Adli Law Group

Chemical

We provide a full range of services in the chemical arts, including patent litigation, patent procurement, and opinion work. Adli Law Group is experienced in litigations involving the chemical arts in district courts and before the International Trade Commission (ITC). Our attorneys are also experienced in drafting and prosecuting patent applications before the US Patent and Trademark office. If you have discovered a new compound, our attorneys will work with you to protect not only that compound, but possible structurally relayed compounds. Often a client’s invention is a new composition that contains the combination of already known ingredients. Our attorneys will work with you to protect the broadest combination of ingredients to minimize design arounds. Out attorneys can also help you protect new synthesis methods and uses.

Biotechnology

We advise clients on how to best protect their biotechnology invention and how to avoid infringement of biotechnology patents. A common challenge with biotechnology inventions is formulating a strategy to protect a final product in order to maximize commercial value of the invention. For example, in a well-known patent case, the inventors at University of Rochester discovered that inhibiting one COX receptor and not the other decreased the side effects of NSAIDS. However, the inventors did not have any compound to show that such selective inhibition was possible. The court in that case found the patent invalid since it claimed a method of treating with a compound that it did not disclose. We can advise you to avoid these common pitfalls with biotechnology inventions.

Another issue with biotechnology inventions is how to disclose and claim a sequence to obtain the greatest protection. Our attorneys draft patent applications in a way that provides you with the broadest patent protection for your sequence.

Medical Device

A medical device is a cross section of the field of life sciences and engineering. We approach protection of a medical device from both of these perspectives. From the engineering perspective, we draft claims with the least features of the device as possible. We then aim to link the medical device to therapeutic and other advantages that it may have so that the medical device is not considered just another mechanical device, but a device with therapeutic and other advantages deserving of a patent.

Pharmaceutical

Our attorneys have years of experience in pharmaceutical prosecution, opinion work, and litigation, which enables us to offer the full range of IP services to our pharmaceutical clients, including obtaining the maximum protection for our clients’ pharmaceutical products.

At first glance, a pharmaceutical patent application may be considered as just another chemical patent application. But we believe that a pharmaceutical patent application needs to be drafted differently than a chemical application, with an emphasis on protecting the final pharmaceutical product that is administered to a patient.

We try to protect not only an active pharmaceutical ingredient when novel, but also the indications of use, the formulation, the polymorphs, the intermediates, combinations, dosages, metabolites, the routes of administration, etc. We understand that many pharmaceutical patent applications relate to active pharmaceutical ingredients that are already known, and we try to protect an improvement over existing, known, ingredients.

If a client has a novel compound that is useful as an active pharmaceutical ingredient or even as an intermediate, then we try to obtain a patent on that compound for our client. We try to broaden the claims to cover compounds that are similar in structure. We believe in obtaining the best possible protection for our clients by drafting broad claims without encompassing the prior art and without having many compounds without utility falling within the claims . We note that the standard for showing utility for a compound as a pharmaceutical before the patent office is much lower than that before the FDA and that a human clinical trial is not necessary to establish utility for an invention related to treatment of human disorders. Often a new indication of use is discovered for an already known compound. For example, a client discovers that aspirin can be useful for preventing colon cancer in addition to being an analgesic. We try to obtain a patent to the new method of use of aspirin for prevention of colon cancer, even though aspirin is already known.

Another area for patent protection is a pharmaceutical formulation. The basis for patentability of a pharmaceutical formulation can include for example more stability, longer shelf life, easier manufacturing, more bioavailability, etc.

Whenever possible, we pursue a patent strategy to new dosages. The classic example of a new dosage is Bristol-Myers Squibb’s U.S. Patent 5,621,001 to Taxol claiming a new dosage that reduces neurotoxicity.

Dietary Supplements & the FDA

Adli Law Group can help you determine if your dietary supplement meets FDA guidelines. Dietary supplement manufacturers and other parties must make sure that product label information is truthful and not misleading. The labels cannot make statements about treating or curing a disease, and any “structure/function” claim (such as supports bone strength) must be substantiated by evidence.

Also manufacturers and other parties must comply with the Dietary Supplement Current Good Manufacturing Practices for quality control. In addition, manufacturer and other parties are required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.

Furthermore, the Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a “new dietary ingredient.” The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

Adli Law Group can help you comply with FDA rules.