Effective protection of rights to inventions and utility models in the pharmaceutical business relies on synchronizing three legal frontiers: pre-trial appeal and invalidation of questionable monopolies at the IP Office Appeal Board, judicial defense via chemical and pharmaceutical expertise (in particular, applying the doctrine of equivalents or the Bolar exemption), and blocking cross-border circulation of illegal batches through the Customs Register of Intellectual Property Rights Objects.
- Three-Tier Defense Contour: Pharmaceutical business requires simultaneous control over regulatory status (IP Office), distribution channels (commercial courts), and physical supplies of active substances (State Customs Service).
- Counteracting “Evergreen” Monopolies: Challenging patents on secondary pharmaceutical forms, salts, isomers, and polymorphs is a key tool for the early market entry of generics without infringing the core rights of originators.
- Litigation Specifics: Establishing infringement of invention rights relies on the literal interpretation of independent claims or the doctrine of equivalents, while the generic sector defends itself using the Bolar exemption rule.
- Customs Barrier: Entering a patent for an active pharmaceutical ingredient (API) into the customs register allows for suspending the customs clearance of questionable drug batches for up to 20 business days for analysis and securing claims.
The pharmaceutical market is a collision field of colossal capitalizations, where the value of a single day of presence for an original blockbuster or a delay in the launch of a generic drug is measured in hundreds of thousands of dollars. Amid intensifying regulatory control and active reform of the intellectual property system in Ukraine, the classical approach to protecting developments no longer works. A patent is no longer an absolute protective charter if the right holder is not ready to defend its validity in quasi-judicial chambers and block grey imports of substances directly at the border.
For foreign innovative corporations (originators), the main challenge remains the aggressive entry of copies before the expiration of the base patent or supplementary protection certificate (SPC). At the same time, for domestic manufacturers forming a developed generic sector, it is vital to clear the regulatory space from fictitious patent obstacles (“evergreen patents”) and neutralize patent trolling in pharma, which for decades was supported by unexamined issuance of utility models.
Proceedings in the Appeal Board Under New Rules
Before entering into lengthy and financially draining court battles, pharmaceutical manufacturers have gained the opportunity to use an updated quasi-judicial filter — the Appeal Board of the National IP Authority (NIPA). The institute of administrative appeal of examination decisions and invalidation of patents has undergone fundamental transformations with the adoption of new procedural regulations. Today, proceedings in the Appeal Board of the national IP authority under the new rules serve as a full-fledged alternative to the commercial court at the initial stages of a conflict, ensuring professional consideration of highly specialized biotechnological and chemical disputes by a panel of specialized experts.
For the pharmaceutical industry, the NIPA Appeal Board (which replaced the former “Ukrpatent Appeal Board” structure) acts as an arbiter in two key scenarios: challenging the final refusal of the examination to issue a patent for an invention in pharmacy, or recognizing an already issued patent as invalid in whole or in part (post-grant opposition). The advantage of the Board lies in the speed and technical competence of the panel, which reduces dependence on third-party forensic experts at the initial stage of assessing compliance with patentability conditions.
Key Action: Formulating a legal position, analyzing the prior art as of the priority date, and paying the fee.
Deadline / Body: 2 months from the date of receiving the decision or the entire patent validity term (for invalidation).
Result: Official registration of the appeal application in the NIPA Appeal Board chancellery.
Key Action: Verifying the applicant’s legal capacity, payment of fees, and powers of a patent attorney or lawyer.
Requirement: Compliance of the material format with the requirements of the Board’s special Regulations.
Result: Ruling on initiating proceedings or granting a term to eliminate deficiencies.
Action: Automated distribution, appointment of 3 experts, study of counterarguments, and hearing of the parties.
Specifics: Detailed analysis of the API chemical structure, crystalline forms, or therapeutic equivalence.
Result: Completion of case clarification and debates by the parties’ representatives.
Action: Issuing the operative part of the decision by the Appeal Board panel.
Basis: Approval of the Board’s decision by an official order of the NIPA head.
Result: Entry into the State Register of Inventions or complete cancellation of the contested decision.
New Regulations and Deadlines for Filing Objections
Procedural deadlines in pharmaceutical disputes are irreversible. According to updated regulations, an objection against a NIPA decision regarding an invention application must be filed within two months from the date the applicant receives the decision or copies of materials cited against the application. Missing this deadline without valid, documented reasons entails the closure of proceedings without the possibility of reinstating the procedure administratively.
