Combination Products Need Careful Patent Strategy

As health care products continue to evolve in the 21st century, combination technologies are becoming more and more common.  In fact, the market for combination products has doubled in five years and some have predicted the industry will rise to $10 billion this year.  While 90% of that total can credited to the sales of drug-eluting stents, plenty of other products, such as orthopedic implants to regenerate bones, are coming out of the woodwork.

These facts set the stage for an interesting article that recently appeared on Mass High Tech.  Author and patent attorney, Joanna Toke, argues that these combination products face unique hurdles in entering the marketplace, and mastering a patent and regulatory strategy is necessary for success.  She has outlined a step by step process that every company should follow when developing one of these products, and we will discuss the highlights of her article.

First, a company must have comprehensive patent coverage to protect their technology.  This means coverage of the device, the biologic, and the device/biologic combination.  Then, once improvements to the technology are made, a company should also make it a goal to also patent those improvements in order to completely insulate their technology.

Next, Toke states that picking the right law firm is critical, as they must have experience in both biologics and medical devices.  Knowledge of both fields is necessary as the firm needs to effectively prosecute patents directed toward each aspect of the product.

Then, the attorneys should conduct a search to determine whether the company is free of third-party patents and can practice its invention.  Once this search is completed on every aspect of the device, the product can be designed to avoid infringing other discovered patents.

Finally, when a product is submitted to the USFDA for approval, it is assigned to a particular center within the FDA.  But inventor beware, as products may be wrongly assigned to unfavorable offices.  Therefore, companies should explain why the combination product should be sent to a particular destination in order to avoid costly delays.

While this definitely not every step that a company must take to ensure that their IP is protected, Toke’s article is definitely a start in the right direction.

Abbott Sues Mylan over AIDS Drug

Abbott Laboratories has accused Mylan Inc. of infringing on two patents for Kaletra, a drug used for AIDS.  The patents are due to expire in 2021, but Abott contends that Mylan plans to sell generic copies of Kaletra before that time, reports the Chicago Tribune.

Abott filed the lawsuit after Mylan announced that is Matrix Laboratories, based in India, had received a USFDA approval for the tablets under the president’s Emergency Plan for AIDS relief.  Abott says that they company will be “irreparably harmed” if the generic versions of Kaletra aren’t blocked.

Article One Looks to Review Singulair Patent

Teva Pharmaceuticals and Merck & Co. are currently tied up in a lawsuit over Merck’s blockbuster drug, Singulair.  While the two are busy battling it out in the court room, and independent firm has just made the case a little more interesting.

According to CNN Money, Article One Partners LLC, an independent firm, specializes in challenging the validity of patents.  Article One has requested that the USPTO review a patent for Singulair, because their online community found two pieces of prior art that suggest the key ingredient in Singulair isn’t novel.

We’ll have to wait and see what impact, if any, this news will have on the case.  Teva had applied to the U.S. Food and Drug Administration for a generic version of Singulair, but Merck responded in 2007 by filing a lawsuit.  The mandatory stay on Teva’s generic Singulair launch is due to expire in the summer, making the current trial even more important.

Singulair generated $4.3 billion last year which accounted for 18% of all Merck sales.

Should the USPTO Use Twitter?

In a recent blog post on Promote the Progress, J. Matthew Buchanan states his position that the USPTO should start utilizing Twitter.  He points out that several other government agencies are already using the system like NASA, the FDA, and even President Obama.

The post states the potential advantages that could arise from the USPTO using Twitter.  First of all, the office could use Twitter to post news items and other links from its news pages.  Using Twitter would also be an easy avenue to instantaneously distribute critical information to Office stakeholders, who may have Twitter updates sent directly to their mobile phone.  Furthermore, the USPTO could use Twitter to answer questions from the community and provide live updates from important meetings.

Yet, the USPTO may not want to use Twitter because of the stigma that could be associated with social networking.  It may be thought that using systems such as Twitter would lower the reputation of the agency, because it is not an established media outlet.  However, such an opinion may not hold much weight, considering how effectively President Obama utilized Twitter and Facebook during this past election.

Buchanan has stated that he has already established a USPTO account on Twitter, and that he will gladly transfer it to someone from the Office.  He has also started to post items that have been made public by the Office.

Of course if you want in depth patent news, you can always follow DynamicPatents on Twitter!

Cubist to File Suit against Teva

Earlier this week, Teva Parenteral Medicines announced they were filing a new drug application for a generic version of Cubicin, a product of Cubist Pharmaceuticals.  According to TradingMarkets.com, Cubist has responded by announcing that they will be filing a patent infringement lawsuit against Teva. 

Cubicin is a treatment for serious skin and bloodstream infections, and Cubist believes their patents prevent Teva from launching a generic version.  Yet, in their notice letter, Teva mentioned to the FDA that two patents for Cubicin expire in September 2019 and June 2016.  Teva maintains that they do not infringe on the patents, nor are the patents invalid.

If Cubist initiates a patent infringement lawsuit within 45 days of receiving the notice letter from Teva, then the FDA would not approve Teva’s drug application for 30 months, or until there was a court ruling on the matter.

“We have confidence in our patents and intend to assert our rights vigorously,” Michael W. Bonney, Cubist’s president and chief executive, said in a statement. “TPM’s filing in no way affects the priorities we have as a business. Our business goals and guidance for 2009 remain unchanged.”