternatives exist (Rn. 38 and 39). Section 85(1) PatG allows provisional permission where it is urgently required in the public interest; this special rule is exhaustive and excludes cumulative application of Sections 935 and 940 ZPO (Rn. 87 to 91).

Question

Were the conditions for provisional permission under a compulsory licence, namely licensing efforts, public interest and urgency, met for raltegravir?

Decision

The lump sum offers, although far below the patentee’s expectations, were not a sham, since the validity of the patent could not be assessed with sufficient certainty (Rn. 21). As the patentee’s own offer required the oppositions to be withdrawn, the applicants could factor their chances of having the patent revoked or annulled into their price, without giving up their challenge; the English High Court decision showed that their position was not hopeless (Rn. 22 and 23). The public interest was made out for several groups: raltegravir is the only integrase inhibitor authorised in Germany for infants from four weeks (Rn. 41), it is the preferred therapy in pregnancy (Rn. 52 and 53) and the only one recommended in Germany for combination post-exposure prophylaxis (Rn. 58); for patients forced to switch therapy, the risk cannot be regarded as negligible (Rn. 65 to 67). The alternatives carry risks (Rn. 73 and 74), and the patentee’s loss, being purely financial, is compensated by reasonable remuneration (Rn. 75 and 82). The BGH refused to confine the permission to particular groups, as patients cannot be sorted by abstract criteria (Rn. 77 and 78). Urgency is assessed by reference to the public interest, so that the applicants’ own delay carries much less weight (Rn. 87). The appeal was dismissed with costs against the respondent (operative part).

Key points for practice

• Modest licence offers may suffice where the patent’s validity is uncertain; the applicant need not abandon its challenge to move towards the patentee’s terms (Rn. 21 to 23).
• The public interest is assessed patient group by patient group, in light of the risks of therapeutic alternatives (Rn. 39 to 74).
• At the provisional stage, urgency is measured against the public interest rather than the applicant’s interests (Rn. 87 and 90).
• Practical point: an applicant for a compulsory licence must document negotiating efforts over an appropriate period before suing; a last minute declaration of willingness is not enough (Rn. 19).

Provisions applied

National law

Sections 24, 85, 99, 121 and 122 PatG; Sections 97, 935 and 940 ZPO

Case law cited

BGH, Interferon-gamma (X ZR 26/92); High Court (Patents Court), [2016] EWHC 2889 (Pat)

Prepared by Dhenne Avocats from the text of the decision (WIPO Lex, German text), consulted on 11 October 2026. Only the official text is authoritative.