If the validity of an already issued patent is challenged by third parties (for example, a pharmaceutical plant preparing to launch a generic and attacking a competitor’s blocking patent), the invalidation procedure in the Board can be initiated throughout the entire validity period of property rights, as well as after their expiration, if the applicant proves a legitimate interest (in particular, the threat of a lawsuit for damages for past periods). A key procedural trap lies in the need to disclose the entire evidence base in advance — submitting new prior art evidence at the oral hearings stage is strictly limited and allowed only upon a motivated petition.
Proving Non-Obviousness of an Invention to the Board Panel
The assessment of a medicinal product’s patentability in the Board most often breaks down over the “inventive step in drugs” criterion. Practice shows that most applications for secondary patents relate not to fundamentally new active pharmaceutical ingredients (new chemical entities – NCEs), but to compositions, specific salts, solvates, or new therapeutic dosage regimens. For the Board panel, an invention is recognized as having an inventive step if it is not obvious to a person skilled in the art (in our case, a pharmaceutical chemist or dosage form technologist) from the known prior art.
Proving non-obviousness requires applying a structured approach (Problem-and-Solution Approach):
- Determining the closest analogue (prototype) among existing drugs of the same therapeutic class;
- Establishing distinguishing features between the claimed invention and the prototype;
- Formulating the objective technical problem solved by the agent (e.g., overcoming hygroscopicity, increasing bioavailability, or eliminating a cardiotoxic effect);
- Proving the presence of an unexpected technical or pharmacological effect that a person skilled in the art could not predict based on general knowledge or standard screening.
Providing only theoretical calculations is not enough: the panel requires comparative clinical or preclinical tables demonstrating a statistically reliable advantage of the specific modification over the known molecule.
Objections Against Drug Formulation Patents
Forming so-called “patent thickets” around a successful blockbuster is a standard strategy of international corporations. Originators strive to create evergreen patents, extending the period of actual market presence by 10-15 years after the expiration of basic molecule protection. The most common object of such patenting becomes the pharmaceutical formulation (extended-release tablets, transdermal patches, liposomal emulsions, etc.).
To unblock the regulatory field, generic companies need to know how to file an objection against the issuance of a pharmaceutical formulation patent already at the invention application publication stage. Such a preventive mechanism (third-party observations) allows providing NIPA experts with devastating materials regarding the lack of novelty or inventive step before information is entered into the register and the protective document is issued.
- Chemical Modification Purity Criterion: Is the claimed isomer, salt, or polymorph a direct derivative of a known compound without changing its pharmacodynamic profile?
- Lack of Therapeutic Synergism: Does the combination formula of two known APIs confirm a mutual enhancement of action, or is there a simple additive effect of mixing components?
- Routine Excipient Selection: Are auxiliary substances (stabilizers, solvents, colorants) used in the pharmaceutical formulation within standard technological practices of pharmaceutical production?
- Unspecified Treatment Regimen: Does the invention formula boil down solely to an altered drug administration schedule or a new target patient group, which under Ukrainian law is not protected as an invention (treatment methods)?
- Prior Disclosure: Were the pharmacokinetic characteristics of the modification mentioned in earlier preclinical reports or dissertations by the patent author themselves prior to the priority date?
Identification of Secondary Patents in Company Pharmaceutical Business
Secondary patents have specific markers in independent claims. Instead of describing a new chemical structure using Markush formulas, they usually focus on solubility parameters, specific particle size (micronization of the substance), or thermodynamically stable crystal lattices. The most toxic practice for the market for a long time was the so-called utility model in pharmacy. Since utility models were registered prior to the reform under the applicant’s responsibility without substantive examination, unscrupulous players patented known drugs in the form of “capsules” or “syrups” and blocked competitors’ activities through law enforcement agencies.
Such challenging of utility model certificates in the generic sector has become a routine practice for unblocking tender procurements. Legislative changes have significantly limited the objects of utility models; however, the accumulated array of previously issued patents continues to create risks for business, requiring active lawsuits to invalidate them due to the lack of worldwide novelty.
Gathering Evidence to Refute Novelty
Successful challenging of a pharmaceutical formulation patent depends on the depth of the patent search. The main sources for destroying novelty are not only publications in specialized journals indexed in PubMed or Scopus databases, but also materials from international clinical trials. According to transparency standards, trial sponsors are required to publish trial protocols on resources like ClinicalTrials.gov or in EMA registries before the completion of the research phase. If such a protocol discloses the qualitative and quantitative composition of the experimental pharmaceutical formulation prior to the priority date of the contested patent, the entire claim loses its novelty criterion.
