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Posts Tagged ‘ fda ’

When Lives Depend on Tech Transfer

Posted: Monday, Nov 3, 2014 @ 10:00 am | Written by Joseph Allen | No Comments »
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Posted in: Authors, Guest Contributors, IP News, Articles, Joe Allen, Pharmaceutical, Technology & Innovation, Technology Transfer, Universities

Every once and a while you get a reminder that lives are literally at stake in some R&D partnerships. Last Wednesday was one of those days. I was privileged to moderate a panel for the Congressional Technology Transfer Caucus on innovative partnerships fostered by the National Center for Advancing Translational Sciences (NCATS) the newest center/institute at the National Institutes of Health. It was anything but a run of the mill tech transfer session.

We often hear that $2 billion to $5 billion are required to commercialize a new drug, with 14 years or more required for development and a 95% chance of failure. Less well known is that for thousands of serious diseases plaguing humanity only about 500 have FDA approved treatments available. Stark as that seems it’s downright cheery compared to rare or neglected diseases. Of more than 6,500 such ailments only 250 have treatments. While these may be “rare” diseases for many of us, to millions of our friends, families and neighbors each morning brings another day of suffering desperately hoping that someone, somewhere is working on a cure.

SCOTUS: FDA Regulations No Bar to Lanham Act Claims

Posted: Thursday, Jun 12, 2014 @ 6:54 pm | Written by Gene Quinn | Comments Off
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Posted in: Advertising, False Advertising, Food & Drug Administration, Gene Quinn, Government, IP News, Articles, Trademark, US Supreme Court

Justice Kennedy

Earlier today the United States Supreme Court issued another of the many intellectual property related decisions the Court took during the October 2013 term. In this case, POM Wonderful LLC v. The Coca-Cola Company, the Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting that the label is deceptive and misleading is precluded by the Federal Food, Drug, and Cosmetic Act (FDCA). The Supreme Court ruled that a claim brought pursuant to the Lanham Act, which makes deceptive and misleading advertising actionable under 15 U.S.C. § 1125(a), is not precluded by the FDCA, which forbids the misbranding of food, including by means of false or misleading labeling.

This case arose relating to the belief of POM that claims made by the Coca-Cola Company were misleading with respect to a juice blend sold by Coca-Cola’s Minute Maid division. The juice sold by Coca-Cola prominently displays the words “pomegranate blueberry,” but in truth the product contains only .3% pomegranate juice and only .2% blueberry juice.

In a unanimous ruling delivered by Justice Kennedy (minus Justice Breyer who took no part in the decision) explained that there is no text within the statutes that would support the contention that the FDCA precludes Lanham Act claims. Indeed, the Supreme Court specifically found the FDCA and the Lanham Act to complement each other.

Pharma Update: News for April 2014

Posted: Friday, May 2, 2014 @ 8:00 am | Written by Gene Quinn | Comments Off
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Posted in: Biotechnology, Gene Quinn, IP News, Articles, Patents, Pharmaceutical, Technology & Innovation

What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. We also published several articles on topics of interest to those in the biotech and pharma world. Please see Compulsory Licenses Won’t Solve a Healthcare Crisis (written by Dr. Kristina Lybecker), Patents, Drugs and the Moral High Ground (written by Gene Quinn) and Leveraging Spin-Out Companies to Support Global Health (written by Erik Iverson, President of the Infectious Disease Research Institute). 

  1. Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Trial
  2. Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014
  3. Actavis Announces Celebrex® Patent Challenge Settlement
  4. TWi Announces Settlement of Lidoderm(R) Patent Litigation
  5. Supreme Court Denies Teva’s Request for an Injunction Relating to Generic Copaxone®
  6. FDA Approves Sublingual Tablet for the Treatment of Short Ragweed Pollen Allergies
  7. Court Enforces Settlement Agreement Between Mylan and Endo Regarding Generic FROVA®

Mylan’s Prevails in Perforomist® Patent Dispute

Posted: Monday, Mar 24, 2014 @ 4:42 pm | Written by IPWatchdog | Comments Off
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Posted in: IP News, Articles, Patent Litigation, Patents, Pharmaceutical

Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) Inhalation Solution, which has as the active ingredient a bronchodialating compound.  The district court confirmed the validity of all patents asserted by Mylan.  At issue were U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.

Mylan previously sued Teva alleging that Teva’s Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist.  After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva’s defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva’s ANDA. The Court’s decision also prevents Teva’s ANDA, which has yet to receive a tentative approval from the U.S. Food and Drug Administration (FDA), from receiving final approval prior to expiration of the patents in suit.

