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March 22, 2010

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Comments

Perhaps someone who has followed this case since the beginning could enlighten me: Couldn't all or most of the claims in the Ariad patent have been found invalid as inherently anticipated? Don't many old and well-known drugs act by the claimed mechanisms?

Kevin,

No surprises here, incluidng that lack of a unanimous opinion or that Lourie would write the majority opinion or that Rader would dissent. In my opinion, Newman's concurrence concisely summarizes the essence of what the first paragaph of 35 USC 112 is about, better and in fewer words than Lourie.

Dear KB,

The issue of inherent anticipation was tried before a jury during the proceedings at the District Court level. As you are probably aware, the concept of inherent anticipation is not an easy one for most people, and especially for individuals with no (or minimal) legal or scientific training. Correspondingly, the claims at issue were found by the jury to not be anticipated. However, the 6,410,516 patent is currently the subject of Reexam No. 90/007,503 (the image file wrapper for which is available at the patent office website). Some of the claims of the '516 patent have been finally rejected at least because they are inherently anticipated by the use or administration of the following compounds or drugs: protein kinase C inhibitors, cyclosporin A, calcitriol (the active form of vitamin D), 5-ASA, glucocorticoids, antibiotics, and N-Acetyl-L-Cysteine. An appeal brief has been filed by the patent holders.

A good write up. Anyone you guys know of up in arms in the university circles?

Dear 6:

The decision preserves the status quo, so while many in the biotech space think it is wrong, they have had 14 years to adapt their practices to the law as it has been and now remains.

On the bright side, the decision certainly points to the benefits of a greater town/gown collaboration between pharma and universities and their startups, something that has long been a tradition in other areas (petroleum and chemical industries partnering with chemical engineering faculty, for example). The biggest remaining problems stem from the different timelines between academic publication schedules and patenting; unlike for companies, professors cannot wait years before disclosing their experimental results (nor would that be a good outcome for society).

Perhaps there needs to be less emphasis on targets (which were the inventions du jour from the Human Genome Project) and more on compounds (small molecules or biologics) that interact with targets to comprise useful drugs. That seems to be where Judge Lourie and his brethren were going in the part of the opinion dealing with the impact (negative, disparate) of a separate written description requirement on universities.

One thing that is certain: if there was ever a group that would continue to "innovate" regardless of the existence of patent protection, it should be university professors. In this context, the benefits of patenting are to attract investment necessary for commercialization. That effort (whether for diagnostic or therapeutic applications of basic research) is many times more costly and uncertain than the original research, and needs patent protection for investors to take the risks associated with early-stage biotechnology companies.

Thanks for the comment.

Kevin,

As I mentioned what Ariad held isn't surprising or even new to me, a patent attorney with a chemical background who has had to deal with the the “supporting the scope of the genus” problem is longstanding issue with us. I’ll also agree that Judge Lourie is not the clearest on what satisfies the “written description” requirement (and his opinion in Prometheus on when a drug dosage calibration method satisifes Bilski is a model of obfuscation of the point).

My biggest problem with Lourie’s opinion is that it spends an inordinate amount of time on the “separate and distinct” aspect of the “written description” requirement which I characterize in my article as equivalent to “how many angels can stand on the head of a pin.” As far as I was concerned, this question was settled by the Federal Circuit at least as far back as the 1996 case of In re Alton, and even earlier by the Supreme Court.

What I was more concerned about Ariad resolving is what does this "written description" requirement (be it "separate and distinct" or otherwise from the "enablement" requirement) mean. Probably the most significant statement in this regard is at page 21 of Lourie's opinion is where he says (referring to Univ. of California v. Eli Lilly) "an adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries." I call this the "black box" analogy because you may define the boundaries of a "black box" without ever defining what its contents are. What Lourie is looking for (and which makes sense to me) is some definition of what's in the "black box," or in patent claim lingo, what's in the broad genus, functionally, structurally, etc. What the ‘516 patent did in Ariad (as the Young patent in the Rochester case also unfortunately did) was simply define the boundaries of the generic “black box” but didn’t give you sufficient explanation as to how define and identify what molecules (in sufficient quantity) that would fit within that ratther large generic “black box.”

