UT is your “go-to” US law firm for pharma and life science IP & FDA law. We harmonize patent strategy with the FDA standards, and take an integrated approach for your legal and business needs. Our team is focused, experienced, and flexible. We save costs by being communicative and efficient, and pass the savings to you.
We Understand Your Business
We are not just tough litigators
We are not just IP/FDA lawyers
We are in the life science business
We Help You Build A Winning Strategy
A winning strategy: one part
courtroom wins, two parts
business and regulatory solutions
We Fight For You In Court
Life science is big business
We fight the big fights
We don’t back down
Nimble, Tough, Thoughtful.
We Plan, Communicate, Execute.
For the Best Results.
Our attorneys started out as tough and efficient courtroom litigators and leading in-house counsels for large pharmaceutical companies. We fight toe-to-toe against some of the biggest law firms in the world.
We are experienced in Hatch-Waxman Act and other litigations involving branded, generic, and 505(b)(2) products, and use that experience for better counseling on all aspects of a pharmaceutical company’s product development cycle.
communication is key
We Will Help You Every Step Of The Way
what do you need?
our team of experts are here for you
We understand the technologies and the business. We plan meticulously and never back down from a good fight. Let us help you achieve your goals.
important things you should know
Questions And Answers
No. You should consider filing a 505(b)(2) NDA, which usually takes a significantly shorter time to be approved by the FDA. Furthermore, if the new formulation, or any aspect of your drug product, is patentable, you should definitely file patent applications to cover those aspects. Once your NDA application is approved and patent-protected, you can for a period of time prevent ANDA filers to your 505(b)(2) drug from going on the market. If you have a specific drug product in mind, please contact us for further discussion.
Absolutely not. Even in a big firm, the core pharmaceutical patent litigation team is often small and revolves around just a couple of key partners, though staffed with many associates. For us, a small, dedicated, and efficient team would work just well to represent your interests, and is better in several ways. First, a small team costs a lot less, because there won’t be many paralegals, science advisors, associates, and junior partners doing somewhat redundant work, or myriads of internal emails and team meetings to make sure everyone on a bloated team is (hopefully) on the same page. Second, as a client, you won’t get confusing or inconsistent messages from different team members when you engage a small team that knows what it’s doing. Our team worked at the global law firm and we learned what worked and didn’t.
No. You can file PIII certifications and/or Section viii carve-out statements to some of the patents. You want to start a PIV challenge on at least one patent, to give you a chance for the 180-Day Exclusivity. Once litigation starts, you can consider converting some of the PIII certifications to PIV, if the conditions are right. If you have a specific drug product in mind, please contact us for further discussion.
The short answer is that you are right, these lawsuits are expensive to fight. Empirical surveys show this is the case. We can help you look at the numbers, and explore cheaper alternatives to lawsuits such as the inter partes review and post grant review processes available at the patent office. Of course, a sensible settlement is always worth considering. If battle must be joined, there are litigation funding options we can discuss with you, and our firm is flexible in structuring our fees.
We are constantly exploring new ways to save our client’s money. We have a long experience working closely with contract review teams, which, with a good set of instructions, constant feedback, and close supervision, from our attorneys, can conduct excellent review at a fraction of the cost of what other firms might charge and you might have experienced. Recently, the use of artificial intelligence in document review has become available. We are actively but somewhat cautiously exploring using this new but still not quite mature technology. Clients can help reduce their own costs by exercising good document management protocols. We can help clients with suggestions on how to reduce the document burden.
Koi fish represent in some Asian cultures the characteristics of success, courage, perseverance, and good fortune. It is in that spirit that we provide our legal services to clients.
Absolutely. Our attorneys have successfully handled traditional patent infringement cases, commercial litigation, trade secret and trademark litigation, false advertising and antitrust cases, class action defense, white collar defense, government investigations, and patent cases involving food/nutritional supplements, medical devices, and even electronics. Aside from litigation and adversarial proceedings, our firm can also evaluate your patent portfolio, help you strategize your investment and product development, handle contract and licensing, and provide legal opinions including advice on FDA proceedings. Our firm does have a focus on life science including pharmaceuticals and biotechnology. Please contact us for more information.
Yes! Regardless of the nature of the patented technology, U.S. patent law and the federal courts that handle patent cases are the same. Our firm can help you protect and enforce your patents in a variety of technology spaces. We are experienced in federal court, ITC, and patent office proceedings, as well as licensing and cross-licensing negotiations.
No. Most patent and FDA related cases are governed by federal law. While the actual court house may be across the country, the law firm need not. And law firms (like ours) outside of NY and DC are often cheaper and we can practice anywhere in the country.
Of course! We represent (b)(1), (b)(2), and ANDA companies. We provide the same high quality and efficient services to all clients. As a brand company against a generic company, don’t you want someone who has a good sense on your generic side opponent’s strategy, concerns, and litigation styles?
We are flexible in our fee arrangements. Between the client and our firm, there must be trust and mutual respect. That’s why any arrangement has to be a win-win for both parties. You can learn more about our Philosophy on Legal Fees by clicking HERE.
A few reasons. First, our website domain name is ipfdalaw.com. It says what we do. Second, Shashank Upadhye writes the 1400+ page book on pharma patent and FDA law. So we literally write the book on the topics. Learn more about the book HERE. Third, we routinely publish other newsletters in the field to educate our clients as to what is going on in the industry. Read and subscribe to our articles HERE. Finally, you can see some of the recent cases HERE.