Pharma

Pharmaceuticals on lab table

We represent individuals, academic and research institutions and companies in the pharmaceutical arts.

Three of the DDK partners are licensed pharmacists and, prior to becoming patent attorneys, have taken courses, e.g., in organic chemistry, inorganic chemistry, medicinal chemistry, physical chemistry, biochemistry, physics, microbiology, physiology, pathophysiology, toxicology, pharmacokinetics, pharmacology, laboratory principles, clinical pharmacy, and pharmaceutical technology. They understand the science, the technology and the business needs of pharmaceutical companies and, combined with their legal expertise, are able to provide and supervise direct, creative, cost-effective strategic advice regarding development, enforcement, life-cycle management, and commercial exploitation of pharmaceutical products.

DDK has drafted and prosecuted patent applications covering virtually all areas of drug development, including new chemical entities, new pharmaceutical formulations (immediate release, controlled release, and multiphasic release; oral dosage forms; injectables; implantables; inhalations, intranasal, sublingual, buccal, suppository and topical formulations; transdermal devices; and opthalmics), pro-drug technologies, new combinations of previously known drugs; new modes of administration of previously known drugs; methods of treatment, including, e.g., pharmacokinetic profiles and new dosing regimens of known drugs; impurity profiles of APIs; shapes of pharmaceutical dosage forms; scents of pharmaceutical dosage forms; abuse-deterrent technologies; pharmaceutical excipients, and methods of preparing pharmaceutical dosage forms.

DDK attorneys are well-known to think “out-of-the-box” and have pioneered strategic patent focus on the pharmacokinetic profiles and the pharmacologic activity of drugs/drug formulations for both established Pharma companies and start-ups.

We have strategized with our clients to protect many platform technologies in the Pharma arts, including but not limited to tablet matrix technologies including delayed release, controlled release, sustained release, fast dissolving, oral, buccal, injectable, implantable, suppository, transdermal patch, topical creams, ointments, lotions and gels, inhalation powders and sprays, intranasal sprays, and the like. Some of these technologies have become well-known and trademarked (e.g., TIMERx®, Direct Effects™, etc.). We have also protected platform technologies for many successful pharmaceutical excipients, such as Prosolv®.

We have strategized with our clients and been involved with the patent protection for many successful pharmaceutical formulations, including patent protection for drugs such as Oxycontin® (oxycodone HCl extended release tablets), Ryzolt® (tramadol HCl extended release tablets), Opana® ER (oxymorphone HCl extended release tablets), Butrans® (buprenorphine transdermal system), Subsys® (fentanyl sublingual spray), Hysingla® ER (Hydrocodone Bitartrate extended-release tablets), Aptensio XR® (methylphenidate HCl extended-release capsules), Targeniq™ ER (oxycodone hydrochloride and naloxone extended-release tablets), Caldolor® (intravenous ibuprofen), Kristalose® (dry powder crystalline formulation of lactulose), among others.

We routinely coordinate and oversee worldwide prosecution of our clients’ patent filings. We have spearheaded strategies for bringing and defending oppositions of foreign patent filings on behalf of our clients, for example, in Europe, Japan, Australia, and Chile.

We have conducted due diligence reviews; rendered patent landscape and freedom to operate opinions; and cleared products for our Pharma clients. On the other hand, we have conducted patent infringement reviews of our clients’ patents.

We have evaluated pharmaceutical formulations with respect to U.S. FDA Orange Book patent issues and guided our clients through patent issues arising with the filing of New Drug Applications (NDAs and 505 (b)(2) applications), and drafted Paragraph (IV) Notice Letters for ANDA filings.

We have also represented clients regarding a variety of Nutraceuticals and dietary Supplements.

In addition to working with formulation technologies, we are well-versed with respect to biomedical devices, and have experience with a variety of technologies including but not limited to inhalation devices and venipuncture devices.

Chemical

Beakers and Jars used for chemistry

We represent individuals, academic and research institutions and companies in chemical, pharmaceutical, food, academic and metallurgy arts.

DDK attorneys have taken courses, e.g., in organic chemistry, inorganic chemistry, medicinal chemistry, physical chemistry, biochemistry, laboratory principles, pharmaceutical technology, chemical engineering and metallurgy prior to becoming patent attorneys, and, combined with their legal expertise, are able to provide direct, creative, cost-effective strategic advice on the development and commercial exploitation of chemical and materials science-based innovations.

DDK has drafted and prosecuted patent applications covering, e.g., new chemical entities (NCE), polymers, adhesives, alloys, catalysts, coatings, cosmetics, nanotechnology, flow chemistry, new methods of preparing known compounds and APIs, methods of controlling particle size and particle distributions, methods of controlling formation of potentially genotoxic impurities, and methods of improving stability of pharmaceutical compositions and dosage forms, steels, and their application in automotive, construction, household appliances and packaging industries.

Biotech

centrifuge used for biotechnology

We represent individuals, academic and research institutions and companies in the biotechnology art. DDK has drafted and prosecuted patent applications covering antibodies; antibody-peptide conjugates; biologics; oligonucleotides; therapeutic and diagnostic peptides, peptidomimetics; stem cells, vaccines; transgenic plants; transgenic animals; uses of the antibodies, antibody-peptide conjugates, biologics, oligonucleotides, peptides, peptidomimetics, stem cells, and vaccines for the diagnosis, prevention and treatment of various diseases; and diagnostic methods involving DNA techniques and analysis of genetic information. A particular focus of DDK has been working with start-up biotechnology companies and drafting and prosecuting patent applications directed to uses of known diagnostic antibodies for the treatment of various diseases.

Mechanical

engine with drive belt

DDK has prosecuted, litigated and provided counsel with respect to hundreds of inventions in various mechanical fields of art, including nuclear energy, aeronautics, automotive drive trains, rail transport, fuel cells, nonwoven fabrics, convertible vehicle tops, printing presses, industrial machinery and pet products. More specifically, DDK performs substantial work with respect to, for example, torque converters, camshaft phasers, airplane engines, handheld power tools, electromagnets, medical devices, food processing equipment, paper machinery, military equipment, turbomachines, bearings, vibration dampers and exhaust gas purification systems.

Electrical

lightbulb lit up with black background

DDK has extensive experience in drafting and prosecuting patents in the electrical arts, as well as drafting opinions of counsel evaluating the validity, infringement, and enforceability of electrical patents. Representative subject matter includes solid state image sensors, electromechanical devices, field effect transistors, semiconductors, computer servers, digital electronics, wireless data transmission systems, robotics, batteries, telecommunication and electronic control systems.

Computer

computer processor chip

DDK has substantial experience with a wide variety of computer hardware and software inventions, in areas including pharmaceutical analytics, aircraft control systems, data analytics, bioinformatics, cryptography, aircraft and automotive diagnostics, gaming, image processing and various other internet, mobile and e-commerce applications.