Posts Tagged ‘Eli Lilly’

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HUMAN GENOME SCIENCES v. ELI LILLY – Increased European Harmony?

Friday, December 2nd, 2011

By Paul Cole, European Patent Attorney, Lucas & Co – Warlingham, UK

Judgement – Human Genome Sciences Inc (Appellant) v Eli Lilly
and Company (Respondent)

The above proceedings relate to European Patent (UK) 0,939,804 concerning a new  human  protein called Neutrokine-α. The specification explained (i) the existence and amino acid sequence of Neutrokine-α, (ii) the nucleotide sequence of the gene encoding for Neutrokine-α, (iii) the tissue distribution of Neutrokine-α, (iv) the expression of Neutrokine-α by its mRNA (the encoding gene) in T-cell and B-cell lymphomas, and (v) that Neutrokine-α is a member of the TNF ligand superfamily.  The specification described the invention as potentially useful for the diagnosis, prevention, or treatment of a large number of disorders of the immune system, either through Neutrokine-α itself or through its antagonists. However, nowhere in the Patent was there any data or any suggestion of in vitro or in vivo studies, so there was no experimental evidence to support any of those suggestions.

(more…)

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Novelty and Obviousness In An Empirical Research Field – The Decision of the UK Court of Appeal in Dr Reddy’s Laboratories v Eli Lilly

Thursday, February 11th, 2010

From Paul Cole

The Lilly patent for olanzapine has been litigated in many jurisdictions including the US, Canada, the Czech Republic, Finland, Romania, Slovakia, Slovenia, Spain, China and Hungary. In US Court of Appeals for the Federal Circuit in Eli Lilly v Zenith Goldline (26 December 2006) Judge Rader held that allegations of lack of novelty and of obviousness did not succeed, whereas in the Canadian decision in Eli Lilly Canada v Novopharm (5 October 2009) O’Reilly J. held that the patent did not meet the requirements for a selection patent and was invalid. Key issues before the UK Court of Appeal were how novelty and obviousness of a secondary patent in the pharmaceutical field should be evaluated, the extent to which decisions of courts within the UK prior to the introduction of a “new law of patents” in 1977 remained relevant, and in particular whether the reasoning in the Canadian decision should be followed. The members of the court included Lord Neuberger in his capacity as Master of the Rolls and Sir Robin Jacob, both very experienced in handling pharmaceutical patent disputes.

Their decision confirms the extent to which, at least in this field, the law in the UK has departed from relatively restrictive pre-1977 standards and has become aligned with more open decisions of the EPO Appeal Boards. It also shows that in future there will be scope for differences between decisions of the UK courts following the “new” post-1977 law and those in e.g. Canada, India, Australia and New Zealand where the link to the older common law remains unbroken.

The Court of Appeal refused to hold that disclosure of a class was disclosure of all members of that class, relying on a quotation from G. K  Chesterton’s Father Brown story “The Sign of the Broken Sword: “Where does a wise man hide a leaf? In a forest?” Accordingly the invention as claimed was novel. And even though prior art disclosures included ethyl olanzepine which differed from the claimed compound in only a single carbon atom, the court refused to hold that an objection of lack of inventive step had been established.

The decision includes scathing comments on a prior art reference with a Markush claim allegedly covering some 10-to-the-19th compounds. The court observed that all the skilled reader would get from that reference was a vague promise of neuroleptic, sedative or relaxant effect for all the 10-to-the-19th compounds with an equally vague promise of high therapeutic index coupled with no evidence to support these promises. Given that the whole field was unpredictable, the woolly teaching of the reference (described by Lord Neuberger as “mere speculation”), if not totally useless, was no guide to any particular compound. It could not be said that any compound out of a vast class was obvious if there was no real idea how any individual member of that class might behave.

Yet further confirmation has been given to the realistic approach of UK courts to inventions in empirical research fields, and to the supportive judicial attitude towards the research-based pharmaceutical industry as also demonstrated by Sir Robin’s speech on 29 November 2008 to the EU Directorate-General of Competition at the time of their preliminary report on their Phrma-sector enquiry, see Patents and Pharmaceuticals

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TALKING WRITTEN DESCRIPTION REQUIREMENT BLUES – ARIAD WOBBLES

Monday, October 12th, 2009

On October 5, 2009, Ariad filed a 60 page brief (not counting attached appendices) with the Federal Circuit in support of its appeal in Ariad v. Lilly. (Attached below.) As you will recall from my post of August 24th, the Fed. Cir. granted en banc rehearing of a panel decision invalidating the claims-in-suit for failure to meet the WDR. See also, my posts of April 13, 2009 and May 5, 2009, on the panel’s decision in Ariad v Lilly and Judge Linn’s concurrence, urging a return of the WDR to post-Lilly status:

“The question is, ‘Does the written description describe the invention recited in the claims – themselves part of the specification – in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?’ That is the mandate of the statute and is all our precedent required, prior to Lilly.”

