How to Align the FDA Approval Process with Paragraph IV Strategy Tips, Best Practices and Case Studies to Optimize FDA Results

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When it comes to ANDA approval, branded and generic drugmakers can agree on one thing — there are far too many lawsuits.

While Paragraph IV tends to be a lightning rod for lawsuits, why not try another approach, a proactive one that can better serve your company’s overall business goals with less reliance on yet another lawsuit?

Read on.

Paragraph IV of the Hatch-Wax Act makes it clear that when a generic company files an ANDA it also needs to certify against patents listed in the Orange Book.  It can do this one of two ways:

1. Suggest the FDA should approve its generic version after the date the last patent expires. (But what company wants to continue to wait to start making money?) Or…

2. Certify to the FDA that the generic version does not infringe on the listed patents or that those patents are not valid or enforceable.  This is the way most cases go — let the lawyers put on the gloves and duke it out.

But it doesn’t have to involve years of litigation and millions in expenses, if you sharpen your Paragraph IV expertise and align it with your approval strategies.

For example, to improve their Paragraph IV defense strategies, branded companies can, on an ongoing basis, evaluate possible FDA issues with bioequivalence, “sameness” and labeling — and prepare their patent litigation teams to spot potential weaknesses early.

And to bump up their approval rates, generics manufacturers can hit the legal stacks and FDA records to fully elevate ANDA and development histories to avoid FDA hotspots, better prepare witnesses for FDA issues in depositions, and more.

To learn about these innovative ways to snag more approvals, mark your calendar for Thursday, June 2, 2011, when leading FDA lawyer Chad Landmon, Esq. will show how you too can revive approvals without scorched earth legal machinations.

Mr. Landmon is a recognized expert in Paragraph IV litigation and Hatch-Waxman Act matters. As chair of the FDA Practice Group at Axinn Veltrop & Harkrider LLP, he has helped dozens of drug companies struggle through these issues.

While no stranger to the courtroom, Mr. Landmon recognizes that internal coordination and proper planning often leads to better outcomes than lawsuits.  You’ll come away from this 90-minute webinar with a better idea of whether or not it’s best to let the lawyers do their thing.

Here are just a few specifics Mr. Landmon will cover:

  • Implementing Paragraph IV strategies without losing sight of FDA approval strategies
  • Training the patent litigation team to spot FDA issues
  • Mastering the marketing exclusivity game and matching it to Paragraph IV strategies
  • How to both preserve and challenge a variety of exclusivities
  • And much more…

How to Align the FDA Approval Process with Paragraph IV Strategy is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. Landmon will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

Is it really possible to restrain trigger-happy legal staff and get them to sit down with your drug approval and marketing people, to work out tactics that can serve your company’s strategic goals? It is, so don’t miss out on this outstanding opportunity to learn more.

This is an ideal learning opportunity for company leadership and legal staff. Be sure to invite as many participants as will benefit, including (but not limited to):

  • CEOs/COOs
  • General Counsel
  • Outside Counsel
  • VP/ Directors of Regulatory Affairs
  • VP/Directors of IP
  • VP/Directors of Portfolio Management

Chad Landmon Esq. is a partner at Axinn Veltrop & Harkrider LLP, where he chairs the FDA Practice Group. He specializes in Paragraph IV litigation and Hatch-Waxman Act issues including: marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling and other matters affecting FDA approval, development and marketing of new and generic drugs. He frequently speaks and writes on issues relating to the Hatch-Waxman Act and pharmaceutical patent litigation. 

Register now!

Date: June 6–24, 2011
Location: Your office or conference room (no need to travel!)
Time: Anytime

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