Author: Delain Law Office

Plaintiffs file for writ of certiorari: In re Ciprofloxacin Hydrochloride Antitrust Litigation

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On March 23, the plaintiffs filed a petition for certiorari in the Cipro litigation seeking review of the Federal Circuit’s decision in In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008). The antitrust case involves so-called “reverse payment” settlements of patent infringement cases between innovator and generic pharmaceutical manufacturers under the Hatch-Waxman Act. The Federal Circuit affirmed the district court’s summary judgment holding that no antitrust violation occurred, stating that “any anti-competitive effects caused by the Agreements were within the exclusionary zone of the patent.” It answers the question whether case “under the Hatch-Waxman Act … a settlement agreement between a patent holder and a generic manufacturer violates the antitrust laws.” The US District Court for the Eastern District of New York granted the defendants’ motion for summary judgment, holding that any anti-competitive effects caused by the settlement agreements between the defendants were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.

Patentee Bayer and the generic manufacturers (“B&G”) of CIPRO®, a popular antibiotic, entered into a total of four settlement agreements to end patent infringement litigation in the US District Court for the Southern District of New York. These agreements, which were entered into before the Hatch-Waxman Act was modified to require settlement agreements to be filed with the FTC and Department of Justice for review, had Bayer, the patentee, paying the generic suppliers to not manufacture or distribute their generic drug until a certain date.

B&G got themselves sued over these agreements in the Eastern District of New York by several trade unions and HMOs, claiming that these agreements restricted free trade, inhibited competition, and thereby violated the Hatch-Waxman Act. The District Court issued a summary judgment that the agreements are fine under the Act (they do not violate antitrust because they fall within the exclusionary provisions of the patent), plaintiffs appealed to the Federal Circuit, and the Federal Circuit affirmed the District Court’s decision.

The US Supreme Court now has the case; their options are (1) deny cert, which would let the Federal Circuit’s ruling stand, or (2) grant cert, which would have the Nine Wise Ones review the case and act on the Federal Circuit’s ruling.

Meanwhile, the question stands unanswered: Do reverse payments of this type violate the antitrust laws of the United States? In other words, who trumps … the exclusionary patent laws (mandated by the US Constitution) under which the agreements were made, or the antitrust laws promoting free trade and fair market pricing of goods and services? I doubt the High Court will phrase its Questions Presented in that manner (if they grant cert), but answering this question is the gist of why the Court should grant cert on this case.

The Federal Circuit’s opinion is online here as a .pdf; the Supreme Court is not yet showing the case in its docket.

Tesla, Awaiting U.S. Aid, Unveils Its Electric Car – NYTimes.com

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Tesla, Awaiting U.S. Aid, Unveils Its Electric Car – NYTimes.com. (subscription required)

A Silicon Valley startup, called Tesla Motors (can’t help but notice the similarity in name to Nicola Tesla, the inventor of the radio … any relation?), has a fully electric sedan that they’re itching to build. They can’t get their design past the modeling stage without a $450M loan from the Feds. Fed loan money has pretty much dried up thanks to the credit crisis, leaving us gas guzzlers laying down our trail of carbon monoxide and other noxious fumes as we drive our fossil fueled sedans, SUVs, and Keystone Kops Kars through the streets.

Tesla has spent $50M developing their new electric sedan — the Model S — and needs $250-300M more. They’ve gotten $186M from investors and need the rest on loan from the government.

The government isn’t lending money right now. This is choking Tesla and other green-energy startups … I hope not completely to death, since I like the idea of a fully electric sedan. I hope it has the power to handle highway speeds.

I also hope that their new fully electric car will be priced and made available such that Real People like you and me can afford to buy it, unlike Tesla’s other product, a $109,000 Roadster that is out in a very limited edition of 300 cars (with 1000 wannabe owners waiting in line). This is a product that everyone needs to be able to afford. Gasoline prices will skyrocket again soon enough (supply and demand requires that; gasoline is a finite resource) and gas-powered internal combustion engines are eating the planet alive. A fully electric car, powered with renewable energy, is just the ticket.

