Identifying and Invalidating Weak Drug Patents in the United States

1. Introduction: The Landscape of Pharmaceutical Patents and the Significance of Invalidation

The pharmaceutical industry relies heavily on patent protection to incentivize the costly and time-consuming process of drug discovery and development.¹ These patents, typically utility patents, grant the owner exclusive commercial rights to produce and use the covered technology for up to 20 years from the date of filing.¹ Pharmaceutical patents can encompass a broad spectrum of claims relating to a single drug, including its formulation, specific indications for treating diseases, the technology used for its administration, methods of manufacturing, and the chemical composition of its active ingredients.¹ Moreover, secondary patents covering new aspects or improvements to an already patented drug can extend this protection, sometimes resulting in a single drug being covered by over 100 patents.¹

Beyond patent protection, the pharmaceutical industry also benefits from regulatory exclusivity granted by the Food and Drug Administration (FDA) upon the approval of new drugs.¹ This regulatory exclusivity operates independently of patent rights and can prohibit the FDA from approving competitor drugs for a specific period, depending on the type of exclusivity granted.¹ Understanding the nuances and interplay between patent and regulatory exclusivity is crucial for navigating the competitive landscape of the pharmaceutical market.

The ability to identify and invalidate weak drug patents holds significant importance for fostering generic competition.⁴ By challenging patents that do not meet the stringent criteria for patentability, generic drug manufacturers can pave the way for the introduction of lower-cost alternatives, thereby increasing patient access to essential medicines and reducing overall healthcare costs.⁴ This report aims to provide a comprehensive overview of the process involved in identifying vulnerabilities in drug patents within the United States and the legal mechanisms available for challenging their validity.

2. Understanding the Foundation: Criteria for Patentability of Pharmaceutical Drugs in the US

To secure patent protection in the United States, a pharmaceutical invention must satisfy three fundamental criteria as outlined in Title 35 of the United States Code: novelty, non-obviousness, and utility.¹

Novelty dictates that an invention must be new and not have been previously known or publicly disclosed in any manner before the effective filing date of the patent application.¹ This encompasses prior patents, printed publications, public use, offers for sale, or other forms of dissemination to the public.⁸ Even disclosures made by the inventor themselves can jeopardize novelty if they occur more than one year prior to the patent application filing.⁸ The concept of public disclosure is interpreted broadly and includes various means of communication, even informal exchanges, emphasizing the importance of maintaining confidentiality before seeking patent protection.⁷ While the US patent law provides a one-year grace period for an inventor’s own disclosure, many foreign jurisdictions do not, underscoring the need for careful consideration of international patent rights.⁸

The criterion of non-obviousness requires that the invention, at the time it was made, would not have been obvious to a person having ordinary skill in the art (POSITA).¹ This assessment is made from the viewpoint of an individual with typical knowledge and expertise in the relevant field of pharmaceutical science or a related area.⁸ The USPTO evaluates obviousness through the lens of a POSITA, who is considered a typical scientist or engineer working in the pertinent domain.⁸ Examiners may rely on a combination of two or more prior art references to assert that an invention would have been obvious, but they must provide a reasoned explanation as to why a POSITA would have combined these references to arrive at the claimed invention.⁸ This standard is often considered subjective and is frequently the subject of contention during patent prosecution and litigation.⁸ The Supreme Court’s decision in KSR v. Teleflex provided a more flexible framework for evaluating obviousness, moving beyond a rigid “teaching-suggestion-motivation” test.⁸

Finally, utility mandates that the invention must have a specific, substantial, and credible use.¹ In the context of pharmaceutical patents, this translates to the drug being effective in treating the condition or disease for which it is intended.¹ The Federal Circuit has clarified that the utility requirement necessitates some immediate benefit to the public.¹¹ An invention that represents a mere incremental step towards a future discovery may not meet this requirement.⁸ The interpretation of the utility requirement has evolved, with a greater emphasis on practical application and tangible benefit to the public.¹¹ Inventions considered “research intermediaries” lacking a known end-user utility may not be deemed patentable.¹⁵

