Legal support for generic drug market entry is a comprehensive preventive and procedural intellectual property audit aimed at minimizing the risks of originator-backed blocking of product registration and sales. The procedure includes Freedom-to-Operate (FTO) analysis, separation of trials under the Bolar exception, cancellation of “evergreen” patents in the Appeals Chamber, and counteraction against unlawful preliminary injunctions.
- Patent Clearance as the Foundation of Investment: FTO research on the formula, synthesis method, crystal lattice, and medical use allows for identifying barriers 2–3 years prior to the planned generic launch.
- Limits of the Bolar Exception in Ukraine: Article 31-1 of the Law on Inventions allows for research and submission of the registration dossier, but strictly prohibits commercial stockpiling and import of the active pharmaceutical ingredient (API) before patent expiration.
- Counteracting Umbrella Patents: The input-output strategy blocks originator attempts to cut off substance supplies through bad-faith inclusion of secondary patents in the Customs Register.
- Judicial Cancellation of Secondary Monopolies: Applying the European “problem-solution approach” test makes it possible to prove the lack of an inventive step in patents for dosages, salts, or treatment regimens.
The pharmaceutical market operates under conditions of fierce patent warfare. For an originator, the entry of a generic means an instant loss of 40% to 80% of market volume within the first six months after the monopoly falls. This is why multinational corporations build multi-layered defenses: from registering dozens of secondary patents (evergreening) to aggressive blocking through preliminary injunctions in pharma disputes.
As an attorney with 20 years of practice in IP litigation, I observe a systemic mistake made by many generic manufacturers: perceiving legal support merely as the stage of processing a registration dossier at the State Expert Center (SEC) of the Ministry of Health of Ukraine. Legal support for generic market entry must begin at the R&D stage. Pharmaceutical patent conflicts are resolved not with emotions, but with dry formulas, crystallographic diagrams, a precise understanding of the limits of the doctrine of equivalents, and aggressive work in judicial authorities and customs bodies.
How the Bolar Exception Works in Ukrainian Legislation: Practical Limits
The Bolar exception in Ukraine serves as the primary legal shield for generic companies during the R&D and registration stages. The concept, enshrined in Article 31-1 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models” (implementing the norms of Directive 2004/27/EC), establishes that it is not considered an infringement of patent rights to import, manufacture, use, or test a patented product if these actions are performed solely for the purpose of obtaining and preparing information for the state registration of a medicinal product.
Law enforcement practice regarding the Bolar exception in Ukrainian patent legislation demonstrates that the line between lawful research and commercial infringement is extremely thin. The State Service of Ukraine on Medicines and Drugs Control and the courts demand clear documentation of the purpose behind every action. Submitting an application for state market authorization of a generic before the primary patent expires does not constitute an intellectual property infringement. At the same time, manufacturing or importing commercial batches of a product to build up stock a week before patent expiration is regarded by judicial practice as direct commercial use, which opens the way for judicial bans.
| Criterion or Activity | Legal Status under the Bolar Exception | Risks and Judicial Practice in Ukraine |
|---|---|---|
| Importing API samples for preclinical and clinical trials | Legal (direct norm of Art. 31-1 of the Law) | Low. It is important to have a contract, a customs declaration indicating the import purpose (“for R&D”), and a testing program. |
| Synthesis of pilot batches to determine bioequivalence | Legal | Minimal. Volumes must strictly comply with clinical trial protocol standards. |
| Submission of the registration dossier to the SEC of the Ministry of Health of Ukraine | Legal | Medium. Originators attempt to interpret the fact of dossier submission as a threat of rights infringement and initiate lawsuits. |
| Obtaining a marketing authorization with deferred market entry | Legal | Low. The position of the Supreme Court confirms that registration itself does not constitute market introduction or monopoly infringement. |
| Production and warehousing of commercial batches “just in case” | Illegal (goes beyond the Bolar limits) | Critical. Classified as market introduction or preparation for it, entailing seizure and confiscation of goods. |
| Participation in Prozorro public tenders before patent expiration with a delivery commitment after expiration | Disputed judicial zone | High. Originators frequently interpret a tender bid as a public offer for the sale of a patented product. |
How to Circumvent a Drug Patent When Launching a Generic: Design-Around Strategies
When the Bolar exception reaches its limits and the basic patent or dependent patent rights remain in force, the R&D center and legal department face the task of circumventing the drug patent upon generic market entry. The main threat here is the doctrine of equivalents. Even if the generic medicinal product does not copy the invention formula word for word (literal infringement), court experts may recognize patent infringement if the substituted element performs substantially the same function in substantially the same way to achieve the identical therapeutic result.
The design-around strategy (technological circumvention) requires a legal and technical dissection of each claim in the originator’s patent. It is necessary to break the chain of mandatory features in the independent claim by replacing at least one key feature with a functionally distinct one, making the application of the doctrine of equivalents impossible.
Key Action: Isolation of the combination of essential features for each independent claim of the originator’s invention (API, dosage, isomers, salts, excipients).
Goal / Requirement: Establishing the scope of protection according to the patent description and prosecution history (file wrapper estoppel).
Result: Compilation of a structural matrix of mandatory and optional monopoly features.
Key Action: Research and synthesis of alternative polymorphic modifications, salts, or solvates of the base molecule.
Requirement: The new crystal form must possess its own X-ray powder diffraction patterns distinct from the patented ones.
Result: Elimination of the risk of infringing the primary patent for a specific crystal lattice or salt form.
Action: Changing the set and proportions of excipients, release regulators, or synthesizing via an alternative chemical reaction scheme.
Requirement: Achieving the required pharmacokinetics through a different mechanism, excluding a direct chemical equivalent.
Result: Ensuring technical non-compliance with the pharmaceutical composition patent formula.
Authority / Action: Conducting a preventive scientific and legal expert examination in the field of intellectual property involving certified forensic experts.
Basis: Testing the product against the doctrine of equivalents (Triple Identity Test: function, way, result).
Result: Obtaining an expert research opinion confirming the non-use of each claim feature.
Decision: Issuing a comprehensive legal opinion by a patent attorney and IP lawyer regarding the patent purity of the developed generic.
Result: A ready procedural argument to oppose preliminary injunctions and refute accusations of bad-faith patent infringement.
The Input-Output Strategy Against Big Pharma Umbrella Patents
Umbrella patents are a tactic used by multinational pharmaceutical companies to create an artificial cluster of protective documents around a single active substance. The owner registers the primary compound and subsequently registers purification methods, metabolites, optical isomers, intermediates, granulation solvents, and specific packaging. The goal is singular: to completely block competitors from both raw material inputs and distribution outputs.
The input-output strategy in combating umbrella patents involves the symmetrical or asymmetrical destruction of this control chain.
At the Input Level (Supply Chain): Originators attempt to intercept the API supply chain. If a generic uses a substance from India or China, the patent holder targets the raw material manufacturers, claiming that the synthesis method is protected in Ukraine or transit countries. Protective tactics involve structuring supply contracts through jurisdictions with SPC manufacturing waivers (EU Regulation 2019/933), concluding contracts with patent indemnity clauses, and dividing synthesis stages among different contractors, preventing the process from being classified as a direct infringement of the process patent.
At the Output Level (Distribution Channel): Protecting the finished product from patent blockades in pharmacy chains and public procurement. When an originator attempts to send cease and desist letters to distributors alleging infringement of “umbrella” patents, the generic’s legal department must immediately initiate response measures in the Antimonopoly Committee of Ukraine (AMCU) on grounds of discrediting a business entity and creating artificial obstacles to competition.
“The most common mistake made by pharmaceutical plant legal departments is focusing exclusively on the final drug formula while ignoring intermediate patents. If you have a crystal-clear final form, but the registration dossier materials record that a patented intermediate compound with a specific protected protective radical in Ukraine was used for its synthesis, the originator will win the lawsuit in a single examination phase. Controlling the input chain must cover the entire chemical history of synthesis from the starting reagent to finished form packaging.”
Patent Clearance and Freedom-to-Operate Analysis
Generic patent clearance (Freedom-to-Operate / FTO analysis) is a comprehensive legal and technical procedure for checking a planned medicinal product for patent purity in a specific jurisdiction. A mistake at the clearance stage costs a pharmaceutical manufacturer millions of dollars spent on preclinical and clinical trials, registration fees, and technological line adaptation.
