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IP NEWS

By ALM Staff | Law Journal Newsletters |
October 02, 2003

The House Wants to Keep Its Blackberrys

In a letter to the attorneys in NTP v. Research In Motion Ltd., James Eagen, the chief administrator of the House of Representatives, asked the parties to settle their differences in a way that would allow the BlackBerry wireless devices at issue to continue operating. The letter was prompted by the November 21, 2002 jury verdict in the U.S. District Court for the Eastern District of Virginia wherein Research In Motion was found to infringe five of NTP's patents and ordered to pay $23 million in damages. The patents at issue cover the use of radio frequencies in wirelessly redirecting corporate e-mail. Research In Motion, which makes the popular BlackBerry devices, indicated that it will appeal the jury's decision.

According to the chief administrator, BlackBerry use by members of Congress and senior staff has increased significantly since the September 11th terrorist attacks. Eagen wrote that Congress has invested nearly $6 million in the technology and any disruption in service could jeopardize the House's critical communication and the public interest.

ANDAs Do Not Infringe Non-FDA Approved Uses

On January 16, 2003, the Federal Circuit affirmed the district court's grant of summary judgment in favor of Apotex in Warner-Lambert Co. v. Apotex Corp. The central issue on appeal concerned whether it is an act of infringement under 35 U.S.C. Section 271(e)(2)(A) to submit an Abbreviated New Drug Application (ANDA) seeking approval to make, use or sell a drug for an approved use if any other use of the drug is claimed in a patent, or if it is only an act of infringement to submit an ANDA seeking approval to make, use or sell a drug if the drug or the use for which FDA approval is sought is claimed in a patent. The issue was a matter of first impression for the court.

In this case, Warner-Lambert had an expired patent for the drug 'gabapentin' to treat epilepsy and a current patent for the drug 'gabapentin' to treat neurodegenerative diseases such as Alzheimer's disease. Warner-Lambert had FDA approval for gabapentin as a method for treating epilepsy, but not as a method for treating neurodegenerative diseases, even though the drug was often prescribed by doctors as a treatment for neurodegenerative diseases. Apotex submitted an ANDA for gabapentin for the treatment of epilepsy, and Warner-Lambert sued claiming infringement of the neurodegenerative patent.

The Federal Circuit held that it is not an act of infringement under Section 217 (e)(2)(A) to submit an ANDA for approval to market a drug for use when neither the drug nor that use is covered by an existing patent, and the patent at issue is for a use that is not approved under the NDA. Accordingly, the Court stated that Warner-Lambert would have to prove that the patent claiming non-FDA approved uses was infringed under traditional infringement analysis.

With no evidence that Apotex did or would practice the method in the neurodegenerative patent, the Federal Circuit ruled that there was no direct infringement. Additionally, since there was no evidence that Apotex intended for physicians or others to use gabapentin in an infringing manner, the court held that there was no induced infringement stating: 'mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven. Thus, if a physician, without inducement by [defendant] prescribes a use of gebapentin in an infringing manner, [defendant's] knowledge is legally irrelevant.'

Legislation Introduced to Increase Access to Generic Drugs

On January 7, 2003, Senator Charles Schumer (D-NY) and Senator Susan Collins (R-ME) reintroduced legislation to close loopholes in the Hatch-Waxman Act (21 U.S.C. Section 355) that allows generic drug makers into the market after a drug patent expires. The legislation is identical to a bill that passed the Senate last year introduced by Schumer and Senator John McCain (R-AZ). The bill was referred to the Committee on Health, Education, Labor, and Pensions, but no hearings have been scheduled so far. Some of the features of the bill include:

  • Eliminating the potential for 'stacked' 30-month stays by allowing only one 30-month stay for the brand company to litigate its patents.
  • Requiring the first generic filer to forfeit the 180-day marketing exclusivity period to a later applicant if the first applicant engages in 'forfeiture events,' which include failing to market a drug within 60 days of approval or within 60 days of a final decision of non-infringement from a legal proceeding, withdrawing the application, or failing to obtain tentative approval of an application within 30 months of filing.
  • Requiring infringement suits under 35 U.S.C. Section 271(e)(2) to be brought within 45 days of notice of a generic application. An infringement suit would be barred if not brought within that time period.
  • Under certain circumstances, establishing a civil cause of action to patent holders who correct or de-list their patent information from the FDA's Orange Book.
  • Requiring patent holders to register their claims in the FDA's Orange Book within 30 days of FDA approval. Failure to register in a timely fashion would bar future infringement suits.
  • Codifying standards on which generic drugs are biologically equal to name brand drugs.