3. Identifying Vulnerabilities: Common Grounds for Challenging Drug Patent Validity

Several established legal grounds can be utilized to challenge the validity of a drug patent that has already been granted by the USPTO.⁴

One of the most prevalent grounds is the existence of prior art, which can lead to challenges based on either anticipation or obviousness.¹⁸ If the claimed invention was already known to the public (anticipated) or would have been obvious to a person skilled in the art based on prior patents or publications, the patent may be deemed invalid.⁴ Generic drug manufacturers frequently target secondary pharmaceutical patents, such as those covering new formulations, dosages, or methods of use for existing drugs, arguing that these are often obvious modifications lacking a genuine inventive step.¹ The practice of “evergreening,” where companies pursue numerous secondary patents on minor variations of a drug to extend market exclusivity, is a common target for obviousness challenges.⁴

Another crucial ground for challenge is the lack of written description.¹⁶ Patent law requires that the patent specification provide a sufficiently detailed written description of the invention to demonstrate that the inventor was in possession of the claimed invention at the time of filing.²⁷ Merely restating the claim language in the specification is not considered adequate.²⁹ Challenges on this basis often arise when the scope of the claims is broader than what is actually described in the patent, or when key features of the claimed invention are not adequately disclosed.²⁹

Similarly, a patent can be challenged for lack of enablement.¹⁶ This requirement dictates that the patent specification must provide enough information to enable a person skilled in the art to make and use the claimed invention without resorting to undue experimentation.²⁹ If the disclosure is too vague or incomplete to allow a skilled artisan to practice the invention, the patent may be invalidated.¹⁸ Lack of enablement is distinct from lack of written description, focusing on the practical teachability of the invention.²⁷

Beyond these primary grounds, other potential challenges to drug patent validity include:

Patent Ineligible Subject Matter: Claims directed to abstract ideas, laws of nature, or natural phenomena that do not include significantly more transformative elements are not patentable.¹⁷
Double Patenting: Obtaining more than one patent for essentially the same invention is prohibited.²⁶
Inequitable Conduct: Intentional deception or withholding of relevant information from the USPTO during the patent prosecution process can render a patent unenforceable.¹⁶
Incorrect Inventorship: Listing the wrong individuals as inventors on the patent application can be grounds for invalidation.¹⁶
Failure to Meet Formal Requirements: Procedural errors or technical deficiencies in the patent application can also lead to challenges.¹⁶

4. Navigating the Information: Accessing and Searching Patent Databases

Identifying weak drug patents necessitates the ability to effectively access and search relevant patent information. Several key resources are available for this purpose.³⁸

The United States Patent and Trademark Office (USPTO) Database serves as the primary repository for all US patents and published patent applications.³⁸ The USPTO offers a comprehensive search tool, Patent Public Search, which features both basic and advanced search functionalities.³⁸ Users can conduct searches using keywords, the names of inventors or assignees, patent or publication numbers, and patent classification codes.⁴⁴ The USPTO database is particularly valuable for examining the complete prosecution history of a US patent, including all communications between the applicant and the patent examiner, which can reveal critical information about the patent’s strengths and weaknesses.¹⁰

Google Patents provides a free and user-friendly interface for searching a vast collection of patents from the USPTO, the European Patent Office (EPO), the World Intellectual Property Organization (WIPO), and numerous other international patent offices.³⁹ It offers both simple keyword searching and advanced search options that allow for the use of Boolean operators and various filters to refine search results.⁴⁷ While Google Patents is a powerful tool for initial exploration, it may have limitations in its search capabilities and the depth of its coverage for certain types of patents compared to more specialized databases.⁵³

The World Intellectual Property Organization (WIPO) PATENTSCOPE database offers access to millions of international patent applications filed under the Patent Cooperation Treaty (PCT), as well as patent documents from numerous national and regional patent offices worldwide.³⁸ Similarly, the European Patent Office (EPO) Espacenet provides free access to a vast collection of over 110 million patent documents from across the globe, including integrated tools for classification searching and machine translation.³⁸

Understanding patent classification systems is essential for conducting precise and targeted patent searches.⁴³ The Cooperative Patent Classification (CPC) system, jointly managed by the EPO and the USPTO, and the International Patent Classification (IPC) system, administered by WIPO, categorize patents based on their technical subject matter.³⁹ For pharmaceutical patents, relevant CPC classes include A61K (Preparations for medical, dental or toiletry purposes) ⁴³ and A61P (Therapeutic activity of medicinal preparations).⁶³ Utilizing these classification systems can significantly enhance the accuracy and efficiency of patent searches by filtering results based on specific technological domains.

5. The Legal Pathways: Patent Invalidation Procedures at the USPTO

The America Invents Act (AIA) of 2011 brought about significant changes to the US patent system, including the introduction of new post-grant proceedings at the USPTO’s Patent Trial and Appeal Board (PTAB) for challenging the validity of issued patents.⁶⁴ The two primary proceedings for invalidating drug patents are Inter Partes Review (IPR) and Post-Grant Review (PGR).

Inter Partes Review (IPR) is a trial proceeding conducted by the PTAB to review the patentability of one or more claims in a patent.⁶⁴ An IPR petition can be filed after the later of nine months from the patent grant or issuance of a reissue patent, or the termination of any instituted PGR proceeding.⁶⁴ Notably, there is no nine-month waiting period for patents granted before the AIA’s effective date.⁷⁴ A crucial timing consideration is that if a party is served with a complaint alleging patent infringement in district court, they must file an IPR petition within one year of being served.⁷⁰ The grounds for challenge in an IPR are limited to anticipation (35 U.S.C. § 102) and obviousness (35 U.S.C. § 103), and these challenges can only be based on prior art consisting of patents or printed publications.⁶⁴ Grounds such as patentable subject matter or lack of written description/enablement cannot be raised in an IPR.⁶⁵

The process begins with a third party filing a petition that demonstrates a reasonable likelihood of success in proving at least one challenged claim unpatentable.⁶⁴ The patent owner has the option to file a preliminary response to the petition.⁶⁴ If the PTAB decides to institute an IPR, it proceeds as a trial-like proceeding with limited discovery, briefing by both parties, and ultimately a final determination by the Board within one year from the institution date, which can be extended by up to six months for good cause.⁶⁴ The standard of proof in an IPR is a preponderance of the evidence, which is a lower threshold than the clear and convincing evidence standard used in district court litigation, making IPR a potentially more favorable venue for patent challengers.⁶⁹ However, it is important to note that IPR proceedings have estoppel effects, meaning that the petitioner is barred from raising in subsequent proceedings any grounds that were raised or reasonably could have been raised during the IPR.⁷⁰

Post-Grant Review (PGR) is another post-issuance proceeding at the PTAB, but it has a narrower window for filing.⁶⁴ A PGR petition must be filed within nine months of the patent grant or the issuance of a reissue patent.⁶⁴ Generally, PGR applies to patents that have an effective filing date on or after March 16, 2013, making them subject to the first-inventor-to-file provisions of the AIA.⁶⁷ A key advantage of PGR over IPR is the broader range of grounds for challenge. In a PGR, a patent’s validity can be reviewed on any ground that could be raised in civil litigation under 35 U.S.C. § 282(b)(2) or (3), including patentable subject matter (35 U.S.C. § 101), novelty (35 U.S.C. § 102), obviousness (35 U.S.C. § 103), written description, enablement, indefiniteness, and utility.⁶⁴

Similar to IPR, the PGR process begins with the filing of a petition, but the petitioner must show that it is more likely than not that at least one claim challenged in the petition is unpatentable.⁶⁴ The patent owner can file a preliminary response.⁶⁴ If the PTAB institutes a PGR, it proceeds as a trial with a final decision typically issued within 12 to 18 months after institution.⁶⁴ The standard of proof is also preponderance of the evidence, and estoppel provisions similar to those in IPR apply.⁷⁰

