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Pharmaceutical Lifecycle Management

Pharmaceutical Lifecycle Management

Pharma Lifecycle Management (PLM) Law Firm having Offices in Boston, Los Angeles, Orange County, and San Diego

One part of our firm's mission is to assist our clients with bringing as many therapeutic drugs and medical devices to market as possible. Our firm's pharmaceutical lifecycle management lawyers have assisted our clients with developing strong pharmaceutical lifecycle management strategies at every stage of the patent term.

The purpose of managing a drug's patent lifecyle is to legally protect a company's ability to improve the safety and efficacy ("effectiveness," in other words) of the underlying drug to treat a certain medical condition. In addition, this legal protection provides an incentive for the company to research and invent new forms of the drug, and possibly new methods of treating unexpected medical conditions, which were not conceived at the time of the original invention. In our view, that is a win-win result that is good for everyone involved.

Our clients spend billions of dollars researching, developing, and creating a recognized market for a *single* drug to help patients in need. High failure rates, the long term investment needed for research and development, and the very tall hurdles erected by each international jurisdiction into which our clients seek to enter make the business of drug development very risky.

In fact, more than a decade will have passed after a first patent application is filed when a putative new therapeutic substance might be approved for sale. Because only 1 or 2 in every 10,000 substances synthesised will meet the high hurdles of safety and effecacy, we help our clients maximize their investment in researching and developing lifesaving therapies.

Generally, a PLM strategy will involve a variety of related patent application submissions:

Pharmaceutical Lifecycle Management Patent Strategy:

  • Composition of Matter (COM) Patents: Covering the core novelty of the active pharmaceutical ingredient (API) itself, the molecule responsible for the drug's therapeutic effect.
  • Formulation Patents: Protecting unique ways of formulating the drug, such as extended-release tablets, inhalers, or nanoparticles, to improve drug delivery, efficacy, or patient compliance.
  • Method of Use Patents: Granted for novel therapeutic uses discovered for existing drugs during later stages of PLM. For example, a drug initially approved for treating heart disease might be patented for a newly discovered application in treating cancer.
  • Process Patents (Methods of Manufacture): Protecting innovative methods for manufacturing the drug or specific steps within the manufacturing process. This can encompass unique purification methods, novel catalyst usage, or particular crystallization techniques.
  • Dosage Regimen Patents: In some jurisdictions, patents might be obtained for specific dosing schedules or treatment regimens using the drug, offering additional protection beyond the core molecule.

These strategies involve not only submitting Continuation, Continuation-in-Part, Divisional applications, Patent Term Extension, and Patent Term Adjustment under US federal law, but also patenting inventions related to novel and non-obvious:

Extended Invention Types:

  • Solid-state salt screens
  • Salt switches
  • Polymorph screens and switches
  • New dosage forms
  • Anticipating Risk Evaluation and Mitigation Strategies regulation
  • Companion Diagnostics
  • Intermediates and Metabolites
  • Improved bioavailability
  • Controlled release
  • Improved stability
  • Methods of screening
  • Rescues and repurposing
  • New indications
  • New modes of administration
  • Pharmacokinetic profiles
  • Pharmacodynamic profiles
  • New dosage regimens
  • Methods of manufacture

The patent attorneys, engineers, scientists, and patent agents at Torrey Pines Law Group have worked in a variety of pharmaceutical industries, both branded and generic, and have assisted with commercializing, researching, and developing pharmaceutical technologies including:

PLM Expertise:

  • Small molecule pharmaceuticals
  • Biopharmaceuticals
  • Central and peripheral pain therapeutics
  • Pharmaceutical formulations
  • Drug combinations
  • Pharmaceutical delivery methods
  • Immuno-Oncology Indications
  • Antiviral drug screening
  • Enzyme mimetics
  • New Salts and Polymorphs
  • Cardiovascular Indications

We welcome the opportunity to provide you more detailed information about our firm and see how we can work together. Please contact us to schedule a free initial consultation, and follow us on Facebook, Twitter, and LinkedIn.

≡
  • Comprehensive IP Protection
  • Patent Preparation & Prosecution
  • ● Artificial Intelligence Patents
  • ● Biotechnology Patents
  • ● Chemistry Patents
  • ● Convergence Technology Patents
  • ● In Vitro Diagnostics Patents
  • ● Lasers & Optics Patents
  • ● Medical Device Patents
  • ● Pharmaceutical Patents
  • ● Pharmaceutical Lifecycle Management
  • ● Semiconductor Patents
  • ● Software Patents
  • ● Telecommunications Patents
  • ● Telemedicine Patents
  • National Phase Entry (PCT)
  • IP Litigation
  • IP Opinions & Counseling
  • IP Resources
    • Patent Rights Overview
    • International Patent Law
    • U.S. Patent Law
      • Patent Eligibility
      • Novelty
      • Obviousness
      • Written Description
      • Enablement
    • Anatomy of a U.S. Patent
      • Utility Patent
      • Design Patent
      • Plant Patent
    • Trademark Law
    • Copyright Law
    • Trade Secrets
    • Know How
    • Intangible Assets

Chambers Spotlight California 2025 Torrey Pines Law Group   Clio Reisman Award Torrey Pines Law Group COPYRIGHT © , TORREY PINES LAW GROUP, PC. ALL RIGHTS RESERVED. | LEGAL NOTICES | SITE MAP

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.

Pharmaceutical Patent Attorneys - Pharmaceutical Patent Preparation & Prosecution Lawyer - Pharmaceutical Intellectual Property Litigation Law Firm - San Francisco Biopharmaceutical IP - New Jersey Pharmaceutical Lawyers - Cambridge Pharmaceutical Counsel