Maryland Intellectual Property Law Blog : Maryland Intellectual Property Lawyer & Attorney : Brian Wm. Higgins : Serving Baltimore, Columbia, Frederick

• Merck & Co. Inc. v. Apotex Inc., No. 2007-1362 (Fed. Cir. July 16, 2008) (non-precedential)

     In this appeal, the Federal Circuit affirmed and vacated a decision by the U.S. District Court for the District of Delaware (J. Sleet) in favor of Plaintiff-Appellee Merck & Co., Inc. (“Merck”). 

     Merck obtained approval from the FDA to market the drug FOSOMAX®. It sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to commercialize a generic version of FOSOMAX®.  Apotex counterclaimed for a declaratory judgment of patent invalidity and noninfringement.

     Following discovery, Merck granted Apotex a covenant not to sue for infringement of all patents-in-suit, and moved to dismiss all claims and counterclaims on the grounds that the case no longer presented an Article III case or controversy. Apotex then moved to amend its counterclaims to add a claim for a violation of the Sherman Antitrust Act, 15 U.S.C. § 2. The district court denied Apotex’s motion to amend its counterclaims, and granted Merck’s motion to dismiss all claims and counterclaims for lack of Article III jurisdiction.

     On appeal, the Federal Circuit affirmed the district court’s denial of Apotex’s motion to add an antitrust counterclaim, and vacated the district court’s decision regarding infringement and invalidity as moot and remanded with instructions to dismiss the claims as moot. In reaching those decisions, the Federal Circuit stated that a justiciable Article III controversy may continue to exist between a patentee drug company and an ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue. Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1296-97 (Fed. Cir. 2008).  However, in this case, two events after oral argument on appeal rendered the infringement and validity claims moot:

1. The FDA decided to treat the statutory automatic 30-month stay on Apotex’s ANDA as dissolved once the district court dismissed the case; thus Apotex's ANDA could be approved; and 
   
   
2. Teva, which filed the first ANDA against FOSOMAX®, began marketing its generic FOSOMAX® on or about February 6, 2008, so Apotex no longer suffered a delay in entering the market that is traceable to Merck and redressible by a court judgment.

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     "eBay tumbled Tiffany's carefully stacked legal arguments," writes law professor and Counterfeit Chic blogger Susan Scafidi.  On Monday, the U.S. District Court for the Southern District of New York held that eBay is not liable to Tiffany & Co. for the sale of counterfeit goods through its auction website. The court ruled that Tiffany, and similar companies, are ultimately responsible for policing their trademarks online, rather than auction-based companies like eBay. "The court's ruling is in line with well established legal precedent which holds that the obligation to enforce trademarks rests with the trademark holder," wrote eBay in a published statement on its website Monday. 

     You win one, you lose one. In stark contrast to the findings of the New York court, just a few weeks ago the Tribunal de Commerce court in Paris ordered Ebay to pay over $60 million dollars to Louis Vuitton and Christian Dior for allowing the sale of counterfeit merchandise through the company's auction website. The Paris court described eBay's anti-counterfeit measures as "empty."  The court concluded that eBay had committed "serious errors" in permitting the sale of counterfeit goods, which, the court found, violated Louis Vuitton and Christian Dior's copyrights and trademarks. eBay is apparently appealing the ruling. In a published statement on its website, eBay characterized Louis Vuitton's and Christian Dior's lawsuit as an "overreaching...attempt to impose, in France, a business model that restricts consumer choice through an anti-competitive business practice."

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     In Grand Canyon West Ranch v. Hualapai Tribe, TTAB No. 91162008 (June 30, 2008), the Trademark Trial and Appeal Board found that an applicant, not registrant, committed fraud on the Trademark Office when it represented to the Office that it provided services in association with its mark GRAND CANYON WEST that, in fact, it did not offer. 

     Applicant Hualapai Tribe ("People of the Tall Pine"), whose tribal lands border the Colorado River and Grand Canyon in the western portion of the Canyon, filed an application for the mark GRAND CANYON WEST for a variety of services under Section 1(a), App. Ser. No. 76484111. The examiner prosecuting the application issued an office action requesting further clarification as to the services associated with the mark. The applicant responded in kind, stating that it provided, among other services, horseback rides, bicycle tours, and tractor-based tram rides. During the publication phase, the mark was opposed by Grand Canyon West Ranch, which argued that the mark was merely descriptive, and that the applicant had committed fraud on the PTO by including services in the application that they were not, in fact, offering under the mark.