Another critical source is the originator’s so-called “prior applications.” Seeking to secure scientific priority, scientists publish preprints or make presentations at symposia where they casually mention the synthesis of a new form. In Ukrainian practice, such a coincidence of dates is an ironclad ground for the complete revocation of a patent.
Litigation Regarding the Validity of Drug Patents
When extrajudicial settlement options are exhausted or a direct threat of blocking production facilities arises, the epicenter of the struggle shifts to the commercial litigation system. Judicial practice in pharmaceutical patent disputes is formed primarily around two categories of lawsuits: claims by generic manufacturers to invalidate patents (attack) and counterclaims by originators for patent infringement and prohibition of introduction into civil circulation (defense).
Courts face the problem of intersecting provisions of special intellectual property legislation and the regulatory norms of the healthcare system. At the same time, the Supreme Court consistently points out the inadmissibility of automatically equating the fact of state registration of a medicinal product with the fact of infringing property rights to a valid patent.
| Analysis Criterion | Patent Invalidation Claim (Generic Manufacturer) | Defense Based on Bolar Exemption (Generic Manufacturer) |
|---|---|---|
| Legal Purpose | Complete or partial cancellation of a competitor’s monopoly from the date of patent issuance. | Legitimizing preparatory actions for drug launch without challenging the patent. |
| Subject of Proof | Non-compliance with patentability conditions (novelty, inventive step, industrial applicability). | Exclusively research nature of actions (conducting bioequivalence, submitting dossier). |
| Procedural Burden | The plaintiff is obliged to provide prior art evidence and pay for forensic examination. | The defendant proves the absence of commercial sale or tender placement of the drug. |
| Financial and Market Consequences | In case of victory, the market completely opens up for all participants in the generic sector. | Protects a specific batch and registration certificate from cancellation until patent expiration. |
| Risk of Counter-Security | Low, as the title of right itself is being challenged. | High: the originator may demand batch arrest at customs or a Ministry of Health ban on price registration. |
Judicial Examination of Claims and the Doctrine of Equivalents
Forensic drug examination establishes the use of an invention if each feature included in the independent claim of the invention, or an equivalent feature, is used. The doctrine of equivalents remains the most complex evidentiary tool in commercial court practice. It is based on the rule: if a certain component is replaced in the drug composition (e.g., potassium salt is used instead of sodium salt, or another known disintegrant is used), but the same result is achieved in the same way using the same functions (Triple Identity Test: function, way, result), the court recognizes patent infringement.
To defend against equivalence-based lawsuits, lawyers must apply the doctrine of procedural estoppel (Prosecution History Estoppel / File Wrapper Estoppel). If during correspondence with the examination the applicant knowingly narrowed the invention formula to bypass prior art references (e.g., explicitly limited the formula only to sodium salt), they have no right in subsequent litigation to claim that the defendant’s potassium salt is an equivalent of their development.
Defense of Generics Against Blocking Patent Lawsuits
To balance the interests of innovative corporations and the accessibility of medicines for the population, international and Ukrainian law provides for the Bolar exemption. This norm explicitly establishes that it is not considered an infringement of rights arising from a patent to import, manufacture, or use medicinal products for the purpose of conducting research, tests, and preparing information for state registration before the expiration of the patent.
The Grand Chamber of the Supreme Court has repeatedly emphasized that the mere fact of submitting a registration dossier to the State Expert Center of the Ministry of Health of Ukraine is not a commercial introduction of the drug into civil circulation. Infringement occurs only when the generic manufacturer obtains a price for the drug in the National List, participates in ProZorro public procurements, or ships commercial batches to pharmacy networks before the expiration of the patent or supplementary protection certificate. If the originator abuses interim measures, blocking regulatory registration through court rulings, the generic manufacturer has the right to claim compensation for damages caused by unjustified claim security.
In cases of critical public needs, such as epidemics or threats to national security, legislation contains a compulsory licensing tool, but in commercial practice in Ukraine, a compulsory license in pharma remains an exceptional tool, giving way to direct agreements or rights invalidation procedures in court.
Customs Control of Pharmaceutical Products at the Border
Even a flawless domestic court victory remains incomplete without creating a barrier to cross-border supplies. The Ukrainian pharmaceutical market largely depends on the import of both finished medicinal products and substances (APIs) imported from India, China, or EU countries for local packaging and production. The entry of an illegal generic or counterfeit substance into the production chain causes irreparable harm to the licensed right holder.
