By MagicMed Intellectual Property Advisor, Dr. Harm Deckers

A powerful patent portfolio can be the single most valuable asset of a business. The operative legal driver behind this is straightforward to grasp: patent rights offer the holder of the patent the right to exclude others from making, using or selling the patented subject matter for a period of time, typically 20 years. In other words, the patent holder has the ability to corner the market by virtue of a legal time-limited monopoly.

The extraordinary force of patent rights is perhaps nowhere more keenly appreciated than in the pharmaceutical and biotechnology industries. Invariably, product development timelines in these industries are long, and the requisite financial investments to bring a product from the research laboratory to hospitals and patients are substantial by any standards. The safe harbor offered by patent rights provides vital protection to these industries and the innovative, life-saving products they develop.

But what constitutes a powerful patent portfolio varies and depends on specifics and circumstances. This article outlines some patent legal principles around which researchers, business teams and patent lawyers frequently strategically orient themselves as they discuss and consider options available for securing patent rights. The here discussed aspects tend to come particularly to the fore in the context of pharmaceutical development efforts which currently are experiencing a great deal of momentum: the exploitation of the therapeutic benefits offered by natural products.

Within the realm of natural products, naturally occurring psychedelic compounds have recently begun to garner a renewed interest of pharmaceutical companies. Psilocybin, for example, is a chemical compound that can be extracted from a wide range of mushroom species and offers promising prospects in the treatment of depression, anxiety and other mental conditions. Other naturally occurring psychedelic compounds the industry has its eye on are mescaline, opium and ayahuasca, to name but a few.

From a patent protection standpoint, natural products present a unique challenge. Much to the chagrin of those developing pharmaceutical products, naturally occurring compounds, such as psilocybin, are not themselves patentable. This in contrast to newly discovered pharmaceutically active molecules synthesized by chemists in a laboratory, which can be protected by patent rights. Thus, it is possible to prevent others from manufacturing or selling novel synthetic chemical compounds by pursuing patent rights. However, the same does not hold true for naturally occurring compounds. The underlying patent legal thinking here may be summarized as: if something already belongs to the public, such as a compound found in nature, you can’t take it away.

Although the developers of natural products are dealt a weaker hand, the patent legal system does not leave them without a game to play. However, the game is more intricate and playing it requires more foresight and planning.

One patent legal strategy that can be used to protect the fruits of natural product development labor is to direct patent protection efforts towards a specific method of use of the natural compound. This approach works provided the method of use is novel, that is to say, the natural compound has not previously been used anywhere in the world in the manner described in a patent application. In actual practice, this often means that the developing company has discovered a new clinical indication which can be targeted by the natural drug.

Another approach to securing patent protection in relation to natural products is to aim for patent protection on methods of making the compound. To successfully go down this road it is required that a novel method for manufacturing the compound is discovered. This approach was used by the chemical firm Sandoz Ltd. when it first realized the potential of psilocybin. U.S. Patent 3,183,172 issued all the way back on May 11, 1965 is directed to techniques for obtaining psilocybin, and a closely related natural compound known as psilocin, by extraction from fungal materials. More generally, this line of patent legal thinking also frequently comes into view as pharmaceutical companies begin to grapple with how to manufacture their products on an industrial scale and on commercially viable terms.

Yet another strategy towards securing patent protection around a naturally occurring product is to consider the chemistry of the natural compound in great detail, and design variations on the existing chemical theme. Instead of the natural compound, the compound that is put to work is a chemical derivative related to, but chemically distinguishable from the natural compound.

MagicMed Industries Inc. is building a robust patent portfolio around a range of naturally occurring psychedelic compounds. Of the various strategic options outlined above, MagicMed favors seeking protection for novel compounds related to naturally occurring psychedelic compounds. From an innovation perspective, this allows the company to build out from the existing first generation known natural compounds, and improve upon the pharmacological profile of the natural compounds. In particular, unwanted side effects of psychedelic compounds, such as hallucination, could potentially be negated in this manner. From a patent protection perspective, this development strategy puts the company on equal footing with chemical pharmaceutical companies: MagicMed can protect the molecules itself and enjoy a 20 year monopoly on their manufacture and sale.

Furthermore, MagicMed is not pinpointing its research and development efforts on just a handful of derivative chemical compounds. Instead, the corporation is building a library of compounds contained in the company’s “PsybraryTM”. In fact, MagicMed’s PsybraryTM is designed and constructed to house 1,000,000s of unique derivatives for each of the naturally occurring psychedelic compounds it is pursuing.

From a patent protection perspective, MagicMed’s PsybraryTM can be thought of as a series of chemical territories. Each territory starts at the edges of a known pharmaceutically active natural compound and radiates outwards in multiple directions to meticulously cover as much chemical terrain surrounding the natural compounds as possible. This forward looking patenting strategy enables MagicMed to exert tight control over its drug development destiny.

And likely the company won’t go it alone. MagicMed’s PsybraryTM holds more compounds than the company can hope to develop. At the same time, pharmaceutical firms are eager to explore the new horizons offered by psychedelic compounds. With the PsybraryTM compounds securely locked into its patent portfolio, MagicMed controls who, when and where can strike within the boundaries of the valuable territories the company has staked its claims in. It is therefore not difficult to see that MagicMed is well positioned to become a partner of choice for household name pharma companies in the near future, and reap financial rewards from its compelling patent assets in the process.