About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
2018 Juristant Badge - MBHB_165
Juristat #4 Overall Rank

E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.
Juristat_165
Juristat #8 Overall Rank

Pharma-50-transparent_216px_red

« Pharma and Software Companies File Joint Amicus Brief in Therasense Case | Main | Pay-For-Delay Provision Added to Senate Appropriations Bill »

August 04, 2010

Comments

Kevin,

From your description of Judge Hilton's opinion, the PTO is in serious trouble in this case. You don't want to get on the "bad side" of a judge, and that's exactly what the PTO did by not complying with Judge Hilton's previous order. I would say the PTO is pretty close to getting sanctioned (if that's possible) in this case, so if I were them I would tread very carefully. I also wouldn't give them very good odds of successfully appealing this case. One thing appellate judges don't like is the orders of one of their own being ignored for no apparently good reason.

Will the USPTO construe the application deadline "liberally" and do away with its "59-day" interpretation?

http://www.pharmapatentsblog.com/district-court-insists-on-fairness-in-patent-term-extension-application-deadline/index.html

The tragedy here is that this is hardly an isolated instance. The PTO's petitions process is totally broken. The PTO has to fix the Petitions process so that applicants get fair adjudications, so we all know what the procedural rules are and can count on them.

I think there is a very broad grey line here, since on the one hand the "drastic consequences" are certainly real, but on the other hand there is little excuse for missing this kind of a deadline. So I think there must have been (perhaps in the papers, or in the earlier briefing that resulted in the courts April Order) some acknowledgement by the court that the PTO's decision was really catastrophic - because I can't see any law firm having sufficient insurance coverage that would compensate the patentee from this kind of error.

The Office (abetted by the FDA) did play into the court's hands here, since its behavior created the impression for the judge that the Office was just going to be intransigent. Of course, the Office might have just been efficient, if the legal staff really thought their hands were tied. Then the Office needed this type of decision to grant the requested relief.

The real issue is whether interest groups have sufficient water pressure to get the decision appealed. It may be hard to overturn if the CAFC buys into the "balancing" nature of the remedial provisions of the Hatch-Waxman Act.

Thanks for the comments.

No, anyone with any experience with the Petitions Office knows that "the Office was just going to be intransigent" is the explanation. I have never gotten a decision on a significant petiton that did not redefine the issues presented, misquote the cases relied on, rely on non-binding guidance against applicants, ignore inconvenient precedent (like from the Supreme Court), and when all else fails, just make up the law out of thin air.

This is outrageous, if the court had determined that the only reasonable action on the part of the PTO was to let them have their way then the court should have come out and said so the first time.

Appeal this nonsense.

This:

"(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use."

Is pretty fin clear that the date has nothing to do with what business day they recieved a communication and only has to do with when the product recieved permission under the provision of law. And it is pretty hard to see how a "liberal" interpretation would introduce such a provision.

Actually, 6, the point was whether the PTO (and, really, the FDA) had reasonably interpreted the statute. The portion of the decision discussing the outcomes if the FDA had failed to mail the letter, mailed it to the wrong address, etc. was meant to highlight the fundamental question for the court: should the date be enforced strictly or not?

Now, most special interest groups, (AARP, etc.) believe that the answer is strictly, since failure to comply will reduce patent term and facilitate generic drug entry. And they are entitled to that opinion.

But the judge said, what was the intent of Congress? And the balance in the law was that generic companies got to perform otherwise infringing acts without infringement liability (Sec. 271(e)(1)), which made them ready to launch the day the patent expired (if they filed an ANDA with a Paragraph III certification). That was the public benefit, because beforehand the generic company could do nothing until the patent(s) expired.

But the court said the other side of the coin was to give back to patentees some of the term lost due to regulatory (here, FDA) delay - not PTO delay. So the court determined that in a case like this, where the FDA waits until after close of business on a Friday, the "date of approval" is the Monday. The fact that this was consistent with FDA's practice when it is the recipient of faxes from applicants helped, but the big thing was that the court felt the statute should not be strictly enforced.

Different case, perhaps, if the fax was sent/arrived at 3pm, or if the attorneys simply miscounted. So while I understand you knee-jerk response to the decision, it is very limited in scope, and does not change the basic statutory plan - just does some equity towards a company that should have been able to rely on a reasonable interpretation of the statute, rather than a strict one.

If Congress disagrees, they can change the law, but I don't think this is very appealable - the judge used a great many factors that would require the CAFC to find he abused his discretion, and that is pretty hard to do.

Thanks for the comment.

I'm not going to argue about a case I care nothing about. But thanks for your explanation Kev.

The comments to this entry are closed.

December 2019

Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31