Pharmaceutical patents disclose innovations relating to innovative pharma product patents and process patents. A patent is a monopoly privilege issued by the government for a limited period that allows the first true inventor of some new idea, product or process to enjoy a period of monopoly which ensures security from competitive imitation leading to economic benefits to the inventor individual or organization.
In most of the pharmaceutical cases, the patent once received for the drug means that the drug can be sold and prescribed under the brand name only thus making it a profit-making asset for the patent-holding company. As it is a patent application for any drug is applied for before getting into a clinical trial for drug effectiveness and safety which leads to the loss of patent duration of twenty years as these trials may take seven to twelve years to complete before launching the drug into the market.
As the patent for any drug expires it can be manufactured and sold by any other company and is referred to as a generic drug. Once the drug is generic the initial patent filing company loses the monopoly thus bringing down the profit substantially for it though it can again file for a patent by making a new version of the drug by substantially changing the compound of the drug.
Pharmaceutical patents for inventions resulting from a combination of previously known active ingredients face a higher level of scrutiny from the patent examiner as the patent office does not generally allow the patent owners to extend the life of existing patents by filing new patents for substantially same or similar inventions, without any novelty or inventive step (non-obviousness).
In one of the drug patent cases in India, Novartis who is a huge drug maker wanted to introduce an oncology drug Gleevec in India which had been a highly effective drug acknowledged around the world but India did not grant the patent as it was said that the drug wasn’t sufficiently innovative that it was just a marginal improvement on an existing medicine.
Such strategies are commonly followed in the pharmaceutical sector for drug patents and hence, patent offices rely on the determination of a new or a non-obvious synergy or a distinct effect. In use, such a novel and non-obvious synergy or the distinct effect have to be covered comprehensively by drafting a strong and focused set of patent claims, which can be further supported by way of accompanying detailed description of the invention including results of clinical (laboratory) and biology test results.
Therefore, while drafting patent applications covering drug patents and pharmaceutical inventions, pharma patent attorneys follow the best practice of writing patent specifications with the required detailed description of the inventions to satisfy the patent eligibility criteria. Read more
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