Feature	Inter Partes Review (IPR)	Post-Grant Review (PGR)
Eligibility (Timing)	After 9 months from patent grant or reissue; within 1 year of infringement suit	Within 9 months of patent grant or reissue
Grounds for Challenge	Anticipation (§102) and Obviousness (§103) based on patents/printed publications	Any ground under § 282(b)(2) or (3), except best mode
Standard of Proof	Reasonable likelihood of prevailing	More likely than not invalid
Prior Art Basis	Patents and printed publications only	Patents, printed publications, public use, on-sale activity, etc.
Estoppel Effects	Broad; applies to grounds raised or reasonably could have been raised	Broad; applies to grounds raised or reasonably could have been raised
Typical Timeline	12-18 months from institution	12-18 months from institution
Who Can File	Any third party not barred by prior litigation	Any third party not barred by prior litigation

6. Learning from the Past: Case Studies of Successfully Challenged Drug Patents

Examining instances where drug patents have been successfully challenged provides valuable insights into the types of weaknesses that can be effectively argued.⁸²

Challenges based on lack of novelty have been seen in cases like Novartis v. Generics in Europe, concerning a second medical use patent.⁸³ Novelty can also be a key issue when patents are sought on naturally occurring substances or through minor modifications known as “product hopping”.²³

Obviousness remains a frequent ground for invalidation. The Vanda Pharmaceuticals v. Teva Pharmaceuticals case established a significant standard for obviousness in the biotech field.⁸⁴ The Janssen v. Teva litigation highlighted errors in the district court’s non-obviousness finding for a dosing regimen patent.⁸⁵ Formulation patents have also been successfully challenged based on the obviousness of their features in light of prior art, as seen in Tyco v. Mutual.⁸⁶ The Federal Circuit’s decision in In re: Nuvasive Inc. underscored the necessity of demonstrating a clear motivation to combine prior art elements.¹⁴ Furthermore, the Salix v. Norwich case affirmed the obviousness of a rifaximin polymorph patent based on prior art processes.⁸⁷

The now-abolished “promise doctrine” in Canada led to several drug patent invalidations based on lack of utility, including patents for ZYPREXA®, ALTACE®, and VALTREX®.³⁵ In the US, the McLeay case involved a rejection for lack of enablement, tied to utility, for a COVID-19 treatment.³⁴ The Eli Lilly v. Novopharm case in Canada also demonstrated a lack of utility due to insufficient disclosure.³⁵

Challenges based on lack of written description were successful in Nuvo Pharmaceuticals v. Reddy’s Laboratories regarding patents for Vimovo.²⁹ Additionally, IPR proceedings have been used to break the priority chain of patents due to a lack of written description or enablement in earlier applications.³⁰

Drug/Technology Area	Patent Type	Ground for Challenge	Outcome	Jurisdiction/Case Reference (Snippet ID)
Second Medical Use	Method of Use	Lack of Novelty	EPO Examining Division refused grant (later overruled)	⁸³
Psychedelics	Compounds/Formulations/Methods	Lack of Novelty	Naturally occurring substances not patentable	²³
Hetlioz	Pharmaceutical Composition	Obviousness	Patent invalidated	⁸⁴
Paliperidone Palmitate	Dosing Regimen	Obviousness	District court judgment vacated and remanded by Federal Circuit	⁸⁵, B7
Temazepam	Dosage Amount	Obviousness	Claim found obvious	⁸⁶
Rifaximin	Polymorph	Obviousness	Claims held invalid as obvious	⁸⁷
ZYPREXA®, ALTACE®, etc.	Various	Lack of Utility (Promise Doctrine)	Patents invalidated (Canada, Promise Doctrine now abolished)	³⁵–⁹¹–⁹³, B8
Ribavirin	Method of Treatment	Lack of Enablement/Utility	Rejection affirmed by Federal Circuit	³⁴
Raloxifene	Method of Use	Lack of Utility	Patent invalidated (Canada)	³⁵
Vimovo	Pharmaceutical Composition	Lack of Written Description	Patents invalidated by Federal Circuit	²⁹, B9
Indivior UK Ltd. v. Dr. Reddy’s	Pharmaceutical Composition	Lack of Written Description	PTAB held claims anticipated by parent application publication	³⁰

