Patents and Pharma Field

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PATENTs And Pharma field:

PATENTs And Pharma field Mr. Nitin M. Kadam R&D [Formulation – Tech. Transfer] Ipca Laboratories Ltd.


Contents.. What is Patent ? – Bird’s Eye view Parts of Patent Costs of Patent Role of Pharmacist in Patent Analysis Design around Patent – An Insight Strategies to design around patent Examples Epilogue

What is Patent ? – Bird’s eye view..:

What is Patent ? – Bird’s eye view.. A patent is a form of intellectual property. A patent is exclusive right granted to a person for an invention, which is a product or a process that is, New Involves an inventive steps and Has an industrial application Patent provides protection for limited period: generally 20years from date of filing. Only one patent is granted for one invention.

Parts of a Patent..:

Parts of a Patent.. Title Cross reference to other patent applications Background & technical field Summary of invention Description of contents in any drawing Detail description of the invention Series of examples Claims Abstract

Costs incurred by the participants in the patent system..:

Costs incurred by the participants in the patent system.. Costs to Patentee: R&D costs Delayed first sale or disclosure Cost of compliance with patent rules and laws (application fees) Legal fees Potential enforcement/defense costs (litigation)

Slide 6:

Costs to society: Higher prices for consumers (distorts the market economy) Societal underutilization of the technology Discourages further research in areas newly patented Opportunity costs (diversion of resources)

Pharmacist in Patent Analysis..:

Pharmacist in Patent Analysis.. Claim interpretation Patent drafting Replying office action Designing around the patent

Patent claims -The border not to be crossed:

Patent claims - The border not to be crossed Provides notice to the society Chilling effect on the competition

Opposing Objectives..:

Opposing Objectives.. Patentee seeks to develop a broad patent protection that : Maximizes the opportunity to charge the monopoly costs Minimizes the likelihood of a successful design around

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Non-patentee (competitor) seeks to create a competitive product: Not burdened with the monopoly costs of the patentee That maximizes the likelihood of finding of non-infringement (or invalidity )

Potential competitor Game Plan..:

Potential competitor Game Plan.. The intentions to design around patent of a potential competitor is: By-pass much of the R & D costs Capture major market share Eliminate costs of patent rules and laws

Claim infringement..:

Claim infringement.. The term infringement means invasion of the boundary of the patentee. Types of infringement Literal infringement Means each and every element of claim can be literally found in accused devise or process. Infringement under DOE (Doctrine of Equivalents) If there is no literal infringement, a claim can still be infringed under the doctrine of equivalents if the accused device or process performs substantially the same function, in substantially the same way, and achieve substantially the same result.

Doctrine of Equivalents..:

Doctrine of Equivalents.. A legal rule in most of the world’s patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention

Prosecution history estoppel..:

Prosecution history estoppel.. Also known as ‘ file wrapper estoppel ’ The term in United States Patent Law to indicate that a person who has filed a patent application and then makes amendments to the application to accommodate a patent law, has no cause of action for infringement to the pre-amendment patent claims that were amended.

Slide 15:

Designing around patent is often at The junction of Doctrine of Equivalents & Prosecution History Estoppel

Designing around Patent -An insight..:

Designing around Patent -An insight.. Designing around patents is, in fact, one of the ways in which the patent system works to the advantage of the public in promoting progress in the useful art, its constitutional purpose , etc. The competitor willing to design around existing patent, with his skill and art can design substantial changes into the new product to avoid infringement .

Two vital supreme court decisions..:

Two vital supreme court decisions.. Markman decisio n Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff’d , 517 U.S. 370 (1996). “The probability that alleged infringer will postpone finalizing its design around until a court defines the limit of the claims.” Festo decision Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd., 234 F. 3d 558, 578 (Fed. Cir. 2000). “If a claim element was narrowed by amendment, and the claim amendment was made for a reason related to patentability, then there can be no infringement of that claim under the doctrine of equivalents.”

