About our Firm
Our website name and email domain says what we do: @ipfdalaw.com. We practice IP and FDA law individually and at the intersection of the two regimes.
Our attorneys also work closely with pharmaceutical and medical device companies through the entire development pipeline, from prototype development and clinical trials with an eye towards gaining FDA approval, through eventual patent applications and possible infringement challenges in court. We are well known in the representation of drug companies in Hatch Waxman Act/Paragraph IV litigation.
Our lawyers have first-chaired litigations at the USPTO PTAB, in federal district court, at the Federal Circuit court of appeals, at the ITC, and other administrative agencies. We are sensitive to the client’s goals to either: (i) litigate the case with an eye to settlement; or (ii) litigate with the goal of trial/appeals.
Every attorney has worked in the large global law firms and in boutique firms. We started Upadhye Tang LLP, initially as Upadhye Cwik. Though we have changed the name of our firm, we remember our founding partner Joe Cwik.
As a boutique firm, we are not beholden to rigid structures. We are open and flexible to different alternate fee arrangements. See our page on our flexible fee structures HERE. To be clear, our law firm is not built to bill countless and valueless hours; rather we are built to produce winning results, be cost effective and transparent, and ensure that we are aligned with our client’s goals.
Drugs
Few industries have such life changing impact on both a macro and a micro level as the pharmaceutical industry. With stakes high and many competing interests, all levels of government are heavily invested in making sure that pharmaceutical products are developed, tested and subject to the highest degrees of scrutiny when attempting to bring them to market.
As an increasing number of blockbuster drugs’ patents are set to expire, the market is inundated with opportunity and challenge. The race to bring lower priced generic equivalents to market has grown heated, and law suits are rising exponentially. Large pharmaceutical firms are seeking to extend patents as up-and-coming companies strive for approvals in this increasingly contentious space.
Our attorneys are embedded in the industry and offer keen insight into the changes in both the marketplace and in the legislative and regulatory space. We understand the issues from all sides: we provide counseling both to Branded and Generic drug companies. We are particularly adept at navigating the intersections of FDA, IP, and antitrust laws.
Our attorneys have strong relationships with the regulatory bodies in the pharmaceutical sector, and our expertise is recognized by industry associations and peers.
For Branded Companies seeking NDA or 505(b)(2) approvals, please see our in-depth practice description HERE.
For Generic Companies seeking ANDA or 505(b)(2) approvals, please see our in-depth practice description HERE.
FDA & GMP Compliance Practice
FDA regulatory issues are part of our core expertise. We have a robust counseling and compliance practice where we advise clients on matters relating to drug approval, drug marketing, supply chain management, and marketing and data exclusivity issues.
To learn more about our FDA & GMP practice, please see our in-depth practice description HERE.
Medical Device Patent and FDA Representation
For medical device companies, we help on the IP and FDA issues raised. We help counsel clients on prosecution strategies, due diligence, freedom to operate, and patent litigation. We also help work with clients to overcome the FDA regulatory obstacles that may exist in pushing the PMA or 501(k) through the process.
For Medical Device Companies, please see our in-depth practice description HERE.
Litigation
Our Litigation practice group steps in when our clients face adversarial challenges from government entities, competitor corporations, and from consumers in class actions alleging labeling, advertising and safety violations. Our firm has deep experience in FDA, USDA, and FTC disputes, patent and trademark infringement, commercial breach of contract claims and Paragraph IV challenges.
By thoroughly understanding the complexities of all facets of the food and drug industries, we are highly qualified to vigorously defend our clients’ interests in a range of forums from state and federal courts to regulatory agencies to alternative dispute resolution. Our team is prized for innovative litigation strategies which are increasingly emulated by others in this field and which provide streamlined and effective results.
To learn more about our Patent Litigation expertise, please see our in-depth practice description HERE.
To learn more about our Commercial Litigation expertise, please see our in-depth practice description HERE.
To learn more about our Consumer & False Advertising expertise, please see our in-depth practice description HERE.
Government Investigations
We can help client navigate government investigations by the State Attorneys’ General, the US FTC, DOJ, and the FDA.
To learn more about our Government Investigations practice, please see our in-depth practice description HERE.
Consumer False Advertising & Unfair Competition
With the rise of competition in the food, beverage, cosmetics, drugs, and device spaces, companies in these industries are increasingly subject to claims of deceptive advertising about health benefits. Many times the claims require a scientific expertise that can analyze the justification for the claim. We help clients substantiate claims, where possible.
To learn more about our Consumer False Advertising and Unfair Competition expertise, please see our in-depth practice description HERE.
Commercial Contracts and Licensing
We help clients with commercial contracts and licensing of pharmaceuticals and medical devices. Because we know the industries, we are aware of unique issues that relate to FDA regulated industries.
To learn more about our Commercial Contracts & Licensing practice, please see our in-depth practice description HERE.