Seven IP Cases Slated on Supreme Court Oral Argument Calendar

Posted: Tuesday, Feb 25, 2014 @ 9:51 am | Written by AIPLA | Comments Off
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Posted in: AIPLA, Authors, Copyright, IP News, Articles, Patents, Trademark, US Supreme Court

The oral argument schedule for the Supreme Court over the next few months is heavy on intellectual property cases.

The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a case (Alice Corp.) on patent eligibility of system and computer-implemented method claims; on April 21, in a case (POM Wonderful) on claims under Section 43 of the Lanham Act challenging labels regulated by the Food and Drug Administration; on April 22, in a case (Aereo) on whether a provider of broadcast television programming over the Internet violates a copyright owner’s public performance right; on April 28, in a case (Nautilus) on the proper standard for finding indefiniteness invalidity for patents; and on April 30, in a case (Limelight) on joint liability for method claim infringement where all of the claimed steps are performed but not by a single entity.

Biotech and Pharma Update: January 2014

Posted: Friday, Jan 31, 2014 @ 1:50 pm | Written by Gene Quinn | 1 Comment »
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Posted in: Biotechnology, Federal Trade Commission, Food & Drug Administration, Gene Quinn, Hatch-Waxman, IP News, Articles, Pharmaceutical, Technology & Innovation

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of January 2014. Please also see Protecting IP is NOT ‘Satanic Genocide’, written by Dr. Kristina Lybecker.


All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1

On January 31, 2014, AbbVie (NYSE: ABBV) announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie’s investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients. Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates.

The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.

Pharma & Biotech Update: News for October 2013

Posted: Monday, Oct 28, 2013 @ 3:43 pm | Written by Gene Quinn | 2 comments
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Posted in: Biotechnology, Food & Drug Administration, Gene Quinn, IP News, Articles, Pharmaceutical

In an attempt to broaden our industry coverage I recently started a more comprehensive Pharma & Biotech monthly update. See Pharma & Biotech Update: News for September 2013.

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of October 2013. I also wrote a couple of other articles for the Patent Practice Center that could be listed here as well. See Forest Labs sues over Generic Version of SAVELLA® and FDA Designates Orphan Drugs Status for Rare Diseases.

Without further ado, here is the rundown for October 2013.

  1. Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer
  2. Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant
  3. NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals
  4. Shang Pharma Appoints Dr. Arthur Taveras President and CSO
  5. Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation
  6. Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation
  7. Therapeutic Vaccine for Hepatitis C Enters Phase I
  8. Urine Test for Cancer Monitoring
  9. Popular Prenatal Vitamin Patent Upheld in District Court
  10. Clinical Trials on Brain Technology to Assist ALS Patients
  11. Patent Awarded to Human Growth Hormone Booster
  12. Mouse Model of Parkinson’s Disease Shows Improved Brain Function
  13. DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™
  14. Actavis Files ANDA for Generic Suboxone® Sublingual Film
  15. AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz
  16. Innovative Cancer Treatment Wins Global Design Competition
  17. Teva Gets Favorable Ruling on COPAXONE in the Netherlands
  18. BVGH Recruits Dr. Linda Venczel as New Program Director
  19. Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott

Patent News and Notes

Posted: Thursday, Aug 1, 2013 @ 7:45 am | Written by Gene Quinn | Comments Off
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Posted in: Federal Circuit, Food & Drug Administration, Gene Quinn, IP News, Articles, Patents, Pharmaceutical, Practising Law Institute, USPTO

Summer is always a busy time for me. Between crisscrossing the country teaching the PLI patent bar review course, I also fit in a week teaching a class at John Marshall Law School. Between keeping up with the Federal Circuit, the inevitable end of term patent decisions from the Supreme Court and whatever nonsense Congress is thinking up (this year relating to patent trolls) I manage to stay pretty busy. What that means is a number of items typically fly under my radar screen until sometime toward the end of July. With this in mind I thought I would do a rundown of some of the more interesting items that perhaps didn’t support an entire article worth of attention.

1. Reed Tech takes over USPTO Contract from Google

Many are probably familiar the fact that the USPTO has wholeheartedly embraced the President’s Open Government Initiative (OGI) to provide increased transparency of government operations and information by making bulk data available directly to the public for no charge. To that end, the USPTO entered into a no-cost contract with Google a number of years ago. Under this no-cost contract Google scraped information from the USPTO servers, transferring the many image files into searchable text documents, which were then released to the public. But all good things must come to an end.

Pharma Update July 2013: FDA, Preemption & SCOTUS

Posted: Wednesday, Jul 24, 2013 @ 7:48 am | Written by Ed Silverman | Comments Off
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Posted in: Authors, Ed Silverman, Food & Drug Administration, IP News, Articles, Pharmaceutical

Once again, it is time to catch up on the news from the pharmaceutical industry. And so, here is the latest monthly compendium in which we attempt to highlight some of the more noteworthy and fascinating news with a focus on the Food and Drug Administration (FDA), preemption and the Supreme Court.

