Pfizer Inc. (PFE) will try to introduce a nonprescription form of Lipitor, its top-selling drug, to help cushion tumbling sales of the cholesterol pill as generic versions reach the market, Chief Executive Officer Ian Read said.
Lipitor loses U.S. patent protection on Nov. 30. The New York-based company is looking for ways to replace its $10.7 billion in annual revenue as cheaper copies drive down prices.
“There is an intent at some point to have an OTC version of Lipitor in the marketplace,” Read said yesterday in a conference call discussing third-quarter earnings.
A nonprescription version of Lipitor wouldn’t be available until at least 2013 because of the regulatory process needed to get it approved, he said.
“We have no definitive evidence we can do it,” Read said in an interview. An over-the-counter version of Lipitor would be the first of the statin cholesterol drugs on the market that consumers could buy without a prescription. The medicine would still compete with generic versions.
The loss of Lipitor’s patent-protected revenue will drop Pfizer from its place atop the pharmaceutical world, where it leads all competitors in drug sales, EvaluatePharma Ltd. said in an Oct. 31 report. In 2012, Paris-based Sanofi will hold the top spot, followed by Basel, Switzerland-based Novartis AG, and Pfizer in third, EvaluatePharma said.
Read said the company expects the decline in Lipitor sales to be “very rapid.” Revenue from the cholesterol drug will fall by about half next year to $4.57 billion and to $3.17 billion in 2013, according to an average estimate by four analysts surveyed by Bloomberg.
Read declined to give a specific sales projection for over- the-counter Lipitor.
“We believe it would be economically important, but you have to look in the context of some of the larger OTC brands,” he said.
The company is divesting its animal health and nutritional units to focus on producing new, brand-name pharmaceuticals. Pfizer will keep its generic drug business, which also oversees sales abroad.
The company has been examining an over-the-counter version of Lipitor, a person familiar with the situation said in August. The U.S. Food and Drug Administration must determine if patients can safely and effectively dose themselves without a doctor’s prescription.
Pfizer successfully took its allergy medicine, Zyrtec, over-the-counter in 2008 before selling its consumer unit that year to Johnson & Johnson for $16.6 billion.
Along with trying to get an over-the-counter Lipitor to market, the company has struck agreements with pharmacy benefit management companies including Medco Health Solutions Inc. and Express Scripts Inc. to sell brand-name Lipitor at a lower price, Timothy Anderson, an analyst with Sanford C. Bernstein & Co., said in a note to clients on Oct. 30. The agreements are mostly for customers who get their drugs by mail, he said.
AMD Loses Bid for Immediate Halt to S3 Patent Case Against Apple
Advanced Micro Devices Inc. (AMD) failed to persuade a U.S. judge to halt a patent dispute S3 Graphics Co. has against Apple Inc. (AAPL) at the U.S. International Trade Commission, according to a filing with the trade agency.
AMD, a maker of chips for Apple computers, sued S3 last month, claiming it owned the patents that S3 has asserted against Apple. In an Oct. 28 filing with the ITC, S3 said the federal judge denied a request for an immediate halt to the ITC case. The commission is scheduled to release its final decision on Nov. 15.
The civil suit is Advanced Micro Devices Inc. v. S3 Graphics Co., 11-cv-965, U.S. District Court for the District of Delaware (Wilmington).
The ITC case is In the Matter of Certain Electronic Devices with Image Processing Systems, 337-724, U.S. International Trade Commission (Washington).
Piramal Healthcare Settles Patent Litigation With Baxter
Piramal didn’t disclose terms of the settlement in a statement. Baxter filed the suit in federal court in Wilmington, Delaware, in 2009, accusing Minrad International Inc. of Orchard Park, New York, of infringing patent 5,617,906.
Baxter, based in Deerfield, Illinois, sued shortly after Piramal said it would acquire Minrad.
The case is Baxter Healthcare Corp. v. Minrad Inc., 1:09- cv-00054-GMS, U.S. District Court, District of Delaware (Wilmington).
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‘Occupy Wall Street’ Draws Competing Trademark Applications
Two competing applications have now been filed to register “Occupy Wall Street” as a trademark, according to the most recent listings in database of the U.S. Patent and Trademark Office.
One group lists itself as “Occupy Wall Street,” and uses a New York City address. According to its website, Occupy Wall Street is a “leaderless resistance movement with people of many colors, genders and political persuasions.”
The other applicant, Fer-Eng Investments LLC, lists an address in Rancho Santa Fe, California. Vincent Ferraro of Fer- Eng told Cable News Network that his company had no affiliation with the movement and simply filed the application as a business proposition.
