Hospira UK Ltd v Genentech Inc

Post-grant patent amendments must be assessed by comparing the properly construed scope of the granted and proposed claims. The prohibition on extending protection is absolute, although the hypothetical infringing product need not be commercially realistic.

A product-by-process claim is construed according to its language for infringement and sufficiency. A product made by a different process cannot be novel merely because its manufacturing process is new; the process must confer a novel attribute. The EPO approach permits such claims only where no other definition of the relevant product characteristic is available.

Obviousness remains a fact-sensitive statutory question. Routine screening of common general knowledge excipients may make a formulation obvious, even where several ingredients are selected and the work is empirical.

Hospira sought to clear the way for generic trastuzumab following expiry of the relevant supplementary protection certificate. Genentech applied to amend EP (UK) 1 516 628 and EP (UK) 2 275 119, concerning stable lyophilised protein formulations containing trastuzumab and specified excipients.

The court considered whether the proposed claims extended the scope of protection, were impermissible product-by-process claims, lacked clarity or added matter, and whether they were obvious over common general knowledge, Carter, or Draber. Hospira also alleged insufficiency in relation to the claims of the 119 patent.

1. Amendments and scope. The proposed amendments, using “comprising”, extended the protection conferred by the granted claims because formulations containing additional antibodies or lyoprotectants could fall within the amended claims but outside the granted claims. Replacing “comprising” with “consisting of” cured that defect. The relevant statutory test under Patents Act 1977, s 76(3)(b), and Art 123(3) EPC is a comparison of the properly construed scopes of the granted and amended claims.
2. Product-by-process claims. Applying Kirin-Amgen, a new process cannot confer novelty on an identical product. The process must confer a novel attribute. That is a rule of novelty law, not claim construction. A claim to a product “obtained by” a process nevertheless means what it says for infringement and sufficiency. Proposed claim 1 of 628 did not identify the characteristic defined by the “obtainable by” language. The skilled reader would be left to identify an indefinite class of characteristics. The amendment was therefore refused for lack of clarity under s 14 of the 1977 Act and Art 84 EPC. The same conclusion applied to claims 1 and 3 of 119.
3. Added matter. The claims taught stable formulations at any protein concentration while retaining the Table 5 molar ratio. That was new information not clearly or unambiguously derivable from the application. All proposed claims therefore added matter under s 76 of the 1977 Act and Art 123(2) EPC. The objections based on lyophilisation conditions, benzyl alcohol and the change to “consisting of” did not independently establish added matter.
4. Obviousness. The skilled team would be motivated by Carter to formulate trastuzumab for therapeutic use and would investigate lyophilisation because liquid formulations were liable to degrade. Histidine, polysorbate 20 and trehalose were common general knowledge candidates for routine screening. Concerns about trehalose toxicity and regulatory approval would not deter testing it. The claimed formulations resulted from routine screening and lacked inventive step under the structured and fact-sensitive approach in Pozzoli, informed by Conor and Generics v Lundbeck.
5. Disposition. The 119 patent was revoked. The 628 patent was amended by deleting claims 1 to 6, leaving claims 7 to 11 to be renumbered. Judgment was given for Hospira.