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polymorph would be present in its product.
Mchemical compound - in a generic find that SmithKline presented conclusive version of a popular antidepressant do not evidence as to the actual presence of such a infringe the brand-name manufacturer's poly- small quantity of the patented polymorph.
morph patent, a federal judge recently ruled.
Therefore, he concluded, the court should The decision could severely limit or even not stop the FDA from approving Apotex's eliminate the ability of brand-name manufac- application for a generic version of Paxil turers to use polymorph patents to protect their blockbuster pharmaceuticals. At the (although the brand-name manufacturer has very least, it puts the industry on notice that asserted infringement of other patents that ispreventing final FDA approval).
Paxil case could reshape the purpose ofpatent law,"says Green.
"When a defendant can't avoid infringement, and the infringement provides no benefit toanyone, should there be a remedy?" extreme care is needed in structuring both Posner's decision is being appealed to the patent portfolios protecting brand-name drugs U.S. Court of Appeals for the Federal Circuit and abbreviated new drug applications for generic products containing active ingredients that exist in several polymorphic forms.
infringement arguments is just as important In the meantime, he adds, it is a warning as the quality of the patent," says Robert bell for the pharmaceutical industry.
Green, a partner in LVM's Chicago office."If this ruling stands, it could potentially lead to turers from protecting their patents, and they can still prevent a company from using a par- that resolve questions of patent infringement ticular polymorph, but it does show the need earlier in litigation, without the expert testi- mony and long legal battles that are now turers to work with experienced patent attor- neys to develop infringement positions and craft drug product specifications," says Sklar.
federal Judge Richard Posner in SmithKline "It is vital for manufacturers, whether brand- Beecham Corp. v. Apotex Corp. involved name or generic, to get expert advice for SmithKline's antidepressant Paxil.
something with the potential for billions of dollars in business - not to mention millions quantity of a polymorph that would be unin- tentionally and unavoidably present in thegeneric product as a result of the manufactur- An in-depth discussion of the Paxil case is ing process would infringe a patent claiming available in Sklar's article in the March 28, 2003, issue of BNA's Pharmaceutical Law & Industry Report - reprinted on LVM's Web site at generic manufacturer, would not benefit com- www.leydig.com. For more information on generic drug patent issues, see Green's article, "Patentable amount (less than 0.5 percent) of the claimed Inventions or Invented Patents?" also onLVM's Web site. actual dilution," says Mark Liss, a partner in LVM's Chicago office."The standard of peting businesses that operate under similar that the mere fact that consumers mentally famous mark "does not reduce the capacity companies claiming trademark "dilution," which is the reduction of a mark's capacity however, that a showing of actual financial to identify and distinguish goods and ser- injury is not required to prove that dilution sion, under many state dilution statutes, show actual dilution in the distinctiveness of their marks - not just that they proba- gerie giant Victoria's Secret against a trying to trade off the senior users' famous Little Secret. Victoria's Secret argued the Kentucky store's name was too close to its Madrid Protocol opens trademark doors in 57 countries virtually every country and can help clients must be filed electronically, to the World Twhich means that as ofNov.2, Intellectual Property Organization 2003, a single U.S. trademark application may be used to register a mark in as many add countries to their international regis- "You have to go through a review in each the U.S. Patent & Trademark Office will that period, registration will be automati- country you add, but you can do it at any cover all the countries that have signed the time," says Sullivan."And one filing with protocol," says Lynn Sullivan, a partner in WIPO is all that's required to assign a LVM's Chicago office."You can designate applicant may respond through an attorney in that country. Qualified U.S. patent and sold or there's a merger in any designated R E P R E S E N T A T I V E
L I S T I N G O F
R E C E N T L Y I S S U E D U. S.
P R O S E C U T E D B Y L E Y D I G V O I T &
6,527,178 Method for authenticating mail pieces 6,530,158 Locating system for molding machine clamp frame 6,541,510 Antiviral methods and compounds 6,544,751 Method of harvesting rare cells from blood products 6,559,610 Continuous wave electron-beam accelerator and continuous wave electron-beam accelerating method thereof Narrow claims throw drug's patent protection off course partner in LVM's Chicago office."When patents are drafted that specifically, it can be The case offers some valuable lessons for Gagala, a partner in LVM's Chicago office.
"Anyone filing a patent application must specification," Gagala says. "Patent attorneys other ingredients not specifically recited be sure the breadth of the invention is ade- stating it could do so without infringing quately described in the specification. If the written description of the invention is too patent's disclosure, including the fact that narrow, it may be too late to ask a court for fenofibrate and surfactant "are the only ingredients present in every comicronized mixture described" in the patent's application.
able to read a patent and fully understand what the terms in it mean," says Hefner.
the patent used some very specific disclo- "Ideally, it should not require hiring experts sure that made it clear that it covered only tional ingredients," says Dan Hefner, a Madrid Protocol continued from page 2 in a non-member country - a restriction several advantages for trademark applicants, registrations than it was with individual tional registrations are based on approval it is anticipated that both countries will rejects an application, it will automatically fail in all the other designated countries.
If a trademark is successfully challenged in take some ironing out," says Naffziger.
international registration is lost, as well.
be wise to retain a reputable intellectual Finally, notes Naffziger, an international property law firm to help them avoid poten- registration can't be assigned to an entity tial problems, especially when the process is Publication of LVM. LVM® is a registered trademark of Leydig, Voit & Mayer, Ltd.
LVM Report is intended for general interest.
Its contents should not be construed as legal R E P O R T A publication for the intellectual property community Preliminary injunction denied in Steel Tank case and Steel Tank Institute, a trade association for contended the characterization of fire-resistance manufacturers of steel tanks, for alleged being claimed as proprietary by U-Fuel was Wwas immediately confronted with infringement ofU-Fuel's patent on non-insu- the result ofa new standard,rather than a new a motion for a preliminary injunction and had less than two months to prepare for a full evi- "We didn't have much time to prepare, but The court agreed, finding that the patent dentiary hearing on the infringement claim.
we knew from experience what it takes to argue and the prior art claimed the same purpose of U-Fuel Inc., a Wisconsin above-ground stor- a preliminary injunction, whether we're repre- storing combustible and flammable materials, age tank manufacturer, sued two competitors senting the plaintiff or the defense," says John and ruled that the defendants' arguments raised Augustyn, a partner in LVM's Chicago office."A a significant question as to whether U-Fuel's plaintiff must show both that its infringement infringement complaint would succeed.
complaint is likely to succeed and that it would "This case is a good example not only of suffer irreparable harm without the injunction.
why patent owners should very carefully assess The hearing requires that both sides present the merits of their cases before seeking prelimi- your LVM Report mailing label? Are you their best evidence, including expert witnesses, nary relief, but also why defendants look to sharing a copy of LVM Report with a col- experienced intellectual property litigators when they must respond to a motion for preliminary Gordon Coons argued that their clients had injunction with a full court press," Augustyn mailing list? Prefer to receive the publica- been manufacturing, licensing and selling says."It's critical to have qualified legal advice tion via e-mail? Just send an e-mail with non-insulated tanks more than a year before every step of the way. There are all kinds of relevant information and your instructions U-Fuel applied for its patent. Additionally, they

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