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« Court Report | Main | AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009) »

September 27, 2009

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"Takeda will permit Amgen, if it wishes to do so, to rely on alternative processes for making the products claimed in the '933 and '422 patents up to their filing dates to prove that the claims of those patents and the claims of the '868 and '698 patents are patentably distinct. If Amgen pursues that course, Roche will be free to rely on subsequent developments in the art up to the filing dates of the '933 and '422 patents to prove that any alternative processes put forth by Amgen do not render the claims of the '933 and '422 patents and the claims of the '868 and '698 patents patentably distinct."

Kevin,

I've puzzled over this statement and whether it's consistent with earlier statements in the Amgen opinion on what Takeda means. Is what's being said only that if Amgen puts in evidence of patentable distinctness for alternative processes up to the filing dates of the '933 and '422 patents, Roche is then (and only then) entitled to put in contervailing evidence to show that these alternative processes aren't patentably distinct?

Dear EG:

I understand that the opinion stands for the proposition that Roche will be precluded from using after-filing art (i.e., after November 30, 1984) to attack the validity of the '933 or '422 patent claims. I think that Roche will be able to rebut any evidence Amgen presents regarding patentable distinctiveness based on new method art between the original filing date and the filing dates of the '933 and '422 patent, which is why the court says that Takeda is a "two-way street" within its confines.

Hope this helps. Thanks for the comment.

Kevin,

It does. What you said is consistent with what this passage on what Takeda means says to me. I just remember reading something earlier in Amgen on the double patenting issue that might appear to be in conflict with this later passge on what Takeda means. The Federal Circuit isn't always as clear (or internally consistent) as it might be as it makes transitions between related issues.

Kevin, I don't disagree with your conclusion about practitioners needing to be careful - this decision certainly grabbed my attention. Nevertheless, I'm not sure the situation is quite so dire. The Amgen patents in question are pre-1995 applications, thus entitled to 17 years from grant. Amgen could obviate any double-patenting issue by filing terminal disclaimers in the later-issued patents. But at four billion plus dollars a year, it's clear why Amgen doesn't want to do that.

In contrast, in the post-1995 world that we now inhabit (save for a handful of pre-1995 apps that are still languishing on an examiner's desk or before the BPAI), US patents get 20-years from earliest claimed US priority, irrespective of whether an application is filed as a divisional or continuation. Which means that often, there won't be a reason to NOT file a terminal disclaimer to avoid an obviousness-type double patenting rejection.

The one situation where a terminal disclaimer is clearly to be avoided is where the later-filed application is entitled to a patent term adjustment under 35 USC 154, since a TD forfeits the adjustment period. (A TD doesn't affect Waxman-Hatch patent term extensions under 35 USC 156.) Even in those cases, though, often the additional time at the end of the patent term won't matter. It's primarily (only?) in pharmaceuticals where each day of extra patent term is critical.

So I agree that following this decision, patent practitioners need to be careful and ensure that they file divisionals as divisionals and not as continuations. (They should probably also be careful in filing claims to ensure that they will invoke a restriction requirement, thus enabling them to avail themselves of safe harbor of 35 USC 121.) In the cases where this distinction is crucial, the sums of money involved can be quite high. But in many technologies, it won't matter, and even in pharma, not all later-filed applications will be entitled an extension under 154; or the later-filed applications may be directed to less-easily enforceable aspects of the invention, such as synthetic methods.

Dear Dan:

There is one more consideration, which could be quite troublesome. Filing a terminal disclaimer requires the patents to be co-owned, and thus incapable of being independently assigned. There may be situations where that creates a problem.

But in general I agree with you. Thanks for the comment.

Can we please get rid of OTDP now? With patent term being calculated as 20 years from first non-provisional priority date, this doctrine is a fossil. And the argument that infringers shouldn't have to worry about more than one party coming after them is garbage. What other area of law do we worry about a liable party damaging more than one plaintiff? Join all rights holders as necessary parties, and that's that.

This is a dead horse. Let's stop beating it. If it's not a proper 103, move on.

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