Intellectual Property

 Intellectual Property

Intellectual property (IP) rights, particularly patents, play a crucial role in the pharmaceutical industry. Patents provide pharmaceutical companies with a period of market exclusivity, allowing them to recoup their research and development costs and generate profits. However, there are also regulations and mechanisms in place to balance these exclusive rights with the public interest in accessing affordable medicines.

6.1. Patents:

• Purpose: Patents grant inventors the exclusive right to make, use, and sell their inventions for a limited period (typically 20 years from the date of filing). In the pharmaceutical industry, patents protect new drugs, formulations, manufacturing processes, and uses.

• Types of Patents:

  • Compound Patents: Protect the chemical structure of a new drug.

  • Formulation Patents: Protect a specific formulation of a drug (e.g., a sustained-release tablet).

  • Process Patents: Protect a new method of manufacturing a drug.

  • Use Patents: Protect a new use of an existing drug.

• Patentability Requirements: To be patentable, an invention must be:

  • Novel: It must be new and not previously known to the public.

  • Non-Obvious: It must not be an obvious modification of something already known.

  • Useful: It must have a practical application.

• Patent Application Process: The patent application process is complex and can take several years. It involves submitting a detailed description of the invention to a patent office (e.g., the USPTO in the US, the EPO in Europe), which examines the application to determine whether it meets the patentability requirements.

• Patent Enforcement: Patent holders have the right to sue anyone who infringes their patent (i.e., makes, uses, or sells the patented invention without permission).

6.2. Data Exclusivity:

• Data exclusivity is a separate form of IP protection that prevents generic manufacturers from relying on the originator company’s clinical trial data to obtain marketing approval for a generic version of the drug. Data exclusivity typically lasts for a certain period (e.g., 5-10 years) after the drug is first approved. This period can be extended in some cases, for example, if the company develops a new indication for the drug.

6.3. Generic Drugs:

• Generic drugs are copies of brand-name drugs that have the same active ingredient, dosage form, strength, route of administration, and intended use.

• Generic drugs can be marketed after the patent and data exclusivity periods for the brand-name drug have expired.

• Generic drugs are typically much less expensive than brand-name drugs because generic manufacturers do not have to bear the costs of research and development.

• Abbreviated New Drug Application (ANDA) (US) / Abbreviated Marketing Authorisation Application (EU): Generic manufacturers must submit an ANDA (in the US) or an abbreviated MAA (in the EU) to the regulatory agency to obtain approval to market a generic drug. The ANDA/MAA must demonstrate that the generic drug is bioequivalent to the brand-name drug (i.e., that it is absorbed into the bloodstream at the same rate and to the same extent).

6.4. Balancing Innovation and Access:

• The patent system is intended to incentivize pharmaceutical innovation by providing a period of market exclusivity. However, this exclusivity can also lead to high drug prices and limited access to medicines.

• There is an ongoing debate about how to strike the right balance between protecting intellectual property rights and ensuring access to affordable medicines.

• Mechanisms to Promote Access:

  • Compulsory Licensing: As mentioned earlier, governments can issue compulsory licenses under certain circumstances, allowing generic manufacturers to produce patented drugs without the consent of the patent holder. The TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) allows for compulsory licensing under certain conditions, such as public health emergencies.

  • Voluntary Licensing: Pharmaceutical companies can voluntarily license their patents to generic manufacturers, allowing them to produce and sell lower-cost versions of the drug in developing countries.

  • Patent Pools: Patent pools are agreements between multiple patent holders to license their patents to each other or to third parties. Patent pools can facilitate the development of new technologies and improve access to medicines.

  • Bolar Exemption: This allows generic drug manufacturers to conduct research and development activities necessary to obtain regulatory approval before the patent on the originator drug expires. This speeds up the entry of generic drugs to the market once the patent protection ends.

6.5. “Evergreening” and Patent Thickets:

• Evergreening: This is a controversial practice where pharmaceutical companies attempt to extend the patent life of a drug by making minor modifications to the drug or its formulation and obtaining new patents on these modifications. These modifications may not offer significant therapeutic advantages over the original drug. Examples include:

  • Obtaining new patents on different salt forms or crystal structures of the drug.

