Ignorance is NOT Bliss: Employee unawareness of copyright law is no shield against damages

In an industry that relies so heavily on the medical literature to develop new drugs, design clinical trials, support regulatory filings, keep abreast of safety issues, and monitor competitor activities, it’s easy to fall into bad habits when it comes to sharing important publications. But when it comes to infringing on copyright (which is incredibly easy to do) the costs can be staggering.

What is copyright infringement?

Copyright infringement occurs when one:

• Copies
• Distributes
• Displays
• Performs
• Produces a derivative

of a protected work without the permission of the copyright owner. Let’s think about what this means in day-to-day life in pharma:

• Copying: A manager makes 10 photocopies of an article from the New England Journal of Medicine to be shared at a staff meeting.
• Distributing: A medical director, who is a member of the American Academy of Ophthalmology, downloads a “free” (for members) PDF from Ophthalmology and forwards it to his team.
• Displaying: The Medical Communications team pulls a graphic from a journal article for use on a poster at a medical congress.
• Producing a derivative: Clinical Development has identified a scale for use in a multi-national clinical trial. They translate the scale into two additional languages and implement the scale in the trial.

Any of these activities, without the permission of the copyright owner, could constitute copyright infringement. And ignorance of the law is not a shield from liability.

Ignorance ≠ Bliss

Should a publisher bring a suit against your company, the court would consider the “level of intent” of the infringer when determining damages. If the infringer were determined to have been unaware of copyright law (i.e. “negligent” or “innocent” infringement), the damages would likely be less than for willful infringement (i.e. infringer acts with knowing disregard for the copyright owner’s rights) but they could still be substantial. Negligent infringement can bring damages of anywhere from $750-30,000 per infringement (think, a single unauthorized photocopy). Willful infringement can lead to damages of up to $150,000 per infringement!

Copyright cases in the News?

You may ask, why don’t I ever hear about these cases? In fact, most infringement suits are settled out of court. Much less embarrassing and costly, especially when it is so much easier for publishers to track unauthorized use of digital publications. But don’t kid yourself, 5 and 6 figure settlements are happening monthly according to a colleague at a major document delivery provider.

So what can I do to protect myself and my company?

Here are some concrete steps that will go a long way to helping keep your company in copyright compliance:

1. ?Develop a comprehensive copyright policy for your organization. If you’re starting from scratch, Copyrightlaws.com offers some excellent tips for creating a corporate copyright policy.
2. Purchase a (very affordable) Annual Copyright License from the Copyright Clearance Center. This license allows internal sharing for most journal articles and sharing with regulatory or legal authorities without the need to purchase additional copies.
3. Educate your employees about copyright compliance in the corporate environment. Make sure your employees are familiar with basic copyright compliance practices for those working in a for-profit company. Help them to understand how easy (and common) it is to infringe on copyright, how costly and embarrassing this can be for the company, and how to avoid infringement.
4. Designate a copyright compliance officer or subject matter expert to field questions on more complex copyright issues. Establish a go-to contact for help obtaining permission to use figures in presentations or to modify copyrighted content, to determine if content is in the public domain, etc.

Safeguarding your company against copyright infringement is not just about avoiding legal repercussions; it's about fostering a culture of respect for intellectual property. By developing a robust copyright policy, securing necessary licenses, educating your team, and designating a compliance expert, you can significantly mitigate risks and uphold ethical standards. Remember, ignorance of the law is no excuse, and the costs of infringement can be substantial. By committing to responsible practices you can ensure that your reliance on medical literature is both legal and ethical.