I've applauded Newman’s concurrence because it concisely distills what the “essence” of the first paragraph of 35 USC 112 is: “the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right.” That’s the key: if you want broad generic coverage, you must adequately describe and enable that scope in the patent spec. As I noted in my article, that’s been true since 1853 O’Reilly v. Morse case (cited directly by Newman and unfortunately only addressed in a footnote by Lourie) which has regretably been miscited (repeatedly) as a 35 USC 101 case, but is really a first paragraph 35 USC 112 case.

My additional 2 cents for what it’s worth.

I'm with Judge Newman: "the real issue of this case is too important to be submerged in rhetoric".
I see Ariad and Rochester as being similar to the "reach-through claim" cases, where the discoverer of a phenomenon attempts to claim (read, receive money from) all yet-to-be-made downstream inventions flowing from the discovery:- in the pharma world, think "A therapeutic compound found by the method of claim 1". Yet interestingly the stake was driven through the heart of reach-through claims in the US, and it seems also in Europe, without all the fuss engendered here.
Perhaps Ariad will live on as one of the "right result, wrong reasoning" cases, perhaps it will come to be considered as "right result, right reasoning", but I'm definitely in the "right result" camp as far as how it came out.

Dear EG and Derek:

I think the point is there cannot be any hard and fast rule, since what is enough disclosure to satisfy the requirement will depend on the facts in each case. Now, it does create uncertainty, much like the question of obviousness, since it may not be a simple matter to have the scope of the claims conform to the extent of the disclosure. The remedy, as imperfect as it may be, is to write claims of varying scope. If that leaves room for a third party to design around, the answer is to make the design around difficult, unpredictable, expensive and inferior to the claimed invention.

Sometimes a tall order, but the alternative are overbroad claims that prevent innovation. The goal of patent law to promote the "better" mousetrap recognizes that there will be an original mousetrap that is the basis of the improvement.

Thanks for the comments.

"but the alternative are overbroad claims that prevent innovation."

Kevin,

I view "overbroad claims" somewhat differently: if the patent spec doesn't describe or enable that broad claim scope, the inventor fails on his part of the "quid pro quo" extracted by the first paragraph of 35 USC 112. That's been true at least as far back as O'Reilly v. Morse.


I also completely agree with your statement that there can't be "any hard and fast rule" on what is adequate description and enablement for broad generic scope claims. The problem of supporting a broad generic scope claim has been with us since I started practice back in 1977 and before. Doing this in the newer "unpredictable" biotech is just another variant on this old problem. As my patent attorney brother Mark and I discussed, there's really no "magic number" for the number of species to support the genus. It all depends on the technology that is claimed. Certainly having a number of species identified, along with a descriptive formula for how to identify others will usually do it.

What academic research unfortunately tends to do is discover the scientific mechanism and stop there. That's what Judge Newman says won't get you a valid broad generic scope claim. Instead, you've got to do is describe and enable (somehow) what's in that broad generic "black box" in a way that the PHOSITA can predict (beforehand) what compounds will satisfy that mechanism. Academia can complain all they want to about the "unfairness" of this rule, but, like the narrow "experimental use" defense, the courts are not persuaded by those complaints.

If you put the holdings and fact patterns together from Univ. of California, Univ. of Rochester, Ariad, and the 2004 In re Wallach cases together, you do start to get a picture of what will satisfy "written description," along with "enablement." (I'm also in Newman's camp that you need to approach "written description" and "enablement" in tandem, not separately). What would really help, and what we currently don't have, is a decision involving a broad generic biotech claim where the Federal Circuit confirms that "written description (as well as "enablement") were satisfied. When that happens, we will at least know one way to reach the goal.

Of course, EG, then there are the instances where an inventor can enable an invention without describing it (think California v. Lilly). That's where the problems arise.

Thanks for the comment.

Kevin,

Yep, that "black box" called human insulin cDNA. Doesn't tell you what nucleotides (and in what order) that cDNA comprises.

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