FTO research is conducted in accordance with international WIPO standards (WIPO ST.14) and examination guidelines. According to the practice of Polikarpov Law Firm specialists, a reliable patent audit must include the analysis not only of direct active patents, but also of those whose validity terms were extended via Supplementary Protection Certificates (SPCs), as well as identifying dependent and hidden applications published in the databases of the State Enterprise “Ukrainian Intellectual Property Institute” (Ukrpatent / IP Office).
To officially formalize rights to proprietary trademarks and industrial property objects, pharmaceutical companies increasingly utilize digital state channels, including intellectual property services on the Diia portal, which streamlines brand portfolio administration prior to market entry.
Invalidating Patents in the Appeals Chamber and Courts: Countering Evergreen Patents
Pharmaceutical companies use evergreen patents as a tool to endlessly extend their legal monopoly. When the 20-year term of a primary patent for a new chemical compound expires, the originator registers hundreds of minor modifications. These are so-called patents for known compounds in a new dose, known molecules with a new administration schedule (e.g., once a day instead of three), or obvious combinations of two long-known substances.
Invalidating a patent is an aggressive yet most reliable offensive strategy for a generic company. Challenging is carried out through two paths: by filing an objection with the Appeals Chamber of the National Intellectual Property Authority (Ukrpatent) or by filing a lawsuit with the Commercial Court of the City of Kyiv.
The key argument against evergreen patents is the lack of an inventive step. According to Supreme Court practice and European Patent Office (EPO) methodology, Ukrainian courts and forensic examiners apply the “problem-solution approach”:
- Determine the “closest prior art.”
- Formulate the objective technical problem solved by the patent.
- Analyze whether the proposed solution would have been obvious to a person skilled in the art based on publicly available sources prior to the patent’s priority date.
In parallel with challenging inventions, companies must account for cross-brand protection risks, where the Law of Ukraine “On Protection of Rights to Trademarks for Goods and Services” plays a crucial role, regulating drug names and protecting against accusations of unfair visual similarity between generic packaging and original medicines.
Parallel Import of Medicines in Ukraine: Hidden Patent Risks for Distributors
Parallel imports of medicines and patent risks in Ukraine have become particularly acute against the backdrop of sectoral legislative reforms and martial law. Parallel (grey) import involves importing an original medicinal product without the direct consent of the rights holder by third parties who purchased it in a jurisdiction with lower prices.
The main stumbling block here is the doctrine of exhaustion of rights. In Ukraine, an international principle of exhaustion of rights essentially applies to inventions: once a product has been put into commercial circulation by the patent owner or with their consent anywhere in the world, resale is not considered a patent infringement (Art. 31 of the Inventions Law). However, a regulatory trap exists, embedded in Article 9 of the Law of Ukraine “On Medicines”:
- Importing any medicinal product requires a national marketing authorization.
- If a distributor imports a drug produced for another country’s market whose registration materials differ in labeling or language, the State Drug Service prohibits its circulation.
- Patent owners use regulatory quality and authenticity enforcement tools to block parallel imports at customs, arguing intellectual property infringement due to unauthorized trademark use on secondary packaging or the lack of a GMP compliance certificate.
For a distributor or generic company diversifying its portfolio with parallel imports, it is vital to have an evidentiary chain of initial commercial release by the rights holder themselves (First Sale Doctrine) and exclude any alteration of original packaging to prevent actions from falling under legislation on falsification and counterfeiting.
Risk Assessment and Grounds for Compulsory Licensing of Medicines
Compulsory licensing is an extreme legal mechanism to overcome a patent monopoly, based on the provisions of Article 31 of the TRIPS Agreement and Article 30 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”. Risk assessment for compulsory licensing of medicines is mandatory if a critical shortage of a vital drug arises on the market and the patent holder unreasonably refuses to grant a voluntary license or sets a monopolistically high price.