IF they makes its new car affordable and powerful enough to handle highways, Tesla just might have a herd of Proboscidea by the very large collective tail. If they price it and do limited production runs such that only multi-millionaires can buy it, the planet and the public will suffer.

60% of older workers are postponing retirement

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CareerBuilder conducted a survey wherein they asked older workers about retirement plans.

Retirement? What’s that? The economic downturn prevents 60% of people who want to retire — who have worked and scrimped and saved their whole lives long in hopes of living the good life — from leaving the work force.

There are those of us who simply don’t want to retire. I, for example, have a delightful time working, I enjoy my business enormously and I plan to go to my grave with my fingers on the keyboard clacking out some client-related legal document. That doesn’t say I don’t enjoy having the option to retire, and it certainly doesn’t say that I don’t enjoy taking time off to visit some tropical paradise.

Some just want to go and live on that tropical island. They’ve been saving for it all their lives. They dreamed from the time they were tots about leaving the winter behind as they fall off the edge of the workaday world and into their dream.

The dream ain’t happening. Money doesn’t let it happen. It’ll be a few years before these folks feel secure enough to take that plunge. 

This may not be a bad thing: I have it from the horse’s mouth that retirement isn’t all it’s cracked up to be. And, according to MedPageToday, early retirement may spell — well, disaster.

So suck it up, Boomers, and keep the work fires burning. Starting a business is a grand way to keep your finger in the non-retired pot — and on your own terms.

CAFC hands down its opinion in Tafas v. Doll rulemaking case

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Tafas et al. v. Doll was handed down from the US Court of Appeals for the Federal Circuit (CAFC) yesterday (to read this file, you will need Adobe’s Acrobat Reader).

This case came about when the USPTO decided a couple of years ago that it wants the patent applicant to take on the burden of patent searching, and threw in some rules limiting the number of total claims, the number of independent claims, and the number of requests for continuing examination that the patentee could make. This was interpreted by the bar as being about the USPTO being understaffed and overworked and trying to dig out from under its enormous backlog of patent applications.

Dr. Tafas, along with GlaxoSmithKline, took exception to the new rules and sued the USPTO in an action that claimed that the new rules went way, way beyond the USPTO’s rulemaking authority as granted by Congress. The case was heard in the US District Court for the Eastern District of Virginia (EDVA), which agreed with Tafas and enjoined the USPTO from enforcing its new rules on October 31, 2007 — the day before the new rules were to go into effect. The district court agreed with Tafas et al. that the Final Rules were “substantive rules that change existing law and alter the rights of applicants such as Tafas et al. under the Patent Act” and issued a summary judgment in favor of Tafas et al. The USPTO appealed the summary judgment to the CAFC, which holds exclusive jurisdiction over patent cases among the circuit appellate courts. Lots and lots of interested parties filed amicus briefs arguing one side or the other of this issue that is being carefully watched by patent practitioners.

Today, the CAFC handed down its decision on the appeal. They affirmed the EDVA’s rejection of Final Rule 78, which deals with the number of continuation applications that an applicant can file based on one parent application, but they overturned the lower court on the other rules and remanded the case to the EDVA for further proceedings.

This case is not over, but a couple of questions that have affected patent practice for the last two years have been answered.

  • Patent applicants are still entitled to file the number of requests for continued examination, without limitation, that are needed to prosecute the patent application to issuance or final, dead rejection;
  • Patent applicants must show valid reason for having more than 25 claims in a patent application, and more than three independent claims based on the prior art;
  • Patent applicants must now provide a search of the patent and non-patent literature with each patent application; and
  • Patent applicants must provide a detailed write-up in the specification explaining why the applicant believes the invention is patentable in the light of the prior art.

The new rules, that will doubtless go into effect soon, will change patent practice, in some cases dramatically but in other cases not so dramatically. It will be interesting to see how the case itself plays out.

