The best way to pave the way for generic market entry

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A recent interlocutory decision[1] Justice Beach discussed the various ways to expedite litigation through the use of motions to strike, summary dismissal and expedited trials.

The decision also provides important insights into the Court’s approach to the increasingly powerful field of the best method as a means of attacking patents and some ideas for pharmaceuticals on “paving the way for it.” ‘entry into the generic pharmaceutical products market’.

The dispute

Celgene Corporation (Celgene) is the proprietor of extended Australian patent 715779 (‘779) and several related processing method patents.

In order to pave the way for the future launch of their generic pharmaceuticals, Juno Pharmaceuticals Pty Ltd and Natco Pharma Limited (Juno) have filed a revocation action against the relevant “compound” claims of the ‘779 patent on the grounds of non-disclosure. of the best method, absence of inventive step and false suggestion. Celgene has filed a counterclaim for infringement.

The move follows a number of interlocutory requests filed by the parties, including a request by Celgene to summarily dismiss Juno’s nullity attack regarding the alleged failure to disclose the best method and a false suggestion. Although Celgene failed, the ruling provides useful information on how the courts will assess an attack based on the best method and the court’s willingness to expedite the process.

The patent

‘Compound’ claims of ‘779 relate to a Markush formula, and one of the 18,000 compounds within their scope is pharmaceutical’ lenalidomide ‘. This patent also contains claims to methods of reducing unwanted levels of tumor necrosis factor-α (TNFα). TNFα is a cell signaling protein involved in mediating many physiological conditions.

The ‘779 patent has been successfully extended for the maximum term of five years open to users of the Australian patent system who have encountered a delay in obtaining regulatory approval.

In Australia, only claims relating to the pharmaceuticals themselves can have their duration extended – the extension scheme does not apply to most methods relating to the use (s) of pharmaceutical compounds.[2] A corollary of this is that during the extended term, a patentee’s rights reside in the pharmaceutical compound claims, and therefore Juno’s invalidity action was limited to those claims of the ‘779 patent.[3]

Regulatory barriers

In order to expedite regulatory approval based on an innovator’s clinical trial data, a generic must show that its competing product is “bioequivalent” and declare that its product does not infringe any existing patents. It is the driving force behind generics which seek to pave the way for launch.

On the other hand, the motivation of an innovator to avoid the entry of generics is explained by the fact that the first generic registration of a given drug triggers a price drop by the PBS and of course, a loss of market shares.

Leading the way through patent revocation – Australia’s ‘best method’ for invalidation?

A specification in Australia must “… disclose it best method known to the applicant to have executed the invention.[4]”

Although this is a long-standing requirement under Australian patent law, an invalidity attack for non-disclosure of the best method has gained momentum in recent times, especially among generic and biosimilar companies because of its potential to invalidate entire patents.[5]

The characterization of the “invention” is the key

In order to determine whether a specification discloses the best method, one must necessarily determine what the “invention” is, a process which goes beyond mere examination of the claims.

In this case, the interpretations of the parties’ competing claims and how those interpretations related to the characterization of the “limits and content of the invention” were essential.[6]

Juno claimed that the invention could be characterized as non-polypeptide compounds which, when administered, decrease the levels of TNFα[7], so that the best method requirement could only be met by a disclosure of compounds known to “most effectively” reduce TNFα levels.

Celgene asserted that the invention resided in a newly discovered class of non-polypeptide compounds, one of which is lenalidomide, and that the “best method” is satisfied by the specification and the knowledge of those skilled in the art on how to do this. make it.[8]

Obviously, establishing the best method of making a pharmaceutical product that bears more than a fleeting resemblance to the infamous drug thalidomide, mass-produced since the 1950s, is a less daunting task than having to show which compound was known to the patentee to be the most active.[9] There is some tension in Celgene’s position in that, although no feature of the compound’s claims relates to TNFα activity, the “promise” statements in the ‘799 patent suggest that it is. the ultimate goal of the invention.[10]

At least at this point, Celgene’s position appears to be the strongest – His Honor stating that it was strongly defensible that the claims were aimed at “simpliciter compounds,” and agreeing that no whole number of the claims concerned the reduction in levels. of TNFα.

Although Juno’s position may be based on a problematic construction of the invention[11], the ruling is another reminder that the best method requirement is particularly onerous in Australia. It requires special attention when asserting and defending rights and can be burdensome for patent owners and lead to onerous discovery obligations.

Accelerated result

Notably, although Juno failed in its own request to strike parts of the counterfeit counterclaim, it was successful in seeking an expedited trial of the invalidity challenge to clear the way for its launch if it is ultimately successful. . The trial is due in August of this year, and His Honor will deliver judgment in a month. The decision provides a good indication that the court is increasingly willing to speed up proceedings initiated by generic pharmaceuticals to “lead the way.”

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