The questions to be resolved en banc, however, are 1) Does s. 112(1) contain a WDR separate from the enablement requirement, and 2) If it does, what is its scope and purpose? The Ariad brief answers “no” to question 1 but seems to retract its “no” in answering question 2. As part of its short answer to question 2 on page 1 of the brief, Ariad asserts: “Properly interpreted, the statute itself requires the specification to describe (i) what the invention is, and (ii) how to make and use it.” At pages 43-46 of the Brief (the only parts you need to read if you are conversant with the debate), Ariad argues:

“[I]t necessarily follows that the statute provides no scope or purpose for a separate written description requirement. Properly interpreted, the written description requirement of s. 112(1) requires, first, that the specification describe (identify) what the invention is and second, that the specification teach how to make and use the invention…Identifying the invention is necessary for enablement, since a specification that does not teach one of ordinary skill what to make and use does not enable the skilled artisan to make and use the unidentified subject matter.”

What a minute! This seems like ascribing an “identifying function” to the WDR that is separate from the enablement requirement. A sentence later, Ariad tries to ascribe this function to the claims, stating: “However, original claims necessarily identify the subject matter that they define; since they are part of the disclosure at the time of filing and ‘constitute their own description’”.

This argument is akin to taking the position that claims that meet s. 112(2) also satisfy the “description function” of s. 112(1), but Ariad must have felt that statutory redundancy was not much of an argument, even though paragraph 2 of 112 requires “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”

If Judge Lourie has been the Big Bad Wolf leading the pack who supports a heightened WDR to police biotechnology, he should be licking his legal chops over arguments like this. As soon as Ariad concedes that the WDR of s. 112(1) requires the specification to describe “what the invention is,” the Pandora’s box filled with descriptors has been flung wide open; the courts are left to grapple with “How much description of the invention should the specification contain?” Well, how about “a precise definition, such as by structure, formula, chemical name, or physical properties.” Lilly, 119 F.3d at 1566. Again, it bears repeating that adequate claims do not need to contain this level of description, e.g., they can describe the invention functionally or with mixed structural/functional terminology in some cases. For example, “An antibody that binds specifically to cytokine hBAD.” Such a claim will still be weighed against the enablement requirement of s. 112(1), but a specification that adequately teaches how to “make and use” such an antibody should meet s. 112(1) without more.

As I wrote in early 2003, “the legal battle lines are sharply drawn. One camp of judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the ‘right to use’ the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by the very specific Wands factors. … The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the ‘right to claim’ the invention at issue. That is nearly as equitable a doctrine as that assigned to the doctrine of equivalents.”

At pages 46-50, the Ariad brief contains a rather confusing discussion of two cases decided in the 1850′s that is supposed to convince the Fed. Cir. that Supreme Court precedent illustrates “[t]he proper approach to the enabling-description requirement of s. 112(1)”. In my next post on Ariad, I review a hypothetical fact situation based on two biotech inventions that is a bit more modern. Eventually, we may even reach the merits of the case.
Ariad v Lilly Brief.pdf

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NATURE/BIOTECHNOLOGY SUMMARIZES ARIAD DECISION

Wednesday, June 10th, 2009

A recent article by Ken Garber in Nature/Biotechnology, 27, 494 (June 2009) summarizes the recent Federal Circuit decision invalidating the claims-in-suit in Ariad v. Lilly for failure to meet the WDR. (See my post of April 13, 2009 “Federal Circuit Throws Wrench Into ‘Mechanism of Action Claims’” for a summary of the decision.) Various patent law “experts,” including this author, are quoted. Mr. Garber did a good job of summarizing the court’s position, but I don’t recall saying that affirming the validity of Ariad’s claims would be like “accepting a claim on anti-gravity.”

Under the Patent Office’s utility requirement guidelines (which I feel are unsupported by case law), an asserted utility must be specific, substantial, and credible. A claim to anti-gravity would surely fail the credibility test, but credibility of the asserted utilities was not an issue presented to the Federal Circuit. The utility of the ‘516 claims is manifest, at least if they are construed to be limited to the treatment of deleterious effects of elevated NF-kB, and many of them recite very specific utilities. However, this big “if” leads to another issue with these claims – are they even patentable subject matter?

In fact, the District Court found that the claims-in-suit were not unpatentable as “natural phenomena.” As you know if you have been reading my previous posts, I am very unsympathetic to infringement defenses asserting that claims cover “products of nature” or pre-empt all uses of “natural phenomena.” Usually, the hand of man is involved in diagnostic, screening or monitoring processes (or methods), even if “natural phenomena” or “products of nature” are being isolated, detected, or measured. However, one of the claims of the ‘516 patent considered by the district court in Ariad, reads as follows:

7. A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-kB-mediated intracellular signaling, the method comprising altering NF-kB activity in the cells such that NF-kB-mediated effects of external influences are modified. [529 F.Supp.2d at 115.]

Lilly argued that this claim, which does not recite administration of any exogenous drug, covers a natural process which the court referred to as “the autoregulatory loop” (regulating NF-kB levels in cells). The court reviewed the testimony and found that Lilly had not established by clear and convincing evidence that this natural process occurred in cells, but only that it might occur in vitro.

Lilly did not appeal this finding, but sorting through the scientific testimony summarized by the District Court, it looks like Lilly had a pretty strong argument that at least claim 7 encompasses a natural phenomenon, in the way that a method claim could encompass both the process of photosynthesis, a natural phenomenon, and an industrial process for making sugars from carbon dioxide, water, and radiation. If such a claim were valid, the patentee could collect royalties from every farmer or horticulturist, as well as from the Acme Sugar Company.

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