Intellectual Property Services
Midas Pharma has built up its own IP department to safeguard its activities in the very competitive pharmaceutical field.
In cooperation with our international network of patent attorneys and lawyers specializing in the field, we offer diverse services related to pharmaceutical drug products and the active drug substances (APIs) therein, as well as finished dosage forms (FDFs).
- Determination of the expiry of the principal exclusivities related to a drug (White Spot Analysis)
- Investigation of the patent landscape surrounding a pharmaceutical product (Product Clearance)
- Support of a product development in order to meet the earliest possible launch date (FTO-Analysis)
- Review and assessment of patent portfolios and technological pipelines (Portfolio & Innovation Management)
- Preparing and filing patent applications and oppositions before the European Patent Office EPO (Prosecution & Opposition).
In the pharmaceutical field, certain regulations directed to patent exclusivities, regulatory data and market exclusivities affect the earliest time-to-market (T2M) for generic products.
Our Patent Landscape provides you with an overview of the expiry of principal exclusivities related to a drug.
Based on a patent search in various specialized pharma databases, we investigate the expiry dates of all basic exclusivities related to the drug of concern and the respective active pharmaceutical ingredient (API), for example:
- Data exclusivity
- Market exclusivity
- Basic patent
- Supplementary Protection Certificate (SPC)
- Pediatric extension (PE).
We provide country specific dates for the earliest possible:
- Production of goods
- Filing of a dossier
- Market entry.
In order to bring a pharmaceutical product onto the market, it is important to assess the related patent landscape.
Our Product Clearance helps you to decide whether the first possible launch date (T2M) of the respective product can be met.
Based on the limits set out by the principal exclusivities (see Patent Landscape), we identify all relevant patents and patent applications related to the pharmaceutical product of concern, for example:
- The active pharmaceutical ingredient (API)
- The route of synthesis (RoS) of the API
- The finished dosage form (FDF)
- New uses (indications) etc.
and assess their territorial coverage, status, claims, terms etc. to determine the earliest possible market entry for the respective product on a country by country basis.
FTO-Analysis & Development Support
If you want to develop a pharmaceutical with the aim of earliest time-to-market (T2M), our Freedom-To-Operate (FTO) Analysis will guide you through the patent thicket related to the respective drug.
Taking into consideration timelines for principal exclusivities (see White Spot Analysis), we investigate and analyze the:
- Patent landscape, indicating all players regarding the respective API and technological field
- Patent life cycle management of the originator, as well as the patenting activities of competitors with respect to the API, RoS, FDF, indications, etc.
- Gaps and weak spots in the patent thicket.
A complete development support additionally includes updating the patent landscape and regular updates of the FTO-analysis at all stages of the development process.
Portfolio & Innovation Management
The IP portfolio of a company often represents a large part of its value, especially in the pharmaceutical field. However, patent maintenance costs often severely burden a patent department's budget.
We help you to optimize your patent portfolio to maintain a strong and competitive position at affordable costs.
We review your complete patent portfolio as well as your internal know-how that is not yet protected, in order to:
- Identify strengths, weaknesses and potential coverage gaps
- Separate valuable inventions from those that are less beneficial.
Each patent family will be evaluated from several perspectives, e.g. commercial, technical and strategic aspects as well as costs.
Prosecution & Opposition
In the highly competitive pharmaceutical field, it is always advisable to protect your own IP adequately. In addition, challenging third-party patents is sometimes unavoidable.
To protect your intellectual property most cost effectively, we elaborate a patenting strategy, considering various factors like the competitive environment, costs/benefit relation, lifecycle stage of the INN, etc.
We further assist you in the elaboration, filing, prosecution and defending of patent applications before the European Patent Office (EPO).
If desired, we also offer to subject your potential innovations to a patentability check, assessing them from a commercial, technical, and strategic viewpoint (also see Portfolio & Innovation Management).
If a European Patent is opposed, we perform a detailed validity search and provide you with a validity assessment with respect to the patent of concern.
Provided a reasonable expectation of success, we elaborate, file and prosecute oppositions before the European Patent Office (EPO).
Specializing in the development of generic medicines, we have solid professional experience in the pharmaceutical industry, covering all relevant areas of pharmaceutical developments where intellectual property plays a role, such as:
- API and derivatives — polymorphs, salts, prodrugs etc.
- Drug synthesis, including intermediates
- Finished dosage forms (FDF)
- Drug combination products.
Midas Pharma’s IP team has a wide academic background in the fields of: