Gedeon Richter Plc v Bayer Pharma AG

In an added-matter inquiry, the court compares the disclosure of the application and patent through the eyes of the skilled addressee. Subject matter may be disclosed implicitly, but it must be clearly and unambiguously disclosed. Obviousness is not the test, and hindsight must be avoided. Claim scope is distinct from disclosure. Where an application teaches a result and gives particular methods by way of example, other known methods may fall within the disclosure. The obvious-to-try approach assists only where there is a fair expectation of success. A speculative possibility is insufficient. An appellate court should exercise caution before disturbing a trial judge’s evaluation of obviousness.

Gedeon Richter plc, a generic pharmaceutical company, appealed from the decision of Floyd J in the Patents Court, reported at [2011] EWHC 583 (Pat). The proceedings concerned Bayer’s patents for oral contraceptive formulations containing drospirenone and ethinylestradiol.

The judge held that certain claims of one patent were obvious but permitted amendment. He held that the surviving claims and the other patent were not obvious and that the patents as amended were not invalid for added matter. Richter appealed the findings of non-obviousness and the dismissal of the added-matter objections. The central issues were whether the parent application clearly and unambiguously disclosed the claimed rapid-dissolution formulations and whether the combination of the prior art made the inventions obvious.

The appeal was dismissed. The joint judgment of Kitchin LJ and Jacob LJ was agreed by Mummery LJ.

1. Added matter. The court applied the strict comparison approach identified in Bonzel v Intervention (No 3) [1991] RPC 553, Vector v Glatt Air Techniques [2007] EWCA Civ 805 and Napp Pharmaceutical Holdings v Ratiopharm [2009] EWCA Civ 252. The court must compare the disclosure of the application and patent through the eyes of the skilled addressee. The comparison includes express and implicit disclosure. Subject matter is added unless clearly and unambiguously disclosed in the application. The inquiry is not an obviousness test, and hindsight must be avoided. Disclosure of subject matter must also be distinguished from the scope of a claim.
2. The parent application taught that rapid dissolution promoted bioavailability. Micronisation and spraying drospirenone onto inert carrier particles were examples of ways to achieve that result, not exhaustive methods. The skilled person would understand that other known techniques could be used. The wording in the 301 and 069 patents therefore made explicit what was implicit in the parent application and added no subject matter. The appeal proceeded on the amended patents, including the amendment addressing the tablet-loading point.
3. Obviousness. The court applied the limitations on the obvious-to-try approach explained in Conor v Angiotech [2008] UKHL 49 and Generics (UK) Ltd v H Lundbeck A/S [2007] RPC 32. Obviousness depends on the facts and may involve motive, the number and extent of research avenues, the effort required and the expectation of success. The Krause papers were not shown likely to be read by the skilled team. Even if read, they suggested only that the drug might survive in the formulation. That was a speculative jump, not a fair expectation of success.
4. The court relied on the caution in Biogen v Medeva [1997] RPC 1 when reviewing the trial judge’s evaluation. The time taken to reach the invention and the absence of an accepted explanation for why rapid dissolution worked supported the conclusion of non-obviousness and reinforced the need to avoid hindsight. The challenges to non-obviousness therefore failed.

• Court of Appeal (Civil Division) — In [2012] EWCA Civ 235, the appeal was dismissed. The findings that the patents as amended were not invalid for added matter and that the surviving claims were not obvious were upheld.
• High Court of Justice, Chancery Division (Patents Court) — Floyd J decided the action in [2011] EWHC 583 (Pat). Claims 1 and 19 of patent 069 were held obvious, subject to amendment; the surviving claim and patent 301 were held non-obvious, and the patents as amended were held not invalid for added matter.