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Sun Pharmaceuticals v. Eli Lilly: Doctrine of Obviousness-Type Double Patenting

A remarkable latest change in the Patentability has risen from the decision of the Federal Circuit in the case Sun Pharmaceuticals v. Eli Lilly, over the later’s patent that claimed the use of gemcitabine (GEMZAR), a drug to treat cancer. Sun Pharma moved to lower court to invalidate this patent on the grounds of obviousness-type double patenting. It stated that Lilly had already got patent rights for the drug and its antiviral usage (expiry date 15 May, 2010), and thus can not file for separate set of patent rights for the same drug as anticancer treatment. The new patent had given Lilly an extended monopoly for 2.5 yrs over gemcitabine. After BIO’s amicus brief, Lilly has requested the Federal Circuit for en banc reconsideration.

Story Behind the case:

A Lilly scientist invented a method to synthesize a genus of chemical compounds including gemcitabine and showed its antiviral activites in 1980s, for which the company got patent rights till May 15, 2010. Shortly after this, they also discovered anticancer activities of the same compound, and a second application was filed, but this one did not claim priority to the first application. All was smooth until the next decision taken by Lilly, of filing a CIP of the first application in order to add onto the definition of the disclosed genus of compounds. What must have been done in good faith, ended up in loss to Eli Lilly, as Sun put forward the disclosure of anticancer activity added to the first patent through the CIP application as the basis to invalidate the second patent on grounds of obviousness type double patenting.

The expansions of obviousness type double patenting:

A two-step process has been established by the Federal Circuit to analyze obviousness type double patenting. Step1- the court interprets the claims of original patent and those of the second patent. Step2- to determine if those differences make the claim’s patentably distinct.

Now, analysis for obviousness under section 103 becomes distinct from obviousness type double patenting in a way that in the later only the claims of the two patents are to be considered. (General Foods v. Studiengesellschaft Kohle, 1992). However, ten years later in 2002 Geneva v. GSK, Federal Circuit started using the description of the original patent to invalidate the second patent, thus marking the expansion of the doctrine of obviousness type double patenting.  The same was repeated yet again in 2007 in Pfizer v. Teva.

In the current Sun v. Lilly decision, the later went into trouble of obviousness type double patenting, due to its CIP filing for the original patent. The decision against Lilly has come opposite to the amended patent statute, 35 USC 103(c), which was brought about to encourage innovations and intra-company growth. The amendment stated that an invention by the company can not become a prior art to any of its own continued innovation made later on, thus giving protection to the company.

What should companies take note of in future:

The inventors should be clear on the repercussions of adding disclosure to a patent application, the details to be added in the disclosure, and the suitable time to invest in follow-on research. The best way would be to include only the minimum disclosure of methods to use the compounds so that it satisfies the utility requirement.

Author – Ms. Ritika Kishore,

Patent Consultant, IIPRD.

The Author of the Blog can be reached: iiprd@iiprd.com.

Indian Pharmaceutical Industry Licensing Deals: Case Studies

  • Glenmark Pharmaceuticals

Glenmark, research-driven, global, integrated pharmaceutical company with Research Focus on Inflammatory Diseases, Metabolic Disorders and Pain has a presence in over 80 countries around the world.

The Company has a proven track record of entering into Licensing deals with Big Pharma and entered into Outlicensing deals in 2004 with Forest laboratories for Oglemilast, a drug that was potentially indicated for chronic obstructive pulmonary disorder (COPD) and asthma and was still in the Development Phase at the time of entering into the deal. The potential value of the deal was $ 190 million in US. Glenmark later entered into an agreement with Teijin Pharma Ltd in Japan for the same molecule where the deal value was $53 million. Till date, Glenmark has received $35 million from Forest and $6 million from Teijin.

In a case of In-licensing, Glenmark announced in 2005 a collaborative agreement with Napo Pharmaceuticals for Napo’s proprietary molecule Crofelemer, indicated for four distinct disease categories. Glenmark has Crofelemer rights for diarrhea Indications in 140 Countries. Currently the drug is into the Phase 3 trial and the product launch is expected to happen sometime in mid-2010.

Glenmark entered into an outlicensing agreement with Merck in 2006 for Melogliptin, an anti diabetes target. Glenmark received $ 31 million as upfront payment for the same. But, in an unfortunate development Merck decided to drop off the agreement due to a shift from the focus on anti diabetes segment (2008). Currently, Glenmark is developing the drug on its own and have completed the Phase IIb trials.

In 2007, Glenmark’s in-house developed molecule for a potential treatment of pain was outlicensed to Eli Lilly for an upfront payment of $ 45 million. Only a year after the deal, work on the clinical trial of the molecule was stalled. Both Glenmark & Eli Lilly are currently working on the way forward on the molecule.

Despite suffering setbacks from 2 out of 3 key licensing deals, spirits at Glenmark are high, courtesy the success it is enjoying in the Generics segment. Only last week, Glenmark Generics ltd, was able to ink 3 key agreements that has not only strengthened its position in the global generics market but also established Glenmark as an aggressive player that knows how to make maximum from an opportunity.

Following two patent law suits filed by Glenmark, Medicis Pharmaceutical came to an agreement with Glenmark to let the latter launch the former’s dermatological product Vanos in 2013, long before the patent is set to expire in 2023. In a separate arrangement, Glenmark and Medicis have agreed to jointly develop a product from the former’s pipeline to treat acne. Glenmark is to receive an upfront of $5 million from Medicis. Apart from this, Glenmark had entered into a licensing deal with Sanofi-Aventis for the development and commercialization of novel molecules to treat chronic pain. It has also announced a licensing deal with Par Pharmaceutical to market Ezetimibe tablets.