7. Weighing the Stakes: Legal and Financial Implications of Patent Challenges

Challenging a drug patent is a significant undertaking with substantial legal and financial ramifications.⁹⁵ The costs associated with IPR and PGR proceedings include filing fees, which can amount to thousands of dollars, and potential post-institution fees.⁷⁰ The engagement of patent litigation attorneys, whose hourly rates can range from $400 to $1,200, can lead to rapidly accumulating legal expenses.⁹⁵ The average cost of a patent litigation case in the United States can reach millions of dollars, depending on the complexity of the case and the potential damages involved.⁹⁵

For the challenger, there are potential legal risks. An unsuccessful challenge in an IPR or PGR can result in estoppel, which may prevent the challenger from raising the same or substantially similar arguments in future proceedings at the USPTO or in district court.⁷⁰ Furthermore, if a generic manufacturer attempts to market a drug before a patent is definitively invalidated, the patent owner may pursue counterclaims for patent infringement.

However, the financial rewards of successfully invalidating a weak drug patent can be substantial.⁴ A successful challenge can pave the way for the generic manufacturer to enter the market earlier than the patent’s expiration date, potentially leading to significant sales volumes and, in some cases, a period of market exclusivity, such as the 180-day exclusivity awarded to the first ANDA filer with a Paragraph IV certification.² The introduction of generic drugs typically results in dramatic price reductions, benefiting consumers and healthcare systems.⁴ Notably, legal expenses incurred by drug manufacturers in defending against patent infringement lawsuits under the Hatch-Waxman Act may be currently deductible for federal tax purposes, which can influence the overall financial assessment of litigation.⁹⁵

The decision to challenge a drug patent necessitates a careful strategic evaluation of the likelihood of success, the potential financial gains, and the associated legal and financial risks.⁴ The Hatch-Waxman Act provides a framework that incentivizes generic manufacturers to challenge patents, aiming to strike a balance between promoting pharmaceutical innovation and ensuring access to affordable medicines.¹ The 30-month stay on FDA approval for generic drugs, triggered by patent litigation, provides a defined period for resolving patent disputes before generic entry.¹

8. Strategic Reconnaissance: Identifying Weaknesses in Drug Patents Through Publicly Available Information

Identifying potential weaknesses in drug patents often begins with a thorough examination of publicly available information.⁴

A critical step is analyzing the patent claims and specifications.¹⁷ This involves scrutinizing the language and scope of the claims to identify any ambiguities, overbroad definitions, or lack of sufficient support in the patent’s detailed description.¹⁷ Functional claim language that lacks specific details can be a target for challenges.⁶⁵ Understanding the different types of pharmaceutical patents, such as those covering the composition of matter, formulation, method of use, or manufacturing process, can guide this analysis.¹

Reviewing the patent prosecution history, also known as the file wrapper, available on the USPTO website, can provide valuable insights.¹⁰³ This record details all communications between the patent applicant and the USPTO examiner, including the examiner’s rejections, the applicant’s arguments and amendments, and the prior art cited during the examination process.¹⁰³ Examining claim complexity and potential design-arounds discussed during prosecution can reveal vulnerabilities.¹⁰³

Monitoring patent litigation and regulatory activities is also essential.⁴³ Tracking ongoing lawsuits related to the drug, including Paragraph IV challenges filed by generic companies, as well as IPR and PGR proceedings at the PTAB, can highlight patents that are already under scrutiny.¹⁰² Monitoring the FDA’s Orange Book, which lists patents covering approved drugs, and any disputes regarding the accuracy or relevance of these listings can also reveal potential weaknesses.²

