the firm's post-grant practitioners are some of the most experienced in the country.


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Artificial Intelligence (AI)
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Fast Facts

About Our

Law Firm

About Our Law Firm

Headquartered within steps of the USPTO with an affiliate office in Tokyo, Oblon is one of the largest law firms in the United States focused exclusively on intellectual property law.

Get to know our


Get to know our History

Norman Oblon with Stanley Fisher and Marvin Spivak launched what was to become Oblon, McClelland, Maier & Neustadt, LLP, one of the nation's leading full-service intellectual property law firms.

Our Local and

Global Reach

Our Local and Global Reach

Outside the US, we service companies based in Japan, France, Germany, Italy, Saudi Arabia, and farther corners of the world. Our culturally aware attorneys speak many languages, including Japanese, French, German, Mandarin, Korean, Russian, Arabic, Farsi, Chinese.

A few of our


A few of our ACCOLADES

Oblon's professionals provide industry-leading IP legal services to many of the world's most admired innovators and brands.




From the minute you walk through our doors, you'll become a valuable part of a team that fosters a culture of innovation, client service and collegiality.

A few ways to

GET In Touch

A few ways to GET In Touch
US Office

Telephone: 703-413-3000
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Tokyo Office

Telephone: +81-3-6212-0550
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Patent Forms

Downloadable Patent Forms

The United States Patent and Trademark Office (USPTO) issued final rules implementing the inventor's oath or declaration provisions of the America Invents Act (AIA) on August 14, 2012.

Patent Eligible Method of Treatment/Prevention Claim

  • March 23, 2020
  • Article

Associated People

Associated Technologies

特許適格性を満たす治療/予防方法クレーム の例

治療方法クレームの101条特許適格性を認めた判例としてVanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018)があります。この判例に沿ってCAFCは、本件Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. et al., No. 19-1172において、治療方法クレームの特許適格性無しとの地裁判決(grant of judgment on the pleadings)を覆し、差し戻しました(nonprecedential, 3/16/2020)。


1. A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

10. The method according to claim 1 wherein the metabolic disorder is type 2 diabetes mellitus and wherein the contraindication is renal disease, renal impairment or renal dysfunction, and wherein said DPP-4 inhibitor is used for said patient in the same dose as for a patient with normal renal function.

クレーム10はII型糖尿病の治療及び/又は予防方法のクレームで、腎疾患などが原因でメトホルミン治療が不適切な患者に対して、腎機能が正常な患者と同じ投与量でDPP-IV阻害剤を経口投与する方法を記載しています。クレーム10が地裁で101条により無効とされたのはVanda 事件のCAFC判決前でした。

本件でクレーム10が特許適格であると判断する際、CAFCはVanda事件のクレームが ”a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome” (特定の患者に対し特定の化合物を特定量投与して特定の結果を得る特定の治療方法)のクレームであり、特許適格であることに言及しました。また、化合物が”natural ability“ (ここではDPP-IV阻害剤が腎臓ではなく肝臓で代謝されること)を持つからといって、クレームが”natural ability” そのものをクレームしていること(directed to)にはならないと述べました。これは2016年のRapid Litigation Management事件を引用した分析です。Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1049 (Fed. Cir. 2016) (stating that the “natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability”).


なお、本件では関連特許9,173,859及び8,673,927のクレームが自明性及び自明性ダブルパテントにより無効との判断が下されました。これらの特許はメトホルミンとDPP-IV阻害剤 (linagliptin)との併用に関するもので、争点となったのはタブレットのクレームと治療方法のクレームでした。linagliptinの経口投与量を2.5 mg or 5 mgに限定してはいるものの、ルーチン的な実験により当業者が見出せる投与量であるとして、従来文献(1-100 mgを開示)から自明かつ特許権者の別特許に基づく自明性ダブルパテントであると判断されました。特に本件では、専門家の複数の証言の中で、FDAのガイドラインに沿って低投与量から徐々に上げるdose-ranging studiesを行うことが指摘され、発明者の下記の証言でも、FDAは効果がある範囲で低投与量を見出すことを求めるという内容が認められたことが影響したと考えられます。


“[r]egulators expect you to define the lowest maximum therapeutic dose,” which may have the benefits of: (1) being a smaller, easier to swallow tablet; (2) being easier to formulate in combination pills; (3) having a lower risk of drug to drug interactions; and (4) reducing the risk of side effects.