Very clearly, Glenmark’s business model involve a lot of in-licensing and out-licensing arrangements and the Company wish to ride upon the success of such deals to project itself as an innovation driven global pharmaceutical player. Add to it the rapidly rising of clout of Glenmark in Generics space and its deal-signing spree with pharma majors and it is not difficult to understand on why Glenmark is set to make its mark in the Global Pharmaceutical domain.

  • Dr Reddy’s Laboratories

Dr Reddy’s has been a frontrunner in many aspects of the Indian Pharmaceutical Industry Growth Story that has been witnessed by the globe. Licensing is one of such aspect. In fact, even during the times when India had just opened its gate to a global economy, Dr Reddy’s had inked its first Outlicensing deal.

In 1997, an in-house developed anti-diabetic molecule, DRF 2593 (Balaglitazone), was licensed to Novo Nordisk. In fact, with this deal Reddy’s became the first Indian pharmaceutical company to out-license an original molecule. But, late in 2004, after phase II studies, Novo Nordisk decided to terminate further clinical development of balaglitazone, as the phase II results did not suggest a sufficient competitive advantage for balaglitazone compared to existing products. Post this development, Dr Reddy’s entered into an agreement with Rheoscience for Balaglitazone (DRF 2593). As on January 2010, Blaglitazone (DRF 2593) Phase III clinical trials were announced.

A year later, Dr Reddy’s licensed another anti-diabetic molecule, DRF 2725 (Ragaglitazar), to Novo Nordisk. In 2003, Novo Nordisk, which had suspended trials on Ragaglitazar in 1999 on finding tumors in long-term animal studies, decided to terminate further trials on the molecule completely.

In 2001, Dr Reddy’s Out-licensed DRF 4158, a potential dual-acting insulin sensitizer, to Novartis for an upfront payment of US $55 million. Later in 2003, Novartis decided to discontinue working on DRF 4158, but continued collaborating with Reddy’s for additional development compound that is a dual-acting insulin sensitizer.

Despite a low success rate from its licensing deals, Dr Reddy’s went ahead with one of its molecule and despite criticism from its original licensing partner, Reddy’s now have successfully completed Phase III trials of the same molecule. This clearly depicts the conviction and faith in one’s abilities that Dr Reddy’s has demonstrated for its first in-house developed drug molecule. This in itself stands as a testimony to Dr Reddy’s capabilities to mark new beginnings for Indian Pharma Sector.

About the Author: Mr. Abhishek Sahay is a Senior Patent Consultant at Institute of Intellectual Property Research & Development (IIPRD). Currently, He is working on Patent Licensing Issues in the Life Sciences domain and some of his success stories can be found at http://iiprd.com. He can be reached at abhishek@iiprd.com.

Eli Lilly Vs Sun Pharma and others

Lilly’s Patent relates to method of treating Attention-Deficit/ Hyperactivity disorder (ADHD) with administration of effective amount of Tomoxetine. Lilly markets atomoxetine capsule under the brand name STRATTERA®. The US Patent 5,658,590 was assigned to Lilly On August 19, 1997 with a principal claim that recites a particular method of treating ADHD. Submission of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of atomoxetine by Sun Pharma and others before the expiry of the said patent led to Lilly’s action against the infringement of their patent.

Although the claims do not include any indication about the dose and the complete composition of the medicine, it specifically discloses the treatment of ADHD by physicians. The independent claim states that  “A method of treating Attention-Deficit/ Hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of Tomoxetine”.

Plaintiff argues that each of the Defendants’ act of filing an ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A) .Plaintiff further argues that the commercialization of generic atomoxetine before the expiration of the ‘590 Patent would constitute further infringement under 35 U.S.C. §§ 271(a), (b), and/or (c).

Defendants assert that Lilly’s patent is for the treatment of patients by physicians and none of the Defendants are doctors, they never treat patients, and they do not prescribe medicines. Rather, they sell drugs to wholesalers or pharmacists, who in turn sell the drugs to patients possessing prescriptions from physicians. Defendants contend that Lilly cannot establish infringement under 35 U.S.C. § 271(e)(2) for the same reasons that Defendants argue infringement does not exist under 35 U.S.C. § 271(a) .

In a similar case Warner-Lambert Co. v. Apotex Corp the Federal Circuit concluded that there was no direct infringement because “there is no evidence in the record that Apotex has directly practiced or will ever practice any of the methods claimed. In reaching this conclusion, based on facts that are identical to the facts at issue in this case, the Federal Circuit explained that the activities of pharmaceutical manufacturers are fundamentally different than prescribing physicians and, therefore, pharmaceutical companies cannot directly infringe such method of treatment claims and defendants’ motion for partial summary judgment as to no direct infringement was granted. Lily lost the battle based on the evidence ground and for the same reasons, also lost the reconsideration request for the decision.

In the present case, the patent specifically teaches about treatment of patients by Physicians, which implies that a particular dose will be prescribed to the patient depending on the age of the patient and severity of the case. Hence, the method involves prescription of atomoxetine in a particular dosage to a patient as per the case. Although, the drug manufacturers neither prescribe nor administer the drug to the patients in any form, but availability of atomoxetine in the market by different manufacturers in different dosages will directly read upon the claimed method as the dosage prescription by the physician is a part and sole of the method involved in the patent. This will further have an impact on the method of treatment.

The above analysis leads to many questions like: Who will be responsible for influencing the treatment method of ADHD, physicians or the drug suppliers? As the drug manufacturers have managed to out themselves by saying they don’t treat patients and only manufacture drugs! It won’t be shocking if the manufacturers come out with a statement that they never forced patients to buy their drug as they just manufacture drugs and don’t treat patients.

Civil Action No. 07-cv-3770 (DMC).

Author:  Mr. Devpriya Kumar, Patent Consultant

The author can be reached devpriya@iiprd.com