It should be easy to find downloadable copies of patent documents on the web, right? Issued patents, published apps, US, PCT, EPO….should be easy, right? Well, it’s not. Unless, of course, you’ve got Steve Nipper’s Guide to Downloading Patent Copies. Bookmark it now.

We’ve welcomed a new member to the blogging team over at PHOSITA. Laura Wood is set to add her perspective to “the People magazine of IP blogs.” Head on over if you get the chance and welcome Laura to the blogosphere.

It’s taken a little longer than expected, but the next round of improvements to Promote the Progress is nearly ready to roll.  Over the next couple days, you’ll notice a bit of construction work.  The design is being tweaked a bit to improve “navagability” and a few new content features are being finalized.

During the construction, the site design may appear a bit goofy at times, but all the content will remain accessible.  Bear with me…it shouldn’t take too long.

In the meantime, and as always, if you have any questions or comments, please don’t hesitate to e-mail me. 

So how much must you disclose in an Information Disclosure Statement filed with the United States Patent and Trademark Office?  It’s simple, really.  If you are aware of relevant prior art, your duty of candor and good faith in dealing with the Office requires that you disclose the art to the Examiner.

But what must you say about the art that you disclose?

Nothing.  Absolutely nothing. (excluding non-English references, which require a statement of relevance).

Remember that…because the Patent and Trademark Office wants you to forget it.

Remember trusty old form 1449?  That’s the PTO form that, if completed properly, satisfies the IDS content requirements of 37 C.F.R. 1.98. 
…Seeking a marginal gain in efficiency by introducing a phantom burden on applicants that has the potential to cause real harm is disturbing, to say the least.
When submitting an IDS to the Office, you’re free to use any form you like, so long as the content requirements of 1.98 are satisfied.  As a service to applicants and patent attorneys, the Office has traditionally provided a form that meets these requirements.

PTO Form 1449 used to be that form.  Used to be.

Awhile back, the Office replaced form 1449 with new form PTO/SB/08.  That’s not so exciting in and of itself, until you consider the content of the SB/08 form.

(view a .pdf of the form here)

One column of the form asks the user to provide, for each patent document listed, the “Pages, columns, lines, where relevant passages or relevant figures appear.”  In essence, the form asks you to provide a point citation for relevant information in each cited reference.

There is no requirement that you make such a statement regarding cited references.  The effect of making such a statement is not clear and may indeed be harmful (e.g., is it inequitable conduct if you cite to a point that is not as relevant as another, uncited point?)

Most patent attorneys would (and do, according to a straw poll I took last night) simply skip past this column, leaving it blank.  Some still use 1449 or their own custom form (which you’re free to do).

But what about those that are unfamiliar with the issue?  What about pro se applicants?  They’re likely to provide the requested information (and probably struggle to do so), especially when you consider that the form contains this warning:  “This collection of information is required by 37 CFR 1.97 and 1.98.  The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application.”

I’m not even sure what is meant by the second sentence of the warning.  But, in a heavy-handed manner, the warning as a whole leaves a clear impression that you must supply the requested information, including the point citations.

The PTO seems hell bent on improving administrative efficiency.  I suppose the issuance of this new form might be a part of that effort (an attempt to get the Examiner to immediately focus on the relevant passages of a reference?).  But, the implication that such information is required is completely unacceptable.  Seeking a marginal gain in efficiency by introducing a phantom burden on applicants that has the potential to cause real harm is disturbing, to say the least.

A discussion on Greg Aharonain’s PATNEWS newsletter drew my attention to this subject.

The House Subcommittee on Courts, the Internet, and Intellectual Property has scheduled an oversight hearing on “Patent Harmonization” for Thursday, April 27, at  9:00 AM.  You can watch a live webcast of the hearing here.

Scheduled witnesses include Q. Todd Dickinson (former USPTO Director and current GE Vice President and Chief Intellectual Property Counsel), Bob Armitage (Eli Lilly General Counsel), Gary Mueller (CEO of Digital Now, Inc.), and Pat Choate (political economist and author of one of my favorite books, Hot Property:  The Stealing of Ideas in an Age of Globalization).