Court Allows Subpoena to Internet Service Provider

Section 512(h) of the Digital Millennium Copyright Act allows a copyright owner to serve a subpoena on an Internet service provider to disclose the identity of a customer alleged to be infringing the owner's copyright. In the case of In re Verizon Internet Services Inc., No. 02-MD-0323 (JDB) (D.D.C. Jan. 21, 2003), the U.S. District Court for the District of Columbia held that this subpoena power applies to all Internet service providers, not just to those that store user information. Thus, the court ruled that Verizon must turn over to the Recording Industry Association of America the identity of a Verizon subscriber who allegedly downloaded hundreds of copyrighted songs using peer-to-peer software. The court reasoned that it was not within the Congress' intent to preclude a copyright owner from obtaining the identity of an alleged infringer from a service provider transmitting the infringing material over its system just because that service provider did not store such user information.

Chinese Country Code Domain Names (.CN) Now Available

China is taking steps to open up its country code, '.cn,' to the world. Now, businesses and organizations without locations in China can register '.cn' domain names. Entities and individuals currently can register third-level domain names of the following forms: (i).com.cn; (ii) .net.cn (iii).org.cn.

In the near future, China plans to make available second-level domain names; i.e., '.cn,' for registration.

Licensing of Vanity Phone Number is Not 'Use' Under the Lanham Act

The U.S. Court of Appeals for the Eighth Circuit ruled in DaimlerChrysler AG v. Bloom, No. 01-3700 (8th Cir. Jan. 9, 2003), that the licensing of a vanity telephone number without advertising or promoting it is not a 'use in commerce' under the Lanham Act. This case involved the licensing of a telephone number, 1-800-637-2333, which can be translated to '1-800-MERCEDES.' The Eighth Circuit affirmed a grant of summary judgment for the defendant, refusing to find an intent to exploit the trademark in commerce. Plaintiff argued that the district court should have examined the use in a similar fashion to cyber-squatting cases involving the sale of domain names. Instead, the court followed the dictates of the Sixth Circuit from Holiday Inns Inc. v. 800 Reservation Inc., 86 F.3d 619 (6th Cir. 1996), which held that the use of a vanity phone number that translated into a phrase similar to a registered mark was not a use in commerce.

The House Wants to Keep Its Blackberrys

In a letter to the attorneys in NTP v. Research In Motion Ltd., James Eagen, the chief administrator of the House of Representatives, asked the parties to settle their differences in a way that would allow the BlackBerry wireless devices at issue to continue operating. The letter was prompted by the November 21, 2002 jury verdict in the U.S. District Court for the Eastern District of Virginia wherein Research In Motion was found to infringe five of NTP's patents and ordered to pay $23 million in damages. The patents at issue cover the use of radio frequencies in wirelessly redirecting corporate e-mail. Research In Motion, which makes the popular BlackBerry devices, indicated that it will appeal the jury's decision.

According to the chief administrator, BlackBerry use by members of Congress and senior staff has increased significantly since the September 11th terrorist attacks. Eagen wrote that Congress has invested nearly $6 million in the technology and any disruption in service could jeopardize the House's critical communication and the public interest.

ANDAs Do Not Infringe Non-FDA Approved Uses

On January 16, 2003, the Federal Circuit affirmed the district court's grant of summary judgment in favor of Apotex in Warner-Lambert Co. v. Apotex Corp. The central issue on appeal concerned whether it is an act of infringement under 35 U.S.C. Section 271(e)(2)(A) to submit an Abbreviated New Drug Application (ANDA) seeking approval to make, use or sell a drug for an approved use if any other use of the drug is claimed in a patent, or if it is only an act of infringement to submit an ANDA seeking approval to make, use or sell a drug if the drug or the use for which FDA approval is sought is claimed in a patent. The issue was a matter of first impression for the court.

In this case, Warner-Lambert had an expired patent for the drug 'gabapentin' to treat epilepsy and a current patent for the drug 'gabapentin' to treat neurodegenerative diseases such as Alzheimer's disease. Warner-Lambert had FDA approval for gabapentin as a method for treating epilepsy, but not as a method for treating neurodegenerative diseases, even though the drug was often prescribed by doctors as a treatment for neurodegenerative diseases. Apotex submitted an ANDA for gabapentin for the treatment of epilepsy, and Warner-Lambert sued claiming infringement of the neurodegenerative patent.

