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 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.
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 generic companies seeking to challenge patents and overcome regulatory obstacles to bring drugs to market, and to brand name pharmaceutical companies seeking to strategically patent and protect brand name products. We are particularly adept at navigating the intersections of FDA, IP, and antitrust laws.
We guide our clients through the evolution of their products, from initial development and testing through approval and challenges. In addition to acting as a strategic partner at inception, we remain with our clients when challenged by competitors and governmental agencies: we provide clients with experienced counsel in Paragraph IV litigation, False Claims Act (whistleblower) suits and patent disputes to name a few. Our attorneys have strong relationships with the regulatory bodies in the pharmaceutical sector, and our expertise is recognized by industry associations and peers.
We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate with drugs and devices. This includes helping with financial, operational, marketing, and investigatory/enforcement issues.
In addition to acting as strategic regulatory counselors from product inception, we remain with our clients through subsequent stages, including when they are challenged by competitors or governmental agencies, defending against consumer class action suits, responding to FDA Warning Letters, and defending patent infringement claims and commercial disputes, to name a few.
505(b)(2) Specialist – Drug Reformulation and Re-positioning
We also maintain a robust practice with drug re-positioning and life cycle management. We help pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. We can assist 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity.
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, ITC 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.
We can help client navigate government investigations by the State Attorneys’ General, the US FTC, DOJ, and the FDA.
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.
Patent & Trademark
Our intellectual property litigation experience includes prosecution and defense of patent and trademark infringement actions and competitor false advertising litigation under Section 43(a) Lanham Act. Our services in this area include:
Paragraph IV, Hatch-Waxman, patent and FDA litigation
Representing clients in enforcing their patents and trademarks, and defending against claims of infringement and disputes concerning inventorship and ownership
Developing strategic litigation strategies including counterclaiming and alternative business objectives such as cross-licensing
Participating in administrative proceedings before the Patent Trial and Appeal Board (PTAB) and the Trademark Trial and Appeal Board (TTAB)
Advising on all aspects of patent litigation including infringement and validity analysis
Prosecution history issues relating to priority of invention and inequitable conduct; patent misuse and damages; antitrust issues and preliminary and permanent injunctions
Counseling on all aspects of trademark litigation including trademark and trade dress infringement, likelihood of confusion analysis, protection of goodwill and brand value of client products, oppositions to pending trademark applications and petitions to cancel existing registrations
Litigating claims of unfair competition, tortious interference, antitrust and related state law claims.
Our business litigation practice encompasses all facets of commercial relations particular to the FDA regulated industries. Much of our work focuses on breach of contract cases involving IP licensing, supply chain problems, theft of trade secrets (including covenants not to compete), and manufacturer/supplier disputes. Examples of our work include:
Assisting with breach of contract matters related to defective manufacturing, misuse or theft of IP confidentiality and non-compete
Litigating corporate matters such as partnership and shareholder disputes
Counseling on all aspects of trade regulation and competitive disputes
Prosecuting and defending professional and product liability claims
Defending state and federal business claims involving the False Claims Act, breach of contract, fraud, replevin, anti-kickback statutes and tortious interference.
Brand & Generic Drug Leaders
Our drug company clients come to us because we help them grow their business. Patents and other FDA regulatory obstacles exist, but we help our clients overcome these legal obstacles. By employing keen business and legal sense, we help our clients win the race to the market, whether on the brand side or generic side. We do this by exercising great business judgment on legal strategy and when necessary, in Paragraph IV- Hatch Waxman litigation. We help provide strategic advice both to generic companies seeking to challenge patents and overcome FDA hurdles to bring drugs to market, and to brand pharmaceutical companies seeking to strategically create patent and FDA barriers to protect their brand name products for the long term.
We are well known in the representation of 505(b)(2) and generic drug companies in Paragraph IV litigation: the process whereby 505(b)(2) and generic companies challenge patents held by brand name companies in order to bring these important, often life-saving, medications to the market in alternate or generic forms. We know this space very well because we live it each day. We know what strategies will work and which won’t. We partner with our clients to provide excellent value-added legal advice that drives their business forward. We are never afraid to litigate, but we also know the value of a strategic settlement. Our client’s business needs come first. This is why clients call upon us.
Shashank Upadhye, Practice Group Leader, is globally recognized as a thought-leader in the area of Brand to Generic Drugs: he is the author of the key legal treatise on the topic, “Generic Pharmaceutical Patent & FDA Law,” (now in its 11th Edition). With years of chief in-house counsel experience at three different international pharmaceutical companies, he is regularly sought out for his interpretation of patent law in the Brand to Generic process and is a frequent keynote speaker at conferences on pharmaceuticals, FDA, antitrust and health care law.
In addition to the firm’s extensive knowledge of the Paragraph IV litigation process, the team represents drug companies at every stage of the lifecycle of their products including:
Strategic advice at the beginning of the development pipeline
Prototype development and clinical trials with an eye toward gaining regulatory approval, and
Eventual patent applications and possible challenges in court
The firm also provides counsel on matters such as product launch management, pre-market approval, labeling, advertising, cGMP (Form 483 observations and Warning Letter responses), and litigation. Our members have deep experience in abbreviated new drug applications, patent opinions and ANDA/Hatch-Waxman patent litigation.
Our lawyers help clients understand and navigate the complex intersection of IP, patent, and antitrust laws, specifically on NDA’s, paper NDA/505(b)(2) applications, ANDAs, suitability petitions for different forms, trademark issues in drug dosage forms (the issues related to size, shape, and color), the 180-Day Exclusivity, Orphan Drug Exclusivity (ODE), REMS protections, and other FDA related non-IP exclusivity.
Patent Protection, Licensing, and Freedom to Operate
When working with clients, our attorneys seek to craft patent applications that look beyond mere patentability to meaningful enforceability when tested in litigation or in other contexts. With extensive experience in both FDA regulations and patent law, we are well-positioned to advise companies on the complex inter-relationship between the two.
Our objective is to provide patent counseling that covers the range of issues from prosecution to protection from infringement. We also assist in finding ways to maximize a patent portfolio’s value in the marketplace by employing such strategies as licensing and freedom to operate.
We are experienced in foods, drugs, supplements, cosmetics, medical devices, biotechnology, and human and animal life sciences, providing our clients with patent advice and representation that is fully sensitive and responsive to particular business and regulatory contexts.
The full extent of our patent counseling includes:
Analyzing patentability for new technologies
Conducting U.S. and international patent searches encompassing state of the art and infringement
Providing opinion letters related to freedom-to-operate, non-infringement and validity/invalidity
Counseling on Hatch-Waxman issues pertaining to branded and generic drug products including non-patent exclusivity periods for new drugs, patent term extensions and expedited FDA approval processes
Providing strategic IP counseling related to infringement risk analysis, mitigation, patent design-around and maintenance and review of IP Portfolios
Counseling on and assistance in International Trade Commission (ITC) matters including proceedings initiated under Section 337 of the U.S. Tariff Act
Preparing and filing of United States and foreign patent applications and patent maintenance
Assistance in patent proceedings such as IPRs, re-examination, interference, and infringement