     The Board found that the mark was not merely descriptive. However, it agreed with Ranch's fraud argument. Specifically, the Board found that there was no evidence that applicant provided horseback rides, bicycle tours, or tractor-based tram rides, as identified in the application. The applicant argued that the error was inadvertent, that it was due to innocent and reasonable reliance on the examiner's instructions to applicant suggesting appropriate services. The Board said that it could not excuse the error. The applicant, it wrote, had an affirmative duty to correct the identification set forth in the examiner's amendment if it contained errors. 

      Acknowledgment: information for this post provided by Alain Lapter, Esq.

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     35 U.S.C. § 156(d)(1) requires the submission of a patent term extension (PTE) application within 60 days from the date the patentee obtains permission from the FDA to commercially market or use a drug product that is the subject of a new drug application (NDA). This provision was enacted because FDA review of NDAs may take years after a patent covering the drug that is the subject of the NDA has issued by the PTO.

     On June 23, 2008, the U.S. House of Representatives passed by voice vote H.R. 6344, which had been introduced the same day by Rep. Delahunt (D-MA), and is similar to a provision included in the House version of the Patent Reform Act of 2007. The current bill is entitled "To provide emergency authority to delay or toll judicial proceedings in United States district and circuit courts, and for other purposes." Sec. 4 states:

"The Director may accept an application under this section that is filed not later than three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional."

     The bill would retroactively cover Massachusetts-based The Medicines Company, which filed a PTE application for U.S. Patent No. 5,196,404 on the 62d day after FDA approved its NDA for ANGIOMAX, an anticoagulant.

     Status: Received in the Senate and read twice and referred to the Committee on the Judiciary.

     Hat tip to the Anticipate This! Patent and Trademark Law Blog.

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    Eric Lane, a patent attorney at Luce, Forward, Hamilton & Scripps in the firm's Intellectual Property and Climate Change & Clean Technologies practice groups, publishes the Green Patent Blog. This relatively new website is dedicated to discussing and analyzing intellectual property issues relating to clean technologies and renewable energy. Mr. Lane's timing couldn't be better, given the media and consumer product industries' hightened interest in all things green.

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     U.S. Patent & Trademark Office (PTO) records show that for the period January through June 2008, the PTO received 28 trademark applications from Maryland resident or entities (based on a search of "owner address" records using TESS). That number is a 55% decline in the number of applications received for the same period in 2007 (62), but only a 3% decline over 2006 numbers (29).

     The number of registrations to Maryland individuals or entities in the first half of 2008 was down compared to last year. According to the PTO, 23 registrations were effective during the period January through June 2008, which is a 4% decline in the number of registrations for the same period in 2007 (24 registrations), but is the same number of registrations in 2006 (23).

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     U.S. Patent & Trademark Office (PTO) records show that for the period January through June 2008, the PTO granted 986 patents naming at least one Maryland resident as an inventor or joint inventor (based on residence addresses supplied by patent applicants to the PTO). That is a 1% decline in the number of patents issued to Maryland inventors for the same period in 2007 (993), and a 5% decline over 2006 numbers (1,038).

     The number of published patent applications naming at least one Maryland inventor in the first half of 2008 was up compared to last year. According to the PTO, 1,579 patent applications naming at least one Maryland inventor were published during the period January through June 2008, which is a 6% increase in the number of patent applications published for the same period in 2007 (1,495 patent applications), and a 5% increase over 2006 numbers (1,511).

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     Last September, the Copyright Office issued an announcement that it had begun beta testing of its web-based registration system, which was part of a new "electronic Copyright Office" (eCO) program (see Copyright Office Announces Electronic Registration Testing). Beginning July 1, 2008, the Copyright Office will offer its online registration system to the public.  Instruction for making claims to copyrighted works may be found here.

     According to a recent Copyright Office announcement, online registration through the eCO is the preferred way to register basic claims for literary works; visual arts works; performing arts works, including motion pictures; sound recordings; and single serials. Advantages of online filing include a lower filing fee; the fastest processing time; online status tracking of your claim; secure payment by credit or debit card, electronic check, or Copyright Office deposit account; and the ability to upload certain categories of deposits directly into eCO as electronic files.

     To register a claim electronically, go to the Copyright Office website at www.copyright.gov and click on the eCO logo shown above.

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