Obviousness In The United Kingdom - Levofloxacin From Daiichi Is Not Obvious

Confirming that the Court of Appeal had not found Daiichi's

medicine, Levofloxacin, to be obvious, Jacob LJ commented

"I am not sorry to reach this conclusion. Daiichi's

work led to a better medicine than ofloxacin. Levofloxacin is not

just twice as active as ofloxacin ....but is a lot more soluble and

less toxic than was predictable. It can be used in higher dosages

than might have been expected with corresponding medical benefit.

Only a curmudgeon would say there was no invention

here."

In his judgement, delivered on 2nd July 2009, in Generics v

Daiichi

[2009] EWCA Civ 646 Jacob LJ began by noting that the

validity of the patent had been attacked at first instance on many

grounds. He once again warned that it is not good practice to

include masses of different objections in a case, as it serves only

to convince the court that none of the individual attacks holds up

to scrutiny.

The only claim of the patent under consideration on appeal

claimed Levofloxacin. Levofloxacin is the (-) enantiomer of a

racemic compound called ofloxacin, which is a quinolone. Ofloxacin

was known to be an excellent synthetic anti-microbial and

Levofloxacin had proved to be a broad spectrum anti-microbial of

low toxicity.

The Law of Obviousness

In the judgement, Jacob LJ reviewed the law of obviousness and

confirmed, as we also saw in a subsequent judgement in Wake

Forest University v Smith & Nephew, [2009] EWCA Civ 848 of

31st July 2009, that the Windsurfing/Pozzoli questions are

fundamental to determining if an invention is obvious.

When considering obviousness, we are told that "There

is at bottom only one test, namely that posed by Art. 56 of the EPC

transposed into UK law by s.3 of the Patents Act 1977. Was the

invention obvious to a person skilled in the art having regard to

any matter which forms part of the state of the art?"

Jacob LJ noted that a tool for answering this statutory question

is the Windsurfing/Pozzoli questions and noted that these

questions provide: "a structure by which the question,

obvious or not, is to be approached. The first three steps do no

more than put the court in the right state to answer that question.

They are necessary inherent preliminary matters to be determined

before one can properly set about answering the fourth question.

Implicitly I think all courts (and patent offices) do and must do

the same. The approach in the Windsurfing/Pozzoli way

merely makes explicit that which is implicit."

..."Some have suggested that...