The biotech and pharmaceutical industries both work at the cutting edge of science to deliver medical innovations to patients around the world. While the intellectual property portfolios of each industry vary widely, the path to obtaining strong IP protection is similar. To recoup R&D investment, both industries need to file their parents broadly and on a global scale, and that path includes extensive patent translations.
What’s the difference?
Biotech & pharma are often used interchangeably but it’s important to understand the distinction. So before we cover the similarities between translation requirements for IP in the biotech and pharma industries, let’s take a brief step back to understand what types of products each industry covers:
- The pharma industry regularly seeks patents for new chemicals, pharmaceuticals, drugs, reformulations of existing medicines, as well as innovative manufacturing methods.
- The biotech industry is more wide-ranging with patents covering biological materials such as proteins, DNA, RNA, cell lines, hormones, engineered tissues, and artificial body parts. Biotech process patents can also include methods for working with DNA, proteins or cloning.
The question of patentability
It’s important to note that the nature of biotech innovations, especially those involving animals, plants and DNA, often makes them more challenging to protect because of the ongoing question of their patentability. In addition to the three global patent standards that an invention must be novel, non-obvious and useful, inventions must also cover a subject matter that is eligible for patent protection.
Many countries around the world are debating whether or not biotech innovations can be claimed by individual human beings or companies, which makes the international landscape for biotech patents extraordinarily complex as each nation works out its own set of rules and regulations.
Similarities in product development
Regardless of where you’re planning to file a pharma or biotech patent application, you will be required to provide extensive supporting documents about each phase of product development in that country’s local language. This continues after the patent has been issued and commercialization begins. A translation flaw anywhere along the way can slow down or even derail the entire process. For example:
- Preclinical studies — This phase often requires translations of internationally sourced case reports and data sheets before clinical trials can begin.
- International clinical trials — This phase requires expertly localized informed consent documents, personal information forms, case report forms, physician protocols and notes, and patient-reported outcome forms. Additionally, live interpretation services may be needed during this phase to help international teams communicate.
- Regulatory approval — Accurate and comprehensive translations must be submitted to national or regional patent offices, as well as other regulatory agencies, in regions where distribution of the product is anticipated. This includes dossiers, labeling, adverse event notifications, and other types of supporting documentation.
- Manufacturing — Documentation for Standard Operating Procedures (SOP), as well as health and safety materials, must be localized for each country or region in which the product will be manufactured.
- Marketing and sales — Customer-facing materials must be translated for each different market, expertly leveraging a deep knowledge of the local language and culture. This phase includes translating product websites, brochures, displays, advertisements, and other promotional materials.
Why a centralized translation source matters
It can take over a decade for a pharma or biotech innovation to go through all the phases of product development before it actually hits the shelves in your local pharmacy. Having a single language service provider (LSP) responsible for coordinating and delivering all of the various translations required throughout the product lifecycle guarantees a level of consistency and accuracy that simply can’t be replicated by the work of multiple independent agencies strung together along the way.
In addition to improving translation quality, using a singular LSP can save you time. Think about it this way: Instead of introducing and explaining yourself, your company and your invention to numerous agents repeatedly over what could be a 10+ year process, an LSP can set you up with a dedicated project manager who acts as your single point of communication for years to come. If you have questions, need clarifications, or require late-stage changes, the dedicated project manager is trained and positioned to shepherd your project to a successful conclusion.
Start early and start right
Now that it’s clear why an LSP is beneficial for biotech and pharma companies, let’s discuss how to choose one. First, the best time to start looking for an LSP is before entering the preclinical studies phase. This allows you and the LSP time to create and implement a clear project lifecycle calendar. Of course, an LSP can start working at any phase of product development, but it will be less stressful for you knowing it’s all taken care of from the start.
When selecting an LSP, you can check the credibility of an organization by asking about its ISO certifications. These are internationally recognized standards of excellence written by the independent, non-governmental International Organization for Standardization (ISO). There are literally thousands of ISO certifications to choose from, which (understandably) can seem a bit overwhelming. Here are three of the most useful ISO standards to look for in the language services industry:
- ISO 9001 — This certification means that a company meets international standards for maintaining a quality management system.
- ISO 13485 — This certification is based on ISO 9001 but adapted specifically for the medical device industry, with an emphasis on risk management and strict quality control.
- ISO 27001 — This certification means that a company meets international standards for information security management. Its primary goal is to help prevent data theft, loss and corruption.
Once you’ve found an LSP you trust, be sure to notify every relevant department in your company as to your choice. This will ensure that you consistently benefit from the quality control and cost-saving tools available to you. For example, biotech and pharma documents contain a great deal of repetitive text. Certain professional translation tools exist to cut out redundant work and increase consistency across projects. These tools are especially handy for families of related products:
- Translation memory (TM) — This tool creates a database of previously translated text segments from which human translators can retrieve and re-use words, sentences, and paragraphs.
- Terminology management and glossaries — Every company has its own terminology, branding, and way of expressing itself. To ensure the consistent use of language across all projects and documents, an LSP can construct confidential, client-specific glossaries of your organization’s terminology which translators can utilize while working on your projects.
Additionally, check to see if the LSP offers an online client portal where you can manage all of your company’s projects, submit new ones and leverage historical data like glossaries, style guides and TMs.
Why make things harder?
The documents required for biotech and pharma patents, regulatory approvals, and marketing are complicated and must be impeccably executed. Quality is king in these industries and either one cannot abide costly, potentially even dangerous, errors in translations. Years of research, millions of dollars and lives are literally at stake – which is why the alternative to using a centralized translation service can quickly border on the nightmarish: identifying, hiring, managing and also verifying qualified service providers in each and every single region or country in which a product is to be sold or where its ownership must be protected. The redundancies are stupefying. Instead, with a centralized translation service, a single good hire of the service itself ensures consistency, quality and timely delivery for years to come.