Ukrainian legislation provides two main procedures for granting a compulsory license:
- By decision of the Cabinet of Ministers of Ukraine (in the public interest / state of emergency): The Government has the right to authorize the use of an invention without the patent holder’s consent to ensure national security, defense, or public health. Adequate market compensation is paid to the patent holder. Under martial law, this mechanism is a legitimate tool for rapidly deploying production of strategic painkillers, hemostatics, and anti-infective drugs by domestic generic plants.
- By court decision (due to non-use of the invention): If a medicinal product is not used or is insufficiently used in Ukraine within three years from the date of publication of information on patent issuance, any person ready and able to manufacture it may apply to court for a license authorization, provided that prior negotiations with the patent holder yielded no results.
The main legal risk of initiating a compulsory license for business is the complexity of navigating the bureaucratic apparatus and the necessity of proving prior good-faith requests for a license on reasonable commercial terms.
Legal Support for Licensing Negotiations Prior to Generic Product Launch
Support for licensing negotiations prior to generic product launch is a civilized alternative pathway that allows bringing a product to market without years of litigation. The “litigation pressure” tactic is frequently combined with negotiation processes. When an originator realizes that a generic’s invalidity lawsuit has serious expert prospects, the willingness to conclude a licensing agreement grows exponentially.
Key terms that an IP lawyer must structure during agreement drafting:
Protection Against Customs Blockades of Generic Imports
Registering patents in the Customs Register of Intellectual Property Objects is a favorite mechanism for sudden supply blocking used by originators against generic importers and finished-form manufacturers importing raw materials. According to Articles 399–401 of the Customs Code of Ukraine, if customs authorities suspect rights infringement based on registry data, customs clearance of the goods batch is suspended for 10 working days (with a possible 10-day extension).
To counter bad-faith competitor actions, companies need systematic legal protection against counterfeit products, as multinational corporations frequently use anti-counterfeit measures as a pretext to destroy legitimate generic competition.
Day 1–2: Receipt of Notification and Primary Audit of Suspension Grounds
Receiving official customs notification regarding the suspension of goods clearance. Identifying the registered patent and comparing the batch’s customs value with potential downtime losses.
Day 3–4: Communication with Rights Holder and Fixing Batch Status
Sending an official demand to the rights holder’s patent attorney providing the FTO opinion or Bolar exception substance compliance certificates. Warning the rights holder of liability for damages (spoilage of temperature-sensitive drugs, storage costs at a customs licensed warehouse).
Day 5–7: Preparation of Counter-Security Motion
If the rights holder prepares a lawsuit seeking attachment, the legal service drafts a counter-motion. In accordance with the Commercial Procedural Code of Ukraine, the rights holder is required to deposit security (counter-security) into the court’s deposit account in the amount of the full goods batch value or the importer’s probable losses.
Day 8–10: Unblocking and Resuming Customs Clearance
If within 10 (or 20) days the rights holder fails to provide customs with a court ruling on securing the claim (goods attachment), the customs authority is obligated to immediately complete cargo clearance. Generic lawyers demand signing the customs declaration in full.
In parallel, to protect software and analytical systems securing logistics and pharmaceutical supply monitoring, companies resort to provisions regulating the Law of Ukraine “On Copyright and Related Rights”, which protects specialized IT solutions from unauthorized copying.
Comprehensive Patent Protection for Pharma Manufacturers in Court: Conclusions
A successful generic market entry into a highly competitive pharmaceutical market is always the result of a synergy between scientific R&D and preventive litigation strategy. Attempting to save on a comprehensive Freedom-to-Operate analysis or superficial interpretation of the Bolar exception leads to catastrophic consequences: blocking marketing authorizations via preliminary injunctions, seizure of finished drug batches worth millions of hryvnias, and years of litigation.
At Polikarpov Law Firm, we base our client strategy on three principles:
1) deep patent auditing of the entire chain (from API to secondary packaging);
2) offensive liquidation of secondary monopolies in the Appeals Chamber prior to industrial release;
3) strict procedural counteraction against bad-faith blocking at customs and in courts.
Patent risk is not force majeure—it is a manageable business factor that, with timely preparation, transforms into your competitive advantage.
Legal Disclaimer: This material is purely informational and analytical in nature and does not constitute individual legal advice. Each pharma IP conflict possesses a unique formula, technology, and evidentiary base requiring a separate legal audit and development of litigation representation tactics.