Conducting thorough prior art searches is paramount.¹⁰ This involves searching patent databases and non-patent literature, such as scientific journals, conference proceedings, technical reports, and websites, to identify any publications that predate the patent’s priority date and could potentially anticipate the invention or render it obvious.¹⁰

Analyzing patent families and continuations can also uncover weaknesses.⁵⁰ Examining related patents within the same family, including continuations, divisionals, and foreign counterparts, can provide a broader understanding of the patentee’s overall strategy and may reveal potential issues such as double patenting or inconsistencies in the claims across different patents.⁵⁰

In some instances, reverse engineering the marketed drug product to understand its composition and manufacturing process may provide information relevant to challenging specific patent claims. Additionally, white space analysis, which involves identifying areas where competitors have not yet secured patent protection, can indirectly highlight potential weaknesses in their existing patent portfolio.¹⁰³ Finally, conducting a SWOT analysis of the patent portfolio can help identify internal vulnerabilities.¹⁰⁷

9. Harnessing the Tools: Utilizing DrugPatentWatch for Drug Patent Analysis

DrugPatentWatch is a specialized business intelligence platform that offers a suite of features particularly relevant to identifying weak drug patents.⁵¹

The platform provides comprehensive patent data covering over 130 countries, including both active and expired patents, offering a global perspective on patent protection.¹³⁴ Users can track patent expiration dates, which is crucial for anticipating generic entry and identifying related patents that might be challenged.¹³¹ DrugPatentWatch also offers robust litigation tracking capabilities, monitoring US District Court cases and PTAB proceedings, including Paragraph IV challenges, which can indicate patents already under scrutiny.¹¹²

The platform helps identify generic entry opportunities and anticipate future market events.¹¹² Its AI Research Assistant can quickly find answers beyond the platform’s scope with proper citations.¹¹² While not a specific patent strength analysis tool, DrugPatentWatch’s features on litigation, challenges, and prior art information contribute to assessing patent strength. Studying failed patent challenges on the platform can also aid in developing more effective invalidation strategies.

DrugPatentWatch also provides information on supplier information, identifying API and finished drug product suppliers, which can be relevant in challenges related to manufacturing processes.¹³⁴ Users can set up customizable dashboards and email alerts to stay informed about relevant drugs and patents.¹¹² The platform also allows for data export to Excel or CSV for in-depth analysis.¹¹²

10. Conclusion and Strategic Recommendations: A Synthesis of Approaches for Identifying and Invalidating Weak Drug Patents

Identifying and invalidating weak drug patents in the United States requires a comprehensive approach grounded in a thorough understanding of patent law, diligent patent searching, and strategic utilization of available resources. The process involves a multi-faceted analysis that integrates legal principles with scientific and technical knowledge.

To effectively identify vulnerabilities, it is recommended to conduct exhaustive prior art searches using a variety of patent databases and non-patent literature, employing patent classification systems to refine search strategies.³⁸ A meticulous analysis of patent claims and specifications is crucial to uncover potential weaknesses related to written description, enablement, or clarity.¹⁶ Reviewing the patent prosecution history can further reveal vulnerabilities or concessions made during the examination process.¹⁰³

Monitoring patent litigation activity, particularly Paragraph IV challenges and PTAB proceedings, provides valuable insights into patents already facing scrutiny.¹⁰² Platforms like DrugPatentWatch offer integrated data on patents, litigation, and regulatory information, facilitating a holistic view of the pharmaceutical patent landscape.¹¹²

The strategic choice between pursuing an IPR or a PGR depends on the specific characteristics of the patent and the grounds for the challenge.⁶⁵ PGR offers a broader scope for challenging newer patents, while IPR is often favored for its later filing window and focus on prior art.⁶⁴

