Posts Tagged ‘ip’

101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

Thursday, September 4th, 2014

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.

“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.

“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”

Scanned from a Xerox multifunction device

Scanned from a Xerox multifunction device[1]

Scanned from a Xerox multifunction device[2]

Scanned from a Xerox multifunction device[3]

 

FDA’s New Biosimilars Guidance

Monday, August 11th, 2014

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.

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August 09, 2014

FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded

By James E. Valentine* & James C. Shehan

On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.”  But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).

Fed. Cir.: Antitrust Issues Can Arise From Hatch-Waxman Litigation

Thursday, August 7th, 2014

In Tyco Healthcare Group v. Mutual Pharm. Co., App. no. 13-1386 (Fed. Cir. August 6, 2014), a divided panel of the court reversed a district court’s summary judgment ruling dismissing antitrust charges brought by ANDA filer Mutual against patent-holder Tyco. (A copy of the decision can be found at the end of this post.) In what appears to be routine Hatch-Waxman litigation, the majority of the panel ruled that the NDA holder’s (the patent-holder’s) initiation of an infringement action following the ANDA filer’s para. IV certification could give rise to antitrust violations as “sham litigation.” The majority further held that the Citizen’s Petition–urged to contain baseless allegations of non-equivalence, filed by the NDA holder, following a finding of non-infringement by the proposed generic product, could also give rise to antitrust liability.

Judge Newman wrote a well-reasoned dissent that basically said that the patent/NDA holder has a statutory right to file an infringement suit after it receives notice of an ANDA filed with a para. IV certification. Judge Newman also wrote that the patent/NDA holder has a constitutional right (to petition), that should trump any speculative antitrust-based claims for damages.

It would take pages to walk through all the factual bases for the parties’ arguments, but if you just read Judge Newman’s dissent, you will get a good refresher course on the historically (limited) role of antitrust law in patent litigation. Maybe I’m getting too sensitive, but this seems like one more decision that is essentially anti-patent. At least the majority followed Therasense and did not find that plaintiff potentially liable for antitrust violations because it asserted a patent that the defendant urged was obtained by fraud committed by the patent owner, Sandoz.

13-1386.Opinion.7-31-2014.1

Ignorance is Bliss – for Teva

Monday, August 4th, 2014

I did not pay much attention to the fairly recent panel decision in Bristol-Myers Squibb Co. v. Teva Pharma. USA, 757 F.3d 967 (Fed. Cir. 2014). It seemed like a fairly routine panel affirmance of the district court’s finding that Bristol-Myers’ patent (5206244) on the nucleoside analog entecavir was obvious in view of a structurally similar nucleoside analog, 2′-CDG. The unexpected results asserted by B-M had been found insufficient to overcome a strong case of structural obviousness.

But when the IPO made the decision to file an amicus brief supporting B-M’s petition for rehearing en banc, my prep/pros radar sounded a warning and I read both the brief closely and the original opinion more closely. [A copy of the opinion and brief can be found at the end of this post.]

The district court found that the POSA would have been motivated to select 2′-CDG as the closest prior art molecule and to make the relatively small structural modifications required to arrive at entecavir, summarizing the law (correctly): “Obviousness, and expectation of success, are evaluated from the perspective of a person having ordinary skill in the art at the time of invention [e.g., the filing date of the B-M patent].”

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