Replies to post #208068 on Biotech Values

[DewDiligence]

How could they keep a marketed, patented drug from being used in another indication?

Drug/biotech companies almost never sue doctors for off-label use of a competing marketed product that technically infringes on a "use" patent. Hence, the only realistic chance to thwart such use is pushback from third-party payers.

ODE doesn't help with this problem insofar as it merely bars FDA approval of a generic version of the orphan drug.

[north40000]

If the molecule itself is new, useful and nonobvious, it may be patented and claimed as a compound, otherwise aka composition of matter. That entitles the patent owner, ordinarily, to enforce its patent against those who make, use, offers to sell or imports that claimed subject matter, and seek to enjoin those parties as infringers of that patent grant. 35 USC 151-154 and particularly 35 USC 271(a).

Dew is thinking of a patent that claims a method of use, or process. A different method or process of use sometimes gets a little trickier but, in general, see also 35 USC 100(b): "the term 'process' means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

There likely are cases going in all directions if the patentee has limited its claims to a particular process or method of use, particularly if the prior art forced such a limited patent grant.

[mcbio]

ACRS/(INCY) - ACRS patents re baricitnib

[I'm assuming for ACRS this still doesn't offset the concerns of baricitnib both being further ahead and already approved for other indications.]

I suck at patents so if this is laughable let me know. But wouldn't they need something like orphan drug protection? How could they keep a marketed, patented drug from being used in another indication?

Aclaris Therapeutics Announces Notice of Allowance for Two U.S. Patent Applications Covering Baricitnib and Decernotinib, Respectively, for Hair Loss Disorders
Forthcoming Issuance of Two U.S. Patent Applications Will Fortify and Broaden Aclaris’ Intellectual Property Portfolio Surrounding JAK Inhibitors for Hair Loss

MALVERN, Pa., April 04, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led, biotechnology company focused on defining new standards of care in medical and aesthetic dermatology, today announced that Columbia University has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for two patent applications covering methods related to the use and administration of baricitinib (LY3009104) and decernotinib (VX-509), respectively, for the treatment of hair loss disorders and for inducing hair growth. These newly allowed patent applications are owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris Therapeutics, Inc. These patent applications are the latest U.S. applications to be allowed in connection with Aclaris' janus kinase inhibitor (JAK) drug development program for hair loss disorders. A separate Columbia patent covering the use of ruxolitinib for the treatment of hair loss disorders and for inducing hair growth was issued in the U.S. in December 2015.

“We are extremely pleased with this expansion of the patent portfolio we exclusively licensed from Columbia. These allowances expand the breadth of and further validate our JAK inhibitor intellectual property portfolio covering methods of use for certain JAK inhibitors for the treatment of hair loss disorders. The allowance of these patent applications is another step towards the development of a robust portfolio relating to JAK inhibition and hair loss,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

The claims of these newly allowed patent applications cover methods of inducing hair growth and treating various hair loss disorders, including alopecia areata and androgenetic alopecia, by administering baricitinib or decernotinib, respectively. Additional allowed claims pertain to methods of using baricitinib or decernotinib to treat other hair loss disorders, as well as to treat particular phenotypes of alopecia areata.

Aclaris has exclusively licensed several patents and patent applications involving novel selective JAK 1/3 inhibitors, including a patent portfolio from Rigel Pharmaceuticals, Inc. that covers ATI-50001 as well as ATI-50002, a topical formulation also being developed as a potential treatment for alopecia areata. In addition, Aclaris has exclusively licensed a patent portfolio from JAKPharm and Key Organics directed to novel covalently binding, highly selective JAK 3 inhibitors. Finally, Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, androgenetic alopecia, and other dermatological conditions. This portfolio includes the recently allowed U.S. applications discussed above, a recently issued U.S. patent directed to methods of treating alopecia areata, androgenetic alopecia and other hair loss disorders by administering ruxolitinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating alopecia areata, androgenetic alopecia and other hair loss disorders.