Legal basis

Section 71 of the Patents Act 1977 allows a court or Comptroller of Patents at the UKIPO (the Comptroller) to grant a declaration that an act or a proposed act does not or will not infringe a patent, provided that the person doing or proposing to do the act has applied in writing to the proprietor for a written acknowledgement for a declaration of non-infringement, furnishing full particulars in writing of such act or proposed act, and the proprietor had refused to give such acknowledgment.  In proceedings in which a declaration in relation to a patent is sought under section 71, challenges to the validity of the patent can also be brought under section 74 of the same act. 

Mylan’s strategy

Generics (UK) Limited (trading as Mylan) found itself in the position of having to "clear obstacles" in the way of the launching of its own generic glatiramer acetate in the United Kingdom and applied for a declaration of non-infringement and revocation of Yeda Research & Development Company Ltd’s patent EP (UK) 07862888, of which Teva Pharmaceutical Industries Limited (Teva) is the exclusive licensee.  The patent relates to a glatiramer acetate product for the treatment of relapsing-remitting multiple sclerosis (RRMS), marketed by Teva under the trade mark, Copaxone.  The claims relate to “copolymer 1” (a polymer composed of units of alanine, glutamic acid, lysine and tyrosine in particular ratios) having a specified molecular weight range and its use for RRMS.

Although Mylan knew that the issue of infringement was likely to arise, if it wanted to avoid the risk of injunction in the future, it had to apply for a declaration of non-infringement and revocation of the patent.  One other alternative available would have been for it to invite the proprietor to take action for infringement, which would have had many difficulties as the proprietor may have not taken this course, or delayed such action for infringement, or claimed that it did not have sufficient information so that it would still be entitled to an injunction when the generic glatiramer acetate was finally launched by Mylan. 

Court’s ruling

Though a large number of issues were raised, one interesting point of law related to the obviousness of the patent for lack of technical contribution and the admissibility of post-dated evidence.  The question being whether a patent, that disclosed what everyone thought was a patentable invention at the time, could be revoked years later because subsequent advances in science had revealed that the invention was obvious.  On 11 July 2012, after 13 days’ trial and a rather long judgment, Arnold J ruled (Generics (t/a Mylan) v Yeda and Teva [2012] EWHC 1848 (Pat))that the patent is valid and Mylan’s proposed generic product and process description were held to infringe.  Arnold J considered this concept of relying on post-dated evidence “bizarre” and said it was not open to an opponent to rely upon post-dated evidence in order to cast doubt on a granted patent that makes the invention plausible, so as to place an evidential burden on the patentee to demonstrate affirmatively that the invention is (still) patentable.  

Another important contention related to the wording of the claim that co-polymer 1 has “a molar ratio of approximately 6:2:5:1” and whether the patent fails to provide any criterion by which to determine what is covered by the term “approximately”, thus making the patent ambiguous.  

The outcome of this case could nevertheless be insignificant.  As branded Copaxone is a complex molecule with a poorly understood mechanism of action and no validated biomarkers for its efficacy, there are serious questions about the ability to prove that a generic product would be bioequivalent to it.  Given the inability to establish acceptable "sameness" of the active ingredients in Copaxone, Teva has repeatedly advised the regulatory authorities of the difficulties associated with approving any applications for an alleged generic version of Copaxone.  Consequently, the regulatory authorities may require a fairly extensive clinical trials program for any generic version of Copaxone, the patent for which expires in 2014 and by which time any debate regarding Copaxone’s patentability would be meaningless.

Barring on Mylan’s patent expert and the principles in Bolkiah

As part of the above patent invalidity proceedings, Mylan also sought an order from the High Court that its director of intellectual property (IP) should be allowed access to Teva’s disclosure documents subject to providing confidentiality undertakings.  Teva then sought an injunction preventing Mylan’s IP director from taking part in the case, on the basis that she had formerly been employed as an in-house patent attorney at Teva.  Teva contended that, although she had not been directly involved with the Copaxone litigation whilst at Teva, Mylan’s IP director had been privy to confidential information about patent litigation involving Copaxone and that she should be barred from sharing any of that knowledge with Mylan's solicitors for use in its rival patent case with Yeda.  

Although Mylan's IP director insisted that she had "no recollection" of being handed any confidential information about Copaxone, the High Court granted the injunction banning Mylan from seeking her advice during this legal dispute with Teva.  

Mylan appealed the decision and on 31 May 2012, the Court of Appeal unanimously set aside the injunction prohibiting the IP director from offering advice to her current employer (Generics (UK) Ltd v Yeda Research & Development Company Ltd and another [2012] EWCA Civ 726)

The Court considered whether or not the principles in Bolkiah v KPMG [1999] 2 AC 222 (which relate to confidential information held by external advisers) applied with equal force to a former in-house employed litigator (in this case, the patent attorney) and if so, whether the burden of proof should lie with the previous employer or with the employee to show if there was a “real risk” of confidential information being disclosed. 

The real question here (and which is likely to arise in the future) is whether an in-house lawyer is to be treated as an employee or as an independent solicitor when seeking employment with competitors of its previous employer.  An in-house lawyer has a sole employer and is closely bound by the contractual relationship with that employer, who is in an inherent position of power when drawing up contracts of employment and has the option of imposing restrictive covenants both on the employee and in-house legal staff alike.  Further, shades of grey appear when an in-house lawyer moves from one employer to another to act directly on a competitor’s opposing side of a case, although not directly related to the in-house lawyer’s previous position. 

Opinion was divided, with the majority of the Court inclined not to extend the Bolkiah principle to this particular case.  Remarkably, Jacob LJ held that the principle in Bolkiah can apply equally to a litigator in private practice and an in-house litigator – stating that Mylan’s IP director had the "burden" of disproving that she would not misuse the confidential information to which she was supposedly privy. Etherton LJ’s and Ward LJ’s view was, however, that the burden was on Teva to show that there was a "real risk" that its former employee would act against its interests with the benefit of confidential information, as in a normal employment relationship.  In any case, further consideration did not follow as the Court unanimously agreed that Teva had failed to show that there was such “real risk” because if Teva had been deeply concerned about its secrets being disclosed, it would not have taken eight months to apply for an injunction. 

The type of order in Bolkiah is being considered increasingly by the UK courts.  It has been held to protect a "quasi-solicitor/client relationship" and there is confusion as to whether this kind of order should be restricted to "solicitors and the like" and not be imposed on former employees other than in the most exceptional circumstances.  Should Jacob LJ’s opinion be followed, it could have rather important ramifications for the legal profession as a whole.