Patent Case Study – Medical Device Patents

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Patent applications for innovative products are registered by the patent office after patent prosecution process including examination. 


Patent applications for innovative products are registered by the patent office after patent prosecution process including examination. The patent examiner issues an office action or the First Examination Report (FER) with a list of objections generally relating to novelty, inventive step or non-obviousness and other objections covering clarity of claims, lack of proper description of invention, and the like. 

Medical Device Patents

Diabetic patients require multiple injections every day which can make children and individuals with a fear of needles, anxious. Seeing this, a Tokyo based medical equipment manufacturer Terumo Corporation (Terumo) works to increase the quality of life, alleviate discomfort and dispel fears surrounding diabetes injection therapy. 

In 2005, Terumo hoped to develop a needle so fine that it makes injections painless. Mr. Tetsuya Oyauchi, an engineer in the company and Mr. Masayuki Okano, head of Okano Industrial Corporation (Okano), combined to make this idea a reality.

Medical Device Innovation

Terumo came together with Okano, a company that is renowned for its skilled craftsmanship and is credited with developing the small lithium batteries that made cellular telephones possible. Working together with Mr. Okano, the company’s founder, Terumo was able to devise the world’s thinnest needle for insulin injections.

Research and Development

Traditional production lines could be used to make a smaller needle but the resulting manufacturing costs would be expensive raising the price exponentially for average patients. Considering this, five years of research and development (R&D) led to the discovery of a new method that defied conventional methods of needle manufacturing. Mr. Okano’s method took a super-thin sheet of stainless steel and rolled it into a tiny tapered cylinder, which is sealed by tightly welding the seam to prevent leaks.

Subsequently, Mr. Oyauchi used his expertise to refine this cylinder into a double tapered needle, with a special coating for lubrication that would lower the insertion force. The resulting syringe is 0.2 millimeters in diameter, decreasing the discomfort to a mere mosquito bite. The syringe costs about 18 Yen per needle, with insurance. It is five percent more expensive than traditional needles, but well within reach for patients.

Filing of Patents and Trademarks

Terumo is a multinational corporation inventing medical technologies, and securing its IP rights (IPRs) is important, to deter plagiarism and establishing a competitive advantage. In line with this policy, Terumo filed an application via the Patent Cooperation Treaty (PCT) in 2003 (published: 2004) for its tapered injection needle. The company emphasized protecting its company and product names by registering a trademark for its company name and logo with the United States Patent and Trademark Office (USPTO).

Patent Commercialization

The new syringe went on to the market in July 2005, in Japan, Australia, Brazil, China, Germany and, the United States. It persisted in all those countries where Terumo had subsidiary companies. The Nanopass 33 syringe is sold through different holdings, such as the diabetes division of Terumo Europe N.V. and Terumo itself for Japan.

Business Strategy

The forty percent increase in the previous year shows Nanopass 33 is a success, with sales of over one billion Yen (over US$ 11 million) in 2008. As a result, Terumo extended its manufacture line and doubled its monthly manufacture of the needles to seven million. Nanopass 33 accomplished the Grand Prize for Good Design in the Japan Industrial Design Promotion Organization, in 2005.

Terumo’s innovative product is a financial success and has helped patients around the world lead better lives. Protecting its IP gives the company the freedom to continue developing new products and novel manufacturing processes. Capitalizing on the success of Nanopass 33, Terumo has educated people on diabetes and dismissed myths surrounding the disease, making a positive social impact.

Patent Strategy

Medical device companies develop strong patent strategy by investing on the appropriate patent searches. The patent search process begins at the stage of determining patent eligibility of an invention by searching for relevant prior art, including patent and non-patent literature. Subsequent patent searches include patent invalidation or patent validation searches, which are used to challenge the validity of patent granted to the competitors. Specifically, while conducting novelty searches, patent searchers conduct a comprehensive patent search followed by a patentability analysis of relevant search results by comparing invention features with the prior art references.

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Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.

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