The main tool for combating this is the customs register of intellectual property objects, administered by the State Customs Service of Ukraine. Comprehensive protection of intellectual property rights at the customs border allows detecting and blocking suspicious batches directly at checkpoints and customs terminals at an early stage.
Registration of Patent Rights in the Customs Register
Unlike trademarks, where an inspector can visually determine counterfeiting by a logo or labeling, registering an invention patent requires a specific approach. A customs inspector is not a certified chemist and does not possess equipment for chromatography-mass spectrometry at a checkpoint. Therefore, the right holder is obliged to develop detailed methodological guidelines for customs officials.
The application for entering a patent into the register must contain:
- Exact product codes according to the Ukrainian Classification of Goods for Foreign Economic Activity (UKT ZED) (e.g., heading 3004 for finished drugs or 2933–2942 for chemical compounds);
- International Nonproprietary Names (INN) corresponding to the patented active substance;
- A list of official licensees, exporters, and importers who have the legal right to import products;
- Features indicating the risk of infringement: typical countries of origin of suspicious cargo, known unauthorized suppliers, packaging methods, or specific packaging of chemical substances.
In addition, one should consider the digitalization of IP registration and verification services, which is gradually being integrated into state systems through the Diia e-services portal in the field of intellectual property, optimizing interaction between business and regulatory authorities.
Action Algorithm for Suspending Drug Imports
When the customs risk analysis system (ASAUR) triggers on a batch of goods containing features of a patented object from an unauthorized importer, the procedure unfolds according to the strict regulations of Section XIV of the Customs Code of Ukraine.
Deadlines and Stages of the Suspension Procedure:
- Suspension of Clearance: Customs suspends customs clearance of goods for 10 business days and sends an electronic notification to the right holder’s representative and the declarant;
- Extension of Term: Upon a motivated request by the right holder (e.g., for conducting chemical-pharmaceutical analysis of selected samples), the term can be extended by customs for another 10 business days;
- Sampling: The right holder or their authorized lawyer has the right to participate in taking product samples to transfer them to a specialized accredited laboratory;
- Filing a Lawsuit or Securing a Claim: Before the expiration of the 20-day term, the right holder is obliged to apply to the court with a lawsuit to protect infringed patent rights or obtain a ruling on securing the claim by seizing the cargo batch. If the court does not initiate proceedings or secure the claim, the batch is subject to mandatory release into free circulation.
It is important to remember financial liability: if sample analysis shows no use of the patented formula (e.g., a different salt not covered by the patent is imported), the right holder will be obliged to compensate the importer for damages regarding demurrage, transport downtime, and warehouse storage.
In cases where medicinal products are accompanied by brand rights violations (similarity of packaging, commercial name, or protected logo), legal protection is additionally reinforced by norms of special legislation, in particular, using the Law of Ukraine “On Protection of Rights to Marks for Goods and Services”, which, combined with patent monitoring, creates an absolute barrier against the penetration of counterfeits into the domestic market.
Strategic Protection of Pharmaceutical Patents in Ukraine
Managing a patent portfolio in the pharmaceutical industry requires a deep understanding of the drug lifecycle. Of particular importance is the mechanism of extending the period of legal protection using Supplementary Protection Certificates (SPC). Since 8 to 12 years of clinical trials pass from the date of filing an invention application to obtaining a Ministry of Health registration certificate and actual market launch, the patentee loses most of the standard 20-year monopoly period. The SPC institute allows extending exclusive rights to an active ingredient for up to 5 years, which becomes the most profitable period for the originator.
Building a reliable IP strategy for the pharmaceutical business must be based on a combination of the following steps:
- Constant Patent Landscaping: Monitoring competitor publications in NIPA bulletins allows identifying threats at the application stage and timely filing third-party observations before a registration decision is made;
- Preventive Market Clearance (Freedom to Operate): Generic manufacturers critically need to conduct legal and patent audits of a molecule 2–3 years before the planned launch, if necessary initiating the invalidation of “evergreen” patents in the Appeal Board or court;
- Cross-Border Coordination: Entering key substances into the customs register allows paralyzing the import of unverified raw materials for producing grey analogues even before they enter the production cycle.
A patent dispute in healthcare is never resolved by chance. It requires mathematical precision in working with the invention formula, flawless mastery of commercial court procedural rules, and lightning-fast reaction in interaction with the State Customs Service.