The Federal Circuit held that it is not an act of infringement under Section 217 (e)(2)(A) to submit an ANDA for approval to market a drug for use when neither the drug nor that use is covered by an existing patent, and the patent at issue is for a use that is not approved under the NDA. Accordingly, the Court stated that Warner-Lambert would have to prove that the patent claiming non-FDA approved uses was infringed under traditional infringement analysis.

With no evidence that Apotex did or would practice the method in the neurodegenerative patent, the Federal Circuit ruled that there was no direct infringement. Additionally, since there was no evidence that Apotex intended for physicians or others to use gabapentin in an infringing manner, the court held that there was no induced infringement stating: 'mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven. Thus, if a physician, without inducement by [defendant] prescribes a use of gebapentin in an infringing manner, [defendant's] knowledge is legally irrelevant.'

Legislation Introduced to Increase Access to Generic Drugs

On January 7, 2003, Senator Charles Schumer (D-NY) and Senator Susan Collins (R-ME) reintroduced legislation to close loopholes in the Hatch-Waxman Act (21 U.S.C. Section 355) that allows generic drug makers into the market after a drug patent expires. The legislation is identical to a bill that passed the Senate last year introduced by Schumer and Senator John McCain (R-AZ). The bill was referred to the Committee on Health, Education, Labor, and Pensions, but no hearings have been scheduled so far. Some of the features of the bill include:

  • Eliminating the potential for 'stacked' 30-month stays by allowing only one 30-month stay for the brand company to litigate its patents.
  • Requiring the first generic filer to forfeit the 180-day marketing exclusivity period to a later applicant if the first applicant engages in 'forfeiture events,' which include failing to market a drug within 60 days of approval or within 60 days of a final decision of non-infringement from a legal proceeding, withdrawing the application, or failing to obtain tentative approval of an application within 30 months of filing.
  • Requiring infringement suits under 35 U.S.C. Section 271(e)(2) to be brought within 45 days of notice of a generic application. An infringement suit would be barred if not brought within that time period.
  • Under certain circumstances, establishing a civil cause of action to patent holders who correct or de-list their patent information from the FDA's Orange Book.
  • Requiring patent holders to register their claims in the FDA's Orange Book within 30 days of FDA approval. Failure to register in a timely fashion would bar future infringement suits.
  • Codifying standards on which generic drugs are biologically equal to name brand drugs.

Court Allows Subpoena to Internet Service Provider

Section 512(h) of the Digital Millennium Copyright Act allows a copyright owner to serve a subpoena on an Internet service provider to disclose the identity of a customer alleged to be infringing the owner's copyright. In the case of In re Verizon Internet Services Inc., No. 02-MD-0323 (JDB) (D.D.C. Jan. 21, 2003), the U.S. District Court for the District of Columbia held that this subpoena power applies to all Internet service providers, not just to those that store user information. Thus, the court ruled that Verizon must turn over to the Recording Industry Association of America the identity of a Verizon subscriber who allegedly downloaded hundreds of copyrighted songs using peer-to-peer software. The court reasoned that it was not within the Congress' intent to preclude a copyright owner from obtaining the identity of an alleged infringer from a service provider transmitting the infringing material over its system just because that service provider did not store such user information.

Chinese Country Code Domain Names (.CN) Now Available

China is taking steps to open up its country code, '.cn,' to the world. Now, businesses and organizations without locations in China can register '.cn' domain names. Entities and individuals currently can register third-level domain names of the following forms: (i).com.cn; (ii) .net.cn (iii).org.cn.

In the near future, China plans to make available second-level domain names; i.e., '.cn,' for registration.

Licensing of Vanity Phone Number is Not 'Use' Under the Lanham Act

The U.S. Court of Appeals for the Eighth Circuit ruled in DaimlerChrysler AG v. Bloom, No. 01-3700 (8th Cir. Jan. 9, 2003), that the licensing of a vanity telephone number without advertising or promoting it is not a 'use in commerce' under the Lanham Act. This case involved the licensing of a telephone number, 1-800-637-2333, which can be translated to '1-800-MERCEDES.' The Eighth Circuit affirmed a grant of summary judgment for the defendant, refusing to find an intent to exploit the trademark in commerce. Plaintiff argued that the district court should have examined the use in a similar fashion to cyber-squatting cases involving the sale of domain names. Instead, the court followed the dictates of the Sixth Circuit from Holiday Inns Inc. v. 800 Reservation Inc., 86 F.3d 619 (6th Cir. 1996), which held that the use of a vanity phone number that translated into a phrase similar to a registered mark was not a use in commerce.

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