Patent Case Study – Medical Device Patents

patent law firm in India

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

Introduction

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.

We provide comprehensive Patent and Trademark legal services via our global network to create valuable patent portfolios and resolve complex patent disputes by providing patent litigation support services.

Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements.

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.

Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).

Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.

Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filingspatent services in India and global patent consulting services.

Global Blockchain Lawyers (www.GlobalBlockchainLawyers.com) is a digital platform to discuss legal issues, latest technology and legal developments, and applicable laws in the dynamic field of Digital Currency, Blockchain, Bitcoin, Cryptocurrency and raising capital through the sale of tokens or coins (ICO or Initial Coin Offerings).

Blockchain ecosystem in India is evolving at a rapid pace and a proactive legal approach is required by blockchain lawyers in India to understand the complex nature of applicable laws and regulations.

Read Our Blogs

Share with Friends

Share on facebook
Share on twitter
Share on linkedin
Share on email
US: 425-270-4712
+91 9650247494
Level18,One Horizon Center,
Golf Course Road
DLF Phase 5,Sector 43

Disclaimer
The Bar Council of India restricts any form of advertisements. This blog contains general information for the convenience of readers and does not purport to dispense legal advice and is not intended to solicit or advertise in any manner.
Gurgaon,Haryana 122002
India

No Attorney-Client Relationship
The use of our blog, and the sending or receipt of information via this platform does not create an attorney-client relationship between you and us.