Posts Tagged ‘Patent Law’

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entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for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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Abbvie V. Janssen Biotech –Written Description Requirement Road Map

Monday, July 7th, 2014

The recent decision in Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014) deserves more attention than it has received. (A copy of the decision is available at the end of this post.) The appeal was by Abbvie from a District Court decision entering a judgment of invalidity of Abbvie’s patents on fully humanized antibodies (Abs) to IL-12. Although Abbvie won an interference involving its U.S. Patent No. 6,914,128, a jury found both patents invalid inter alia as failing the written description requirement (“WDR”) of s.112, para. 1.

The “modern” WDR as created in UC v. Lilly and applied in decisions such as U. of Rochester v. Searle and Ariad v. Lilly has been a potent patent-killer, particularly when functional claims are asserted. That is just what Abbvie attempted, e.g.:

Claim 29. A neutralizing isolated human antibody…that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1×10(-2)s(-1) or less, as determined by surface plasmon resonance. See slip. op p.7.

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