Both applications were filed Oct. 24. The California applicant said the mark would be used mainly for clothing and accessories such as T-shirts, backpacks and hats.
The New York applicant seeks to register the mark for a broader range of uses, including newsletters, periodicals, and photo, audio, video and press “educational and entertaining materials relating to Occupy Wall Street and the Occupy movement in general.” That application also seeks to register the mark for clothing items such as t-shirts.
The application from the California company doesn’t list an attorney. The New York application was submitted on Occupy Wall Street’s behalf by Wylie Stecklow, a New York attorney who does criminal defense, immigration and plaintiffs personal injury work, according to his website.
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‘Hello Dolly’ Set Design Infringed, Copyright Holder Claims
Smith, who died in 1994, was known for his innovative set design for American Ballet Theater productions such as “Rodeo,” “Fancy Free,” and “Swan Lake.” He also designed the Broadway productions of “Hello Dolly,” “West Side Story” and “Auntie Mame.”
Rosaria Sinisi of Brooklyn, New York, is the inheritor of the Smith copyrights, according to the complaint filed in federal court in New Orleans. For a fee, she licenses the copyrights for use in productions in the U.S, and abroad, she said in the complaint.
Broadway Bound Costumes Inc. of New Orleans bought a set for a production of “Hello Dolly” from a licensee, and used it for a production of the musical at Le Petit Theatre du Vieux Carre, in New Orleans’ French Quarter in 2003 and has since rented the set to productions in New York, Pennsylvania and Massachusetts, according to court papers.
Sinisi claims that the New Orleans company never had the right to use the design in any performance or to rent the set to others using this design. She also accused Broadway Bound of modifying the design without permission.
As a result of the company’s actions, Sinisi said she’s harmed and claims she will continue to sustain “substantial, immediate and irreparable injury” without intervention by the court.
She asked the court to bar further infringement of her copyright, and for awards of money damages, attorney fees and litigation costs.
Sinisi is represented by Jennifer Stierman Edwards and R. Vaughn Cimini of Cimini & Associates of Metairie, Louisiana.
The case is Sinisi v. Broadway Bound Costumes Inc., 2:11- cv-02625-ILRL-ALC, U.S. District Court, Eastern District of Louisiana (New Orleans).
First Infringement Notices Under New Law Hit New Zealand ISPS
The first infringement notices have been received by Internet service providers under New Zealand’s newest copyright regime, the New Zealand Herald reported.
To date, all notices were sent by the Recording Industry Association of New Zealand, according to the newspaper.
Most of the first batch of infringement notices were related to unauthorized downloading of music by Rihanna, Lady Gaga and the British musician Taio Cruz, according to the newspaper.
In many cases, teenage children of the Internet subscribers did the unauthorized downloading, which meant that the infringement notices are likely to be an unpleasant surprise to recipients, the Herald reported.
Taiwan Funeral Homes Become Music Copyright Enforcement Targets
As part of growing efforts toward copyright enforcement, nine infringement suits were filed against Taiwan funeral homes in connection with the pre-recorded music they use at funerals, the Voice of America reported.
The funeral homes say they shouldn’t have to pay the $30 per service demanded by the music studios, according to VOA.
The music is based on Buddhist chants and not protected by copyright, VOA reported.
The five Taiwan music-collection management societies may also begin demanding payment for live performances of music at some funerals, according to VOA.
Manga Creator Says Copyright Change Will Damage His Industry
Ken Akamatsu, creator of the “Negima” and “Love Hina” series of the Japanese comics known as “manga,” warned that changes in Japan’s copyright law could destroy derivative self- published works and diminish the entire Japanese comics industry, AnimeNation reported.
Japan is presently involved in regional trade-agreement discussions involving nine other nations, aimed at making copyright laws more uniform, according to AnimeNation.
If Japan joins the Trans-Pacific Partnership Agreement under discussion, a formal complaint from the content owner would no longer be required to trigger infringement prosecution, AnimeNation reported.
Akamatsu, who operates the j-comi.jp website, posts, with permission of the creators, derivative self-published works alongside the originals, according to AnimeNation.
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Mints Levin Scores Life-Sciences Litigator From Fulbright Firm
Mintz Levin Cohn Ferris Glovsky & Popeo PC hired John A. Bauer for its IP practice group, the Boston-based firm said in a statement.
Bauer, who joins from Houston’s Fulbright & Jaworski LLP, is a litigator. He has mainly represented clients in disputes involving life sciences and high technology.
He has an undergraduate degree in genetics from Ohio State University and a law degree from Catholic University of America.
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