Festo effects..:

Festo effects.. Provides a recipe for designing around for a competitor Provides greater challenges for patent applicants in thwarting design around efforts

Design around patent -From perspective of the patent holder:

Design around patent - From perspective of the patent holder Will draft applications keeping in mind the festo decision file with narrower claims to avoid amending during prosecution use one-sided range criteria (avoid double-ended ranges) format claims for clear demarcation between elements when forced to amend, add a new element rather than amend an existing element conduct a reasonably thorough art search before filing appeal rather than amend draft claims using a problem-oriented approach

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Avoidance of Design around - Overview: No missing element possibilities No unnecessary estoppel No alternative methods/functions get the same outcome

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Avoidance of Design around tactics: File a strong and comprehensive specification Do a thorough prior art search and draft accordingly Be careful with the amendments, arguments and the claim changes Claim differences from prior art Capture all the ground you know which is not prior art Diversify claims to cover invention territory Avoid un-necessary claim limitations

Design around patent -From perspective of the competitor..:

Design around patent - From perspective of the competitor.. Simplified design around strategy in light of festo read the prosecution history to identify amendments made for patentability reasons; copy all other limitations exactly, but substitute any known interchangeable structure, matter, or step for any limitation that has been amended. Any change, no matter how "unimportant and insubstantial," to even one amended limitation will be sufficient to avoid liability under the majority's rule.

Slide 23:

Conservative design around strategies Select a solution from the prior art (if enforceable patent, then obtain a license, acquire rights; if unenforceable document, then freely practice); OR Develop an alternative solution based on a problem-oriented approach and obtain a competent non-infringement opinion

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Alternative design around strategy (Prior to festo and possibly if Festo overturned) Focus on the broadest valid claim (identification based on the review of the prior art and the prosecution history) Substitute an element One that performs substantially same function in a substantially different way Identified by prosecution history estoppel Obtain a competent non-infringement opinion

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For Pharma world Designing around Patent Pain OR Gain ????

Ranbaxy Labs Vs Glaxo Inc.:

Ranbaxy Labs Vs Glaxo Inc. Ranbaxy was developing a generic form of Ceftin, an antibiotic manufactured by London-based Glaxo. Ceftin had annual revenue of $403 million in 2001 and its patent was going to expire in 2004. Instead of waiting, Ranbaxy begin to market its generic in United States. In 2001, Glaxo filed suit in the U.S. District Court of New Jersey but in vain. The claim of [Glaxo’s] patent called for the product to be ‘essentially free’ (<10%) from crystalline form of the material while Ranbaxy’s product had in excess of 10 % of the crystalline form. In April 2004, a district court determined that Ranbaxy’s product did not infringe on Glaxo’s patent. Glaxo did not appeal. The trial cost Ranbaxy $5 million.

Ranbaxy Labs Vs Pfizer Inc.:

Ranbaxy Labs Vs Pfizer Inc. In 1999, Ranbaxy’s R & D team began thinking about developing a generic version of Pfizer Inc.’s anti-cholesterol drug, Lipitor. After exhaustive study on existing patents on Lipitor, Ranbaxy concluded that two patents pertaining to Lipitor were defective—one didn’t actually cover the brand-name drug and another patent was invalid. Ranbaxy soon filed ANDA with FDA and started manufacturing generic version of Lipitor. In February 2003, as expected Pfizer sued.

The ideology..:

The ideology.. The alleged infringer’s design around should be so good that “It should persuade the patentee to settle”


Epilogue.. Implementing a well-thought design around strategy can yield substantial benefits for an alleged patent infringer . If design around efforts are unsuccessful, the table may be turned in the patent holder’s favour . Regardless, the patentee is well-advised to diligently discover into the accused infringer’s design around efforts at the first opportunity .


References... . INTELLECTUAL PROPERTY – a special report from Corporate Legal Times; Page 9 - 16 INTELLECTUAL PROPERTY TODAY -September, 2006; Page 16 - 18

Slide 31:

Thank you…

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