Topics to be addressed will likely include legislative changes needed for harmonization efforts, including adoption of a first inventor to file system.  Noticeably absent from the witness list is a representative of the current USPTO administration.  An update on the Office’s harmonization efforts, including both internal and external efforts, seems appropriate for the topic.  The current status of the “Trilateral First Package” seems particularly relevant.

If you don’t yet believe that the fight to make fundamental change to our patent system is moving beyond Congress and onto new battlefields, consider the following observation that a reader, who wishes only to be identified as a Palo Alto patent attorney, submitted to me this week:

The Patent and Trademark Office has published some of the comments that have been submitted in connection with the proposed rule changes.  As of today, April 21, 2006, the listing of comments relating to the proposed limits on continuation and request for continued examination practice includes comments from several individuals.  No comments from corporations have been published.

The list includes published comments from four law firms.

…four law firms supporting the proposed rules, one common letter…In stark contrast to the comments received from individuals, the comments from each of the law firms are submitted in favor of the proposed rule that would place limits on continuation and RCE practice.  All of the law firm comments share several paragraphs of identical language.  The similarities are so striking that it becomes immediately clear that they very likely arose from a common template.

Is there a common denominator amongst the law firms?

Maybe.  Here’s one possibility.  Two of the firms have a significant number of issued patents under their name that are assigned to Intel (14/14 for one; 23/24 for the other).  The third firm has a small group of its patents assigned to Intel (7/253).  Nota Bene – the fourth firm only has two issued patents, neither of which are assigned to Intel.

The source isn’t as important as the underlying issue…four letters of support for the new rules are, in essence, one.

It’s interesting to note that three of the four published comments include the following statement:

“Unlike individuals expressing their personal views and bar associations stating a consensus position, we also represent our clients’ interests who both own patents and have to deal with assertions.” (emphasis mine)

The battle for fundamental change is on.  It’s on in Congress, it’s on in the Supreme Court, and, apparently, it’s on in the Patent and Trademark Office as well.

Comments on the USPTO proposed rules placing limits on continuation practice and on the number of claims for initial examination are due on or before May 3, 2006.  Struggling over the idea of preparing extensive comments?  Don’t fret….they’ve made it easy.  And brief comments are fine.

You can e-mail comments on the proposed continuation rule to AB93Comments@uspto.gov.  Comments on the proposed representative claims rule can be e-mailed to AB94Comments@uspto.gov.

Remember, there will not be any public hearing on either of the rules.  Written comments will be critically important as the Office determines its next moves on these controversial issues (all signs continue to indicate that it prepares to move forward with the proposals….).

Still wondering about the potential effects of these rules?  Start here (continuation limit) and here (representative claims).

Chinese President Hu Jinatao is scheduled to arrive in the United States this morning to kick off a round of checkbook diplomacy.  Intellectual property rights will, of course, be a main topic of discussion as the President visits the White House (which, officially, is not a full-blown state visit), Yale, and, uh, Bill Gates.

Huh?  Bill Gates?

Yep…the Chinese President is scheduled to visit Microsoft’s Redmond campus and the Home of the Future.  He’s even going to dine with the Chairman of the world’s largest victim of intellectual property piracy (along with about 100 other business people).  The timing of the Lenovo/Microsoft deal, inked yesterday, seems to indicate that the check for that meal is already in the mail, especially considering that the announced deal is about three times larger than what was expected by Wall Street.

Last week, Sandoz (a Novartis company) scored a major victory in federal court against the Food and Drug Administration that could mark the beginning of a significant change in the biotech drug industry.  The decision highlights the need for clarification on the issue of generic biotech approvals and should remind pioneer biotech companies of the importance of strong patent protection.

Currently, the regulatory landscape for the approval of generic biotech drugs is about as clear as a contaminated cell culture.  FDA openly struggles with such applications and often  is urged to refuse approval by the pioneer, which typically cites the complex nature of the drug and the difficulties associated with reproducing the sensitive manufacturing environment.  Frustration continues to mount among would-be generic manufacturers as more and more pioneer biotechnology drugs go “off patent.”  The end result is, in effect, non-patent market exclusivity for pioneer biotech drug manufacturers reminiscent of the de facto patent term extensions for traditional drugs that provided one of the driving forces behind enactment of the Hatch-Waxman amendments in 1984.