The search requirement is interesting, to say the least, especially since under the new rules the applicant is now required to provide the USPTO with a detailed reasoning as to how the invention is patentable over the prior art (that’ll be interesting…). Until now, the USPTO has been responsible for the searching of literature that pertains to a patent application. Now, however, the patent applicant is required to help the USPTO along by providing a search and an analysis of that search in the patent application.

This is not as much of a boon to the patent searching industry as it may appear at first glance to be; patent searching is something that most sensible patent applicants do anyway, since it makes absolutely no sense to submit a patent application only to have the examiner find a prior-art reference that stands squarely in the way of the applied-for patent. A search avoids that, and has been common practice before the new rule went into effect. The difference now is that we must tell our clients that searching is required before a patent application can be submitted under this Tafas case.

This places a burden of requirement on applicants where none existed before (although common sense dictates that a patent search be done).

I’m watching to see how the rest of this case plays out. Meanwhile, watch out, World; here come the new rules!

United States Supreme Court Grants Cert to Decide Significance Of Copyright Registrations

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United States Supreme Court Grants Certiorari To Decide Significance Of Copyright Registrations

Wow…

Of course, if you apply to the Copyright Office for special handling and use the words “ongoing infringement,” they will bring your application to the top of the pile and get the registration, if granted, to you in a few days or weeks rather than a few months.

However, it would be delightful if the Nine Wise Ones decide that filing for copyright registration is sufficient to proceed to litigation under 17 USC 411(a); that would ease the burden on the litigants to either wait for the Copyright Office to operate in due course or pay the extra fees to get them to operate more quickly than due course. It would ease the burden on the Copyright Office to handle “rush” jobs that are waiting at the courthouse door. Of course, the defense bar would disagree with me….

I’ve been known to take my own sweet time with the pre-filing settlement negotiations while I await the Copyright Office’s action in registering a client’s infringed work. That sometimes works better than litigation for all parties, so I’ve never actually found that the Copyright Office has held up anything I desperately wanted to do, especially since the fact of removing the infringing item does not negate the fact of the infringement for which my plaintiff is entitled to remedy.

The USPTO's Website

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Found at www.uspto.gov , the United States Patent and Trademark Office’s website provides its users with a huge amount of information about the Office and about patents and trademarks.

The site includes search engines for:

  • Issued patents (text entries from 1976, scanned entries before that)
  • Published patent applications (from 2001)
  • Trademarks – registered and applied-for

There are filing mechanisms for both patent and trademark applications; the mechanisms even work reasonably well.

I send clients to this site regularly; it is readable by those who do not possess the knowledge of an IP practitioner and those clients who actually go to the site come back with awe in their voices, telling me that they didn’t know there was that much information out there.

The home page is always a running flow of USPTO news. Two items in today’s flow are worth mentioning here.

  • The National Inventors’ Hall of Fame has found a home at the USPTO’s museum. This exhibit is well worth visiting. Find the full story here.
  • April 6, 2009 is Design Day at the USPTO. Starting at 9 a.m., design patent examiners, design managers, independent inventors and patent attorneys and agents will have the opportunity to exchange ideas, information, and knowledge about design patent practice. Hon. Randall R. Rader, Chief Judge of the US Court of Appeals for the Federal Circuit (which has exclusive jurisdiction over patent appeals) is the scheduled keynote speaker. Find registration information here, and find the agenda here. This event is FREE, but you have to pre-register.

PCT Signs 140th Member Country

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Chile is that long, thin sliver on the western edge of South America

WIPO-Administered Treaties.

It hasn’t even been added to the list on the internet as of this writing, but Chile has deposited its instrument of accession to the Patent Cooperation Treaty (PCT) with the World Intellectual Property Organization (WIPO), the administrator of the PCT, and will become the 140th PCT Contracting State. The PCT will enter into force in Chile on June 2, 2009.

Welcome, Chile, to the Wonderful World of the PCT!

The map, btw, is from GOOGLE Maps. Chile is that long, narrow strip of a country along the western shore of South America. Just west of Argentina. Argentina, btw, is currently in the process of signing the PCT, but has not yet deposited its instrument of accession with WIPO.