Judge Birss QC assures us that his decision in Merck Sharp Dohme Corp & Anor v Teva Pharma
BV & Anor  EWHC 627 (Pat), relating to an application by Bristol-Myers Squibb for an
interim injunction pending trial, raises no issue of principle, but he does provide an enlightening
discussion of how to address some issues of fact that are common in an application for a quia
timet injunction, including a review of the European case law. (Merpel wonders if this amounts
to an issue of principle after all.)
On the question of the inferences that might be drawn from the marketing authorisation, Judge Birss accepted that merely obtaining a marketing authorisation is not an infringement. He also accepted that obtaining such an authorisation prior to the expiry of the patent would not in itself give rise to an inference of an intent to infringe. For example, it would be natural for a generic to obtain marketing authorisation prior to the expiry of the patent in order to put itself in a position to launch immediately on expiry. But in this case “[t]he key is the length of time between the marketing authorisation and expiry and the absence of any specific factor about this market which might explain it” . Obtaining marketing authorisation almost two years before the expiry of any rights anywhere in Europe supports a natural inference that Teva intended to infringe.
Moreover, even though the evidence showed that Teva held many unused marketing authorisations, this does not mean that the authorisation is irrelevant to Teva’s intent; it means only that it is not determinative. Judge Birss also noted that Teva’s evidence was only that it held hundreds of marketing authorisations that were not currently in use; “[t]hat does not mean that Teva has ever acquired a marketing authorisation with no intention of using it” . This cautious appreciation of Teva’s evidence was no doubt related to its prior conduct in the atorvastatin episode: “In my judgment atorvastatin does not lead to an inference that Teva has a policy of always launching at risk of infringement in the face of a compound patent. However it does show that Teva are prepared to do it if they choose to and it does place into context any prior assurances they may have given” .
On the third point, Teva argued that they were entitled to remain silent about their intentions “because to answer it involves divulging a valuable commercial secret which will harm Teva” . Judge Birss indicated that Teva was in a squeeze, because if Teva intended to launch prior to expiry, the application was well founded , and on the other hand it would not be news to anyone that they intended to launch after expiry . This comes close to the argument rejected by Harman LJ in K.S. Paul v Southern  RPC 118 at 122:
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Finally, Judge Birss considered a number of Euorpean cases in which a preliminary injunction had been refused in similar situations. However, he noted, persuasively, in this Kat’s view, that those decisions were generally distinguishable on their facts. This led to the dictum that “there is no issue of principle. The cases do no more than show that courts throughout Europe require evidence on which to base an assessment of a threat to infringe. At the end of the day each case turns on its particular facts” .
It is an interesting question as to whether the early authorisation and silence as to its intentions alone would have been sufficient to justify the grant of an interim injunction. Judge Birss referred several times to the atorvastatin episode, and while that was clearly not determinative in itself, it did affect the inferences he was willing to draw from the evidence on both sides. The law of defamation recognizes that a reputation is an important commodity; that is true of a poor reputation, as well as a good one.