  • Developing new formulations, such as extended-release versions.

  • Obtaining patents on new uses of the drug (although this can also represent genuine innovation).

  • Combining the drug with another existing drug.

• Criticisms of Evergreening:

  • Critics argue that evergreening stifles competition from generic drugs, keeps drug prices high, and does not represent genuine innovation.

  • It can delay the entry of lower-cost generic drugs into the market, limiting access for patients.

• Patent Thickets: This refers to a dense web of overlapping patents that cover different aspects of a single drug or technology. A company might obtain numerous patents on various aspects of a drug (manufacturing process, formulations, uses, etc.), making it difficult for competitors to enter the market even after the primary patent on the drug’s active ingredient has expired.

• Impact of Patent Thickets:

  • They can create a significant barrier to entry for generic manufacturers, who may face the risk of patent infringement lawsuits even if they believe their product does not infringe any valid patents.

  • The complexity and cost of navigating a patent thicket can discourage generic competition.

• Defenses Against Evergreening and Patent Thickets:

  • Patent Challenges: Generic manufacturers can challenge the validity of patents they believe are invalid or not infringed.

  • Regulatory Scrutiny: Patent offices and regulatory agencies are increasingly scrutinizing patent applications for evergreening tactics.

  • Competition Law: Antitrust authorities may investigate cases where patent thickets are used to anti-competitively exclude generic competitors.

  • “Skinny Labeling” (US): A generic company can seek approval for a subset of the approved uses of a brand-name drug, avoiding patented uses.

6.6. Biosimilars:

• Definition: Biosimilars are highly similar versions of approved biologic drugs (drugs derived from living organisms, such as antibodies, proteins, and vaccines). Unlike generic drugs, which are exact chemical copies of small-molecule drugs, biosimilars are not identical to the reference biologic due to the inherent complexity of biological manufacturing processes.

• Regulatory Pathway: Regulatory agencies (e.g., FDA, EMA) have established specific pathways for the approval of biosimilars. These pathways require biosimilar manufacturers to demonstrate that their product is highly similar to the reference biologic in terms of structure, function, safety, and efficacy. This typically involves extensive analytical testing, preclinical studies, and clinical trials, although the clinical trial requirements are generally less extensive than those for a new biologic.

• Interchangeability: In some jurisdictions (e.g., the US), a biosimilar can be designated as “interchangeable” with the reference biologic. This means that a pharmacist can substitute the biosimilar for the reference biologic without the intervention of the prescribing physician (subject to state laws). Obtaining interchangeability status typically requires additional data demonstrating that switching between the biosimilar and the reference biologic does not affect safety or efficacy.

• Challenges for Biosimilars:

  • Complex Manufacturing: The manufacturing of biologics is complex and requires significant investment and expertise.

  • Patent Litigation: Biosimilar manufacturers often face patent litigation from the manufacturers of the reference biologics.

  • Market Acceptance: Gaining market acceptance for biosimilars can be challenging due to concerns about their similarity to the reference biologic and the potential for immunogenicity (the body’s immune response to the drug).

  • Naming Conventions: The naming of biosimilars is a complex issue, with different approaches taken in different regions. This can affect prescribing and substitution practices.

6.7. Trade Agreements and Intellectual Property:

• International trade agreements, such as the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) administered by the World Trade Organization (WTO), set minimum standards for intellectual property protection, including patents on pharmaceuticals.

• TRIPS requires member countries to provide patent protection for pharmaceuticals for at least 20 years.

• TRIPS also includes flexibilities, such as compulsory licensing, that allow countries to address public health concerns.

• More recent trade agreements (e.g., the Trans-Pacific Partnership (TPP), the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), and the United States-Mexico-Canada Agreement (USMCA)) have included provisions that go beyond TRIPS in terms of intellectual property protection for pharmaceuticals (often referred to as “TRIPS-plus” provisions). These provisions have been controversial, with some arguing that they limit access to medicines in developing countries.