Before initiating a patent challenge, a careful evaluation of the potential legal and financial risks and rewards is essential.¹ Engaging experienced patent litigation counsel is highly recommended to assess the strength of the case and navigate the complexities of the legal procedures.⁷⁴

Feature	Inter Partes Review (IPR)	Post-Grant Review (PGR)
Eligibility (Timing)	After 9 months from patent grant or reissue; within 1 year of infringement suit	Within 9 months of patent grant or reissue
Grounds for Challenge	Anticipation (§102) and Obviousness (§103) based on patents/printed publications	Any ground under § 282(b)(2) or (3), except best mode
Standard of Proof	Reasonable likelihood of prevailing	More likely than not invalid
Prior Art Basis	Patents and printed publications only	Patents, printed publications, public use, on-sale activity, etc.
Estoppel Effects	Broad; applies to grounds raised or reasonably could have been raised	Broad; applies to grounds raised or reasonably could have been raised
Typical Timeline	12-18 months from institution	12-18 months from institution
Who Can File	Any third party not barred by prior litigation	Any third party not barred by prior litigation

Drug/Technology Area	Patent Type	Ground for Challenge	Outcome	Jurisdiction/Case Reference (Snippet ID)
Second Medical Use	Method of Use	Lack of Novelty	EPO Examining Division refused grant (later overruled)	⁸³
Psychedelics	Compounds/Formulations/Methods	Lack of Novelty	Naturally occurring substances not patentable	²³
Hetlioz	Pharmaceutical Composition	Obviousness	Patent invalidated	⁸⁴
Paliperidone Palmitate	Dosing Regimen	Obviousness	District court judgment vacated and remanded by Federal Circuit	⁸⁵, B7
Temazepam	Dosage Amount	Obviousness	Claim found obvious	⁸⁶
Rifaximin	Polymorph	Obviousness	Claims held invalid as obvious	⁸⁷
ZYPREXA®, ALTACE®, etc.	Various	Lack of Utility (Promise Doctrine)	Patents invalidated (Canada, Promise Doctrine now abolished)	³⁵–⁹¹–⁹³, B8
Ribavirin	Method of Treatment	Lack of Enablement/Utility	Rejection affirmed by Federal Circuit	³⁴
Raloxifene	Method of Use	Lack of Utility	Patent invalidated (Canada)	³⁵
Vimovo	Pharmaceutical Composition	Lack of Written Description	Patents invalidated by Federal Circuit	²⁹, B9
Indivior UK Ltd. v. Dr. Reddy’s	Pharmaceutical Composition	Lack of Written Description	PTAB held claims anticipated by parent application publication	³⁰

Feature	Description	How it Aids in Identifying Weak Patents
Global Patent Data	Access to patents in over 130 countries, active and expired.	Provides a broad view of patent protection and helps identify prior art outside the US.
Patent Expiration Dates	Tracks when drug patents are set to expire.	Highlights opportunities for generic entry and related patents that might be challenged.
Litigation Tracking	Monitors US District Court and PTAB proceedings, including Paragraph IV challenges.	Reveals patents already under scrutiny, indicating potential weaknesses.
Generic Entry Opps	Identifies first generic entrants and anticipates future market events.	Shows patents that are not effectively blocking generic competition.
AI Research Assistant	Quickly finds answers beyond the platform’s database with citations.	Assists in gathering information relevant to patent validity, such as prior art or legal precedents.
Patent Strength Analysis	Features related to litigation, challenges, and prior art.	Contributes to assessing the robustness of a patent based on its history and the challenges it has faced.
Supplier Information	Identifies API and finished drug product suppliers.	Potentially relevant for challenges related to manufacturing processes or sourcing of materials.
Customizable Dashboards & Email Alerts	Allows users to set up watchlists for daily updates on relevant drugs and patents.	Keeps users informed of new patent filings or litigation events that might signal emerging weaknesses.
Data Export	Enables exporting data to Excel or CSV for further analysis.	Allows for in-depth analysis of patent trends, competitor activity, and identification of patterns indicative of weak patents.