The pharmaceutical industry spends astronomical sums on research, development, manufacturing, and advertising for each new drug. The standard period for a patent is 20 years, but the time it takes for a drug to pass FDA rules and enter the market is far shorter. After a drug’s patent expires, generic manufacturers release their versions of the drug at much-reduced costs. Therefore, innovative businesses attempt to prolong the drug’s life to remain competitive. This is “extending the protection of a well-known drug for a longer period.” That’s why various patents, including the blocking patents, protect any given medicine instead of just one. Rather than pharmaceuticals, it is “inventions” that are safeguarded by patents.
It is crucial for patent professionals working in pharmaceutical research to be thoroughly familiar with the many forms of pharmaceutical patents and the methods available for extending the life duration of drug patents. There are several broad groups into which patents for pharmaceuticals can be placed.
Composition Formulations
Product formulation New chemical entity drug-releasing compound
Patents on Particle Size and Shape Selection
Metabolic substances
Prodrugs
Dosage/dose
A Technique or Means
Making use of; using
Drug transport
Devices
1) Pieces of Art
Pharmaceutically acceptable carriers or excipients such as solvents, buffers, fillers, binders, disintegrants, lubricants, and emulsifiers are disclosed in composition patents. The selected combination of molecules and their precise novel function application makes these patents so innovative.
The lack of synergy between the active molecule and the inert carrier renders pharmaceutical compositions containing a single active ingredient (whether known or novel) without patentability in India.
2) Conception
Preparing a substance in a particular form for improved effect, state, or release is the subject of a formulation patent.
2.1) Product form: This refers to alternate dosage forms of a medicine or pharmaceutical composition, whether brand-new or well-established, with an improved active drug release strategy. Tablets, capsules, and aqueous parenteral solutions all contain the same active component but are administered differently. It would be evident that a tablet for diabetes control, including the letter “A,” is not the same as an anti-inflammatory cream containing the letter “A.” Since “A” cream like this doesn’t exist, the creators of this product can consider themselves clever if they can develop a way to make it work topically.
2.2) Blood-controlled medication delivery is one benefit linked to the claimed formulation in several patents. The medicine can also be released over a more extended period or at a slower rate.
The third compound
The discovery of a novel chemical, biological, herbal, or pharmaceutical compound was the focus of these patents. The composition (combined with other components), use, and application of the patented compounds may or may not be specified. In most situations, the claim (Markush claims) will use distinct formulas to represent these novel compounds. These substances may be NCEs (new chemical entities) or novel molecules derived from natural or biological sources. The compound’s nature allows for additional classification as polymorphs, isomers, crystal structures, amorphous forms, or salts.
3.1) New chemical entity: Markush structures are commonly used to represent NCEs in patent claims, which reveal various chemical formulas and derivatives of innovative medications.
3.2) Physical form: Pharmaceutical businesses take advantage of the polymorphism and enantiomerism properties of chemical compounds by developing novel polymorphs, isomers, physical forms (crystalline or amorphous), and enantiomers of general medicine.
Inherent solubility and particle size also influence how quickly a medication dissolves in water. Several patents in the pharmaceutical industry are connected to compositions with specified particle sizes of the constituents and dosage forms (for example, suspensions or dispersions), as they can lead to an enhanced rate of dissolution and higher bioavailability.
3.4) Selection patents: a selection patent’ is a patent in which a single element or a tiny segment within a big known group is selected and separately claimed based on a particular property not stated in the broader group. For instance, if a compound with n-carbon atoms is previously patented, a patent on a specific range (such as C3-C12) may be claimed.
3.5) Biologically active metabolites: Some patents specify the chemical and the active metabolite responsible for the therapeutic action. It has the same physiological impact as the original medication ingredient.
3.6) Prodrugs: Medicinally valuable substances can be synthesized from inert molecules (‘prodrugs’) by bodily metabolic processing. Some drug patents protect the drug’s prodrug(s).
Fourthly, Dosage
Some patent documents claim inventions that are just new ways to give patients an existing product (such as a solid dosage form for oral administration). Since the claimed invention is not a product or process but rather the technique by which the effect is therapeutic, it is treated as similarly as a claim over a medical treatment method.
5) Technique or procedure
These patents explain the procedure for producing or making a compound or composition. In most cases, they also detail how the disclosed component or design can be used. Method patents for finding novel compounds, healing, screening, or diagnosing are included here. These patents likewise cover methods for conducting various assays.
Sixthly, put to use
These patents concern the therapeutic or preventative use of a substance or composition on the human body or other organisms.
7) Drug distribution
These patents describe any means, apparatus, or system for administering medication to a living organism. In this context, “drug delivery” refers to broad and specific approaches.
7) Tools
Patents that describe a device, apparatus, kit, or even a system for the production, distribution, monitoring, screening, or diagnosis of a particular drug or its action are included.
Conclusion Patent analysts often falsely assume that reading and comprehending rug patents is difficult. It’s true, but you’ll have a much easier time with things if you take the time to educate yourself about the many sorts of patents, drug formulations, and basic terminology used in pharmaceutical patents. Any invention’s innovation and inventiveness can be gleaned from carefully examining the claims, the title, and the abstract.
Email: vinod.patent@gmail.com Vinod Kumar Singh Assistant Manager, IP Information and Technical Writer, IP/Patent Intelligence, Dolcera Infomaxx Pvt. Ltd.
Cellular: +919392387277
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