1. FDA to Allow Generic Drugmakers to Update Labeling

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval.

The moves comes in response to a US Supreme Court ruling two years ago that generic drugmakers are not required to strengthen product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.

FDA Approves New Labeling for Merck Blockbuster HIV Drug ISENTRESS

Posted: Wednesday, Jul 10, 2013 @ 10:44 am | Written by Gene Quinn | Comments Off
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Posted in: Biotechnology, Food & Drug Administration, Gene Quinn, IP News, Articles, Patents, Pharmaceutical

On July 1, 2013, Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets. The primary purpose of the FDA labeling requirements and regulations is to give healthcare professionals the information they need to prescribe drugs appropriately. See An Introduction to the Improved FDA Prescription Drug Labeling.

ISENTRESS is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination Human Immunodeficiency Virus (HIV) therapy. It is the first and only integrase inhibitor approved by the FDA. ISENTRESS had sales of $243,636,000 during Q1 of 2013, and has experienced growth quarter over quarter, which means that ISENTRESS is flirting with the $1 billion per year in sales that would make it a blockbuster drug. See Isentress Sales Data. The FDA approving new labeling seems likely to guarantee that during FY 2013 ISENTRESS will achieve blockbuster status.

The Food and Drug Administration (FDA), originally approved ISENTRESS on October 12, 2007, granting accelerated approval for raltegravir tablets (400 mg) for treatment of  HIV-1 infection in combination with other antiretroviral agents. ISENTRESS received a priority review by the FDA, with the review and approval of the New Drug Application being completed within six months. At the time of the initial approval the FDA explained that when ISENTRESS is used with other anti-HIV medicines, it “may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight other infections.”

ICAP to Sell Smokeless Electronic Cigarette Patent Portfolio

Posted: Tuesday, Jun 25, 2013 @ 12:04 pm | Written by Gene Quinn | Comments Off
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Posted in: Gene Quinn, IP News, Articles, Patent Business & Deals, Patents

Fig. 7 from U.S. Patent No. 6,769,436.

A variety of electronic cigarettes have hit the market in recent months, and lately it seems that I am seeing a lot of electronic cigarette commercials on TV. Retail sales for these tobacco alternatives are expected to eclipse U.S. market sales for tobacco cigarettes within the next decade. So there is a lot of interest in this technology as more and more states and cities ban smoking in public forums.

While there seems to be a lot of growing interest in electronic cigarettes from consumers, is there a commensurate level of interest in a patent portfolio covering the technology? We may soon have a definitive answer to that question. Last week ICAP Patent Brokerage announced that it would be selling a patent portfolio of heatless and smokeless cigarette technology that exclusively advances electronic cigarette science. The patent portfolio includes U.S. Patent No. 6,769,436 and related patents that are still pending. To view a demonstration of the technology covered by the ‘436 patent click here.

The disclosed smoking substitute is designed to have the feel, draw, and full taste satisfaction identical to that of tobacco cigarettes, thus providing a realistic smoking experience for users. However, this technology operates using only inhaled air rather than cartridges or batteries that require replacement. The patented smokeless cigarette contains a filter system and distributor. Inhaled air passes through a nicotine-moistened distributor to release nicotine vapor that is completely invisible. Simultaneously, the aerodynamic distributor filter system within the cigarette tube automatically recharges itself. Plus, this smokeless cigarette can be used anywhere without restriction as it does not emit any smoke, mist, or odor. Mist-emitting electronic cigarettes (like smoke-emitting traditional cigarettes) are already banned for use in many areas.

Pharma Law and Business Roundup: June 2013

Posted: Monday, Jun 24, 2013 @ 7:45 am | Written by Ed Silverman | Comments Off
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Posted in: Authors, Ed Silverman, Food & Drug Administration, IP News, Articles, Patents, Pharmaceutical, US Supreme Court

Once again, it is time to catch up on the onslaught of news emanating from the pharmaceutical industry. By now, most are probably are aware of a pair of Supreme Court rulings, but we will very briefly recap those and then move on to some other highlights. Here you go…

After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position held by the Federal Trade Commission, which argued the deals are anti-competitive because generic drugmakers are given incentive to file lawsuits against brand-name rivals and then settle for a quick profit, rather than challenge a patent in court. The FTC calculated the reverse settlments, as some call them, cost consumers $3.5 billion annually.

“This court declines to hold that reverse payment settlement agreements are presumptively unlawful. Courts reviewing such agreements should proceed by applying the ‘rule of reason,’ rather than under a ‘quick look’ approach,” Justice Stephen Breyer wrote in a 5-to-3 decision. “…The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment and the lack of any other convincing justification” (here is the ruling).