Clarifying the path to regulatory approval for generic biotechnology drugs is a massive effort that will likely take years to accomplish. The decision of the United States District Court for the District of Columbia in Sandoz v. Leavitt (2006 U.S. Dist. LEXIS 17549; April 10, 2006) provides an early step in the direction of change and may have interesting patent implications in the future.

Sandoz had filed an application with the FDA to market a generic version of Pfizer’s Genotropin, an approved biotechnology drug (its a human growth hormone) that has been ok’d for marketing since 1995.  Months passed and nothing happened.  Eventually, Sandoz grew impatient and ultimately filed suit against FDA and Health and Human Services officials, claiming that the agency failed to meet its statutory obligation to act on the Abbreviated New Drug Application (ANDA) within 180 days of the filing of the application.

Last week, the court issued a strongly-worded opinion holding that the agency had failed to meet the deadline imposed by the Federal Food Drug and Cosmetic Act (FDCA; 21 U.S.C. 355(c)) and instructed it to end this “marathon round of keep-away”  (citation omitted).

While the practical effect of the decision on the Sandoz NDA may be minimal (under the FDCA, the agency isn’t required to make a final decision on the application within 180 days; it can also satisfy its obligation by giving the applicant notice of an opportunity for a hearing on the question of whether the application is approvable), the case is interesting for several reasons:

First, it highlights the difficulty the FDA is having with applications for generic biotechnology drugs and the growing impatience of the generic biotechnology industry.  The regulatory pathway to approval of generic biotechnology drugs is not crystal clear and many believe that the agency freezes like a deer in the headlights when faced with a generic biotech application.  Sandoz harnessed the growing frustration of the industry and sought the judicial interpretation of the deadline that seemed necessary before a clear pathway could be established.  The Court stated, in no uncertain terms, that the deadline is in fact a real one, and that the agency should treat it accordingly.

Second, it may ultimately impact the non-patent exclusivity enjoyed by many pioneer biotechnology manufacturers created by the FDA’s inability to efficiently handle generic applications.  Remember, no one can market a generic version of a drug, including biotechnology drugs, in the United States until the FDA approves it.  Once patent protection expires, market exclusivity may still exist for the pioneer if the FDA has yet to approve a generic.  Sandoz makes it clear that the FDA must act on biotech (and all) drug applications promptly, which, with all things being equal, may ultimately lead to a faster path to market for generic biotechnology drugs.  If such non-patent exclusivity is reduced or eliminated, strong patent protection for biotechnology drugs becomes even more important.

Third, the case may prompt Congressional action on the subject.  The de facto patent term extension described above was one of the driving forces behind the Hatch-Waxman amendments in 1984 that dealt with the same situation as applied to traditional drugs.  As the first generation of biotech drugs continues to go off patent, more attention will be paid to the de facto extension enjoyed by pioneer biotech drugs and the murky regulatory pathway for generic versions of these drugs.  With the court stressing the agency’s statutory obligation to act on generic applications in a timely manner, there may be opportunity to clarify the path to approval by legislative and/or regulatory action.

If history is a guide, a thriving generic biotechnology industry may be just around the corner.  The Sandoz decision is a victory for generics that may ultimately be a victory for the entire population.  In the meantime, it should serve as a not-so-subtle reminder to pioneer companies that change is likely inevitable and that strong patent protection is critically important.

Everyone’s favorite court watcher, Hal Wegner, has distributed the most recent copy of his “Top Ten List” of Supreme Court patent cases (it’s a telling sign of the times that Hal has a list these days that is focused exclusively on the Supreme Court).

In the latest version of The List, Hal predicts that eBay v. MercExchange will be decided by a 6-3 (or possibly a 7-2) margin in favor of confirming the availability of injunctive relief for “non-working” patentees.  He expects negative votes from Associate Justices Breyer and Stevens.  His prediction is based on hearing the oral arguments and extensive study of the pleadings.

Since the days of the oral arguments, I’ve seen many predictions on the forthcoming decision in eBay.  I know Hal, and I know the effort he puts in to studying the cases he watches.  His is the only prediction I’m paying attention to.